Dexamethasone therapy and cortisol excretion in severe pediatric head injury . Glucocorticoids are used in an attempt to reduce brain edema secondary to head injury . Nevertheless , their usefulness remains uncertain and contradictory . In a randomized study of 24 children with severe head injury , urinary free cortisol was measured by radioimmunoassay . Twelve patients ( group 1 ) received dexamethasone and 12 ( group 2 ) did not . All patients were treated with a standardized regimen . In group 1 there was complete suppression of endogenous cortisol production . In group 2 free cortisol was up to 20-fold higher than under basal conditions and reached maximum values on days 1-3 . Since the excretion of cortisol in urine reflects the production rate closely and is not influenced by liver function and barbiturates , the results in group 2 show that the endogenous production of steroids is an adequate reaction to severe head injury . Exogenous glucocorticoids are thus unlikely to have any more beneficial effects than endogenous cortisol .

Dexamethasone therapy

Glucocorticoids

dexamethasone

cortisol

excretion of cortisol in urine


Therapeutic strategies in acute myelocytic leukemia : a status report of the experience of CALGB . Cancer and Leukemia Group B .

acute myelocytic leukemia :

Cancer and Leukemia


Alpha interferon clinical trial for multiple sclerosis : design considerations . The design and course of a placebo-controlled alpha-2 interferon trial in MS patients are described . No beneficial effect of the interferon on the course of MS could be shown .

Alpha interferon

placebo-controlled

alpha-2 interferon

interferon

No beneficial effect

interferon

multiple sclerosis

MS


Diclofenac , a nonsteroidal anti-inflammatory drug , decreases proteinuria in some glomerular diseases : a controlled study . Treatment with nonsteroidal anti-inflammatory drugs ( NSAIDs ) was first used in glomerulonephritis ( GN ) in 1966 but its efficiency is still debated . We studied the antiproteinuric effect of such a treatment in a double-blind study . 29 GN patients with normal renal function ( 17 membranoproliferative GN , 12 IgA GN ) were randomly assigned to receive 100 mg/day of diclofenac or placebo for at least 2 months . There was a significant antiproteinuric effect of diclofenac versus placebo with a fall of 70 % in the diclofenac group versus 6 % in the placebo group ( p less than 0.001 with the Mann-Whitney test ) . The median was 3 mg/min at onset and 2.45 mg/min after 2 months treatment with the placebo . In the diclofenac group , it was 2.2 and 0.95 mg/min , respectively ( p less than 0.01 ) . Diclofenac did not significantly increase creatinine levels . Gastric irritation was noted only once . This study establishes the short-term antiproteinuric action of diclofenac . Whether this action affects the final outcome is not yet determined .

Diclofenac

diclofenac

placebo

diclofenac

placebo

placebo

diclofenac

Diclofenac

antiproteinuric effect

antiproteinuric effect

creatinine levels

Gastric irritation

short-term antiproteinuric action

glomerular diseases

glomerulonephritis

29 GN

normal renal function


Oral ribavirin treatment of influenza A and B . A loading dose and short-term administration of oral ribavirin significantly improved symptoms and signs of influenza type A or B infection in 25 patients . The antiviral effect was not significant . No adverse clinical effects or significant laboratory values were observed . Oral treatment of patients with influenza A or B infection might be possible with ribavirin .

Oral ribavirin treatment

administration of oral ribavirin

ribavirin .

adverse clinical effects


Incidence of infectious symptoms after radiation therapy for breast cancer . Long-term effects . The incidence of symptoms generally associated with infectious disease was assessed by a questionnaire sent out to 519 disease-free breast cancer patients 7 to 12 years after primary treatment . All patients were treated in the context of a randomized trial where pre- and postoperative radiation ( 45 Gy ) was evaluated versus surgery only . The results indicate a significantly higher morbidity among patients treated with preoperative irradiation compared with those irradiated postoperative ( p less than 0.05 ) . This increased morbidity mainly seemed to be caused by symptoms usually associated with respiratory tract infection ( p less than 0.05 ) . Although statistically not significant the preoperatively irradiated patients also had a higher morbidity than those treated with surgery alone . There was no difference between postoperatively irradiated patients and patients treated with surgery only . A significantly higher integral dose ( absorbed energy within the body ) of the pre- compared with the postoperative group ( p less than 0.025 ) is associated with the differences in morbidity between the two irradiated groups . An explanation for the increased morbidity seems to be that the volume of lung tissue , encompassed within the full-dose target volume , is the crucial factor . This volume was considerable in the preoperatively treated patients but kept at a minimum in the postoperative group .

radiation therapy

surgery only

preoperative irradiation

irradiated postoperative

preoperatively irradiated

surgery

postoperatively irradiated

surgery

preoperatively treated

postoperative

infectious symptoms

higher morbidity

morbidity

morbidity


[ Prevention of migraine with flunarizine and acetylsalicylic acid . A double-blind study ] . UNLABELLED 30 children between 7 and 17 years suffering from at least 2 attacks/month of common or classical migraine since more than 1 year were studied . After clinical exclusion of symptomatic headache 4 weeks were documented by means of a migraine diary . Prophylaxis with Calcium entry blocker Flunarizine ( Sibelium ) or Thromboxane A inhibitor Acetylsalicylic acid ( ASS ) was carried out in a double blind design for 3 months . Medication was given as one dosage in the evening : 2-5 mg/kg KG ASS or 5-10 mg Flunarizine . Documented attack frequency and duration were controlled at monthly physical examinations . Final results showed no differences in significant reduction of attack frequency or symptoms between both different therapeutic principals . 72.4 % ( ASS 73.3 % ; Flunarizine 71.4 % ) of patients were attack-free or had at least a 50 % reduction . Migraine frequency of initially 7-8 was reduced to 1-2 attacks/month . Duration remained constant in both groups ( 1-3 h ) . Side effects were slight body weight gain or abdominal pain after intake , prophylaxis had not to be interrupted therefore . Longtime prognosis is not yet possible because the time of observation is too short so far . CONCLUSION Both substances are definitely useful and have few side effects in childhood migraine . If the response to one is insufficient the other substance should be tried .

flunarizine

acetylsalicylic acid

blocker Flunarizine ( Sibelium )

Acetylsalicylic acid ( ASS )

ASS

Flunarizine

Flunarizine

migraine

attack frequency and duration

Migraine frequency

Duration

slight body weight gain

abdominal pain

migraine

children between 7 and 17

common or classical migraine

childhood migraine .


Effects of maternal glucose infusion on fetal acid-base status in human pregnancy . The maternal and fetal metabolic effects of three commonly used intravenous fluids administered before regional anesthesia were studied in 32 gravid women undergoing elective cesarean section at term . Patients were randomized into one of three groups to receive 1 L of either 5 % dextrose ( 50 gm of glucose ) or Ringer 's lactate or isotonic saline solution before epidural anesthesia . Acute glucose infusion resulted in maternal hyperglycemia , hyperinsulinemia , and an increase in the blood lactate level . Cord blood glucose , insulin , and lactate levels were also increased in this group . The key finding of this study was the significant lowering of pH in the umbilical cord vein ( 7.31 +/- 0.04 ) and artery ( 7.21 +/- 0.06 ) in the glucose-infused group when compared with the non-glucose infusion groups ( p less than 0.05 ) . Confounding perinatal factors such as maternal position , maternal hypotension , and prolonged time of surgery did not influence the fetal acid-base status . Thus acute maternal glucose infusion in normal patients can cause fetal hyperglycemia , metabolic acidosis , and neonatal hypoglycemia . These findings may be of particular clinical importance when fetal distress or fetal hypoxemia is due to other perinatal events . Under these circumstances , acute maternal glucose infusion may further contribute to fetal metabolic acidosis .

maternal glucose infusion

5 % dextrose

glucose

Ringer 's lactate

isotonic saline solution

epidural anesthesia

Acute glucose infusion

maternal hyperglycemia

hyperinsulinemia

increase in the blood lactate level

artery

non-glucose infusion

maternal position

maternal hypotension

prolonged time of surgery

maternal glucose infusion

fetal hyperglycemia

metabolic acidosis

neonatal hypoglycemia

fetal distress

fetal hypoxemia

acute maternal glucose infusion

fetal metabolic acidosis

pregnancy

gravid

women

elective cesarean section


Continuous thoracic epidural analgesia for postoperative pain relief following thoracotomy : a randomized prospective study .

Continuous thoracic epidural analgesia

thoracotomy :

postoperative pain relief

thoracotomy


Intravenous lignocaine & haemodynamic responses to cystoscopy .

lignocaine

haemodynamic responses

cystoscopy


An evaluation of family therapy in anorexia nervosa and bulimia nervosa . A controlled trial comparing family therapy with individual supportive therapy in anorexia nervosa and bulimia nervosa was undertaken . Eighty patients ( 57 with anorexia nervosa ; 23 with bulimia nervosa ) were first admitted to a specialized unit to restore their weight to normal . Before discharge , they were randomly allocated to family therapy or the control treatment ( individual supportive therapy ) . After one year of psychological treatment , they were reassessed , using body weight , menstrual function , and ratings on the Morgan and Russell scales . Family therapy was found to be more effective than individual therapy in patients whose illness was not chronic and had begun before the age of 19 years . A more tentative finding was the greater value of individual supportive therapy in older patients . To our knowledge , this is the first controlled trial of family therapy in anorexia nervosa and clarifies the specific indications for this treatment .

family therapy

family therapy

family therapy

Eighty

anorexia nervosa

bulimia nervosa


Comparison of nicardipine and propranolol in the treatment of mild and moderate hypertension . In a double-blind controlled trial 22 patients with mild or moderate essential hypertension were treated with nicardipine 30 mg t.d.s . and 19 patients with propranolol 80 mg t.d.s . as monotherapy for 24 weeks . Blood pressure in both groups at the end of trial was equally and significantly reduced ; systolic pressure 22.2 mmHg and diastolic pressure 15.5 mmHg in the supine position , and 24.4 mmHg and 18.4 mmHg , respectively , in the standing position in those on nicardipine , and by 23.7 and 16.2 mmHg and 28.0 and 19.2 mmHg , respectively , in the propranolol group . There was an initial increase in heart rate in the nicardipine group , but the rise was only moderate ( 3 beats/min supine p = 0.3219 , and 7 beats/min standing , p = 0.0203 ) at the end of the 24 weeks . In the propranolol group heart rate was reduced markedly . Adverse effects occurred in 77 % of patients on nicardipine and in 63 % of those on propranolol , and there were no unexpected findings . The effects were mild in both groups and did not lead any patient to stop medication . One patient on propranolol was withdrawn from the trial because of poor blood pressure control and suspected angina pectoris after 5 weeks on active medication . There were no significant changes in blood chemistry , including lipoprotein classes . Overall , in comparison with propranolol , nicardipine was effective , well-tolerated and safe to use in the monotherapy of mild or moderate essential hypertension .

nicardipine

propranolol

nicardipine

propranolol

nicardipine

propranolol

nicardipine

propranolol

nicardipine

propranolol

propranolol

propranolol

Blood pressure

heart rate

heart rate

Adverse effects

blood pressure control

suspected angina pectoris

blood chemistry

lipoprotein classes

hypertension

mild or moderate essential hypertension


Pouch versus esophagojejunostomy after total gastrectomy : a randomized clinical trial .

