[ Tocolysis with hexoprenalin and salbutamol in a clinical comparison ] . 140 patients with a threatening premature birth at the greater than or equal to 24-less than 37 week of gestation were in this study randomly treated with hexoprenalin or salbutamol . In 77 % in the hexoprenalin and in 74 % in the salbutamol group the weight of the newborn was greater than or equal to 2500 g. In 66 % in both study groups the birth occurred after the completed 37 weeks of gestation . During infusion of hexoprenalin tachycardia in mothers occurred statistically highly significantly less than during salbutamol . 11 % of the mothers in the hexoprenalin group had side-effects during infusion compared to 30 % in the salbutamol group . The correlation between the tocolysis-index ( Baumgarten ) and the prolongation-index ( Richter ) given by the regression lines facilitates in some measure the comparison of different tocolytic drugs concerning its tocolytic effect .

hexoprenalin

salbutamol

hexoprenalin

salbutamol

hexoprenalin

salbutamol

hexoprenalin

salbutamol

hexoprenalin

salbutamol

weight of the newborn

weeks of gestation .

tachycardia

side-effects during infusion

tocolysis-index ( Baumgarten )

prolongation-index ( Richter )


Evaluation of AMSA in children with acute leukemia . A Pediatric Oncology Group study . One hundred four children with advanced leukemia in relapse ( 74 with acute lymphocytic leukemia [ ALL ] and 30 with acute nonlymphocytic leukemia [ ANLL ] ) received AMSA ( 4'- ( 9-Acridinylamino ) methanesulfon -m-anisidide ) at a dose of 120 mg/m2/day for 5 days ( Regimen I ) or 60 mg/m2/day for 10 days ( Regimen II ) . Children with ALL were randomized between Regimens I and II ( 31 and 36 evaluable patients , respectively ) . All 29 evaluable patients with ANLL were treated on Regimen I. Eighty-eight percent of evaluable patients experienced severe or life-threatening toxicity , with no statistical differences between Regimens I and II . Bacterial or fungal infections ( considered life-threatening or fatal ) occurred in 17 children with ALL and in 7 with ANLL . Fatal cardiac toxicity occurred in one patient . Complete or partial response occurred in 25.0 % ( SE = 8.8 % ) , 28.1 % ( SE = 8.0 % ) , and 25.9 % ( SE = 8.4 % ) of evaluable patients on ALL Regimen I , ALL Regimen II , and ANLL , respectively . However , responses were of short duration ( 16-91 days ) . There was no significant difference in the duration of survival from treatment start for the two ALL regimens ( P = 0.46 ) . The median duration of survival for ANLL patients was significantly longer ( P = 0.004 ) than that of ALL patients treated on Regimens I and II combined . Eighty-two percent of the complete or partial responses ( 18 of 22 ) occurred after the first course of AMSA . At the dose schedules investigated , and in a heavily pretreated patient population , AMSA had activity in childhood leukemia . However , the high incidence of severe , life-threatening , or fatal infections meant that the quality and quantity of responses and survival was not commensurate with the toxicity , and that it would be difficult to incorporate this drug into combination chemotherapy with other myelosuppressive agents .

AMSA

AMSA .

severe or life-threatening toxicity

Bacterial or fungal infections

Fatal cardiac toxicity

Complete or partial response

responses

duration of survival

median duration of survival

activity in childhood leukemia

toxicity

children

acute leukemia

One hundred four

children

advanced leukemia

acute lymphocytic leukemia [ ALL ]

Children

ALL

ANLL

Fatal cardiac toxicity


Double contrast arthrography of the knee . Comparison between three contrast media . Meglumine iothalamate ( Conray Meglumin ) , sodium-calcium-meglumine metrizoate ( Isopaque Cerebral ) and dimeglumine iocarmate ( Dimerex ) , each containing about 280 mg I/ml , were compared in two series of double contrast knee arthrography , 190 and 184 patients each . With Dimerex the mixing of the contrast medium with the synovial fluid was slower than with Conray Meglumin , and a good or fair image quality , as evaluated subjectively , lasted longer . No difference was observed between Isopaque Cerebral and Conray Meglumin , regardless of dosage .

contrast arthrography

dimeglumine iocarmate ( Dimerex )

Conray Meglumin

Isopaque Cerebral

Conray Meglumin

synovial fluid

image quality

arthrography

arthrography


A controlled trial of 'Senokot ' in faecal soiling treated by behavioural methods . A double-blind randomly controlled trial of one particular laxative , Senokot , used in moderate dosage , was carried out on a group of 40 children with severe and persistent soiling and often with a history of faecal retention . Significant improvement occurred following three months of outpatient treatment using a behavioural approach and either Senokot , placebo or no medication . However , there was no evidence either during the trial or subsequently when Senokot was employed to supplement behavioural treatment in every child who continued with therapy that this laxative contributed in any way to relieving the problem in this group of cases .

'Senokot

Senokot

and either Senokot

placebo

or no medication

relieving the problem


Carbon dioxide laser treatment of vaginal adenosis in DES-exposed offspring : a prospective study . Seventy-nine patients with history and physical findings characteristic of antenatal DES exposure were randomly divided into two groups . Fourty-four DES-exposed offspring had their vaginal adenosis treated with the carbon dioxide laser ( group I ) , and the remaining 35 DES-exposed offspring ( group II ) did not receive any specific treatment for this condition . Additionally , the 79 DES-exposed offspring were compared to an age-matched control population ( group III ) . Treatment of vaginal adenosis with the carbon dioxide laser did not significantly reduce the incidence of development of new dysplasia in the DES-exposed offspring . This study also showed no statistical difference ( p less than or equal to 0.05 ) in the incidence of dysplasia in DES-exposed offspring as compared to a control population .

Carbon dioxide laser treatment

carbon dioxide laser

did not receive any specific treatment

carbon dioxide laser

development of new dysplasia

incidence of dysplasia

vaginal adenosis

DES-exposed

Seventy-nine patients

antenatal DES exposure

Fourty-four

DES-exposed

DES-exposed

DES-exposed


[ Maintaining sinus rhythm with quinidine and amiodarone after electric cardioversion ] .

quinidine

amiodarone

after electric cardioversion ]


Bovine carotid artery heterografts versus polytetrafluoroethylene grafts . A prospective , randomized study . A prospective , randomized comparison of BCAH and PTFE vascular access grafts resulted in no statistically significant difference when analyzed for survival rates of complications , types of complications , reasons for failure , and clot salvageability . The results in diabetic patients were similar to those in nondiabetic patients . The majority of retrospective studies and subjective experiences favor PTFE grafts over BCAHs . The explanation may be part that BCAH preceded PTFE grafts into clinical use , and inexperience in the operating room and in the dialysis unit had an effect on BCAH results . A review of impressions of the graft materials indicated a decided preference for PTFE grafts .

BCAH

PTFE vascular access grafts

PTFE grafts

BCAHs

BCAH

PTFE grafts

PTFE grafts

survival rates of complications

types of complications

reasons for failure

clot salvageability

Bovine carotid artery heterografts

polytetrafluoroethylene

diabetic

nondiabetic


Diazoxide and labetalol in acute hypertension during haemodialysis . The antihypertensive effect of the peripheral vasodilator diazoxide in 13 patients and the alpha-beta adrenoceptor blocking agent labetalol in 12 patients were compared in 46 severe acute hypertensive episodes during haemodialysis . A single dose of diazoxide 150 mg or labetalol 50 mg was effective in 74 % and 70 % of the hypertensive episodes , respectively . In the diazoxide-treated patients blood pressure fell from 192 +/- 3/115 +/- 4 mmHg to 141 +/- 8/85 +/- 4 mmHg 2 h after injection . In 7 hypertensive episodes a second dose of diazoxide 150 mg was given 60 +/- 11 min after the first injection . The reduction in mean arterial blood pressure at the end of haemodialysis was 21.5 +/- 2.6 % in patients treated with a single dose and 24.8 +/- 3.5 % in patients treated with the repeated dose of diazoxide . In the labetalol-treated patients blood pressure in 17 instances fell from 198 +/- 5/104 +/- 4 mmHg to 143 +/- 7/89 +/- 5 mmHg 180 min following injection of labetalol 50 mg . In 6 episodes a second dose labetalol 50 mg was given 41 +/- 9 min after the first injection . At the end of haemodialysis the decrease in mean arterial blood pressure was 17.2 % in patients treated with a single dose and 18 +/- 5 % in patients given the repeated dose of labetalol . The reduction in blood pressure caused by diazoxide was slightly greater than that due to labetalol . At the end of haemodialysis the percentage reduction in mean arterial blood pressure was 23 +/- 2 % in the diazoxide-treated group and 17 +/- 2 % after labetalol . ( ABSTRACT TRUNCATED AT 250 WORDS )

Diazoxide

labetalol

peripheral vasodilator diazoxide

diazoxide 150 mg

labetalol 50 mg

diazoxide-treated

diazoxide

diazoxide

labetalol-treated

labetalol

labetalol

labetalol

diazoxide

blood pressure

mean arterial blood pressure

blood pressure

mean arterial blood pressure

blood pressure


Comparison of the hypotensive effects of bendrofluazide , bumetanide and xipamide . A randomized , triple crossover study was carried out in 24 elderly patients requiring chronic diuretic therapy to assess the different hypotensive effects of a fixed daily dose of 5 mg bendrofluazide , 1 mg bumetanide and 40 mg xipamide . Each treatment was given for 3 months . The results showed that no significant weight change took place during the study period . There was , however , a significant ( p less than 0.001 ) decrease compared to baseline values both in systolic and diastolic blood pressure during the xipamide period and a decrease in diastolic blood pressure ( p less than 0.05 ) when taking bumetanide . Only minor side-effects were reported .

bendrofluazide

bumetanide

xipamide

chronic diuretic therapy

5 mg bendrofluazide

1 mg bumetanide

40 mg xipamide

bumetanide

weight change

diastolic blood pressure

minor side-effects

elderly

requiring chronic diuretic therapy


Effect of antacids on intragastric pH in healthy subjects and duodenal ulcer patients . Influence of the size of the antacid dose and of anticholinergics . Different doses of two liquid antacids , alone and combined with an anticholinergic agent , were studied with respect to the duration of antacid action . The studies were performed in healthy subjects with MAO less than 30 mmol/h and in duodenal ulcer patients with MAO greater than 35 mmol/h . Gastric pH was recorded using radiotelemetric technique ( Heidelberg capsule ) . In the healthy subjects , there was no significant difference in the duration of action with the different doses but in duodenal ulcer patients a tenfold increase of the antacid dose resulted in a doubling of the duration of action . Combined treatment with an anticholinergic and antacids enhanced the antacid effects in both groups . It is concluded that an antacid dose should be so great that it binds secreted acid before the dose leaves the stomach . Further increase of the dose will not increase the duration . Concomitant use of an anticholinergic agent increases the duration of antacid action .

antacids

antacid dose

anticholinergics .

antacids

anticholinergic

antacid

anticholinergic

antacids

anticholinergic agent

Effect

intragastric pH

duration of antacid action

Gastric pH

radiotelemetric

duration of action

duration of action

antacid effects

duration

duration of antacid action

healthy subjects

duodenal ulcer

duodenal ulcer

duodenal ulcer


General anaesthesia for caesarean section in severe pre-eclampsia . Comparison of the renal and hepatic effects of enflurane and halothane . In a randomized study of patients undergoing Caesarean section , either enflurane ( mean 0.24 MAC-h ) or halothane ( mean 0.23 MAC-h ) and 50 % nitrous oxide in oxygen were administered to women ( n = 12 ) with severe pre-eclampsia-eclampsia and to 16 healthy pregnant patients with normal renal and hepatic function . No evidence of nephrotoxicity was found in any pre-eclamptic or normal patient . Metabolism of enflurane resulted in plasma inorganic fluoride concentrations ( max 15 mumol litre -1 ) which were well below the toxic value . Postoperative liver function tests showed no important changes from preoperative values , although reductive metabolites of halothane were not measured . In patients with severe pre-eclampsia there appears no contraindication to enflurane or , probably , halothane as volatile supplements during general anaesthesia .

