Single and combined effects of atropine and metoclopramide on the lower oesophageal sphincter pressure . The effects of atropine and metoclopramide on the lower oesophageal sphincter pressure ( LOSP ) were studied in 12 healthy volunteers using oesophageal pressure transducers . Atropine decreased LOSP significantly at 5 min after i.v . injection ( P less than 0.005 ) and this change was sustained for 60 min . Metoclopramide increased LOSP significantly at 3 min after administration i.v . ( P less than 0.05 ) and this change was sustained for 40 min . Following consecutive administration of the drugs the effects of atropine predominated .

atropine

metoclopramide

atropine

metoclopramide

Atropine

Metoclopramide

atropine

LOSP

LOSP


[ Changes in renal arterial flow during the treatment of essential arterial hypertension ; prazosin in comparison with propranolol ] .

prazosin

propranolol

renal arterial flow


Changing sodium intake in children . The Minneapolis Children 's Blood Pressure Study . To assess the effects of modifying dietary sodium intake , 80 school children with blood pressures above the 95th percentile for age and sex but below 130/90 mm Hg at school screening were randomized to a family intervention program or a control group . Twenty children aged 6 to 9 years and their families began a program to modify the family diet toward a goal of 70 mEq sodium per person per day . Adherence was assessed by 3-day food records and urine collections in children and adults . The sodium intakes and blood pressures of the intervention and control group were compared 1 year after randomization . Sodium intake was significantly lower in the intervention group only in the active participants as compared to dropouts and controls ( 87 vs 130 and 133 mmoles/24 hr ) . There were no significant differences between the groups in height , weight , or blood pressure .

family intervention program

control group

Adherence

sodium intakes

blood pressures

Sodium intake

height

weight

blood pressure

children

children

Twenty

children aged 6 to 9 years


Lower relapse rates after neighbourhood injection of Corynebacterium parvum in operable cervix carcinoma . The effect of adjuvant immunotherapy with a single neighbourhood injection of 2 mg C. parvum ( CP ) was investigated in a randomized study involving 43 patients with carcinoma of the cervix uteri , all of whom were treated by radical surgery . All patients had carcinoma confined to the cervix , the upper part of the vagina or the parametrial region . When the malignancy had spread to the parametrial region , additional postoperative radiotherapy was given . 22 patients received immunotherapy 10 days before surgery , whereas the remaining 21 control patients received no immune stimulation . Only minor side effects of CP were encountered . Follow-up shows a relapse rate of 5 % in the CP treated group and of 29 % in the controls ( P less than 0.05 ) . A further 15 patients with more advanced malignancies were added to our studies . In these , CP stimulation had no effect on relapse rates , but the relapse-free intervals were longer after immune stimulation : control 3.5 months ( mean ) +/- 1.5 ( s.d . ) , CP 13.0 months +/- 7.0 ( P less than 0.05 ) . The number of peripheral T cells and the ability to become sensitized to DNCB were increased after CP stimulation . A decrease was found in the number of blood monocytes and the number of monocytes capable of transforming into active macrophages , indicating a possible sequestration of these cells in the tissues .

Corynebacterium parvum

parvum ( CP )

radical surgery

postoperative radiotherapy

immunotherapy

no immune stimulation

CP stimulation

immune stimulation

CP stimulation

side effects

relapse rate

relapse rates

relapse-free intervals


Is anti-Pseudomonas therapy warranted in acute respiratory exacerbations in children with cystic fibrosis ? A controlled study was designed to clarify the indications for antibiotic therapy in children with advanced cystic fibrosis hospitalized with respiratory exacerbations . Twenty-two children with severe CF and signs of acute lower respiratory infection were randomly assigned to receive either cloxacillin or carbenicillin plus gentamicin administered intravenously for ten days . Other aspects of therapy were constant . The groups were comparable in all respects and Pseudomonas aeruginosa was the predominant sputum pathogen in most patients . Clinical improvement , chest radiograph changes , evidence of airway obstruction , and bacteriologic flora of sputum were no different regardless of the regimen used . These results suggest that the use of anti-Pseudomonas medication in these children may not always be necessary . These observations need to be confirmed by blind-controlled studies in larger numbers of patients with mild as well as severe respiratory involvement .

cloxacillin

carbenicillin plus gentamicin

respiratory exacerbations

children

cystic fibrosis

children

advanced cystic fibrosis hospitalized

respiratory exacerbations

Twenty-two

children

severe CF

acute lower respiratory infection


Vaginal pH and microflora related to yeast infections and treatment . The relationship between vaginal pH , microflora , and yeast infection was investigated in 93 women randomly treated with either nystatin or miconazole pessaries and cream for two weeks . The vaginal pH was measured in a control group of 48 women . In the study group , 37 patients defaulted , 39 were cured , and 17 required treatment during the six-month follow-up period . In both study and control groups before and after treatment the mean vaginal pH was in the range of 4.3-4.6 . Lactobacilli were plentiful in 78 ( 91 % ) out of 86 patients and shows that lactobacilli and yeasts commonly coexist . The influence of other organisms appeared to be negligible . The trial showed that nystatin and micromazole were equallly effective in the treatment of vaginal yeast infection and that the broad-spectrum activity of micronazole offered no advantage in this condition .

nystatin

miconazole pessaries and cream

micronazole

Vaginal pH and microflora

vaginal pH , microflora

vaginal pH

mean vaginal pH

Lactobacilli

effective

yeast infections

women

women .