Pouch versus esophagojejunostomy

esophagojejunostomy

gastrectomy :


Physicians ' management of hypertension : a randomized controlled CME trial .

management of hypertension

Physicians ' management of hypertension


Predictors of blood pressure change in a series of controlled dietary intervention studies . Three controlled dietary intervention studies were carried out in 1981-1983 in North Karelia , Finland , to asses the impact of dietary fat intake modification on blood pressure ( BP ) . All these studies involved middle-aged men and women in rural or semirural areas and comprised a baseline period , a six week ( or 12 weeks in the third study ) intervention period and a four to six week return to baseline . During the intervention period the total fat intake was reduced from 39 % to 24 % of energy and the polyunsaturated/saturated ( P/S ) ratio increased from 0.2 to 0.4-1.2 . In all groups energy intake was kept constant . For the present report data from the three studies were pooled for a series of stepwise regression analyses to predict changes in BP with different dietary changes . For both systolic ( SBP ) and diastolic ( DBP ) blood pressure , change in polyunsaturated fatty acid intake was the strongest dietary predictor of BP change . Changes in body weight , total fat intake , urinary sodium and potassium did not have significant predictive power in any of the analyses . The findings support the hypothesis that modification of dietary fat intake is a significant predictor of change in BP .

dietary intervention

fat intake

polyunsaturated/saturated ( P/S ) ratio

blood pressure change

blood pressure ( BP )

total fat intake

BP

BP change

BP

1981-1983 in North Karelia , Finland


Iron intake and iron nutritional status of infants fed iron-fortified beikost with meat . We compared iron intake and iron nutritional status of two groups of healthy term infants who received meat-containing baby foods fortified with ferrous sulphate ( 2 mg Fe/100 g ) . One group received an Fe-fortified formula ( 1.6 mg Fe/100 kcal ) and the other a nonfortified formula . Fe intake of the group fed the nonfortified formula was significantly lower ( p less than 0.0001 ) . These infants received Fe mainly from fortification Fe with beikost ( 75-86 % ) and less than 10 % met the recommended intake of 1 mg.kg-1.d-1 ; whereas 80-85 % of the infants fed the Fe-fortified formula did . Hb , Hct , FEP , and ferritin were similar in both groups with the exception of lower ferritin values at age 365 d ( p less than 0.05 ) in the group fed the nonfortified formula . No infant had hemoglobin less than 100 g/L . We conclude that regular consumption of commercially prepared Fe-fortified beikost with meat prevents most healthy term infants from Fe deficiency even if Fe intake is substantially below the recommended intake .

Iron intake and iron nutritional status

iron-fortified beikost with meat

Fe-fortified formula

and the other a

nonfortified formula

Fe intake

Fe-fortified formula

Hb , Hct , FEP , and ferritin

hemoglobin


Topical fibronectin therapy for treatment of a patient with chronic stasis ulcers .

Topical fibronectin therapy

chronic stasis ulcers .

chronic stasis ulcers


The effects of hypoxemia on cardiac output . A dose-response curve . To establish a dose-response curve for the effects of isocapnic hypoxemia on cardiac output ( CO ) , we studied 20 healthy men , aged 20 to 34 years , using a tight-fitting face mask and an isocapnic partial rebreathing system ( a modified anesthesia machine ) . We blended oxygen and hypoxic gas to achieve arterial oxygen saturations ( SaO2 ) of 80 , 85 , and 90 percent ; subjects also breathed 100 percent oxygen and room air ( RA ) . Target SaO2 and end-tidal carbon dioxide were continuously monitored using an ear oximeter and CO2 gas analyzer . Subjects experienced the five SaO2 measurements in random order . CO was measured noninvasively at approximately two-minute intervals , using continuous-wave Doppler echocardiography . Mean cardiac output increased with increasing hypoxemia from 6.84 L/min at FIo2 1.0 to 8.44 L/min at SaO2 80 percent ( p less than 0.0005 ) ; the increase was entirely due to increased heart rate . We concluded that cardiac output increases significantly in a dose-response manner in response to acute isocapnic hypoxemia in normal persons .

room air

cardiac output ( CO )

CO

Mean cardiac output

heart rate

cardiac output

hypoxemia

healthy

men

aged 20 to 34 years


[ The effect of thoracic peridural analgesia on the cortisol and glucose response in surgery of the abdominal aorta ] . UNLABELLED It has been shown that the stress response to lower abdominal surgery can be inhibited by epidural analgesia ( EA ) . But EA seems to have little influence on the stress reaction to major abdominal surgery . The purpose of our study was to find out whether EA is able to diminish the cortisol and glucose response to major transabdominal surgery . METHODS 31 patients undergoing elective surgery of the abdominal aorta were subdivided at random into 3 different anaesthesia groups : 1. halothane anesthesia , 2. neuroleptanalgesia ( NLA ) and 3. thoracic EA with bupivacaine ( 0.5 % ) in combination with a light general anesthesia . Some patients of each group received an intravenous infusion of 5 % glucose . Blood samples were drawn before anesthesia , after intubation , 5 times during surgery and at the end of the operation and were analysed for cortisol and glucose . During the early postoperative period , 1 , 2 and 24 h after surgery , only cortisol was measured . RESULTS Only the glucose levels of patients who received no carbohydrate-containing infusion fluids were used for evaluation of the stress response . In the halothane group , there was a significant increase of the mean cortisol and glucose levels after the start of surgery . No intraoperative elevations of blood glucose and cortisol were seen in the EA group . Patients of the NLA group showed no hyperglycaemia and only mild elevations of the cortisol levels during the intraoperative period . ( ABSTRACT TRUNCATED AT 250 WORDS )

thoracic peridural analgesia

epidural analgesia ( EA )

halothane anesthesia

neuroleptanalgesia ( NLA )

thoracic EA with bupivacaine ( 0.5 % )

general anesthesia

cortisol and glucose response

cortisol and glucose response

cortisol

glucose levels

mean cortisol

glucose levels

blood glucose

cortisol


Moisture-vapour-permeable film as an outpatient burn dressing . This study compares a moisture-vapour-permeable film ( MVPF ) with silver sulphadiazine in a randomized prospective manner for the treatment of outpatient burns . The two treatment groups were closely matched in age , sex , per cent of BSA burned , and in burn severity and locations . The MVPF group demonstrated a 39.0 per cent greater reduction in pain after application of the dressing over the silver sulphadiazine group . Patients in the MVPF film group also reported significantly less difficulty in wound care and in dressing interference with their daily functions . The clinical infection rate and time to healing were similar in both groups . In the management of outpatient burns , MVPF was found to be superior to silver sulphadiazine .

Moisture-vapour-permeable film

moisture-vapour-permeable film ( MVPF )

silver sulphadiazine

MVPF

silver sulphadiazine

MVPF

MVPF

silver sulphadiazine

pain

difficulty in wound care

clinical infection rate

time to healing

management

burn

burns

burned

burn

burns


Effect of nimodipine upon electroencephalographic vigilance in elderly persons with minor impairment of brain functions . 10 volunteers ( 61-78 years ) with minor impairment of brain function were given placebo , 40 mg and 60 mg nimodipine ( Nimotop ) in single doses with intervals of 3 medication-free days between medications under double-blind conditions . Consecutive 2-s epochs of a 10-min EEG record ( resting conditions ) of F3/C3-F4/C4-P3/01-P4/02 were subjected to FFT ( Fast Fourier Transform ) . Using the information given by the 4 leads for each minute of recording the number of epochs which correspond to a stage A or non-A were determined . In order to evaluate subtle effects on electroencephalographic vigilance within stage A , also the anterior-posterior and left-right relations of absolute alpha-power were calculated . Since previous findings suggested that a nimodipine effect can only be demonstrated when individual differences in the baseline-EEG are considered , the subjects were subdivided in equal subgroups according to the number of non-A epochs under placebo . The rationale for this is the finding that in geriatric patients two electroencephalographically distinguishable forms of dissolution can be observed . Under both 40 mg and 60 mg nimodipine the subgroup with a prevalence of non-A epochs ( poor alpha-activity ) showed a decrease of non-A epochs ; the subgroup with a prevalence of A-epochs ( abundant alpha-activity ) , an increase . Opposite results for the two subgroups were also obtained for the left-right relations of alpha-power over the anterior regions . Under 40 mg nimodipine the subgroup with poor alpha-activity showed a shift to the left ; the subgroup with abundant alpha-activity to the right . Under 60 mg nimodipine both subgroups showed a shift to the left . The results confirm findings that nimodipine stabilizes electroencephalographic vigilance at a medium level . Moreover they suggest a dose dependence of the effect , i.e. , at higher doses nimodipine seems to act as a sedative .

placebo

nimodipine ( Nimotop )

10-min EEG

nimodipine

electroencephalographic vigilance

number of epochs

baseline-EEG

forms

non-A epochs

non-A epochs

left-right relations of alpha-power

alpha-activity

shift to the left

alpha-activity to the right

shift to the left

electroencephalographic vigilance


Actions of platelet activating factor ( PAF ) homologues and their combinations on neutrophil chemokinesis and cutaneous inflammatory responses in man . The inflammatory actions of synthetic C16:0 and C18:0 platelet activating factor ( PAF ) homologues , both alone and in combination , have been compared in an in vitro human neutrophil chemokinesis assay and by intradermal injection in human skin . In the chemokinesis assay , the maximum distance moved by neutrophils in the presence of C18:0 PAF was significantly greater than that seen with the C16:0 compound . A mixture of C16:0 and C18:0 PAFs in a ratio of 1:9 appeared to be more active than in a ratio of 3:1 . Intradermal injection of the C16:0 and C18:0 PAF homologues induced dose-dependent increases in weal volume and flare area responses which were not significantly different . Combination of these phospholipids in a ratio of 3:1 or 1:9 of C16:0 : C18:0 did not significantly alter the dose response curves . Thus , changes in the chain length of the alkyl substituent of synthetic PAF homologues and combination of these homologues , in ratios found in vivo or formed by leukocytes in vitro , did not alter the cutaneous inflammatory responses to PAF in man . The C18:0 homologue was , however , more active as a human neutrophil chemoattractant in vitro .

C18:0 PAF

C16:0 compound .