General anaesthesia

enflurane

halothane

enflurane

halothane

nitrous oxide in oxygen

enflurane

halothane

enflurane

halothane

general anaesthesia

nephrotoxicity

liver function

contraindication to enflurane


High-dose weekly fractionation radiotherapy in advanced cancer of the uterine cervix . A trial comparing two different radiotherapy techniques and schedules in the treatment of 83 patients with advanced cancer of the uterine cervix ( stage IIIB ) employing external irradiation alone is described . The one technique , used routinely in this department , employed a conventional daily fractionation schedule while the other used a high-dose weekly fractionation regimen . The techniques are described . The aim of the trial was to compare the efficacy and morbidity of these two methods of treatment . Dose distribution curves in cross-section and midsagittal planes are shown and calculations or equivalent doses at various selected points using Ellis 's nominal single-dose formula are tabulated . The 2-year survival figures were 33 % for the daily fractionation technique and 22 % for the weekly regimen . Serious late complication rates were 6 % for the daily regimen and 22 % for the weekly schedule . These differences are not statistically significant . Late complication rates in the weekly fractionation regimen appeared to be lower than figures quoted by other authors . Local control within the irradiated volume was better in the group treated by the daily fractionation method .

external irradiation

efficacy

morbidity

survival

Serious late complication rates

Late complication rates

advanced cancer of the uterine cervix


Short-term studies on the use of glycerol as an osmotic agent in continuous ambulatory peritoneal dialysis ( CAPD ) . The use of glycerol as an osmotic agent in two different concentrations ( 92 mmol/l and 272 mmol/l ) in peritoneal dialysis fluid was investigated over 3 days in six patients on continuous ambulatory peritoneal dialysis and compared with two concentrations of glucose ( 76 mmol/l and 215 mmol/l ) in the same patients . The calorific value of the absorbed osmotic agent was lower , by 19 % with isotonic and 22 % with hypertonic solutions , when glycerol was used in place of glucose . However , glycerol provided significantly lower total ultrafiltration than glucose at each concentration , despite a higher initial osmotic pressure of the glycerol-based solutions . Thus , the higher concentration of glycerol required to provide equal ultrafiltration may offset any calorific advantage . Equilibration of creatinine and urea was slower and creatinine clearance lower with glycerol . Solutions containing glycerol were initially less acid ( pH 6.5 ) than those containing glucose ( pH 5.1 ) . Blood glycerol levels , which were in the physiological range with glucose as the osmotic agent , reached a peak 80-fold greater at 4.3 +/- 0.8 mmol/l during dialysis with fluid containing glycerol at 272 mmol/l and eightfold higher at 0.42 +/- 0.09 mmol/l with glycerol at 92 mmol/l . There was no evidence of haemolysis or other toxic effect despite these levels . The rise in blood glucose and insulin noted during the use of glucose-based solutions was not found with glycerol . Circulating levels of lactate , pyruvate , alanine , non-esterified fatty acids and the ketone bodies were similar with the two agents . Although these short-term studies have shown no conclusive advantage of glycerol over glucose , long-term effects of glycerol , particularly on circulating lipid levels , will determine its future role as an osmotic agent in continuous ambulatory peritoneal dialysis .

glycerol

glycerol

glucose

glycerol

glucose

glycerol

glycerol

glycerol

glycerol

glycerol

glycerol

glucose

glycerol

calorific value

total ultrafiltration

equal ultrafiltration

Equilibration of creatinine and urea

creatinine clearance

Blood glycerol levels

haemolysis

toxic effect

blood glucose and insulin

Circulating levels of lactate

pyruvate

alanine , non-esterified fatty acids

the ketone bodies

circulating lipid levels

CAPD

six


A comparison of the serologic responses to oral and injectable trivalent poliovirus vaccines . United States children two months of age were randomly assigned to two groups that received either the commercially available oral trivalent poliovirus vaccine ( OPV ) or an injectable ( inactivated ) trivalent poliovirus vaccine ( IPV ) with a confirmed minimum D-antigen content of 27 , 3.5 , and 29 units for poliovirus types 1 , 2 , and 3 , respectively . Vaccine was given at two , four , and 18 months of age . Sera obtained from 439 children at two , four , and six months of age and from 85 children at 18 and 20 months of age were examined for neutralizing antibodies . The percentage of children with detectable antibodies and the reciprocal geometric mean titers were similar for both groups at two months of age for antibodies to all three poliovirus types . At 20 months of age , all children but one had detectable antibodies to all three poliovirus types . Significantly higher geometric mean titers against types 2 and 3 were noted at 20 months of age for the IPV group .

trivalent poliovirus vaccines

IPV

neutralizing antibodies

children two months

children at 18 and 20 months of age


Epidural morphine in the elderly . A controlled trial after upper abdominal surgery . The effectiveness of epidurally administered morphine in the relief of pain after upper abdominal surgery was assessed in a controlled study involving 20 patients aged 61 to 78 years . Analgesia provided by epidural morphine was comparable to that obtained in matched patients given an intramuscular regime . The total dose required by the epidural route was less than one-fifth that required intramuscularly , and sedation was correspondingly reduced . Postoperative respiratory mechanics , however , were not significantly improved and delayed respiratory depression was observed in one patient . It is concluded that in elderly patients undergoing upper abdominal surgery the risks related to the use of morphine by the epidural route outweigh the marginal advantages it may offer over conventional analgesic techniques .

Epidural morphine

epidurally administered morphine

epidural morphine

intramuscular regime

morphine

relief of pain

Analgesia

Postoperative respiratory mechanics

delayed respiratory depression

elderly

aged 61 to 78 years

undergoing upper abdominal surgery


[ Treatment of the hyperkinetic response to exercise after myocardial infarct . Results of a randomized ergometric study ] .


A randomized trial of intranasal beclomethasone dipropionate after polypectomy . Beneficial effects of intranasal beclomethasone dipropionate ( Bdp ) in patients with nasal polyposis have been reported earlier . This study was carried out to investigate whether long-term treatment with Bdp after polypectomy could prevent formation of new polyps and reduce the number of surgical removals . Forty consecutive patients without laboratory or other clinical signs of allergy but with severe nasal polyposis were included in the study . Twenty patients were treated with intranasal Bdp and twenty patients received no treatment after polypectomy . All patients were followed for at least 2.5 years . The size of the polyps that recurred was estimated at different time-intervals by the examining doctor . After six months there was already a significant difference in favour of the group treated with intranasal Bdp . Further results of the study and the clinical implications are discussed .

beclomethasone dipropionate

Bdp

intranasal Bdp

polypectomy

Bdp

size of the polyps that recurred

difference

nasal polyposis

Forty

severe nasal polyposis

Twenty

intranasal Bdp

twenty

polypectomy


Comparative efficacy and safety of lofexidine and clonidine given alone or concomitantly with hydrochlorothiazide in hypertensive outpatients .

lofexidine and clonidine

hydrochlorothiazide

Comparative efficacy and safety

hypertensive outpatients


Randomized clinical trial of tamoxifen plus sequential CMF chemotherapy versus tamoxifen alone in postmenopausal women with advanced breast cancer . Eighty-eight postmenopausal women with metastatic breast cancer , in whom estrogen receptors ( ER ) were positive or unknown , were treated on a controlled trial to determine the effectiveness of tamoxifen and to assess the therapeutic advantage of sequentially adding low-dose cyclophosphamide-methotrexate-5-fluorouracil ( CMF ) chemotherapy in tamoxifen responders . Patients with known ER negative status were not studied . After the initial 12-week treatment with tamoxifen alone , 60 % of ER positive patients achieved complete or partial response as did 35 % in whom ER were unknown . Response status further improved in 18 % randomized to continue tamoxifen alone vs 31 % in whom CMF was added to tamoxifen . There were no statistically significant differences in time to the development of progressive disease or survival between the ER positive and ER unknown patients or between the tamoxifen and tamoxifen plus CMF groups . We conclude that inability to determine ER status should not prejudice against the use of tamoxifen in postmenopausal patients with advanced breast cancer . No benefit has been demonstrated from the addition of CMF chemotherapy in tamoxifen responders .

tamoxifen

tamoxifen alone

effectiveness

therapeutic advantage

complete or partial response

development of progressive disease

or

survival

postmenopausal

women

advanced breast cancer

Eighty-eight


[ The analgetic effect of intramuscular pethidine compared with epidural morphine in upper abdominal laparotomies ] .

pethidine

epidural morphine

upper abdominal laparotomies ]


Platelet inhibitory drugs : an in vivo method of evaluation in patients . The measurement of platelet deposition in human thrombi is essential for the evaluation of platelet-inhibitory drugs and prosthetic materials for use in patients . The rate of 111Indium-labelled platelet accumulation on Dacron arterial grafts was measured in 27 patients randomised to take either aspirin and dipyridamole ( ASA + DPM ) or placebo . Autologous platelets were labelled and re-injected seven days following surgery and the graft thrombogenicity index calculated as the daily rise in the ratio of emissions from the graft over a reference site . The mean ( +/- SD ) thrombogenicity index in 12 patients undergoing femoro-popliteal bypass was 0.25 +/- 0.09 on placebo and 0.16 +/- 0.07 on ASA + DPM started pre-operatively ( p less than 0.05 ) . Post-operative ASA + DPM therapy started two days following platelet labelling in 15 patients with aorto-femoral grafts also significantly reduce thrombogenicity to 0.12 +/- 0.05 compared with 0.25 +/- 0.08 on placebo ( p less than 0.01 ) . In the latter patients the ratio of emissions from the graft over reference fell significantly on starting ASA + DPM , suggesting a net loss of platelets from the graft . These results indicate that the rate of in vivo platelet accumulation on Dacron grafts can be quantitated and that ASA + DPM reduced this rate in man .