[ Obstetrical analgesia with tramadol ] . Parenteral analgesia with Tramal was performed in 23 normal deliveries . The results were compared with a group of normal deliveries in which analgesia was achieved with pethidine . Both medicaments excerted an identical analgetic efficiency . No adverse side effects were observed with Tramal concerning the follow-up of labour or the newborn . Tramal can be recommended for obstetrical analgesia since it does not excert inhibitory effects upon the respiratory center .

tramadol

Tramal

pethidine

Tramal

Tramal

analgesia

identical

analgetic efficiency

adverse side effects

obstetrical analgesia

inhibitory effects

[ Obstetrical analgesia


Scaling clinical judgments of symptom pathology by means of the psychophysiological method of magnitude estimation . Summing scores across heterogeneous symptom items without consideration of their differing psychopathological significance has been criticized as producing an inadequate picture of an individual 's clinical status . The purpose of this study was to derive symptom item weights representing clinically judged seriousness of each symptom through the application of Steven 's psychophysical method of magnitude estimation . A nationwide sample of 129 clinicians rated the pathological significance of 221 symptom items in a design such that every rater rated 121 items , 21 of which were rated by all raters and 100 of which were rated only by the A or B subgroup to which each rater was randomly assigned . Each item was rated as to the seriousness of the pathology it would represent if manifested by either a boy child , girl child , boy adolescent , or girl adolescent , with one-fourth of the raters assigned to each condition . The results of 211 two-way analyses of variance revealed that age and age and sex in interaction , but not sex alone , significantly influenced the clinical ratings . The resulting magnitude estimation ratings of symptom pathology ranged from 1.0 to 9.9 . They were demonstrated to have satisfactoy reliability and convergent validity and to have the psychophysical characteristics of a prothetic continuum .

age and sex


Liquid antacids : palatability and predictability study .

Liquid antacids

antacids :


Cardiac and haemodynamic measurements in hypertensive pregnancy . 1 . Haemodynamic and left ventricular variables were determined by M-mode echocardiography in 21 normotensive and 36 hypertensive patients during the last trimester of pregnancy . 2 . Blood pressure of hypertensive patients was lowered by bed rest only , or by oxprenolol or methyldopa , but remained elevated . 3 . Cardiac output was raised in the last trimester of pregnancy in both normotensive and hypertensive patients . 4 . Left ventricular mass was increased in normal pregnancy , but displayed an exaggerated increase in hypertensive patients . 5 . Total peripheral resistance was inappropriately elevated in hypertensive pregnancy , except in the oxprenolol-treated group . 6 . There ws no reduction in heart rate or cardiac output in the group treated with beta-adrenoreceptor blocking agents . These factors , in combination with normal peripheral resistance , may contribute to the improvement in foetal outcome described in maternal hypertension of pregnancy treated with oxprenolol .

oxprenolol or methyldopa

beta-adrenoreceptor blocking agents

oxprenolol .

Blood pressure

Cardiac output

Left ventricular mass

Total peripheral resistance

heart rate

cardiac output

hypertensive pregnancy

normotensive

hypertensive

hypertensive

normotensive

hypertensive

hypertensive


A randomized surveillance study of patients with pedunculated and small sessile tubular and tubulovillous adenomas . The Funen Adenoma Follow-up Study . BACKGROUND We wanted to assess the influence of various surveillance intervals on the risk of new neoplasia after removal of pedunculated and small sessile tubular and tubulovillous adenomas . METHODS After initial colonoscopic polypectomy patients were randomized to surveillance with either 2 years ( group A ) or 4 years ( group B ) between colorectal examinations . RESULTS The cumulated risk of a patient having new adenomas was 35.0 % ( 28.7-41.4 % ) in group A and 35.5 % ( 28.4-42.7 % ) in group B after 48 months . The risk increased to 44.9 % ( 36.0-53.9 % ) and 60.1 % ( 48.5-71.7 % ) , respectively , after 96 months . The risk of significant neoplasia ( carcinoma or adenoma with villous structure , severe dysplasia , or diameter > 10 mm ) was 5.2 % ( 2.3-8.1 % ) and 8.6 % ( 3.8-13.3 % ) after 48 months and 8.6 % ( 4.2-13.0 % ) and 17.4 % ( 7.6-27.2 % ) after 96 months . More than one adenoma at first examination was associated with higher risk of new adenomas . Furthermore , we found a tendency for age above 60 years and male gender to be associated with higher risk of new adenomas . More than two adenomas at first examination was the only factor found to be associated with a higher risk of new significant neoplasia . One patient in group A and two patients in group B developed cancer , which is not significantly different from the number expected ( 3.43 ) in the average Danish population ( RR = 0.9 , 0.2-2.6 ) . CONCLUSION After colonoscopy with removal of all polyps , colorectal examination at 4 years resulted in a similar risk of new adenomas compared with examinations at 2 and 4 years . However , new significant neoplasia tended to be more frequent when first surveillance was at 4 years . Extending the surveillance to 8 years also tended to increase the risk more in the group being examined every 4 years , but reduction of the number of surveillance examinations by more than 50 % and a probable reduction of complications from surveillance examinations themselves may justify a recommendation for the longest interval .