C18:0 PAFs

C16:0 and C18:0 PAF homologues

PAF homologues

C18:0 homologue

maximum distance moved by neutrophils

weal volume

flare area responses

inflammatory responses to PAF

neutrophil chemokinesis

cutaneous inflammatory responses

man

neutrophil chemokinesis

cutaneous inflammatory responses

man


Levamisole versus placebo as an adjunct to primary therapy of laryngopharyngeal epidermoid carcinoma . Evaluation of the immune status . Twenty-four patients , with a biopsy-proven laryngeal or hypopharyngeal carcinoma , received as an adjunct to their primary treatment ( surgery and/or radiotherapy ) , levamisole ( 150 mg daily during three consecutive days , every fortnight ) or placebo , following a single-blind , but randomized method . At the end of the follow-up , an investigation of the immune status was done , and compared with that of a healthy control-group . It is concluded that the immunity is disturbed in patients with laryngo-pharyngeal cancer , but that this disturbance does not clearly correlate with the clinical state of the disease . Also , the immunological measures did not appear relevant to the significantly favourable effect of levamisole on the prognosis .

Levamisole

placebo

levamisole

immune

immunity


Speech following sign language training in autistic children with minimal verbal language . This study was carried out to test the main and interaction effects of training condition and pretreatment-elicited verbal imitation ability when predicting spoken language use during language training of 60 minimally verbal autistic children . Subjects were randomly assigned to Speech Alone , Sign Alone , Simultaneous Presentation of Sign and Speech , and Alternating Presentation of Sign and Speech training conditions . Speech Alone , Simultaneous Presentation , and Alternating Presentation condition facilitated more child-initiated speech during treatment than did the Sign Alone condition . Regardless of training condition , pretreatment verbal imitation ability positively predicted the size of child-initiated spoken vocabulary observed during training . Exploratory analyses indicated that , in addition to verbal imitation , pretreatment age and IQ may also predict spoken language developed during training .

Speech following sign language training

language training

Alternating Presentation

Sign Alone

main and interaction effects

autistic

children

minimally verbal autistic children


The effect of metronidazole on the incidence of postoperative wound infection in elective colon surgery . A prospective randomized clinical trial assessing the relative effectiveness of erythromycin-neomycin and metronidazole-neomycin as a preoperative bowel preparation was carried out . Bacteriologic studies of feces and colon content revealed no significant difference in the reduction of aerobic bacteria between the two groups . There was , however , a significantly greater reduction in anaerobic bacteria in the feces and colon contents of patients receiving metronidazole . Wound infection rate was 25 % in the erythromycin group , and organisms recovered from the wound in all cases were fecal in nature . Two wound infections occurred in the metronidazole group ( 5 % ) and in both cases the organisms recovered were staphylococci of presumed skin origin . These studies suggest that anaerobic bacteria are the major contributors to wound infection after colon surgery and that their specific reduction is associated with a lower incidence of wound infection .

metronidazole

erythromycin-neomycin

metronidazole-neomycin

reduction of aerobic bacteria

reduction

anaerobic bacteria

Wound infection rate


Placebo-controlled double-blind trial of mianserin hydrochloride .

Placebo-controlled

mianserin hydrochloride .


Comparison of ketoconazole and griseofulvin in the treatment of tinea pedis . Twenty-nine patients with mycologically proven tinea pedis were randomly allocated to oral treatment with either ketoconazole 200 mg daily or griseofulvin 1 g daily for a period of up to 8 weeks . Mycological cure rate at 4 weeks was 33 % for ketoconazole and 29 % for griseofulvin , and at 8 weeks was 53 % and 57 % respectively . The efficacy of both drugs in the treatment of interdigital tinea pedis is similar , and is considerably lower than that found with topical imidazole preparations where cure rates of over 70 % are generally expected .

ketoconazole

griseofulvin

ketoconazole 200 mg daily

griseofulvin 1 g

ketoconazole

griseofulvin

Mycological cure rate

efficacy

cure rates

tinea pedis

Twenty-nine

tinea pedis


Effect of negative air ionization on hyperactive and autistic children . Twenty-one attention deficit disorder with hyperactivity and seven autistic children were randomly exposed to negatively ionized and ambient atmospheres under rigorously controlled experimental conditions . The negatively ionized condition did not significantly affect measurements of activity level , impulsivity , reality orientation , destructive/constructiveness , attention , or task performance . Significant results might be obtained if subgroups of known hyperserotoninemic autistic and attention deficit disorder children were exposed to negatively ionized conditions .

negative air ionization

negatively ionized condition

negatively ionized conditions

activity level

impulsivity

reality orientation

destructive/constructiveness

attention

task performance

hyperactive

autistic

children

Twenty-one

attention deficit disorder

hyperactivity

seven

autistic

children

hyperserotoninemic autistic

attention deficit disorder

children


A prospective , randomized study of 5-fluorouracil and filtration surgery . Our study shows that use of a small dose of subconjunctival 5-FU provides significantly lower postoperative intraocular pressure than does no antimetabolite treatment . Morphology of the postoperative blebs suggests that increased filtration results in lower intraocular pressure in the 5-FU group . Corneal epithelial defects were as common with a low dose as with higher doses previously described .

filtration surgery

subconjunctival 5-FU

no antimetabolite treatment

postoperative intraocular pressure

intraocular pressure

Corneal epithelial defects

5-fluorouracil and filtration surgery .


Effects of platelet suppressant , anticoagulant and fibrinolytic therapy in patients with recurrent venous thrombosis .


A 30-month longitudinal study of the effects of some oral hygiene measures on Streptococcus mutans and approximal dental caries . The effects of some oral hygiene measures on Streptococcus mutants and approximal dental caries were evaluated . One hundred and eighty-seven 13-year-old individuals with high levels of salivary S. mutans ( greater than 10 ( 6 ) /mL ) were selected . They were randomly distributed into three groups . Group I initially received professional mechanical tooth-cleaning , tongue-scraping , chlorhexidine treatment , and oral hygiene instructions concentrated on the approximal surfaces most colonized by S. mutans . The treatment was given four times with intervals of two days , followed by one single treatment every six months throughout the experimental period . The initial treatment period for group II , also consisting of four visits , included the same oral hygiene instructions as for group I . The instructions were repeated every six months . Group III was maintained in the preventive program provided by the local Dental Health Office , based on mechanical plaque control and topical use of fluorides and chlorhexidine at individualized intervals . Group I showed a significant immediate reduction of S. mutans in saliva as well as an approximal tooth surfaces . After six months , there were no differences among the three groups regarding these variables . Compared with baseline , there was a significant reduction of S. mutans in all groups . There was no significant difference in caries progression among the three groups . However , the selected " high-risk " individuals in group I developed 0.25 new manifest caries lesions approximally/year , compared with 0.27 for all children of the same age group in the area . Seventeen individuals had approximal surfaces with consistently high or consistently low S. mutans levels . Forty-six percent of the surfaces with high values developed new or progressive caries , compared with 2 % of the surfaces with low values .

oral hygiene measures

oral hygiene measures

professional mechanical tooth-cleaning

tongue-scraping

chlorhexidine treatment

oral hygiene instructions

oral hygiene instructions

mechanical plaque control

Streptococcus mutants

approximal dental caries

S. mutans

caries progression

mutans levels

new or progressive caries


Nebulized racemic epinephrine by IPPB for the treatment of croup : a double-blind study . Racemic epinephrine has been advocated for the treatment of croup , but controlled studies have not proved it more effective than saline . Twenty patients ( aged 4 months to 5 years ) hospitalized with acute croup and persistent inspiratory stridor at rest were randomly assigned to one of two treatment groups : saline or racemic epinephrine , both nebulized and delivered by intermittent positive pressure breathing . Clinical scores were significantly improved ( P less than .01 ) at ten and 30 minutes following the treatment with racemic epinephrine but not at 120 minutes . Racemic epinephrine was significantly more effective than saline at 10 ( P less than .01 ) and 30 minutes ( P less than .05 ) but not at 120 minutes after the treatment . We conclude that nebulized racemic epinephrine is effective treatment for the acute signs of croup .

racemic epinephrine

Racemic epinephrine

saline or racemic epinephrine

racemic epinephrine

Racemic epinephrine

racemic epinephrine

Clinical scores

effective

croup

Twenty patients

aged 4 months to 5 years

croup


Hemolytic streptococcus preparation OK-432 ; beneficial adjuvant therapy in recurrent gastric carcinoma . The administration of a hemolytic streptococcus preparation , OK-432 , is thought to be of therapeutic value in the treatment of cancer patients through a stimulatory effect on the immune system . In order to evaluate any beneficial effect of such an administration , a group of patients with recurrent gastric cancer was studied . This group was randomly subdivided into 3 groups : 1 ) Intradermal group ( ID Group ) , 42 patients given an intradermal injections of OK-432 . 2 ) Intramuscular group ( IM Group ) , 40 patients given an intramuscular injections of OK-432 . 3 ) Control group ( C Group ) , 39 patients not given injections . Each group was studied in regards to the length of survival , the host immune response and the incidence of side effects . When compared to the IM and C Groups , the ID Group showed improved survival . Accompanying this improved survival , the ID Group also had greater white cell and lymphocyte counts , a greater number of T cells , and a more dramatic skin reaction to the extracted cell wall polysaccharide of hemolytic streptococcus Su-strain ( Su-PS ) . The ID Group , following OK-432 injection , had a 4.8 % incidence of fever and a 52.4 % incidence of local abscess formation at the injection site . 90 % of the IM Group developed fever but abscess formation was absent in all patients . From these results , it was concluded that in the patients tested , intradermal injection of OK-432 appears to be clinically superior to intramuscular injection .

hemolytic streptococcus preparation

intradermal injections of OK-432

intramuscular injections of OK-432

Control

length of survival

host immune response

incidence of side effects

survival .

white cell and lymphocyte counts

T cells

dramatic skin reaction

fever

local abscess formation

fever

abscess formation

recurrent gastric carcinoma .

cancer


Randomized trial of high-dose cytarabine versus amsacrine in acute myelogenous leukemia in relapse : a Leukemia Intergroup Study . Patients with acute myelogenous leukemia in relapse who were ineligible for further anthracycline therapy either because they were judged to be anthracycline resistant or had received the maximum doses were randomized to receive high-dose cytarabine ( 3 g/m2 every 12 hours for 6 days ) or amsacrine ( 75 mg/m2 daily for 7 days ) . The response rates in both groups were similar : three of 25 patients given high-dose cytarabine and three of 23 given amsacrine obtained complete remissions .

cytarabine

amsacrine

anthracycline therapy

anthracycline

cytarabine

amsacrine

cytarabine

amsacrine

response rates

complete remissions .