Platelet inhibitory drugs

platelet-inhibitory drugs

aspirin and dipyridamole ( ASA + DPM )

placebo

ASA

DPM

ASA + DPM

ASA + DPM

method of evaluation

platelet deposition

evaluation of platelet-inhibitory drugs

prosthetic materials

platelet accumulation

ratio of emissions

thrombogenicity index

thrombogenicity

emissions

rate of in vivo platelet accumulation

Platelet inhibitory drugs :

platelet deposition in human thrombi

27 patients


Immunotherapy maintenance in acute non-lymphocytic leukaemia . Between January 1975 and December 1977 , 264 adult patients with acute non-lymphocytic leukaemia entered the Australian National Leukaemia Trial . Of 251 evaluable patients , three induction regimens achieved similar complete response ( CR ) rates . CROP ( cytosine arabinoside , daunorubicin , vincristine , prednisolone ) produced CR in 41 % of patients , 7 and 3 ( cytosine arabinoside , daunorubicin ) in 42 % and 7 and 3 plus hydroxyurea in 52 % . Remission duration and survival were similar when induction regimens were compared . Forty-five patients reaching maintenance therapy were randomised to either chemo-immunotherapy ( BCG plus intradermal leukaemic blast cells ) or chemotherapy alone . The duration of CR in these two groups was almost identical , though patients receiving chemotherapy alone had prolonged survival ( median 161 weeks ) when compared to the chemo-immunotherapy group ( 84 weeks , p = 0 . 07 ) . Institutions with less developed supportive facilities reported lower CR rates ( p = 0 . 04 ) . Leucocytosis ( greater than 100 X 10 ( 9 ) /1 ) and older age ( greater than 50 years ) were associated with shortened survival . The Trial has failed to show any advantage for this form of immunotherapy .

Immunotherapy

CROP

cytosine arabinoside

daunorubicin

vincristine

prednisolone

cytosine arabinoside

daunorubicin

hydroxyurea

maintenance therapy

chemo-immunotherapy

BCG

intradermal leukaemic blast cells

chemotherapy

chemotherapy

chemo-immunotherapy

immunotherapy

complete response ( CR ) rates

Remission duration

survival

duration of CR

survival

Leucocytosis

acute non-lymphocytic leukaemia .


Two blind randomized cross-over trials in the treatment of primary open angle glaucoma . We present the results of two blind randomized trials comparing both guanethidine 3 per cent and adrenaline 0.5 per cent ( Ganda 3.0/0.5 ) and guanethidine 1 per cent and adrenaline 0.2 per cent ( Ganda 1.0/0.2 ) in single drop form with Timolol ( Timoptol ) 0.25 per cent . Results of 48-hour phasing at the end of one month 's treatment demonstrated a significantly greater fall in intraocular pressure with Ganda 3.0/0.5 ( 9.8 mm Hg ) than with Timolol 0.25 per cent ( 7.67 mm Hg ) P less than 0.001 . There was no significant difference in the fall in intraocular pressure between Ganda 1.0/0.2 ( 8.87 mm Hg ) and Timolol 0.25 per cent ( 8.24 mm Hg ) .

guanethidine 1 per cent

Timolol ( Timoptol ) 0.25 per cent

Ganda 3.0/0.5

Timolol 0.25 per cent

Ganda 1.0/0.2

Timolol 0.25 per cent

primary open angle glaucoma

fall in intraocular pressure

fall in intraocular pressure


Treatment of stable angina of effort with verapamil : a double-blind , placebo-controlled randomized crossover study . The effects of verapamil were assessed in 26 patients with stable exertional angina pectoris in a double-blind , placebo-controlled , randomized crossover protocol using serial treadmill tests . Verapamil , 480 mg/day , reduced anginal frequency from 5.6 +/- 7.3 to 2.2 +/- 3.9 attacks per week ( p less than 0.001 ) and nitroglycerin consumption from 3.4 +/- 4.9 to 1.2 +/- 2.5 tablets per week ( p less than 0.05 ) compared with placebo . Treadmill time increased from 6.4 +/- 2.1 minutes during the placebo phase to 7.5 +/- 1.8 minutes during the verapamil phase ( p less than 0.001 ) . Verapamil 's beneficial effect appeared to be related , in part , to a 10 % reduction of the rate-pressure product at rest ( p less than 0.05 ) and a 12 % reduction during submaximal exercise ( p less than 0.001 ) . Verapamil also caused less marked ST-segment depressions at peak exercise ( p less than 0.05 ) at a similar rate-pressure product , suggesting a favorable redistribution of coronary blood flow to the ischemic zone . Side effects from verapamil were minimal , consisting mainly of constipation ( six patients ) . Verapamil appears to be a safe and effective drug for treating angina of effort .

verapamil

placebo-controlled

verapamil

Verapamil

nitroglycerin

placebo

placebo

verapamil

Verapamil 's

Verapamil

verapamil

Verapamil

anginal frequency

nitroglycerin consumption

Treadmill time

rate-pressure product

ST-segment depressions at peak exercise

coronary blood flow

constipation

safe and effective

stable angina of effort

angina


Pilot study with adjuvant hormone therapy in FIGO stage I endometrial carcinoma with myometrial invasion . A pilot study with adjuvant hormone therapy in FIGO stage I endometrial carcinoma with myometrial invasion was carried out . All patients received total abdominal hysterectomy and bilateral salpingo-oophorectomy plus complementary radium therapy on the vaginal stump . After the conventional treatment , patients were randomly allocated to adjuvant hormone therapy or no further treatment . Hormone therapy consisted of gestonorone caproate ( 17 alpha-hydroxy-19-norpregn-4-en 3 , 20 dione caproate ) administered i.m . at the dose of 200 mg/week for 1 year . Of the 62 patients who entered the study , 51 were considered evaluable ( 24 with adjuvant hormone therapy and 27 with no further treatment ) . Five patients had a relapse : four of these were in the group with no further treatment . Actuarial relapse-free survival analysis at 5 years was 95.7 % in the group of adjuvant-treated patients and 82.8 % in the control group . Although there is no statistical significance , adjuvant therapy appears to result in an increase in relapse-free survival in the group of patients with deep myometrial invasion and undifferentiated carcinoma . Further studies are necessary to assess the effectiveness of hormone adjuvant treatment in FIGO stage I endometrial carcinoma with myometrial invasion .

adjuvant hormone therapy

adjuvant hormone therapy

total abdominal hysterectomy

bilateral salpingo-oophorectomy

at the dose of 200 mg/week for 1 year

adjuvant hormone therapy

no further treatment

adjuvant therapy

hormone adjuvant treatment

relapse

no further treatment

Actuarial relapse-free survival

relapse-free survival

FIGO stage I endometrial carcinoma

myometrial invasion

FIGO stage I endometrial carcinoma

myometrial invasion

FIGO stage I endometrial carcinoma

myometrial invasion


Human platelet response to three salicylate dosage forms . Acetylsalicylic acid ( ASA ) inhibition of platelet aggregation as evaluated by collagen-induced 14C-serotonin release , has been measured in 12 healthy male subjects . Each subject received a single oral dose ( 650 mg ) of enteric-coated ASA ( ecASA ) and compressed ASA tablets ( cASA ) , or ecASA and sodium salicylate ( 578 mg ) separated by a minimum of 5 weeks . The platelet response was related to plasma ASA and salicyclic acid determined by high-pressure liquid chromatography . Both ecASA and cASA inhibited 14C-serotonin release ; no significant difference was observed in the maximum effect between these two products ( p less than 0.05 ) . No relationship was found between the maximum observed plasma ASA level and the maximum effect . Further , no correlation was found between the maximum inhibition of 14C-serotonin release in vivo and the release predicted from in vitro experiments wherein the effect was measured after incubating plasma containing specified ASA concentrations .

salicylate

Acetylsalicylic acid

enteric-coated ASA

compressed ASA tablets ( cASA )

ecASA

sodium salicylate

ecASA

cASA

ASA

ASA

maximum effect

plasma ASA level and the maximum effect

male


Modifying the Type A coronary-prone behavior pattern .

Type A coronary-prone behavior pattern

Type A coronary-prone behavior


Breathlessness and psychiatric morbidity in chronic bronchitis and emphysema : a study of psychotherapeutic management . This paper describes a study of the outcome of psychotherapy with patients disabled by chronic obstructive airways disease giving rise to dyspnoea . Forty-three men and 22 women with severe COAD were randomly allocated for 8 weeks to one of three types of psychotherapy or to an untreated control group , and were followed up six months later . The group treated by a medical nurse without training in psychotherapy experienced sustained relief of dyspnoea but tended to undergo less psychodynamic change ; psychiatric symptoms were reduced in those receiving supportive , but not analytical , psychotherapy . The psychosomatic mechanisms involved and the implications for medical and nursing practice and for liaison psychotherapy are discussed .

psychotherapeutic management

psychotherapy

psychotherapy

untreated control

psychotherapy

psychotherapy

dyspnoea

Forty-three

men

and 22

women

severe COAD


Interactions of morphine and methotrimeprazine in mouse and man with respect to analgesia , respiration and sedation . Interactions between morphine and methotrimeprazine have been studied in mice and man with respect to analgesia or antinociceptive activity , respiratory effects and sedation . The volunteer study was a double-blind cross-over trial with 10 volunteers . In mice , methotrimeprazine only possessed antinociceptive activity in doses which caused marked sedation . However , small non-sedative doses of methotrimeprazine potentiated the analgesic action of morphine . The volunteer study did not confirm this finding in man . Methotrimeprazine 7.5 mg i.m . caused significant sedation , but did not alter the effects of morphine 5 mg on pain threshold or ventilatory response to carbon dioxide .

morphine

methotrimeprazine

morphine

methotrimeprazine

methotrimeprazine

Methotrimeprazine

morphine

analgesia , respiration and sedation

analgesia or antinociceptive activity

respiratory effects

sedation

antinociceptive activity

marked sedation

analgesic action of morphine

significant sedation

pain threshold

ventilatory response

man

man

10 volunteers


Changes in heart rate and forearm blood flow following intravenous boluses of isoprenaline in the presence of practolol and propranolol . 1 Increases in heart rate and forearm blood flow following graded intravenous bolus injections of isoprenaline sulphate , were measured in a double-blind randomised study of six subjects who received either placebo , practolol 50 mg , practolol 200 mg , propranolol 10 mg or propranolol 40 mg. 2 Dose related increases in forearm blood flow were produced by the graded boluses of isoprenaline sulphate . 3 Practolol 50 mg attenuated the heart rate response to isoprenaline but did not significantly affect the changes in forearm blood flow . Practolol 200 mg further attenuated the heart rate responses but also decreased the forearm blood flow responses . 4 Propranolol 10 mg and propranolol 40 mg significantly attenuated both the heart rate and forearm blood flow responses . The effect on forearm blood flow tended to be greater than the effect on heart rate . 5 Practolol 200 mg had the same effect on heart rate responses as propranolol 10 mg but a significantly smaller effect on the forearm blood flow responses . 6 The measurement of forearm blood flow following intravenous bolus injections of isoprenaline provides useful information about the beta 2-adrenoceptor antagonism of propranolol and practolol . However , application of the technique may be limited by the magnitude of the heart rate response and by the short-lived nature of the increase in forearm blood flow .

isoprenaline

isoprenaline sulphate

placebo

practolol

practolol

propranolol

propranolol

isoprenaline sulphate

Practolol

Practolol

Propranolol

Practolol

propranolol

propranolol

practolol

heart rate

forearm blood flow

heart rate

forearm blood flow

forearm blood flow

heart rate response

forearm blood flow

heart rate responses

forearm blood flow responses

heart rate

and

forearm blood flow responses

forearm blood flow

heart rate

heart rate responses

forearm blood flow responses

forearm blood flow

heart rate

forearm blood flow

six


Nonspecific and selective stimulation of the immune system in the treatment of carcinoma in humans . The experience of the Toronto General Hospital in the use of nonspecific stimulation of the immune system with bacille Calmette-Guérin ( BCG ) for the treatment of cancer of the gastrointestinal tract , malignant melanoma and breast cancer is described . The results are presented in terms of survival curves . The use of BCG administered intraperitoneally in a randomized study of patients with gastric , pancreatic and colorectal cancer proved of no benefit . On the other hand , when BCG was given orally in a randomized study of patients with resectable cancer of the colon and in nonrandomized consecutive studies of patients with malignant melanoma and stage IV carcinoma of the breast survival was increased . In a group of patients with advanced gastrointestinal cancer selective stimulation of the immune system with NED 137 produced a significant increase in survival when compared with the survival of historical controls ( the patients given BCG intraperitoneally along with 5-fluorouracil for gastrointestinal cancer ) . The results of these studies suggest the need for a more rational approach in manipulating the immune response that would combine chemotherapy with selective stimulation of the immune system .