risk of new neoplasia

risk of a patient having new adenomas

higher risk of new adenomas

adenomas

risk of new significant neoplasia

cancer

risk of new adenomas

neoplasia

initial colonoscopic polypectomy

age above 60 years

male


[ Erythropoietin therapy during frequent autologous blood donations . Dose-finding study ] . Avoidance of homologous blood products and patients ' demand for preoperative autologous blood donation programs are increasing . As many of these patients are older , with a compromised cardiovascular system and a slow response of the erythropoietic system when anemia occurs , the feasibility and benefit of autologous blood donation is often limited . Augmentation of preoperative blood donation by therapy with recombinant human erythropoietin ( rHuEPO ) has been described in animal models and in patients . METHODS . In a multicenter , controlled , randomized trial , 49 patients scheduled for orthopaedic or vascular surgery received 0 ( control group , n = 9 ) , 200 ( n = 10 ) , 300 ( n = 11 ) , 400 ( n = 10 ) or 500 ( n = 9 ) U/kg rHuEPO ( Erypo , Cilag , Sulzbach , distributor Fresenius , Oberursel , Germany ) subcutaneously twice a week for 3 weeks while every week 450 ml blood was collected . Iron sulphate 100 mg was prescribed orally twice a day . Patients were ineligible if they had uncontrolled hypertension , recent myocardial infarction , haematological disorders or a history of seizures . Blood donation had to be cancelled if the haematocrit was below 30 % . RESULTS . There was a significant ( ANOVA ) drop of the haematocrit value only in the control group , and end-point values for haematocrit and haemoglobin were significantly elevated in the 400 and 500 U/kg groups compared with the control group ( Table 9 ) . DISCUSSION . The erythropoietic stimulus of phlebotomy for autologous blood donations is often not efficient enough to guarantee a constant haematocrit . Lowering of the preoperative haematocrit jeopardizes the aim of avoidance of homologous blood transfusions . rHuEPO increased the efficiency of autologous blood collections , as predonation haematocrit values could be preserved in the high-dosage groups . As a consequence , homologous transfusions could be avoided . However , there were broad interindividual differences in the erythropoietic response , possibly due to limitations in iron availability . Adverse effects of rHuEPO therapy , such as hypertension , thrombosis or neurologic disorders , are mostly reported in patients with terminal kidney failure . No such disturbances were observed in the present study . CONCLUSION . rHuEPO ameliorates the preoperative decrease of haemoglobin and haematocrit values due to autologous blood donations in a dose-related fashion . The individually adjusted dosage of rHuEPO and iron supplementation merits further investigation .

Erythropoietin

recombinant human erythropoietin

rHuEPO

Erypo

Cilag

Sulzbach

distributor Fresenius

Oberursel

Iron sulphate 100 mg

rHuEPO

haematocrit value

haematocrit

haematocrit

efficiency

erythropoietic response

hypertension

thrombosis

neurologic disorders

terminal kidney failure .

ameliorates

haemoglobin and haematocrit values

autologous blood donations

older

compromised cardiovascular system

orthopaedic or vascular surgery

terminal kidney failure


Comparison of fluoxetine and placebo in the treatment of obesity . Our study aims at assessing the efficacy and safety of fluoxetine as compared with placebo in the treatment of obesity using a double-blind crossover design . We studied 42 obese women ( body mass index 35.9 +/- 5.3 kg/m2 ) . The obese patients were randomized to start treatment with fluoxetine ( group A ) or placebo ( group B ) for 3 months ( period 1 ) . After a 1-month washout period , treatment was crossed for the following 3 months ( period 2 ) . There was no significant difference in weight loss when the patients were treated with fluoxetine ( group A period 1 and group B period 2 ) as compared with patients treated with placebo ( group B period 1 and group A period 2 ) . There were no significant differences in monthly weight reduction during both treatments . In conclusion , we demonstrated that serotoninergic drugs such as fluoxetine need further investigation before being used indiscriminately in obese subjects .

fluoxetine

placebo

fluoxetine

placebo

fluoxetine

placebo

fluoxetine

placebo

fluoxetine

obesity .

weight loss

monthly weight reduction

obesity .