acute myelogenous leukemia in relapse

acute myelogenous leukemia in relapse

anthracycline resistant

had received the maximum doses


Veterans Administration Cooperative Study on antiplatelet agents in diabetic patients after amputation for gangrene : II . Effects of aspirin and dipyridamole on atherosclerotic vascular disease rates . We report the results of a randomized multicenter clinical trial on the effects of aspirin plus dipyridamole versus placebo on major vascular end points in 231 non-insulin-dependent diabetic men with either a recent amputation for gangrene or active gangrene . Primary end points were death from atherosclerotic vascular disease plus amputation of the opposite extremity for gangrene . There were 24 atherosclerotic deaths in the drug treatment group ( 21.8 % ) and 23 in the placebo group ( 19.0 % ) . There were 22 patients in the drug treatment group ( 20.0 % ) and 29 patients in the placebo group ( 24.0 % ) with opposite-side amputations . Survival curve analyses revealed little difference between these groups for major vascular end points , total mortality , all amputations , or myocardial infarctions . The most noteworthy group difference was observed for cerebrovascular end points ( strokes and transient ischemic attacks ) , with an incidence of 8.2 % ( 9 patients ) in the drug treatment group and 19.0 % ( 23 patients ) in the placebo group . We conclude from this study that antiplatelet agents have no effect on the primary vascular end points , vascular deaths and/or amputation of the opposite extremity , in this population . Similarly , no effects were seen on secondary vascular end points , except for a suggestion of protection versus strokes and transient ischemic attacks . However , this finding must be interpreted with caution , since it is a secondary end point and was found only after multiple analyses of the data .

antiplatelet agents

aspirin

dipyridamole

aspirin plus dipyridamole

placebo

placebo

atherosclerotic vascular disease rates

vascular end points

death

atherosclerotic deaths

opposite-side amputations

vascular end points

total mortality

amputations

myocardial infarctions

cerebrovascular end points

strokes and transient ischemic attacks

vascular deaths

amputation of the opposite extremity

diabetic

amputation

gangrene

non-insulin-dependent diabetic

gangrene

gangrene


Hexetidine ( 'Oraldene ' ) : a report on its antibacterial and antifungal properties on the oral flora in healthy subjects . A randomized , double-blind crossover trial , in 10 adult healthy subjects , was carried out to compare the antibacterial and antifungal activity of a 0.1 % solution of hexetidine with that of placebo . The pre-dosing oral flora of the subjects was assessed from saliva samples cultured for aerobic and anaerobic bacteria , as well as Candida albicans . Subjects then rinsed their mouths for 1 minute 3-times a day with 15 ml 0.1 % hexetidine or placebo , saliva samples being collected at 2 minutes , 30 minutes , 1 hour , 3 hours and 5 hours post-dosing . Dosing was continued for 8 consecutive days on each treatment with an intervening wash-out period of 1 week . Hexetidine reduced aerobic bacterial counts on Day 1 and Day 8 by a maximum of 83 % and 86 % , respectively , at 2 minutes post-dosing . The reductions were statistically significantly lower than placebo up to 1 hour post-dose on Day 1 and up to 3 hours post-dose on Day 8 . Similarly for anaerobic bacterial counts , 92 % and 88 % maximum reductions were recorded on Day 1 and Day 8 , which again were significantly lower than placebo for up to 3 hours post-dose . For Candida albicans , however , the maximum reduction was 91 % on the first day and 67 % on Day 8 , maintained for 30 minutes post-dosing . Although not eradicating completely aerobic and anaerobic bacteria , it is concluded that the substantial reduction in their numbers should prove clinically useful .

Hexetidine ( 'Oraldene ' )

0.1 % solution of hexetidine

placebo

hexetidine

placebo

Hexetidine

placebo

antibacterial and antifungal properties

antibacterial and antifungal activity

aerobic bacterial counts

anaerobic bacterial counts

healthy

adult

healthy


Postoperative radiotherapy in breast cancer -- long-term results from the Oslo study . The long-term results of a randomized clinical trial evaluating the effect of postoperative radiotherapy as an adjuvant to radical mastectomy are presented . There were 1115 patients including 27 protocol deviants . The follow-up time is 11-20 years . In the first part a conventional roentgen unit was used , and in the second part a 60Co unit , with considerably increased dosage and altered treatment plan . Both types of radiation techniques lowered the incidence of loco-regional recurrences significantly , but had no significant influence on the overall survival . The relapse-free survival was significantly improved by 60Co radiation in Stage II patients , but was unaffected by radiation in the other subgroups . Regarding survival , Stage II patients with medially located tumors seemed to benefit more from 60Co radiation than those with lateral tumors . A significant increase in the number of deaths caused by myocardial infarction was observed in Stage I patients having 60Co radiation , indicating that the radiation dose to the heart is of significance .

radiotherapy

postoperative radiotherapy

radical mastectomy

conventional roentgen unit

60Co unit

60Co radiation

60Co radiation

incidence of loco-regional recurrences

survival

Oslo study .


A prospective study of streptokinase and heparin in the treatment of deep vein thrombosis . In a prospective trial , 42 medical patients with a history of deep vein thrombosis of less than five days were allocated at random to treatment with streptokinase or heparin . Only patients with extensive thromboses were included . Streptokinase was given in a loading dose of 250 000 IU and a maintenance dose of 100 000 IU/hour for 4 days as a mean . Heparin was given in a loading dose of 15 000 IU and a maintenance dose of 20 000-50 000 IU/day . The therapeutic results were evaluated by phlebography . Significant thrombolysis occurred in 71.4 % of 21 patients treated with streptokinase and in 23.8 % of the 21 heparin-treated patients . Using the chi2-test for overall association , this difference was statistically highly significant ( p = 0.002 ) . Three patients in each treatment group experienced major bleeding , two in each group requiring blood transfusions . Minor bleeding and slight rise in temperature were encountered more often in the streptokinase than in the heparin group . It is concluded that patients with acute deep vein thrombosis with proximal extension of the thrombus beyond the calf veins should be offered a therapeutic trial with streptokinase .

streptokinase

heparin

streptokinase

heparin .

Streptokinase

Heparin

streptokinase

heparin-treated

streptokinase

heparin

streptokinase .

deep vein thrombosis

Significant thrombolysis

major bleeding

blood transfusions

Minor bleeding

and slight rise in temperature

deep vein thrombosis

42 medical patients


A randomized comparison of tamoxifen with surgical oophorectomy in premenopausal patients with advanced breast cancer . We randomized 122 premenopausal women to receive tamoxifen or to undergo a surgical oophorectomy . Of 54 evaluable women treated with tamoxifen , 24 % had an objective response , as compared with 21 % of 53 women having an oophorectomy . The median duration of response for tamoxifen ( 20 months ) was longer than that for surgical oophorectomy ( 7 months ) , but this did not achieve statistical significance ( P = .056 ) . Overall median survival was 15 months for 58 patients receiving tamoxifen and 25 months for 53 patients undergoing oophorectomy ( P = .18 ) . Toxicity was greater in those undergoing oophorectomy , though both treatments were well tolerated . In those premenopausal women for whom hormonal therapy is indicated , tamoxifen is a suitable alternative to surgical oophorectomy .

tamoxifen

surgical oophorectomy

tamoxifen

undergo a surgical oophorectomy .

tamoxifen

oophorectomy

tamoxifen

surgical oophorectomy

tamoxifen

surgical oophorectomy

objective response

median duration of response

Overall median survival

Toxicity

well tolerated .

premenopausal

women

women

women

premenopausal

women


Trial of ( + ) -cyanidanol-3 in patients with hepatitis B chronic liver disease . A double-blind controlled trial of 12 months ' treatment with ( + ) -cyanidanol-3 was carried out in 26 patients with chronic hepatitis B liver disease . Treatment did not improve liver blood tests nor histological appearances of the liver , but there was a trend towards reduction of serum titres of hepatitis B surface antigen .

( + ) -cyanidanol-3

hepatitis B chronic liver disease

26 patients


Treatment of gastrointestinal cancer : the Southeastern Cancer Study Group experience , 1979 to 1983 . The treatment of gastrointestinal cancer was studied in 20 phase I , II , and III clinical trials from 1979 to 1983 at 30 member institutions of the Southeastern Cancer Study Group ( SECSG ) . These studies used both new and commercially available drugs , as well as surgery and/or radiation therapy in 1,087 patients . No significant benefit was seen from 18 agents , and one agent is still under evaluation . Unfortunately , no recommendations can be drawn from these studies that would alter presently accepted methods of management . Adenocarcinoma of the gastrointestinal tract remains a major challenge to tumor biologists and clinical oncologists because it is generally resistant to chemotherapy and radiation therapy , yet common enough to represent a vital public health concern in America .

new and commercially available drugs

surgery

radiation therapy

18 agents

chemotherapy

radiation therapy

gastrointestinal cancer

gastrointestinal cancer


NSAID ionisation in the management of soft-tissue rheumatism : role played by the drug , electrical stimulation and suggestion . Four treatments for soft-tissue rheumatism -- sham ionisation , placebo ionisation , and pharmacological ionisation with pirprofen ( two-dose levels ) -- were assessed in a randomized double-blind , between-patient controlled trial in 73 outpatients affected by scapulo-humeral periarthritis or elbow epicondylitis . Treatment lasted two weeks ( 5 sessions a week ) . Progress was measured by patient 's assessment on pain at rest and on movement and by physician 's assessment on functional impairment . At two weeks each treatment was associated with a significant degree of improvement ; however , pharmacological ionisation produced a significantly higher improvement in symptoms . No differences were detected between sham ionisation and placebo ionisation . These results suggest that the ionisation procedure displays per se a moderate therapeutic effect which seems to be due more to a simple placebo effect than to the biological effect of electricity .

placebo ionisation

pain at rest and on movement

improvement

therapeutic effect

soft-tissue rheumatism


An international multi-clinic study comparing the therapeutic efficacy of colloidal bismuth subcitrate coated tablets with chewing tablets in the treatment of duodenal ulceration . The results of a randomized , single-blind , multi-clinic study comparing the therapeutic efficacy and degree of oral staining of new colloidal bismuth subcitrate ( CBS ) coated tablets over 4 weeks of treatment in patients suffering from duodenal ulceration are reported . The data were collected from 9 clinics in the Netherlands , Belgium , Ireland , the United Kingdom , and Italy . The results from 94 patients treated with CBS coated tablets and 95 patients treated with CBS chewing tablets were statistically evaluated . Healing rates after 4 weeks of therapy appeared to be 76 % for CBS coated tablets and 72 % for CBS chewing tablets , so no statistically significant difference in therapeutic efficacy was seen . A highly significant degree of discolouration of all parts of the oral cavity was observed in patients treated with CBS chewing tablets , whereas only a few patients treated with CBS coated tablets experienced a slight staining of the tongue . Blood bismuth concentrations during the study had a range of less than or equal to 3 to 33 micrograms/l . The new CBS coated tablet form has an excellent patient compliance as compared to the chewing tablets .