Postoperative dreaming . A comparison of the incidence following pentazocine and morphine premedication . The incidence of postoperative dreaming following the use of morphine and pentazocine as premedicants in an otherwise standard anaesthetic sequence is compared in healthy volunteers . No statistically significant difference was demonstrated between the two drugs . The causes of psychotomimetic problems in the postoperative period and the difficulty of precise definition of hallucinations are discussed .

pentazocine

morphine

morphine

pentazocine


Delayed alloimmunization using random single donor platelet transfusions : a prospective study in thrombocytopenic patients with acute leukemia . A randomized study was performed in 54 thrombocytopenic patients with acute leukemia . Alloimmunization of recipients of random multiple-donor platelet concentrates ( MD group ) was compared to that of patients receiving random single-donor platelets ( SD group ) . In the SD patients , formation of alloantibodies ( mostly anti-HLA ) occurred less frequently ( p less than 0.002 ) , after a longer time period ( p less than 0.002 ) , and after a higher number of transfusions ( p less than 0.005 ) as compared to MD patients . SD patients also became refractory to random platelets less frequently ( p less than 0.005 ) , after a longer time period , and after a higher number of transfusions ( p less than 0.02 ) . In SD patients , the increments after the first and the last transfusion were in the same range , whereas in MD patients , the 1-hr ( p less than 0.001 ) and the 24-hr ( p less than 0.025 ) increments decreased from the first to the last transfusion . Thus , the use of random SD platelet transfusions postponed alloimmunization .

multiple-donor platelet concentrates

random single-donor platelets

random SD platelet transfusions

Delayed alloimmunization

higher number of transfusions

first and the last transfusion

thrombocytopenic

acute leukemia

thrombocytopenic

acute leukemia


Adriamycin and chlorambucil versus adriamycin and thiabendazole in the treatment of extensive , non-small cell carcinoma of the lung : a Southwest Oncology Group pilot study .

Adriamycin and chlorambucil

adriamycin and thiabendazole


Handwarming and relaxation in temperature feedback : positive placebo effects . Sixteen males and females were randomly assigned to either temperature feedback groups warm-relax ( WR ) or cool-relax ( CR ) to determine how successful hand-warming and -cooling alters the subjective report of relaxation . After eight 1/2-hour sessions the WR and CR demonstrated a significant difference in temperature change , but there were no significant main effects in reported subjective relaxation . The reported feelings of relaxation were negatively correlated to the directionality of temperature change and were primarily attributed to nonspecific expectancies .

placebo

temperature change

subjective relaxation

relaxation

Sixteen males and females


Pharmacokinetics of naproxen after oral administration of two tablet formulations in healthy volunteers . The pharmacokinetics of two naproxen tablet formulations were compared after oral administration . The 250-mg naproxen tablets , tablet I from AFI , Oslo , Norway , and tablet II Naprosyn , Astra-Syntex , were taken by 12 healthy volunteers in a randomized two-period crossover study . Plasma levels of naproxen were measured by a sensitive and specific HPLC method . The data were analyzed by means of two-way analysis of variance to test for significant differences between tablet formulation and differences between the first and second trial periods . Rapid absorption , with most Cmax values from 50-60 micrograms/ml reached within 1.5-3 h , was found for both tablet formulations . No significant difference was found in the rate and extent of absorption between the two formulations : the relative bioavailability of tablet I compared to tablet II was 1.05 +/- 0.21 ( mean +/- SD ) . The naproxen concentration 2 h after ingestion and the Cmax were higher on the second occasion , regardless of preparation , suggesting that the subjects were clinically different on the two occasions .

naproxen

naproxen

250-mg naproxen tablets

naproxen

naproxen

sensitive and specific HPLC method

Rapid absorption

Cmax values

difference

rate and extent of absorption

bioavailability

naproxen concentration

clinically different


Extra prompts versus no extra prompts in self-care training of autistic children and adolescents . A color-coded " extra prompt " procedure was compared to a " no extra prompt " procedure in teaching autistic children and adolescents how to lace shoes . One randomly assigned group of 10 autistic subjects first learned to lace shoes whose laces and eyelets were color-coded red and white , and then encountered the no extra prompt condition in which color codes could no longer be depended upon to solve the position discriminations required to lace properly . In a counterbalanced fashion , the other group of 10 autistic subjects reached criterion on the non-color-coded , naturalistic shoe before experiencing the extra prompt condition . Analysis of variance and post-hoc analyses suggest that subjects who first learned under the color-coded , extra prompt condition encountered significant difficulty in transferring their newly acquired skill to the naturalistic , non-color-coded condition , whereas subjects who learned initially without the extra prompts had little difficulty with the subsequent color-coded condition . A follow-up procedure requiring all subjects to choose between the color prompt and the position cue revealed that 11 of 20 subjects consistently chose the color cue , even though it resulted in improper lacing . It is recommended that clinicians avoid the use of highly salient , non-criterion-related prompts in teaching certain types of adaptive skills to autistic children .

Extra prompts

no extra prompts

color-coded " extra prompt " procedure

lace shoes

eyelets


Cardiovascular complications to treatment of prostate cancer with estramustine phosphate ( Estracyt ) or conventional estrogen . A follow-up of 212 randomized patients . Two hundred and twelve patients treated for prostatic cancer grade I or II were investigated for cardiovascular complications . The patients were part of a multicentre study in the Stockholm area and had been randomized to treatment with either estramustine phosphate ( Estracyt ) or polyestradiol phosphate and ethinyl estradiol . Cardiovascular complications categorized as impaired arterial circulation including ischemic heart disease , venous thromboembolism , cardiac incompensation and cerebral depression were found to be equally frequent following the two different forms of treatment . Among the patients getting cardiovascular complications , these occurred within two months after the start of treatment in 50 % and within one year in 85 % of them . There was a statistically significant correlation between the incidence of cardiovascular complications and a history of previous cardiovascular disease . This criterion was however in retrospect found to predict cardiovascular complications in only 67 of the 126 patients getting one or several of these complications .

estramustine phosphate ( Estracyt )

conventional estrogen

estramustine phosphate ( Estracyt )

ischemic heart disease

venous thromboembolism

cardiac incompensation

cerebral depression

cardiovascular complications

prostate cancer

follow-up of 212 randomized patients .


Budesonide and beclomethasone dipropionate in hay fever - a single blind comparison . 93 patients with seasonal allergic rhinitis took part in a single blind randomized clinical comparison of budesonide and beclomethasone dipropionate ( Becotide Nasal ) . All patients were sensitive to either birch or grass pollen , their sensitivity being confirmed by a skin prick test . The total daily dose was 400 micrograms for both drugs . Budesonide was administered twice a day and Becotide Nasal four times a day . Symptoms were assessed over a four-week period starting with a run-in period of one week . There was no placebo control group . Daily pollen counts were measured throughout the trial . The patients ' diary cards revealed that both drugs had a beneficial therapeutic effect , and that budesonide was significantly more active than Becotide Nasal . The side effects of both drugs were few and transient .

Budesonide

Becotide Nasal

budesonide

Becotide Nasal .

Daily pollen counts

side effects

hay fever

seasonal allergic rhinitis


Whole pelvic irradiation in stage I endometrial carcinoma : changes in numbers and reactivities of some blood lymphocyte subpopulations .

irradiation

stage I endometrial carcinoma

blood lymphocyte subpopulations


Tolfenamic acid and caffeine : a useful combination in migraine . Tolfenamic acid is a potent inhibitor of prostaglandin biosynthesis , which has been proved effective in the treatment of acute migraine attacks . The usefulness of caffeine , metoclopramide and pyridoxine as adjuncts to tolfenamic acid was tested in acute migraine attacks in ten patients . A combination of tolfenamic acid ( 200 mg ) with either caffeine ( 100 mg ) , metoclopramide ( 10 mg ) or pyridoxine ( 300 mg ) was given twice to each patient in random order . Thus 60 attacks were treated . The tolfenamic acid-caffeine combination proved the most effective as judged by duration and intensity of attacks , working ability , vigilance , and overall evaluation of the drugs by the patients . Metoclopramide was somewhat better than pyridoxine as an additive .

Tolfenamic acid and caffeine

Tolfenamic acid

caffeine

metoclopramide

pyridoxine

tolfenamic acid

tolfenamic acid

caffeine

metoclopramide

pyridoxine

tolfenamic acid-caffeine combination

Metoclopramide

pyridoxine

migraine

acute migraine attacks

duration and intensity of attacks

working ability , vigilance

overall evaluation of the drugs

migraine

migraine


Ambulation in labour . In a randomised prospective study of 68 women in spontaneous labour half were allocated to an ambulant group and half to a recumbent group . The duration of labour was significantly shorter , the need for analgesia significantly less , and the incidence of fetal heart abnormalities significantly smaller in the ambulant group than in the recumbent group . Apgar scores at one and five minutes were also significantly greater in the ambulant group . More patients in the recumbent group required augmentations with oxytocic drugs . There was no statistically significant difference in the third stage loss in the two groups . Ambulation in labour should be encouraged : it may bring human benefits while allowing the advantages of hospital supervision .

Ambulation

ambulant

recumbent

oxytocic

Ambulation

duration of labour

need for analgesia

incidence of fetal heart abnormalities

Apgar scores

augmentations with oxytocic drugs .

third stage loss

women

in spontaneous labour


A comparative trial of liver biopsy needles . A sheathed needle ( Tru-Cut ) was compared with a suction biopsy needle ( Menghini ) in a randomised prospective trial over 18 months to determine whether the former offered any special advantages in routine percutaneous liver biopsy . Seventy-seven consecutive biopsies were performed by a single operator . Although biopsy fragmentation was commoner with the suction needle , the length and volume of the largest core obtained was similar to results with the sheathed needle . Cytology provided useful additional information with the Menghini technique . The suction needle was repeatedly reusable and considerably cheaper than the sheathed needle , which may be used once only .

sheathed needle

suction biopsy needle ( Menghini )

routine percutaneous liver biopsy

suction needle

Menghini technique

Seventy-seven


Carbenicillin-trimethoprim/sulfamethoxazole versus carbenicillin-gentamicin as empiric therapy of infection in granulocytopenic patients . A prospective , randomized , double-blind study . The results of therapy with carbenicillin plus trimethoprim-sulfamethoxazole ( C-T/S ) were compared to those obtained with carbenicillin plus gentamicin ( C-G ) in a prospective double-blind study of empiric antibiotic therapy in granulocytopenic patients . Patients were stratified into two groups : favorable-prognosis , group 1 ( carcinoma , lymphoma , multiple myeloma ) , or unfavorable-prognosis , group 2 ( acute leukemia , bone marrow transplantation ) , based on anticipated duration of granulocytopenia . Over-all , empiric antibiotic trials were more often successful ( P = 0.004 ) in group 1 ( 55 of 62 patients or 89 per cent ) than in group 2 ( 42 of 64 patients , 66 per cent ) mwithin group 1 , there was a favorable outcome in 30 of 32 ( 94 per cent ) C-T/S trials and in 25 of 30 ( 83 per cent ) C-G trials ( P = 0.25 ) ; within group 2 , there was a favorable outcome in 23 of 30 ( 77 per cent ) C-T/S trials and in 19 of 34 ( 56 per cent ) C-G trials ( P = 0.14 ) , Combined results in both groups indicated a higher proportion of favorable outcome in C-T/S trials ( 53 of 62 , 85 per cent ) than in C-G trials ( 44 of 64 , 69 per cent ) . Further analysis ( Manetl-Naenszel test ) showed the over-all difference in outcome to be significant ( P = 0.049 ) , but the general applicability of this result may be limited by the rather low incidence of gram-negative bacterial infections in this study . There was no difference between the treatment regimens in antibiotic toxicity , and serious superinfection occurred only in group 2 patients ( 21 per cent of trials ) , equally divided between treatment arms . Initial protocol dosing achieved target plasma levels of trimethoprim ( 3 to 8 micrograms/ml ) or gentamicin ( 4 to 10 micrograms/ml ) in 57 of 68 ( 84 per cent ) C-T/S trials compared to 21 of 60 ( 35 per cent ) C-G trials .

successful

favorable outcome

favorable outcome

analysis ( Manetl-Naenszel test

no difference

antibiotic toxicity

serious superinfection

granulocytopenic

granulocytopenic

two

group 1

carcinoma

lymphoma

multiple myeloma

group 2

acute leukemia

bone marrow transplantation

granulocytopenia


[ Median and mediolateral episiotomy ] .

Median and mediolateral episiotomy


Comparison of antihypertensive effects of captopril and propranolol in essential hypertension . The antihypertensive effects of the oral converting enzyme inhibitor captopril and of propranolol were evaluated in a single-blind trial of 12 weeks in 19 ambulatory men with moderated essential hypertension ( supine diastolic blood pressure [ DPB ] , 100 to 120 mm Hg after receiving placebo for two weeks ) whose sodium intake was unrestricted . The captopril group included 12 patients and the propranolol group seven . After the initial dose-finding period of four weeks , supine DBP was significantly reduced in eight patients receiving captopril and in four of the patients receiving propranolol . In these patients DBP decreased throughout the following eight weeks . In the remaining patients from each group , DBP was not reduced by either drug given alone at maximum allowable dosages during dose-finding periods , nor by combined administration in following weeks . No adverse side effects attributable to captopril were noted , except in one patient in whom proteinuria developed after seven weeks . Captopril has potential value in the treatment of moderate essential hypertension .

captopril

propranolol

captopril

propranolol

placebo

captopril

propranolol

captopril

propranolol

captopril

Captopril

antihypertensive effects

supine DBP

DBP

DBP

No adverse side effects

proteinuria


Report on the second myelomatosis trial after five years of follow-up . Medical Research Council 's Working Party on Leukaemia in Adults . Three hundred and seventy-two patients were randomized between 3 regimens of chemotherapy : cyclophosphamide , intermittent melphalan , and melphalan with prednisone , and were followed up to death or for at least 5 years . There was no difference in survival between the treatments , either overall or in any subgroup of patients . Therefore , the choice among these 3 treatments should be guided by the patient 's comfort and convenience . The most important prognostic feature at presentation was the quality of renal function . It was possible to define good , intermediate and poor renal-function groups which were highly correlated with prognosis ( X2 for trend = 62.6 ) . The haemoglobin level at presentation was strongly correlated with prognosis among patients in the good renal-function group . Among 107 patients who presented with good renal function and with haemoglobin above 100 g/l , the 5-year survival was 43 % . Other prognostic features were much less important when account was taken of renal function and haemoglobin level .

survival

renal function

haemoglobin level

survival

Leukaemia

Adults

Three hundred and seventy-two

good

intermediate

poor

good renal-function

good renal function


Effects of topical and systemic folic acid supplementation on gingivitis in pregnancy . A double-blind study evaluated the effects of systemic and topical folate on gingival inflammation during the fourth and eighth months of pregnancy . Thirty women were randomly divided into three groups . Group A received placebo mouthwash and tablets ; Group B ; placebo mouthwash and 5 mg folate tablets ; Group C : folate mouthwash and placebo tablets . Supplementation lasted for 14 days during months 4 and 8 . Subjects took one tablet daily and rinsed twice daily for 1 min with the mouthwash . At the start and finish of each 14-day period , fasting serum and red cell folate levels were estimated and oral status assessed by a plaque index ( P1I ) , a gingival index ( GI ) , and gingival exudate flow meter ( GEF ) . Subjects completed 1-week diet sheets which were analysed for dietary folate . All groups were similar in each parameter at the start . Correlation was demonstrated between GI and P1I , and between GI and GEF . GI tended to increase throughout pregnancy in all groups except Group C , when in the eighth month there was a highly significant improvement ( 0.001 less than P 0.01 ) despite no significant change in P1I . Although dietary intake of folate was significantly higher during the eighth month in Group C as compared with Groups A and B , ( 0.001 less than P less than 0.01 ) , the folate mouthwash produced highly significantly improvement in gingival health in pregnancy .

topical and systemic folic acid

systemic and topical folate

placebo mouthwash and tablets

folate mouthwash and placebo tablets .

gingivitis in pregnancy .

dietary folate

GI and P1I

GI and GEF

GI

gingival health


The influence of amiloride on the therapeutic and metabolic effects of carbenoxolone in patients with gastric ulcer . A double-blind controlled trial . Patients with benign gastric ulcer were treated for four weeks with carbenoxolone sodium as Biogastrone tablets 100 mg three times a day , and if the ulcers were not healed at 4 weeks treatment was continued for a further 4 weeks . Fifty two patients entered the trial , and 12 were withdrawn . In 17 patients who were randomly allotted double-blind additional dummy tablets 16 of their ulcer healed completely endoscopically , whereas of the 23 patients given additional amiloride 5 mg three times a day only 14 ulcers healed , a significant reduction in ulcer healing . The clinical ( weight gain and oedema ) and metabolic ( hypertension , hypokalaemia and hypernatraemia ) side-effects were reduced by the active amiloride therapy , but serum carbenoxolone levels were not affected . Thus the potassium-retaining diuretic amiloride , like the aldosterone antagonist spironolactone , markedly reduces both the ulcer-healing and the metabolic side-effects of carbenoxolone sodium , and should not be used together with it in the treatment of peptic ulcer .

amiloride

carbenoxolone

dummy tablets

amiloride

amiloride

carbenoxolone

amiloride

spironolactone

weight gain

oedema

serum carbenoxolone levels

ulcer-healing

metabolic side-effects

patients with gastric ulcer .

Patients with benign gastric ulcer

peptic ulcer .


[ Biological and clinical effects of oral magnesium and associated magnesium-vitamin B6 administration on certain disorders observed in infantile autism ( author 's transl ) ] .

oral magnesium


Clinical evaluation of the antihypertensive effect of metoprolol in combination with hydrochlorothiazide and hydralazine in an unselected hypertensive population . One hundred nineteen patients with essential hypertension ( 96 completing six months and 92 a one year study period ) were randomized into four parallel groups and treated with one of four programs : 200 mg of metoprolol plus placebo ; 200 mg of metoprolol plus 25 mg of hydrochlorothiazide ; 200 mg of metoprolol plus 50 mg hydrochlorothiazide , or ; 200 mg metoprolol plus 50 mg of hydralazine . Blood pressure reduction was significant in these all groups and no differences were observed in blood pressure reduction among the groups . During the one year therapy the levels of serum bilirubin , uric acid and triglycerides were significantly increased in all groups but the group treated with metoprolol and hydralazine . Serum cholesterol level did not increase in any group during the one year therapy . The results indicate that the combination therapy in mild to moderate hypertension should not be initiated before individual response to single drug therapy is evaluated . Antihypertensive drug treatment may cause some biochemical changes and those changes seem to be smallest patients treated with combination of beta-blocker and hydralazine .

metoprolol

hydrochlorothiazide

hydralazine

200 mg of metoprolol plus placebo

200 mg of metoprolol

25 mg of hydrochlorothiazide

200 mg of metoprolol

50 mg hydrochlorothiazide

200 mg metoprolol

50 mg of hydralazine

metoprolol

hydralazine

beta-blocker

hydralazine

Blood pressure reduction

levels of serum bilirubin

uric acid

triglycerides

Serum cholesterol level

mild to moderate hypertension

hypertensive

One hundred nineteen

essential hypertension


Preventive treatment of serotonin-migraine with 1,3,4,14b-tetrahydro-2,7-dimethyl-2H-dibenzo ( b , f ) pyrazino- ( 1,2 -- d ) - ( 1,4 ) -oxazepine hydrogen maleate ( Org GC 94 ) . A double-blind study . 1,3,4,14b-Tetrahydro-2,7-dimethyl-2H-dibenzo ( b , f ) pyrazino- ( 1,2-d ) - ( 1,4 ) -oxazepine hydrogen maleate ( Org GC 94 ) is an oral " antamine " preparation with anti-serotoninergic and anti-histaminic effects . Its lack of unpleasant side-effects permits protracted use for the preventive treatment of serotonin-migraine . Its chemical structure -- tetracyclic ring , C-beta , C-alpha , amine in a secondary position -- allows block of the receptors for serotonin and histamine . Preventive treatment with 3 x 5 mg/day of Org GC 94 for a period of 3 months can almost completely eliminate migraine attacks . 21 out of 30 patients ( 70 % ) profited from such a treatment , showing a drop from 5 -- 30 attacks to 0 -- 1 attack per month and normalization of high urinary serotonin , 5-HIAA or histamine levels . However , 30 patients receiving 3 x 0.5 mg or placebo daily reacted only rarely . The typical side-effects of anti-serotonin drugs , especially sedation or dizziness and hyperorexia were hardly observed . Randomization of the serotonin-migraine cases and double-blind methodology were applied throughout the trial .