chewing tablets

CBS coated tablets

CBS chewing tablets

CBS coated tablets

CBS chewing tablets

CBS chewing tablets

CBS coated tablets

CBS coated tablet

chewing tablets

Healing rates

slight staining of the tongue

Blood bismuth concentrations

excellent patient compliance


Transcutaneous electrical nerve stimulation following appendicectomy : the placebo effect . A controlled trial was undertaken to compare the efficacy of transcutaneous electrical nerve stimulation ( TENS ) with standard intramuscular opiate analgesia in the management of postoperative pain following appendicectomy . Consecutive patients undergoing emergency appendicectomy were randomised into control , sham TENS and active TENS groups . There was a significant decrease in pain severity and analgesic intake in both active and sham TENS groups when compared with the control group ( P less than 0.01 ) . No difference was demonstrated in pain severity between active and sham TENS groups but the active TENS group required slightly less analgesia . These results suggest that the major benefit of TENS in the postappendicectomy patient is due to its 'placebo effect ' and its use in this situation can not be recommended .

standard intramuscular opiate analgesia

emergency appendicectomy

sham TENS and active TENS groups

active

sham TENS

control group

active

sham TENS

active TENS

TENS

pain severity and analgesic intake

pain severity

following appendicectomy

following appendicectomy

undergoing emergency appendicectomy

postappendicectomy patient


An analysis of the radiation related morbidity observed in a randomized trial of neutron therapy for bladder cancer . This report is an analysis of the morbidity in the bladder and bowel observed in a randomized trial of d ( 15 ) +Be neutrons versus megavoltage photons in the treatment of bladder cancer . Acute reactions in the bladder and bowel were significantly worse after photon therapy . Of the patients treated with photons 45.7 % had severe reactions in the bladder compared with 10.6 % after neutron therapy ( p less than 0.001 ) . Severe acute bowel reactions were observed in 8.5 % of the patients after photon therapy compared with 3.8 % after neutron therapy ( p less than 0.05 ) . Late reactions were significantly worse after neutrons . Severe late reactions in the bladder were seen in 58.5 % of patients after neutron therapy and in 40.5 % after photon therapy ( p less than 0.05 ) . In the bowel they were observed in 53.3 % of patients after neutron therapy compared with 8 % after photon therapy ( p less than 0.0001 ) . The disparity in the degree of early and late complications makes assessment of RBE values difficult . It is estimated that for bladder morbidity the RBE value , for photon dose fractions of 2.75 Gy , is less than 3.3 for early reactions and equal to 3.4 for late effects . The respective RBE values for early and late effects in the bowel are less than 3.4 and 3.8 .

neutron therapy

d ( 15 ) +Be neutrons

megavoltage photons

photon therapy

photons

neutron therapy

photon therapy

neutron therapy

neutrons

neutron therapy

photon therapy

neutron therapy

photon therapy

morbidity

morbidity

Acute reactions

reactions in the bladder

Severe acute bowel reactions

Late reactions

Severe late reactions in the bladder

RBE values

bladder morbidity

RBE value

RBE values

bladder cancer .

morbidity in the bladder


Monotherapy of mild hypertension with nifedipine . The effectiveness of nifedipine as first-line monotherapy for mild diastolic hypertension ( range : 95 to 105 mm Hg ) was tested in this placebo-controlled , double-blind , randomized trial . Fifty-six patients were enrolled and , after titration of the placebo or active drug , they were followed for 12 weeks . Significant declines in the sitting systolic and diastolic pressures of -19 +/- 4 mm Hg ( standard error ) and -13 +/- 2 mm Hg , respectively , were observed during this follow-up period . Overall , 75 percent of patients receiving active drug had diastolic pressures less than or equal to 90 mm Hg at the last treatment visit . Heart rate was not significantly changed in the sitting position during the treatment period , and the majority of patients ( 75 percent ) showed a response to nifedipine doses of 10 or 20 mg orally three times daily in the capsule form . The levels of the systolic and diastolic pressures at entry were not predictive of the dose of nifedipine required for effective blood pressure control .

nifedipine

nifedipine

placebo-controlled

nifedipine

nifedipine

hypertension

effectiveness

diastolic hypertension

systolic and diastolic pressures

diastolic pressures

Heart rate

systolic

diastolic pressures

effective blood pressure

mild hypertension

mild diastolic hypertension

Fifty-six


Prazosin versus captopril as initial therapy . Effect on hypertension and lipid levels . A randomized , parallel group study evaluated the safety , efficacy , and effect of the alpha blocking agent prazosin and the angiotensin converting enzyme inhibitor captopril on serum lipid levels in patients with mild to moderate hypertension . Baseline evaluations were performed on 31 patients after a four-week placebo washout period . Patients were randomly assigned to receive either prazosin ( n = 15 ) or captopril ( n = 16 ) . Daily doses were titrated as follows : for prazosin , 1 mg two times daily to maximum of 20 mg per day ; for captopril , 25 mg three times daily to a maximum of 450 mg per day . If diastolic blood pressure was not adequately controlled ( less than 85 mm Hg ) after four weeks of monotherapy , 1 mg of polythiazide was added to the daily regimen . There were no statistically significant differences between the drug groups for the measured variables in either the parallel or crossover phase of the study . Five of 15 prazosin-treated patients and six of 16 captopril-treated patients required the addition of thiazide to achieve blood pressure control .

Prazosin

captopril

prazosin

captopril

prazosin

captopril

prazosin

captopril

polythiazide

prazosin-treated

thiazide

hypertension and lipid levels

safety , efficacy , and effect

diastolic blood pressure

blood pressure control

hypertension and lipid levels .


Untoward effects of fenfluramine in autistic children . Several recent studies have described the benefits of fenfluramine for the symptomatic treatment of infantile autism . No large surveys of side effects of this drug have been reported in autistic children . To evaluate the untoward effects of fenfluramine in children with autism , 12 subjects were systematically studied . Medication was administered in a double-blind , placebo-controlled cross-over study . Parents were trained in monitoring untoward effects . These observations were compiled in detailed daily notes . In addition , four cases describing unusual effects found in a sample of 170 patients treated with fenfluramine are also reported . In the initial 2 weeks of active drug listlessness , food refusal , and stomach upset were frequently seen . A different pattern of untoward effects was seen in the final 14 weeks of treatment . Irritability , agitation , and crying along with continued food refusal were noted . The subjects lost 2.1 % of body weight during active drug phase , but there was a rebound weight gain during the subsequent placebo phase . A thorough understanding of fenfluramine 's side effects and adverse reactions is necessary so as to differentiate them from the multiple symptoms inherent in the syndrome of autism .

fenfluramine

fenfluramine

fenfluramine

placebo-controlled

fenfluramine

placebo

fenfluramine 's

food refusal

stomach upset

untoward effects

body weight

rebound weight gain

children

infantile

autism .

four

sample of 170 patients


Treatment of duodenal ulcer with low-dose antacids . The aim of the present investigation was to compare the efficacy of a low-dose antacid ( Maalox 70 , 280 mmol/day ) with that of the H2-receptor antagonist cimetidine ( Tagamet , 200 mg three times daily and 400 mg/day ) after 14 and 28 days in the treatment of duodenal ulcer . The prospective multicentre study included 171 patients with endoscopically confirmed duodenal ulcers . The patients were randomly assigned to the treatment groups with antacid containing Mg and Al hydroxide ( M ) ( 4 X 70 mmol/day ; n = 86 ) or to the group receiving cimetidine ( T ) ( 1000 mg/day ; n = 85 ) . The two treatment groups were matched for age , sex , drinking and smoking habits , and drug use . Endoscopic examinations were carried out before the start of treatment and 14 days later . If the ulcer was still present at this time , the second endoscopic examination was done after a further 14 days . Endoscopically , the ulcer had healed at 14 days in 38.8 % ( M ) and in 34.9 % ( T ) and at 28 days in 80.0 % ( M ) and 74.7 % ( T ) , respectively . The healing rate did not differ significantly between the two treatment groups . Complaints , measured as percentage of days per week with upper abdominal pain , were significantly reduced in both groups . No significant differences were found between the two treatment groups with regard to pain relief or side effects . Treatment had to be abandoned in one patient receiving antacid because of diarrhoea and in one patient receiving cimetidine because of the absence of any response . ( ABSTRACT TRUNCATED AT 250 WORDS )

low-dose antacids

low-dose antacid ( Maalox 70

cimetidine

healed

healing rate

Complaints

upper abdominal pain

pain relief

side effects

duodenal ulcer

duodenal ulcer

duodenal ulcers


The UKEP study : multicentre clinical trial on two local regimens of urokinase in massive pulmonary embolism . The UKEP Study Research Group . A multicentre trial ( 10 centres ) of urokinase ( UK ) was performed in patients with acute severe pulmonary embolism ( PE ) . The aim of this trial was , to compare the efficacy of two doses of UK administered via a catheter in the pulmonary artery : 2000 IU kg-1 h-1 for 24 hours ( UK 2000 ) in conjunction with heparin versus 4400 IU kg-1 h-1 UK alone for 12 hours ( UK 4400 ) followed by heparin . PE was less than 5 days old and the clinical diagnosis was confirmed by pulmonary angiograms demonstrating a vascular obstruction of more than 30 % ( Miller 's index greater than 11 ) . The efficacy of treatment was evaluated by the degree of early revascularization ( pulmonary angiograms were performed 30 to 48 hours after initiation of thrombolytic treatment and analysed blindly by four independent vascular radiologists ) . 133 patients were included in this trial : two patients died before treatment and two were excluded retrospectively , leaving 129 patients for final analysis ( 67 : UK 2000 + heparin ; 62 : UK 4400 ) . The two groups had similar pretreatment clinical , haemodynamic and angiographic characteristics : the Miller angiographic index of severity averaged 22.6 +/- 3.7 for patients in the UK 2000 group , and 22.6 +/- 3.4 for patients in the UK 4400 group ( average filling defect of 66 % on pulmonary angiograms ) . There was a similar and significant degree of resolution in the two groups : 26 % and 20 % , respectively . Minor and major bleeding problems were observed with equal frequency in the two groups ( 24 % and 29 % , respectively ) . These bleeding complications were severe in only 4.5 % and 3 % , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS )

urokinase

two doses of UK

thrombolytic treatment

degree of early revascularization

died

Miller angiographic index

significant degree of resolution

Minor and major bleeding problems


Antihypertensive and volume-depleting effects of mild exercise on essential hypertension . After a general clinical observation period of over 4 weeks , 20 essential hypertensive subjects ( Japanese ) were randomly divided into two groups . One group ( n = 10 ; 4 men and 6 women ; 51.4 +/- 2.8 years of age ) agreed to physical training using bicycle ergometer exercise with the intensity at blood lactate threshold for 60 minutes three times a week for 10 weeks , while the other group ( n = 10 ; 4 men and 6 women ; 51.0 +/- 2.9 years of age ) did no particular physical training and was followed once a week as the control . Changes in blood pressure , hemodynamics , and humoral factors of the exercised group were compared with values in the controls . The following significant changes were found only in the exercised group . Blood pressure was significantly ( p less than 0.01 ) reduced . Whole blood and plasma volume indices were significantly reduced ( p less than 0.05 , p less than 0.01 , respectively ) . The change in ratio of serum sodium to potassium positively correlated with the change in systolic blood pressure ( r = 0.76 , p less than 0.02 ) . Plasma norepinephrine concentrations both at rest and at the workload of blood lactate threshold during graded exercise tests were significantly reduced ( p less than 0.05 , p less than 0.02 respectively ) after 10 weeks of exercise training . The change in the resting level of plasma norepinephrine positively correlated with that in the mean blood pressure . No such changes were observed in the control group . In both groups , body weight and urinary sodium excretion showed no statistically significant changes . ( ABSTRACT TRUNCATED AT 250 WORDS )

mild exercise

no particular physical training

exercise training .

blood pressure

hemodynamics

humoral factors

Blood pressure

Whole blood and plasma volume indices

systolic blood pressure

Plasma norepinephrine concentrations

resting level of plasma norepinephrine

mean blood pressure .