Org GC 94

placebo

migraine

attack per month

5-HIAA or histamine levels

sedation

dizziness

hyperorexia

serotonin-migraine

30 patients


[ Prevention of stress ulcers with synthetic depot secretin ] . The pathogenesis of stress ulcers is still far from being understood . It is reported about a synthetic secretin ( Hoe 069 + depot component ) given prophylactically to 100 patients postoperatively . It eliminated or ameliorated stress ulcers . The result , confirmed by gastroscopy , demonstrates the treatment with secretin plus depot component as a highly recommendable prophylaxis in the postsurgical intensive care treatment .

synthetic depot secretin ]

eliminated or ameliorated stress ulcers

stress ulcers

stress ulcers


Poylmerized whole ragweed : an improved method of immunotherapy . A single-blind study compared the effectiveness of glutaraldehyde-treated polymerized ragweed with nonpolymerized monomeric ragweed . These studies are an extension of those previously reported for polymerized AgE using a readily available ragweed preparation containing all ragweed antigens . Nineteen ragweed-sensitive patients were randomized into 2 groups ; 10 received the polymerized form and 9 received the monomeric form . Four parameters were followed : serum-specific IgE against antigen E , total blocking antibody against antigen E , local and systemic reactions to injection therapy , and symptom score indices . Pretreatment levels of antigen E -- specific IgE and blocking antibody activity were similar in both groups . After a total of 15,000 protein nitrogen units ( PNU ) had been given , blocking antibody activity in the monomer group rose from a mean of 170 ng AgE bound per ml to a mean of 2,813 . The rise in blocking antibody activity in the polymer group was from a mean of 181 ng AgE bound per ml to 1,574 . At 15,000 PNU , blocking antibody activity levels were not statistically different in the 2 groups . After 1 year of treatment , no consistent decrease in postseasonal specific IgE rise could be shown in either group . Forty times less erythema and 15 times less induration were found with polymerized ragweed . There were 7 systemic reactions with the monomer and none with the polymer . Both groups experienced symptomatic improvement with treatment .

Poylmerized whole ragweed

nonpolymerized monomeric ragweed .

ragweed

polymerized form

monomeric form

polymerized ragweed

blocking antibody activity

rise in blocking antibody activity

blocking antibody activity levels

postseasonal specific IgE rise

erythema

induration

systemic reactions

symptomatic improvement

Nineteen

ragweed-sensitive

were randomized into 2 groups ;

and


Value of an anal dilator after anal stretch for haemorrhoids . A prospective randomized trial compared anal stretch with or without continued dilatation for three months in 89 consecutive patients with haemorrhoids . Complications of therapy occurred in only 4 patients , 3 of whom had transient incontinence of flatus . When patients were reviewed four months after treatment , only 4 of 44 patients ( 9 % ) who used a dilator had not been improved and required additional therapy , compared with 15 of 42 patients ( 36 % ) who had anal stretch alone ( P less than 0.02 ) . It is concluded that the use of an anal dilator improves the results of anal stretch .

anal dilator

anal stretch

continued dilatation

anal stretch

anal stretch

haemorrhoids .

Complications of therapy

incontinence

anal stretch .

haemorrhoids

haemorrhoids


A controlled trial with diclofensine , a new psychoactive drug , in the treatment of depression . Diclofensine inhibits the uptake of serotonin , noradrenaline and dopamine . In a controlled study , out-patients suffering from moderate to severe depression were treated with the objective of assessing the new drug 's therapeutically effective dose range . Maprotiline was used as a reference drug : fourteen patients were assigned to receive diclofensine and thirteen to receive maprotiline in a double-blind design . Depending on tolerance and efficacy , they were treated for periods ranging from 5 to 150 days . Doses were titrated to the optimum . Findings suggest that a 50 mg daily dose of diclofensine would be sufficient for the majority of the patients . The dosage can be safely increased up to 150 mg daily but this offers few therapeutic advantages . While the efficacy index of the two drugs was similar ( approximately 60 % ) , they differed greatly in their profile of side-effects . No signs of abrupt dissipation of the achieved clinical effects were observed during continued treatment , and no withdrawal reactions were observed when the treatment was stopped . The new drug may be more effective in treating patients in whom a psycho-energizing and mood alleviating effect is desired .

diclofensine

Diclofensine

Maprotiline

diclofensine

maprotiline

diclofensine

efficacy index

profile of side-effects

no withdrawal reactions

effective

fourteen

thirteen


Multimodal therapy for the management of primary , nonmetastatic Ewing 's sarcoma of bone : an Intergroup Study . A randomized study of 264 children and adults with previously untreated localized Ewing 's sarcoma of bone was undertaken between 1973 and 1978 by 83 institutions of three national study groups : Children 's Cancer Study Group , Southwest Oncology Group , and Cancer and Leukemia Group B . The Intergroup Study was designed to determine if the addition of adriamycin ( ADR ) or bilateral pulmonary radiotherapy ( RT ) to vincristine , dactinomycin , and cyclophosphamide ( VAC therapy ) would improve survival and reduce local recurrences and metastases . All patients received RT to the primary lesion , and the survival rate after 3 years was 65 % . The most effective treatment regimen was VAC plus ADR ; 74 % of the patients were free of disease at 2 years . The lengths of disease-free status and survival of patients treated with VAC plus ADR or VAC plus RT did not differ . However , both regimens were significantly superior to treatment with VAC alone . The addition of ADR or bilateral pulmonary RT to VAC was highly advantageous to patients with nonpelvic primaries . Bone and lung were the major sites of distant relapse , but the addition of bilateral pulmonary RT showed no advantage over that of ADR in reducing the occurrence of lung metastases . These recent results should eliminate some of the pessimism that has accompanied a diagnosis of Ewing 's sarcoma , although distant metastases continued to be a major reason for failure in the control of this tumor . Survival of these patients can be improved through well-controlled clinical trials designed to determine optimal adjuvant chemotherapy and treatment of the primary lesion .

addition of adriamycin ( ADR )

or

bilateral pulmonary radiotherapy ( RT )

to

improve survival

survival rate

highly advantageous

no advantage

occurrence of lung metastases .


Double-blind study on the activity of plafibride in the treatment of type IV hyperlipoproteinemia . The effects of a new drug , N-2- ( p-chlorophenoxy ) -isobutyryl-N'-morpholinomethylurea ( plafibride , ITA 104 ) , were studied in a double blind study lasting four months on a group of 30 patients with a type IV hyperlipoproteinemia . In the patients treated with the active drug significant reductions in blood triglycerides were obtained , with a trend to normal . Reduction in blood cholesterol was inconsistent and not significant . As for the lipoproteinogram , a tendency towards a decrease in the pre-beta-lipoprotein fraction was observed and so was a non-significant tendency towards an increase in the alpha- and beta-lipoprotein fractions . Studies on the platelet functioning showed an obvious decrease in platelet aggregation in those patients treated with the active drug . This was very evident for the ADP and adrenaline inductors and rather less significant for collagen . Neither platelet adhesiveness nor aggregation rate changed . Tolerance of the drug was generally excellent . In one patient a decrease in some palpebral xanthelasmas was observed after two months of treatment with the active drug . In only one case there was heartburn and this was corrected with alkalines . In one other case an urticarial rash appeared , but disappeared spontaneously when the drug was temporarily stopped and did not reappear when it was administered again . During the trial no evidence of renal , hepatic or hematological malfunctions were observed . However , a slight tendency towards an increase in the GOT , GPT and LDH was observed , which was not statistically significant . The drug tested may be very useful in the treatment of type IV hyperlipoproteinemia , especially in those forms in which an increase in thromboembolic risk is suspected , either associated with , or secondary to , the actual atherosclerotic disease .

plafibride

blood triglycerides

blood cholesterol

pre-beta-lipoprotein fraction

platelet aggregation

platelet adhesiveness

aggregation rate

Tolerance

palpebral xanthelasmas

heartburn

urticarial rash

thromboembolic risk


Effects of a low-salt diet and of acute salt loading on blood pressure and intralymphocytic sodium concentration in young subjects with borderline hypertension . 1 . Three groups of young patients with borderline hypertension were studied for a 12 months period . The first was on a free sodium diet while the second was on a low-salt diet . The third group of patients underwent acute salt loading . 2 . After 12 months the group on free diet showed a significant increase of intralymphocytic sodium but no change in blood pressure was noted . Five patients who were re-checked after 24 months also had a significant increase in blood pressure . 3 . Patients treated with a low-salt diet showed a significant decrease of both intralymphocytic sodium concentration and blood pressure . 4 . After acute salt loading , borderline subjects with high intralymphocytic sodium showed a significant greater natriuresis whereas intralymphocytic sodium increased only in those subjects in whom it was initially normal .

low-salt diet

acute salt loading

free sodium diet

low-salt diet .

acute salt loading .

free diet

low-salt diet

blood pressure

intralymphocytic sodium concentration

intralymphocytic sodium

blood pressure

blood pressure

intralymphocytic sodium concentration

blood pressure

natriuresis

intralymphocytic sodium

young subjects

with borderline hypertension .

young patients

borderline hypertension


Age-related response to two Haemophilus influenzae type b vaccines . Two types of Hib vaccines were compared for efficacy and safety in 71 normal children in three age groups : 36 to 72 months , 15 to 18 months , and 6 to 8 months . One vaccine contained the Hib-specific capsular polysaccharide , PRP ; the second vaccine contained PRP combined with pertussis vaccine , PRP-P. A third vaccine , DTP , was administered to a control group for each age . Anti-PRP antibody levels were greater after vaccination with PRP-P than after PRP in all three age groups . Immunoresponsiveness to both vaccines increased with age . A lower incidence of side effects was seen with both PRP ( 15 % ) and PRP-P ( 20 % ) than with DTP ( 56 % ) . The results suggest that PRP-P is both well tolerated clinically and has greater immunogenicity than PRP .

Hib vaccines

PRP

pertussis vaccine , PRP-P.

DTP

control

PRP

PRP-P

PRP-P

Age-related response

efficacy and safety

Anti-PRP antibody levels

Immunoresponsiveness

lower incidence of side effects

children

36 to 72 months , 15 to 18 months

6 to 8 months


[ Credé 's prevention method has lost its justification today ] .

Credé 's prevention method

[ Credé 's prevention method


Lidocaine and bupivacaine mixtures for epidural blockade . In a prospective double-blind clinical study , single-dose lumbar epidural blockade was instituted in 60 healthy patients undergoing lower abdominal surgery . Patients were randomly assigned to one of five groups . Each group received treatment with a different local anesthetic solution containing 1:200,000 epinephrine . Local anesthetic solutions used were 0.5 per cent bupivacaine HCl , 2 per cent lidocaine HCl , and lidocaine-bupivacaine mixtures in the ratios of 1:3 , 1:1 or 3:1 by volume . Onset and complete spread of sensory blockade were similar in all five groups . Time to regression to two segments of partial and complete sensory blockade was positively correlated ( P less than 0.05 ) with increasing dose of bupivacaine in the solutions and ranged from 84 min ( partial ) and 70 min ( complete ) for lidocaine , to 128 min ( partial ) and 101 min ( complete ) for bupivacaine . Using skin temperature as a criterion of sympathetic blockade , all three mixtures demonstrated a duration of action intermediate between the two single drugs , lidocaine ( 124 +/- 13 min ) and bupivacaine ( 286 +/- 32 min ) . Onset of complete motor blockade was fastest and the degree of motor blockade was most profound with the mixture containing equal proportions of lidocaine and bupivacaine . Pharmacokinetics of individual drugs were unaltered in any of the mixtures .

Lidocaine

bupivacaine

epinephrine .

bupivacaine

lidocaine

bupivacaine

bupivacaine

lidocaine

bupivacaine

Onset and complete spread of

sensory blockade

duration of action

Onset of complete motor blockade

degree of motor blockade


Preliminary report of the M.D . Anderson Hospital randomized trial of neutron and photon irradiation for locally advanced carcinoma of the uterine cervix .

neutron and photon irradiation

advanced carcinoma

uterine cervix .


Treatment of human tungiasis with niridazole ( Ambilhar ) a double-blind placebo-controlled trial .

niridazole ( Ambilhar )

human tungiasis


Corticosteroid-induced osteopenia and vitamin D metabolism . Effect of vitamin D2 , calcium phosphate and sodium fluoride administration . Thirty-one patients scheduled for long-term ( 24 weeks ) treatment with prednisone in comparatively high doses were randomly allocated to two further treatment groups . Group A received prednisone plus 'triple-treatment ' ( vitamin D2 45000 iu twice weekly , sodium fluoride 50 mg and calcium phosphate 4.5 g daily ) , group B received only prednisone . The study was undertaken in order to evaluate the effect of prednisone- and triple-treatment upon bone mineral content ( BMC ) and vitamin D metabolism . The groups were comparable with regard to age , sex and prednisone dose . BMC fell rapidly and similarly in both groups , demonstrating that the triple-treatment has no preventive effect on corticosteroid induced osteopenia . Serum concentrations of 25OHD2 , 25OHD3 and 1,25 ( OH ) 2D were unchanged in group B ( without triple-treatment ) , whereas in group A 25OHD2 increased enormously , 25OHD3 was suppressed possibly by substrate competition for hydroxylation in the liver and 1,25 ( OH ) 2D was halved . The suppression of 1,25 ( OH ) 2D may be an effect of raised 25OHD2 alone , or in combination with corticosteroid excess .

vitamin D2 , calcium phosphate

sodium fluoride

prednisone

prednisone-

triple-treatment

osteopenia

vitamin D metabolism

bone mineral content ( BMC )

vitamin D metabolism

BMC

1,25 ( OH ) 2D

1,25 ( OH ) 2D

Thirty-one


Non-Hodgkin 's malignant lymphomas : treatment of localized relapses with chemo + radio + BCG-therapy . 16 patients with relapsing non-Hodgkin 's malignant lymphomas considered as clinical stage I or II were treated by an association of chemo + radiotherapy and thereafter by maintenance BCG therapy . 5 of them were included in a randomized trial and have a significantly different disease-free survival from patients receiving the same treatment but without BCG . 11 were systematically treated by BCG and they also have a fairly good disease-free survival . Such a treatment appears to be of value in treating these patients and even probably of curing some of them .

chemo + radio + BCG-therapy

BCG

BCG

disease-free survival

disease-free survival


Laser conization versus cold knife conization . This prospective , randomized study compares , for the first time , measured blood loss at conization and within 24 hours after using either the cold knife technique or the carbon dioxide laser scalpel . One hundred and ten consecutive patients were evaluated . The median blood loss in the laser group of 55 patients was 4.6 milliliters at , and within , 24 hours after operation compared with 30.1 milliliters in the cold knife group of 55 patients . More important , however , is that the corresponding figures for the range of bleeding were 0.4 to 155.4 milliliters and 5.6 to 1,570.9 milliliters , respectively . The incidence rate for bleeding complications requiring surgical intervention was 1.8 per cet for the laser group and 14.6 per cent for the cold knife group . This difference was statistically significant , p less than 0.015 -- Fischer 's exact test . Conization for treatment of premalignant changes of the cervix uteri will probably remain the treatment of choice for some time to come . It is our opinion that , in the future , laser conization will replace cold knife conization .

Laser conization

cold knife conization

cold knife technique

carbon dioxide laser scalpel

cold knife

cold knife

laser

cold knife

median blood loss

range of bleeding

One hundred and ten


Effects of vicarious reinforcement in normal and severely disturbed children .

vicarious reinforcement

normal and severely disturbed

children


Perception of social interactions in depressed psychiatric patients .

social interactions

social interactions

depressed psychiatric


Memory aids in longitudinal health surveys : results from a field experiment . The use of memory aids to improve respondent recall is becoming increasingly popular in health surveys . In a one-year field experiment involving over 1,200 respondents , people assigned memory aids reported over 50 per cent more symptom episodes than those not assigned memory aids . Differences in reporting levels were particularly striking during the first six to 12 weeks of the survey , for symptoms related to acute , transitory illness , and among minorities and the lower socioeconomic groups . Respondents assigned memory aids were also more likely to report a doctor contact -- especially during the fall/winter months . Among respondent who used their memory aids at least once ( N = 252 ) , nearly 35 per cent said they were influenced by the information recorded in their memory aids , and most of those who were influenced said that they became more aware of their health . Ten of these people said that they became more worried or depressed because of the information recorded in their memory aids . This constitutes about a four per cent risk among those people who reported using their memory aids at least once . There was no evidence to suggest that the memory aids influenced perceptions of health status .

Memory aids

memory aids

memory aids

memory aids

memory aids

memory aids

became more aware of their health

more worried or depressed

perceptions of health status


[ Dose-effect relationship of isosorbide dinitrate in the treatment of angina pectoris ( author 's transl ) ] . Fifteen males with angiographic evidence of coronary heart disease and stable , exercise-induced angina pectoris were given placebo or isosorbide dinitrate ( ISDN ) in a dialy dose of 30 mg , 120 mg , 240 mg and 480 mg in a randomized single-blind trial . The daily doses were given as a single oral dose of 5 mg , 20 mg , 40 mg and 80 mg tablets . Each dose and placebo was given for seven days . On the seventh day an exercise ECG of standardized level and duration of exercise was recorded . The ischaemia response in the ECG revealed a dose-dependent reduction by 28 % ( 5 mg ISDN ) , 43 % ( 20 mg ) , 60 % ( 40 mg ) and 73 % ( 80 mg ) . The number of anginal attacks similarly fell parallel to dose . Plasma level of ISDN and the mononitrates , measured one and four hours after drug intake , rose almost linearly in relation to dose . Oral ISDN thus has a dose-dependent effect on the frequency of angina and ischaemia parameters during ergometric exercise . The protracted anti-anginal effect of ISDN is largely due to its metabolites . At high doses there is presumably an added effect of the high blood level of the basic substance.U

isosorbide dinitrate

placebo

isosorbide dinitrate ( ISDN )

exercise ECG

duration of exercise

ischaemia

reduction

number of anginal attacks

anti-anginal effect


[ Comparative study of cinoxacin ( Cinobac ) , nitrofurantoin ( Furadantine MC ) and oxolinic acid ( Uritrate ) in urinary tract infections . Results of a random study of three groups of 30 patients with uncomplicated urinary infections ] .

urinary infections


Antibiotic therapy of acute exacerbations of chronic bronchitis . A controlled study using tetracycline . We conducted a double-blind , randomized , placebo-controlled trial in 40 patients to evaluate the need for antibiotics in acute exacerbations of chronic bronchitis . All patients were sufficiently ill to require hospitalization although none needed ventilatory support ; the presence of pneumonia was excluded . Treatment consisted of bronchodilators , corticosteroids , and either tetracycline , 500 mg , or placebo by mouth every 6 hours for 1 week . Arterial blood gases , spirometric tests , bacteriologic evaluation of sputum , and patient and physician evaluation of the severity of illness were assessed at the beginning and end of the study . All patients improved both symptomatically and by objective measures of lung function . At the end of the study period there were no differences between those patients receiving tetracycline and those receiving placebo . We conclude that antibiotic therapy is not needed in moderately ill patients with exacerbations of chronic bronchitis .

tetracycline

placebo-controlled

bronchodilators

corticosteroids

tetracycline

placebo

placebo

Arterial blood gases

spirometric tests

bacteriologic evaluation of sputum

patient and physician evaluation of the

severity of illness


Comparison of the therapeutic effects of adriamycin alone versus adriamycin plus vincristine versus adriamycin plus cyclophosphamide in the treatment of advanced carcinoma of the cervix .

advanced carcinoma of the cervix .


Intraoperative microscopy of bile -- is it useful ? Direct microscopy of the bile was performed during cholecystectomy in 111 patients in an attempt to identify those with a high risk of wound infection . Bacteria were identified in 23 patients , 11 of 83 undergoing cholecystectomy alone and 12 of 28 undergoing exploration of the common bile duct ( P less than 0.01 ) . These 23 patients were randomly allocated to an antibiotic group or a control group ; there was one wound infection in the antibiotic group and two in the control group . A total of 14 patients developed wound sepsis . Infection was more likely if the common bile duct was explored ( 6 of 28 ) rather than cholecystectomy alone ( 8 of 83 ) . There was a poor correlation between microscopy and culture of the bile for bacteria and there was no increase in sepsis when bacteria were observed on microscopy . We were not able to identify a high risk group of patients by intraoperative microscopy of bile .

Intraoperative microscopy

Direct microscopy of the bile

cholecystectomy

cholecystectomy

antibiotic group

antibiotic group

control group

cholecystectomy

wound sepsis .

Infection

bacteria

sepsis

cholecystectomy

cholecystectomy

exploration of the common bile duct


The pharmacokinetics of metronidazole and tinidazole in patients with mixed aerobic -- anaerobic infections .

metronidazole and tinidazole

pharmacokinetics


Inhibition of spontaneous platelet aggregation and adhesion by indobufen ( K 3920 ) . A randomized , double-blind crossover study on platelet , coagulation and fibrinolysis function tests . In a randomized double-blind crossover study in 12 patients with atherosclerotic disease , the effect of 2 dosages ( 100 and 200 mg twice daily ) of indobufen , a new synthetic inhibition of platelet aggregation , on some platelet functions , coagulation and fibrinolysis tests was investigated . Regardless of the dosage used , indobufen was shown to induce a prompt normalization of the enhanced platelet aggregation of these patients . The effect lasted for the entire period of drug administration and in 50 % of patients a normal platelet aggregation was maintained until the fourth day after discontinuation of the drug . Indobufen was also able to reduce platelet adhesiveness and to lengthen bleeding time , especially when the higher dosage was used .

indobufen ( K 3920 ) .

indobufen

indobufen

Indobufen

platelet aggregation and adhesion

enhanced platelet aggregation

platelet adhesiveness

bleeding time

atherosclerotic disease


A comparison of dorsal and volar resting hand splints in the reduction of hypertonus . Ten adults with hypertonic wrist flexors volunteered as subjects in an experiment comparing the effectiveness of dorsal and volar resting hand splints in the reduction of abnormal muscle tone . Subjects were randomly assigned to two groups of five each . Individuals in one group were fitted with dorsal splints , and individuals in a second group with volar splints . Measurements by spring-weighted scales were taken to assess the efficiency of each splint design in the reduction of hypertonus . Results demonstrated no significant differences between the volar and dorsal splints in reducing hypertonus . However , the age of the subjects was found to be an intervening variable : The older subjects of both groups demonstrated a gradual but not significant decline in hypertonus , whereas the younger adults demonstrated a significant decline in hypertonus over a 6-week period .

dorsal and volar resting hand splints

dorsal and volar resting hand splints

dorsal splints

volar splints

volar and dorsal splints

abnormal muscle tone .

hypertonus .

no significant differences

hypertonus

hypertonus .