Hepatorenal syndrome . Studies of the effect of vascular volume and intraperitoneal pressure on renal and hepatic function . Eleven patients with well-documented hepatorenal syndrome were studied by measurement of blood volume , glomerular filtration rate , renal plasma flow , plasma aldosterone concentration , renin substrate concentration , and plasma renin activity . They were then given 750 ml of stored plasma , 750 ml of fresh frozen plasma , and then an infusion of angiotensin II , in random order on successive days . Infusion of fresh frozen plasma improved function more than did stored plasma and in addition returned a very low filtration fraction toward normal . Angiotensin II infusion increased filtration fraction , but decreased glomerular filtration rate , renal plasma flow , and urine flow sharply . Patients were then given a daily infusion of 1,000 ml of fresh frozen plasma for seven to 18 days to expand the blood volume to supranormal levels as assayed by serial measurement of blood volume . Plasma aldosterone levels decreased to a normal range , glomerular filtration rate and renal plasma flow both increased , and urinary excretion of sodium and potassium both returned toward normal . The effect of intraperitoneal pressure was then studied by measuring glomerular filtration rate , renal plasma flow , pressure in the vena cava , hepatic vein free flow , and hepatic vein wedged pressure before , during , and after paracentesis to reduce the intraperitoneal pressure from 30 to 40 cm H2O to 12 to 17 cm H2O . Venous pressures moved parallel to ascitic fluid pressures , and glomerular filtration rate , renal plasma flow , and urine flow all improved sharply ; then , as ascitic fluid continued to form , reducing vascular volume , urine flow , glomerular filtration rate , and renal plasma flow all decreased slowly . Six patients then underwent placement of a LeVeen shunt . Improvement in glomerular filtration rate and renal plasma flow and clinical condition was dramatic . During postoperative observation of up to two years , progressive improvement in hepatic function has occurred .

750 ml of stored plasma

750 ml of fresh frozen plasma

infusion of angiotensin II

Infusion of fresh frozen plasma

Angiotensin II infusion

1,000 ml of fresh frozen plasma

renal and hepatic function

blood volume

glomerular filtration rate

renal plasma flow

plasma aldosterone concentration

renin substrate concentration

plasma renin activity

filtration fraction

glomerular filtration rate

renal plasma flow

urine flow

Plasma aldosterone levels

glomerular filtration rate

renal plasma flow

glomerular filtration rate

renal plasma flow

pressure in the vena cava

hepatic vein free flow

hepatic vein wedged pressure

Venous pressures

ascitic fluid pressures

glomerular filtration rate

renal plasma flow

urine flow

vascular volume

urine flow , glomerular filtration rate

renal plasma flow

glomerular filtration rate

renal plasma flow

clinical condition

hepatic function


A randomized study of fetal abdominal diameter and fetal weight estimation for detection of light-for-gestation infants in low-risk pregnancies . A total of 2771 pregnant women with gestational age estimated by ultrasound measurement of the fetal biparietal diameter ( BPD ) before the 22nd week of gestation were re-examined by ultrasound in the 32nd and 37th week of pregnancy at which time the fetal BPD and abdominal diameter ( AD ) were measured . An additional examination was performed at 34 weeks if the fetal weight in the 32nd week was estimated to be less than 95 % of the expected mean weight . Light-for-gestational age ( LGA ) was suspected if the estimated birth-weight was less than 85 % of the expected mean birthweight . This applied to 186 uncomplicated pregnancies in which there was no clinical suspicion of poor intrauterine growth . These pregnancies were randomly allocated to a treatment group ( AD and estimated weight reported ) or to a control group ( AD and estimated weight withheld ) . Induction of labour was significantly more common in the treatment group ( 41 % ) than in the control group ( 15 % ) . No statistically significant difference was found in the use of instrumental vaginal delivery or caesarean section . There was a suggestion of marginal benefit in terms of neonatal morbidity but this was not statistically significant .

ultrasound

Light-for-gestational age ( LGA )

poor intrauterine growth

Induction of labour

neonatal morbidity

light-for-gestation

infants

low-risk pregnancies

pregnant

women

32nd and 37th week of pregnancy


Cognitive and psychomotor effects of different antidepressants in the treatment of old age depression .

antidepressants

Cognitive and psychomotor

old age

depression


The effects of delay in standard treatment due to induction chemotherapy in two randomized prospective studies . It is often suggested that tumors will respond to induction chemotherapy and result in improved survival for patients with squamous cell carcinoma of the head and neck . Two regimens of induction chemotherapy were studied in separate randomized , prospective trials over the last 6 years . Eighty-three patients with advanced disease were entered into the first study ( 43/chemotherapy ; 40/control ) , and 60 into the second ( 27/chemotherapy ; 33/control ) . Patient randomization was stratified by stage ( III/IV ) and site ( oral cavity , oropharynx , nasopharynx , hypopharynx , larynx , paranasal sinuses ) . The first study utilized bleomycin , Cytoxan , methotrexate and 5-fluorouracil in two cycles ( one cycle if no tumor response ) , followed by standard treatment which consisted of combined irradiation and surgery or , in some instances , primary irradiation alone . The second study utilized cisplatin and 5-fluorouracil in three cycles prior to standard treatment . An objective tumor response to chemotherapy was observed in 68 % in the first study and 85 % in the second . The patient survival in both studies ( at 24 months in the first ; at 19 in the second ) was better in the control than that in the experimental groups ( 43 % to 31 % ; 69 % to 46 % ) . In the second study , the average length of delay of standard treatment was longer than in the first study ( 95 days vs. 66 days ; P less than .02 ) . Results combining the P-values of both studies indicate that the relative risk of having persistent disease was 2.9 times greater for patients who received chemotherapy . While toxicity to chemotherapy was not a factor in survival , the number of patients who withdrew from the studies and those who did not comply with treatment were greater in the chemotherapy groups . Except for new drug regimens of exceptional promise , it is recommended that future studies be designed so that chemotherapy is given concurrent with , or following the completion of standard treatment .

induction chemotherapy

utilized bleomycin

Cytoxan

methotrexate

cisplatin

prior to standard treatment

survival

objective tumor response

patient survival

toxicity to chemotherapy


Comparison of inhaled albuterol powder and aerosol in asthma . In this multicenter , randomized , double-blind study comparing the efficacy and safety of aerosolized albuterol with the dry powder formulation , 231 patients with chronic reversible obstructive airway disease were randomly allocated to receive either placebo albuterol aerosol followed immediately by active albuterol powder ( 200 micrograms ) or active albuterol aerosol ( two puffs , 180 micrograms ) followed immediately by placebo lactose powder four times a day for a period of 12 weeks . No statistically significant differences were found between the powder and aerosol formulations with respect to pulmonary function , length of time mean FEV1 remained greater than or equal to 15 % above baseline , physicians ' assessments of patients ' clinical response , or patients ' subjective symptom scores . There were also no significant differences between treatment groups in cardiovascular effects , laboratory values , or adverse events . Among patients who expressed a preference for one of the delivery systems , half preferred using the powder . Results of this study demonstrate that 200 micrograms of albuterol powder is as safe and effective as 180 micrograms of albuterol aerosol .

inhaled albuterol powder and aerosol

placebo albuterol aerosol

active albuterol powder

active albuterol aerosol

placebo lactose powder

powder

aerosol

albuterol powder

albuterol aerosol

pulmonary function

length of time mean FEV1

patients ' subjective symptom scores

cardiovascular effects

laboratory values

adverse events

asthma

half


Effects of nifedipine on gastric acid secretion and gastrin release in man . As calcium is important in the regulation of gastric acid secretion and gastrin release , we have examined the effect of the calcium antagonist nifedipine on these processes in man . Nifedipine 30 mg orally inhibited basal acid output by 37 % ( p less than 0.025 ) and that stimulated by low infusion rates of pentagastrin -- that is , 0.031 and 0.062 microgram/kg/h by 44 % ( p = 0.05 ) and 39 % ( p less than 0.02 ) respectively . On increasing the pentagastrin infusion rate the inhibition was surmounted suggesting it was competitive in type . Nifedipine did not affect basal or Oxo meal stimulated gastrin concentrations in normal volunteers nor did it affect resting serum gastrin or calcium stimulated increase in gastrin in a single patient with Zollinger-Ellison syndrome . These findings are consistent with the transmembrane flux of calcium ions being involved in basal and pentagastrin stimulated acid secretion in man .

nifedipine

nifedipine

Nifedipine

pentagastrin

pentagastrin

Nifedipine

gastric acid secretion

gastrin release

resting serum gastrin

calcium stimulated increase in gastrin

gastric acid secretion

gastrin release

man

Zollinger-Ellison syndrome

pentagastrin stimulated acid secretion


Sucralfate overcomes adverse effect of cigarette smoking on duodenal ulcer healing and prolongs subsequent remission . A unicenter , single-blind , randomized study was conducted on 283 patients with active duodenal ulcer to compare possible factors that may affect healing and relapse in patients treated with a potent antisecretory agent , cimetidine , or a site-protective and cytoprotective agent , sucralfate . The endoscopic healing rates at 4 wk were 76 % and 79 % , respectively , and cross-over treatment of the failures for a further 4 wk resulted in 68 % healing with cimetidine and 69 % healing with sucralfate , both differences being not statistically different . Unlike cimetidine , healing by sucralfate was unaffected by cigarette smoking , reluctance to give up smoking , habitual use of alcohol , high maximal acid output , and large ulcer diameter . In particular , the healing rate of smokers treated with sucralfate ( 82 % ) was significantly greater than that of smokers treated with cimetidine ( 63 % ) . Duodenal bulb deformity significantly affected healing in both groups , and was the only offsetting factor identifiable for sucralfate out of 46 factors examined . Of the patients with healed ulcers , 238 participated in a 24-mo follow-up study consisting of interviews at 2-mo intervals and endoscopy at 4-mo intervals or whenever symptoms recurred . The cumulative relapse rate was significantly ( p less than 0.007 ) greater in patients healed with cimetidine than with sucralfate , 50 % relapse occurring at 6 and 12 mo , respectively . In both , the cumulative relapse rate was significantly greater in cigarette smokers than in nonsmokers , but smokers and nonsmokers treated with cimetidine relapsed ( 50 % at 4 and 8 mo , respectively ) faster than the corresponding smokers and nonsmokers treated with sucralfate ( 50 % at 8 and 18 mo , respectively ) . Furthermore , in cimetidine- but not sucralfate-healed patients , early ulcer relapse ( within 6 mo ) was associated with short duration of illness , short remission period , long symptomatic spell , and reluctance to give up smoking . We conclude that smoking adversely affects duodenal ulcer healing by cimetidine and hastens subsequent relapse , and that sucralfate overcomes the adverse effect of smoking on healing as encountered with cimetidine , and results in a subsequent remission period double that of cimetidine .

Sucralfate

antisecretory agent

cimetidine

sucralfate

cimetidine

sucralfate

cimetidine

sucralfate

sucralfate

cimetidine

sucralfate

cimetidine

sucralfate

cimetidine

sucralfate

cimetidine-

sucralfate-healed

cimetidine

sucralfate

cimetidine

cimetidine

ulcer healing

endoscopic healing rates

healing rate

cumulative relapse rate

cumulative relapse rate

relapsed

duration of illness

remission period

long symptomatic spell

reluctance to give up smoking

duodenal ulcer

duodenal ulcer

antisecretory agent , cimetidine ,

ulcers


Fasting and meal-stimulated plasma levels of neurotensin in obese patients after jejunoileal bypass with 3:1 or 1:3 jejunoileal ratio . The functional role of the jejunum and ileum with regard to peripheral plasma levels of intact neurotensin and NH2-terminal immunoreactivity of neurotensin was studied by using jejunoileal bypass as a model . Plasma levels were measured by radioimmunoassay before and after jejunoileal bypass randomized to different jejunoileal ratios . Seven patients were studied before bypass surgery and 28 were examined after end-to-side jejunoileal bypass with 50 cm intestine in continuity and a 3:1 or 1:3 ratio between the length of the jejunal and ileal segments . Fasting levels of intact neurotensin were unchanged by surgery , whereas levels of NH2-terminal immunoreactivity were higher in bypass patients with a long ileal segment ( 37.5 cm ) than in unoperated patients and in those with a short ileal segment ( 12.5 cm ) . Meal-stimulated levels of intact neurotensin were higher after 1:3 than 3:1 jejunoileal bypass . The levels of NH2-terminal immunoreactivity in patients with a short ileal segment and in controls were lower than in patients with a long ileal segment . The results show that postprandial levels of both intact neurotensin and NH2-terminal immunoreactivity are related to the length of the functioning ileum and that even a difference in length of 25 cm is reflected in the circulating levels of neurotensin .

jejunoileal bypass

Fasting levels of intact neurotensin

NH2-terminal immunoreactivity

levels of NH2-terminal immunoreactivity

Seven patients

bypass surgery


Antifibrinolytic therapy for prevention of hemorrhage during surgery of the thyroid gland . The amount of fibrinolytic activity in the thyroid gland equals that of the prostate . In order to examine the effect of the antifibrinolytic drug tranexemic acid on perioperative bleeding saline or tranexemic acid were given randomized double blind to 76 consecutive patients who came for scheduled thyroid surgery . No significant differences were found in perioperative bleeding between patients in the treatment group ( n = 39 ) and control group ( n = 37 ) .

Antifibrinolytic therapy

antifibrinolytic drug tranexemic acid

saline

tranexemic acid

perioperative bleeding

perioperative bleeding

thyroid


Effects of pindolol and clopamide on blood lipids in arterial hypertensive patients . The effects of clopamide , pindolol and its combination on plasma lipids in 49 hypertensive patients ( WHO I-II ) , divided into three parallel randomized groups , were studied over a 6 months period . Total cholesterol , triglycerides , HDL and LDL cholesterol fractions were determined twice during an initial 4-week washout phase , and after a 1- , 3- and 6-month active hypotensive drug phase . Patients were instructed to maintain their usual dietary habits . Daily drug doses were adjusted progressively to attain optimal hypotensive effects . In the clopamide monotherapy group , total cholesterol increased significantly ( p less than 0.05 ) ; triglycerides and LDL showed a tendency to increase while for HDL a tendency to decrease was observed . In the pindolol monotherapy group , a significant reduction of triglycerides ( p less than 0.01 ) and a significant increase of HDL cholesterol ( p less than 0.05 ) were recorded . No significant changes in total cholesterol or LDL fraction were observed . Combined pindolol-clopamide therapy decreased total triglycerides ( NS ) , increased HDL significantly ( p less than 0.05 ) and did not influence total cholesterol and LDL fraction . It is concluded that pindolol does not negatively influence blood lipids as the thiazide-type diuretic clopamide does , and that when both drugs are used together , the beta-blocker can probably counterbalance the diuretic-induced negative effects on blood lipids . Accordingly , it is suggested that pindolol could be a more favorable beta-blocker drug to be used on hypertensive subjects with metabolic coronary risk factors .

pindolol

clopamide

clopamide

pindolol

combination on plasma lipids

blood lipids

Total cholesterol

triglycerides

HDL and LDL cholesterol fractions

total cholesterol

triglycerides

LDL

HDL

triglycerides

HDL cholesterol

total cholesterol or LDL fraction

total triglycerides ( NS )

HDL

total cholesterol and LDL fraction

blood lipids

blood lipids

arterial hypertensive

hypertensive

three

hypertensive

metabolic coronary risk


The efficacy and safety of fenfluramine in autistic children : preliminary analysis of a double-blind study .

fenfluramine

efficacy and safety

autistic

children


The effects of amantadine vs. trihexyphenidyl on memory in elderly normal volunteers .

amantadine vs. trihexyphenidyl

memory

elderly


Circadian changes in the pharmacokinetics of oral ketoprofen . Several investigations which have taken treatment time into account have shown that the pharmacokinetic parameters , the therapeutic efficacy and even the toxicity of a large number of products may vary according to the administration schedule . The present study was carried out in order to evaluate any circadian changes in pharmacokinetic parameters of ketoprofen , a new non-steroidal anti-inflammatory drug ( NSAID ) . This randomised crossover study consisted of a single oral dose of ketoprofen 100mg administered to 8 healthy male volunteers , mean age 27.2 years , at 07.00 hours , 13.00 hours , 19.00 hours or 01.00 hours in 4 study periods during the first 3 months of the year . The order of administration was randomised , with each subject acting as his own control . A total of 14 blood and 4 urine samples were taken over a 12-hour period . The peak plasma concentration was twice as high after drug administration at 07.00 hours ( 13.4 +/- 1 mg/L ) than after other administration times ( 13.00 hours : 6.9 +/- 1 ; 19.00 hours : 7.2 +/- 0.7 ; 01.00 hours : 6.3 +/- 0.5 mg/L ) [ p less than 0.001 ] . The time to reach peak concentration was much longer after drug administration at 01.00 hours ( 135 +/- 16.7 min ) than at 07.00 ( 73.1 +/- 14.1 min ) , 13.00 ( 75 +/- 16.5 min ) or 19.00 hours ( 82.5 +/- 12.7 min ) [ p less than 0.05 ] . The lag time was significantly longer at 01.00 hours than at 13.00 hours ( p less than 0.01 ) . The absorption rate constant after treatment at 01.00 hours was less than at the other times of administration ( p less than 0.05 ) . The bodyweight-corrected area under the curve ( AUC0-12 ) was greater after 07.00 hours than after 13.00 ( p less than 0.01 ) or 19.00 hours ( p less than 0.05 ) and greater after 01.00 hours than after 13.00 hours ( p less than 0.05 ) . The elimination half-life was significantly longer after administration at 01.00 hours than after 19.00 hours ( p less than 0.05 ) , while the total clearance was lowest at 07.00 hours . Cosinor analysis demonstrated statistically significant circadian rhythms for all pharmacokinetic parameters described above . The amount of ketoprofen eliminated in the urine was delayed , and was significantly greater after the administration at 01.00 hours than 07.00 hours or 19.00 hours ( p less than 0.01 ) . The relationship between absorption , diffusion and/or elimination mechanisms of the drug are discussed .

ketoprofen

ketoprofen

ketoprofen

ketoprofen

pharmacokinetics

therapeutic efficacy

toxicity

peak plasma concentration

time to reach peak concentration

lag time

absorption rate

elimination half-life

total clearance

circadian rhythms

healthy

male


[ Intra-arterial chemotherapy in advanced ovarian cancers . 2 . Therapeutic results in relation to prognostic factors ] . 85 patients with advanced ovarian carcinomas were treated either intra-arterially with MTX and 5-FU , later systemically with the CMFV-combination ( therapy arm A ) or only systemically ( therapy arm B ) after randomization . The achieved rates of remission and survival time showed an obvious dependence on the histological type of tumor and on the degree of differentiation . Whereas the results of the treatment were nearly identical in both groups of treatment with badly differentiated carcinomas , a significant improvement could be achieved by the initial local treatment of well and moderately differentiated malignancies . More than one third of the cases of advanced tumors were operable by local chemotherapy . Thus the survival time could be extended . The intra-arterial chemotherapy represents an expensive , but effective method of treatment of advanced ovarian carcinomas .

Intra-arterial chemotherapy

intra-arterially with MTX

and

systemically with the CMFV-combination

only systemically

intra-arterial chemotherapy

rates of remission and survival time

survival time


Disopyramide-pyridostigmine interaction : selective reversal of anticholinergic symptoms with preservation of antiarrhythmic effect . This double-blind , randomized , placebo crossover study was used to evaluate the effects of a cholinesterase inhibitor -- slow-release pyridostigmine ( 180 mg orally every 12 hours ) -- on the anticholinergic and antiarrhythmic properties of disopyramide . Quantitative side effects questionnaire scores were used to guide disopyramide administration in 20 men with ventricular tachycardia . Disopyramide was given to each patient both with placebo and with active pyridostigmine . The maximal administered dose for each regimen was used in conjunction with corresponding questionnaire scores to calculate an index or estimate of the maximal tolerable dose of disopyramide . Additional evaluations performed at baseline and at each maximal administered dose regimen included tear and saliva quantitation , 24 hour electrocardiogram ( ECG ) , exercise testing and programmed ventricular stimulation . Results showed that the maximal administered dose of disopyramide was greater with active pyridostigmine than with placebo : 295 +/- 75 versus 245 +/- 100 mg every 6 hours ( p less than 0.05 ) . The calculated maximal tolerable dose was substantially greater in the presence of pyridostigmine : 355 +/- 90 versus 260 +/- 115 mg every 6 hours ( p less than 0.001 ) . Maximal side effects questionnaire scores also reflected decreased anticholinergic activity in the presence of pyridostigmine compared with placebo : 101.9 +/- 2.2 versus 104.6 +/- 2.8 , respectively ( p less than 0.005 ) . Baseline tear and saliva production was significantly reduced during disopyramide therapy , but was restored toward normal by the addition of pyridostigmine . ( ABSTRACT TRUNCATED AT 250 WORDS )

Disopyramide-pyridostigmine

placebo

disopyramide

disopyramide

Disopyramide

placebo

pyridostigmine

disopyramide

disopyramide

pyridostigmine

pyridostigmine

pyridostigmine

placebo

maximal tolerable dose

maximal tolerable dose

anticholinergic activity

men

ventricular tachycardia

placebo

active pyridostigmine .