Ten

adults

hypertonic

hypertonus .

older

younger adults


Treatment of familial hypercholesterolemia with a combination of bezafibrate and guar . The effect of guar ( 15.6 g/day ) , a dietary fibre , and simultaneous administration of bezafibrate ( 600 mg/day ) during dietetic treatment on the plasma lipoproteins and apolipoproteins was investigated in 12 patients with familial hypercholesterolemia ( corresponding to the HLP type IIa pattern ) . Either bezafibrate alone or bezafibrate in combination with guar was administered in a cross-over study for 3 months . Guar led to an additional lowering of the total cholesterol in the plasma by 7 % ( P less than or equal to 0.05 ) associated with a fall of the low density lipoprotein cholesterol ( LDL-cholesterol ( LDL-cholesterol ) by 13 % ( P less than or equal to 0.01 ) without any changes in the very low density lipoprotein ( VLDL ) and high density lipoprotein ( HDL ) cholesterols . In parallel with the decrease in LDL-cholesterol , the apoprotein B also was diminished by 20 % ( P less than or equal to 0.05 ) . The plasma triglyceride level and the triglyceride distribution within the individual lipoprotein fractions were not altered in any consistent manner by the addition of guar . Neither the fasting plasma glucose level nor the body weight were affected . The side-effects due to guar treatment consisted of slight nausea , meteorism and constipation , but this did not in any of the cases lead to early termination of the study . These results demonstrate that guar exerts its cholesterol-lowering effect in addition to that of bezafibrate .

combination of bezafibrate and guar

guar

a dietary fibre

bezafibrate

Guar

guar .

guar treatment

guar

bezafibrate .

effect

total cholesterol

LDL-cholesterol

apoprotein B


The effects of haloperidol on learning and behavior in autistic children . The effects of haloperidol on behavioral symptoms and learning were critically assessed in autistic children in an ongoing double-blind placebo-controlled clinical trial . Children were randomly assigned to haloperidol-placebo-haloperidol or placebo-haloperidol-placebo treatment sequences . Statistically , haloperidol was significantly superior to placebo in reducing behavioral symptoms . In discrimination learning paradigm , children receiving haloperidol learned the discrimination while those on placebo did not . Discrimination attained on haloperidol was retained when the children were switched to placebo .

haloperidol

haloperidol

placebo-controlled

haloperidol-placebo-haloperidol

placebo-haloperidol-placebo

haloperidol

placebo

haloperidol

placebo

haloperidol

placebo

learning and behavior

behavioral symptoms and learning

behavioral symptoms

learned the discrimination

autistic children .


Menstrual cycle symptoms in infertile and control subjects : a re-evaluation of the evidence for psychological changes .

re-evaluation of the evidence

Menstrual cycle symptoms

psychological changes

infertile

control


Prostaglandin E1 as a hypotensive drug during general anaesthesia . Hypotension induced by prostaglandin E1 ( PGE1 ) infusion ( 100-150 ng/kg/minute ) during halothane anaesthesia to reduce operative blood loss during mastectomy was investigated . PGE1 decreased systolic arterial pressure approximately 34 % from pre-administration values . The duration of induced hypotension was about 75 minutes . When the infusion was stopped , blood pressure returned to within 15 % of the control with 15 minutes . Heart rate did not change significantly during PGE1 infusion ; the pre-ejection period and left ventricular ejection period were shortened . Renal function during the hypotensive period was well maintained . Blood loss during surgery was significantly decreased . These findings suggest that PGE1 can be used safely to control arterial pressure during surgery .

prostaglandin E1 ( PGE1 ) infusion

halothane anaesthesia

Hypotension

systolic arterial pressure

blood pressure

Heart rate

pre-ejection period

left ventricular ejection

Renal function

Blood loss

arterial pressure

mastectomy


An evaluation method providing confidence intervals applied to radioimmunoassay . A method for evaluation of radioimmunoassay results is described . The order of the single tubes in each assay run is randomized . A polynomial is fitted to untransformed data ( y = counts per minute ; x = concentration of curve.A confidence interval is calculated for each sample , taking into account the variance of the standard curve and that of the actual duplicate assay jointly .

radioimmunoassay

evaluation of radioimmunoassay

single tubes


Breast cancer screening in Sweden . The single modality approach . Four population-based breast cancer screening projects are in progress in Sweden , three of which are randomized studies . Mammography is the only screening method . 51 % of all carcinomas detected at the first screening were either in situ or invasive with a diameter of 10 mm or less . Axillary metastases were found in 16 % of the patients . Sensitivity was over 90 % in all projects . The ultimate aim of the randomized projects is to demonstrate the effect of screening on breast cancer mortality . It is estimated that mortality statistics will reach significant levels in 1983. ,

screening

Mammography

screening

Axillary metastases

Sensitivity

mortality statistics

Breast cancer screening

Sweden .


Heparin therapy in venous thromboembolism . Patients with pulmonary embolism or deep venous thrombosis were randomly assigned to receive either intermittent or continuous intravenous heparin therapy . In patients with an enhanced risk of bleeding , major bleeding was significantly more common during the intermittent use of heparin ; in patients without these risk factors , hemorrhage occurred with equal frequency during intermittent and continuous heparin therapy . Recurrent thromboembolism was seen significantly more often in patients receiving continuous heparin therapy . Controlling the dose of heparin with coagulation tests resulted in the administration of significantly larger daily doses of heparin with intermittent injections than with continuous infusion . Therefore , the bleeding complications of intermittent heparin therapy could have been due to the higher dose , and the recurrences associated with continuous heparin therapy may have resulted from lower doses rather than from differences in the method of administration . In a small trial , arbitrary lower doses of heparin given intermittently similar to the doses of heparin given continuously resulted in fewer bleeding complications and more recurrences . In patients without risk factors for bleeding , the intermittent administration of heparin in the higher dose is preferable because of fewer recurrences and no increase in hemorrhagic complications . In patients with a high risk of bleeding , conventional doses of heparin given continuously can reduce the rate of hemorrhagic complications but will result in more recurrences .

Heparin

continuous heparin therapy

heparin

heparin

bleeding

hemorrhage

Recurrent thromboembolism

bleeding complications

recurrences .

hemorrhagic complications .

rate of hemorrhagic complications


Are oral cathartics of value in optimizing the gallium scan ? Concise communication . The normal intestinal secretion of 9-15 % of an administered dose of gallium-67 may prevent early detection of intra-abdominal disease . We randomized 50 patients to receive either no bowel preparation or 30 cc of milk of magnesia plus 5 cc of cascara . No significant difference was found between the two groups in frequency with which gallium interfered with readings or time to complete the study .

30 cc of milk of magnesia

5 cc of cascara

randomized


The effects of prophylactic management and therapeutics on hypertensive disease in pregnancy : preliminary studies . A controlled prospective evaluation of pregnancy complicated by chronic hypertension is proposed and preliminary data on population selection and pregnancy outcome are presented . Sixty-three women with evidence of underlying hypertensive disease were followed prospectively throughout pregnancy . Twenty-three patients were followed in a protocol of intensified prenatal care and randomized assignment of antihypertensive agents : placebo , hydralazine , or methyldopa . Forty patients were followed in the high-risk pregnancy clinics at Duke University . The incidence of preeclampsia in the randomized prophylactic antihypertensive group was statistically lower than that in the nonrandomized group ( 8.7 versus 32.5 % ; P less than .01 ) . There were no other statistically significant differences between the groups . The 63 hypertensive women had a high incidence of diabetes mellitus diagnosed during pregnancy ( 49.2 % ) as compared to the authors ' general obstetric population ( 8.1 % ) .

effects

hypertensive disease

population selection

incidence of preeclampsia

diabetes mellitus

hypertensive disease

Sixty-three

women

hypertensive disease

Forty

hypertensive


Theophylline concentrations in serum and saliva after oral microcrystalline and sustained-release preparations in asthmatics . Theophylline concentrations in saliva have been compared with those in serum in 13 asthmatic patients after single and multiple oral dosage of a microcrystalline theophylline tablet ( Nuelin ) and a sustained-release preparation ( Nuelin Retard ) . There was wide individual variation in the ratio of serum to saliva concentrations indicating that , even when individual serum to saliva ratios have been established , the use of saliva theophylline measurements alone is unreliable for the routine monitoring of theophylline therapy . Both preparations produced mean serum theophylline concentrations within the 10 -- 20 mcg/ml range , the sustained-release tablet giving higher monitoring through values and smaller through to peak variation . The preparations were equally and highly bioavailable . Side effects were reported by three patients , which were the patients with the highest AUC . The Nuelin Retard preparation appears to provide smooth , sustained serum theophylline concentrations within the therapeutic range and the simple , twice-daily dosage should result in improved patient compliance .

Theophylline

microcrystalline

sustained-release preparations

Theophylline

microcrystalline theophylline tablet

sustained-release preparation

theophylline

theophylline

Nuelin Retard

Theophylline concentrations

Theophylline concentrations

ratio of serum to saliva concentrations

mean serum theophylline concentrations

Side effects

serum theophylline concentrations

asthmatics

asthmatic


Topical treatment of alopecia areata . It has been shown previously that alopecia areata can be treated with dinitrochlorobenzene ( DNCB ) and other contact allergens . Whether these agents work by inducing immunologic stimulation or simply a nonspecific inflammatory reaction has not been definitively demonstrated . To test the relative importance of these two mechanisms , we have randomly studied 22 patients with alopecia areata to whom either DNCB or croton oil was applied topically . Sixty-three percent of patients without spontaneous regrowth of hair regrew hair after DNCB application . None of those treated with croton oil regrew hair when treated later with DNCB . Therefore , a proved contact allergen was shown to be required for therapeutic success . Patient acceptance of the induced contact dermatitis was excellent . In light of recent data on the mutagenicity of DNCB to bacteria , other contact allergens for topical immunotherapy are being sought .

Topical treatment

dinitrochlorobenzene ( DNCB )

contact allergens

DNCB

croton oil

croton oil

DNCB

DNCB

regrowth of hair regrew hair

regrew hair

Patient acceptance