Gastric contents and pH after oral premedication . Forty women , aged 26-40 years , were investigated with regard to gastric contents and pH before general anaesthesia . The patients were divided into two groups ( 20 in each ) . Group 100 received 0.3 mg kg-1 diazepam orally with 100 ml of water 2 h before surgery . Group 50 received 0.3 mg kg-1 diazepam with 50 ml of water 2 h before surgery . The amount of gastric content was significantly greater in Group 100 than in Group 50 ( P less than 0.05 ) . There was no statistical difference in pH values between the groups . The number of patients with both gastric pH less than 2.5 and gastric volume greater than 25 ml was significantly higher in Group 100 compared to Group 50 ( P less than 0.05 ) . We can not recommend the use of oral premedication using these amounts of water , considering the increased risk of aspiration of gastric contents .

premedication

anaesthesia

diazepam

water

diazepam with

water

premedication

Gastric contents

amount of gastric content

pH values

gastric pH

gastric volume

Forty women , aged 26-40 years


Deleterious effects of low-dose oestrogen therapy on coronary status in patients with prostatic cancer . The effects of oestrogen therapy and of orchidectomy on coronary status , as reflected by exercise ECG-testing before and after one year of treatment , were assessed in a randomized study of patients ( N = 100 ) with prostatic cancer . Oestrogen was given as polyestradiol phosphate 80 mg i.m . per month in combination with 150 micrograms ethinylestradiol p.o . per day . There were no significant inter-group differences in conventional risk factors or in pre-treatment exercise test results . Twelve months after the start of therapy the oestrogen group showed a significantly greater depression of the ST-segment during maximal exercise in leads CH2 ( P less than 0.0005 ) and CH5 ( P less than 0.01 ) compared with the pre-treatment depression . Twenty-five per cent ( N = 13 ) of the patients in the oestrogen group suffered cardiovascular complications during the year of therapy , whereas no such complications were observed in the orchidectomy group . However , even the patients in the oestrogen group who had not suffered cardiovascular complications had significantly greater depressions of the ST-segment during exercise both in lead CH2 ( P less than 0.0005 ) and in CH5 ( P less than 0.05 ) . There was no significant change in the ST-segment level in the orchidectomy group twelve months after surgery . In summary , we found evidence of an induction of myocardial ischaemia during treatment with exogenous oestrogens at low dosage in patients with prostatic cancer . This deleterious effect of oestrogen on the coronary status argues against oestrogen therapy , since oestrogen has not been shown to be more beneficial than orchidectomy against prostatic carcinoma .

low-dose oestrogen therapy

oestrogen therapy

orchidectomy

Oestrogen

polyestradiol phosphate

150 micrograms ethinylestradiol

exogenous oestrogens

oestrogen

oestrogen

cardiovascular complications

cardiovascular complications

depressions of the ST-segment

ST-segment level

myocardial ischaemia

patients with prostatic cancer .

N = 100

prostatic cancer


Pre-exposure studies with purified chick embryo cell culture rabies vaccine and human diploid cell vaccine : serological and clinical responses in man . Clinical reactions and neutralizing antibody responses to six pre-exposure regimens of purified chick embryo cell culture rabies vaccine ( PCECV ) and human diploid cell strain rabies vaccine ( HDCSV ) were studied in 177 volunteers . Antibody kinetics , height of the response and persistence of antibody over two years were virtually identical after PCECV and HDCSV . An antibody response was detected in all subjects on day 14 when the highest titres were found after two intramuscular ( i.m . ) 1.0 ml doses of a schedule of immunization on days 0 , 7 and 21 . In comparison , a schedule of immunization on days 0 , 28 and 56 ultimately evoked the highest titres 21 days after the final injection , but antibody persisted equally well over two years with either schedule . Neutralizing antibody titres were lower after intradermal ( i.d . ) vaccination with 0.1 ml compared to 1.0 ml i.m . on days 0 , 7 and 21 , but when given on days 0 , 28 and 56 the responses were comparable . Three subjects with a personal or family history of atopy developed urticarial lesions after PCECV . Both vaccines were otherwise well tolerated .

human diploid cell vaccine

PCECV

HDCSV

PCECV

response

persistence of antibody over two years

antibody response

Neutralizing

antibody titres

urticarial lesions

man


A randomised comparison of three drainage systems following cholecystectomy . The efficacy of low pressure , high pressure and passive drainage systems have been compared after cholecystectomy . Symptoms of pain , discomfort and nausea were compared using linear analogue scales and spirometry was used to examine pre-operative and postoperative respiratory function . The low pressure suction drain removed an intraperitoneal marker , gentamicin , more effectively than the high pressure suction drain , but not more effectively than the passive drain . There were no differences in postoperative respiratory function nor in the amount of pain or discomfort between the groups . The passive drain group reported less nausea than the suction drain groups . If a negative pressure drainage system is to be used , a low pressure suction drain should be used in preference to a high pressure system .

low pressure suction drain

high pressure suction drain

passive drain

efficacy

Symptoms of pain

discomfort and nausea

respiratory function .

intraperitoneal marker , gentamicin

postoperative respiratory function

amount of pain or discomfort

nausea

following cholecystectomy .

after cholecystectomy .


The additive analgesic efficacy of acetaminophen , 1000 mg , and codeine , 60 mg , in dental pain . In a double-blind , randomized , single-dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 X 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P less than 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo .

acetaminophen

codeine

acetaminophen , 1000 mg

codeine , 60 mg

acetaminophen

acetaminophen plus 60 mg codeine

placebo .

acetaminophen

codeine

pain intensity

pain relief

analgesic effectiveness

sum of pain intensity differences

largest pain intensity difference

total pain relief

largest pain relief

time to remedication

incidence of adverse effects

dental pain


Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols . The PVSG was organized in 1967 to establish effective diagnostic criteria for polycythemia vera , to study the natural history of the disease and to define the optimal treatment . Although polycythemia vera and the other myeloproliferative diseases are relatively uncommon , the PVSG was able to accumulate well over 1,000 patients with these various disorders and to study them according to a total of 15 different protocols . PVSG-01 , a long-term randomized controlled study of phlebotomy alone compared with the myelosuppressive agents , 32P or chlorambucil supplemented by phlebotomy , continues to receive follow-up data on 93 % of surviving patients 18 years after initiation of the study . During its lifetime , PVSG has developed a widely accepted and highly effective set of criteria for the specific diagnosis of polycythemia vera as well as useful criteria for the diagnosis of essential thrombocythemia . It has gathered an enormous volume of data on the natural history of the myeloproliferative diseases and in particular on the nature of the prevalent complications , such as thrombotic events and hematologic and nonhematologic malignancies . With respect to the final question , the optimal treatment for polycythemia vera , it is apparent that the expectation of a single optimal therapy that would apply to all patients at all ages and stages of the disease was naive . Nevertheless considerable progress has been made . Moreover , the group has defined more precisely than ever before the nature of the complications of the disease and the association of the risks of specific complications with specific forms of therapy . It thus has made it possible to pose the next series of therapeutic questions that must be addressed in this disorder with a greater degree of sophistication than was previously possible .

phlebotomy alone

myelosuppressive agents

chlorambucil

phlebotomy

recommendations

nature of the complications

risks of

specific complications

polycythemia vera

myeloproliferative diseases

well over 1,000


Acute reduction of arterial blood pressure reduces urinary albumin excretion in type 1 ( insulin-dependent ) diabetic patients with incipient nephropathy . The effect of an acute reduction in arterial blood pressure upon kidney function was studied in 12 patients with Type 1 ( insulin-dependent ) diabetes and incipient nephropathy ( persistent microalbuminuria ) . Renal function was assessed by measurement of the glomerular filtration rate ( single bolus 51Cr-EDTA technique ) and by the urinary albumin excretion rate ( radioimmunoassay ) . The study was performed twice within 2 weeks , with the patients receiving a slow intravenous injection of either clonidine ( 225 micrograms ) or saline ( 154 mmol/l ) in random order . Clonidine reduced arterial blood pressure from 125/79 +/- 13/8 to 104/68 +/- 9/7 mmHg ( p less than 0.01 ) , urinary albumin excretion rate from 68 ( 31-369 ) to 46 ( 6-200 ) micrograms/min ( median and range ) ( p less than 0.01 ) , and fractional clearance of albumin in all patients ( median 29 % ) ( p less than 0.01 ) . Glomerular filtration rate was 110 +/- 11 before and 106 +/- 13 ml/min/1.73 m2 after clonidine injection . The blood glucose concentration was 15 +/- 4 mmol/l before and 14 +/- 5 mmol/l after clonidine injection . In agreement with findings in animal studies , our results suggest that microalbuminuria is to a large extent pressure-dependent , probably because of glomerular hypertension , and that autoregulation of glomerular filtration rate is normal in most patients with incipient diabetic nephropathy .

clonidine

saline

Clonidine

clonidine

clonidine

urinary albumin excretion

kidney function

Renal function

glomerular filtration rate

arterial blood pressure

urinary albumin excretion rate

fractional clearance of albumin

Glomerular filtration rate

blood glucose concentration

glomerular filtration rate


[ Randomized cooperative studies of the surgical treatment of cancer of the thyroid gland ] .

surgical treatment

cancer of the thyroid gland ]


Management of unstable angina at rest by verapamil . A double-blind cross-over study in coronary care unit . A therapeutic trial with verapamil , a calcium-antagonist drug , was performed in 12 patients admitted to our coronary care unit because of frequent daily attacks of angina at rest attributed to coronary vasospasm . After a 48-hour run-in period , oral verapamil 480 mg/day and placebo were administered alternately during 4 randomised 48-hour periods . Transient ischaemic attacks with ST segment elevation or depression , with or without pain , were documented by continuous electrocardiographic monitoring . The number of attacks during the run-in and 2 placebo periods were 128 , 123 , and 130 , respectively , and 31 and 23 during the 2 treatment periods ( P less than 0.006 and P less than 0.003 ) . This drug therefore appears to be effective in the management of patients with frequent attacks of angina at rest .

verapamil

verapamil

calcium-antagonist drug

oral verapamil 480 mg/day

placebo

placebo

number of attacks

attacks of angina at rest

unstable angina

12 patients

angina

coronary vasospasm

angina