Corticosteroids plus pulse cyclophosphamide and plasma exchanges versus corticosteroids plus pulse cyclophosphamide alone in the treatment of polyarteritis nodosa and Churg-Strauss syndrome patients with factors predicting poor prognosis . A prospective , randomized trial in sixty-two patients . OBJECTIVE To define the most effective treatment for severe polyarteritis nodosa ( PAN ) and Churg-Strauss syndrome ( CSS ) and to investigate the indication for plasma exchange treatment . METHODS We conducted a prospective , randomized , multicenter trial in which 62 patients were randomly assigned to receive either prednisone plus cyclophosphamide ( intravenous bolus ) ( group A ; n = 28 ) or prednisone plus cyclophosphamide ( intravenous bolus ) plus plasma exchanges ( group B ; n = 34 ) as first-line treatment for severe PAN or CSS . Factors predicting poor prognosis were renal symptoms , gastrointestinal tract involvement , cardiomyopathy , central nervous system involvement , weight loss > 10 % of body weight , and age > 50 years old . Patients with hepatitis B virus-related PAN were not included in this study . The end point of the study was control of the disease ( recovery or remission ) or death . RESULTS Clinical symptoms and laboratory findings did not differ significantly in the 2 groups . Initial control of the disease was similar in both groups . Relapse after initial control of the disease was observed in 7 patients ( 4 in group A and 3 in group B ) . The mean +/- SD followup period was 31.1 +/- 20 months for group A and 35.9 +/- 16.8 months for group B . At 5 years of followup , 38 patients ( 61.3 % ) were cured ( 16 in group A and 22 in group B ) , and 5 ( 8.1 % ) were in remission without treatment but had not yet completed the cure-defining period of 18 months ( 3 in group A and 2 in group B ) . Eight ( 12.9 % ) ( 2 in group A and 2 in group B ) were considered to be in clinical remission and required a maintenance regimen of low-dose corticosteroids . Eleven patients died during the study period ( 7 in group A [ 25 % ] , 4 in group B [ 11.8 % ] ) . Uncontrolled vasculitis was responsible for 4 deaths ( 2 in each group ) , and treatment side effects caused the death of 1 patient in group A . There was no significant difference between the 5-year cumulative survival rates of the 2 groups ( 75 % and 88 % , respectively ) . CONCLUSION Based on our data , combined treatment with prednisone , cyclophosphamide , and plasma exchanges is not superior to treatment with prednisone and cyclophosphamide alone , and plasma exchanges should not be systematically proposed for initial treatment of severe PAN or CSS .

prednisone , cyclophosphamide

plasma exchanges

prednisone

cyclophosphamide

Relapse

mean +/- SD followup

cured

clinical remission

died

deaths

treatment side effects

death

5-year cumulative survival rates

62 patients


Cholesterol-lowering therapy may retard the progression of diabetic nephropathy . There is experimental evidence to suggest that hypercholesterolaemia may play a pathogenetic role in progressive glomerular injury . We investigated the effect of cholesterol-lowering therapy on the progression of diabetic nephropathy in 34 patients with non-insulin-dependent diabetes mellitus . Patients were randomly assigned in a single-blind fashion to treatment with either lovastatin , an HMG CoA reductase inhibitor ( n = 16 ; mean dose 30.0 +/- 12.6 mg/day ) or placebo ( n = 18 ) for 2 years . Renal function was assessed by serially measuring the serum creatinine , glomerular filtration rate ( using Cr51-EDTA ) , and 24-h urinary protein excretion . Lovastatin treatment was associated with significant reductions in total cholesterol ( p < 0.001 ) , LDL-cholesterol ( p < 0.001 ) and apo B ( p < 0.01 ) , the reductions at 24 months being 26 , 30 and 18 % , respectively . Beneficial effects on serum triglyceride , HDL-cholesterol and apo A1 levels were also observed . Lp ( a ) showed no significant change in both groups . Glomerular filtration rate deteriorated significantly in the placebo group after 24 months ( p < 0.025 ) but showed no significant change in the lovastatin-treated patients . The increase in serum creatinine was statistically significant ( p < 0.02 ) in placebo-treated patients at 12 and 24 months , and in the lovastatin group after 24 months . Twenty-four hour urinary protein excretion increased in both groups ( p < 0.05 ) . Lovastatin treatment was not associated with significant elevations in liver or muscle enzymes . We conclude that effective normalisation of hypercholesterolaemia may retard the progression of diabetic nephropathy .

Cholesterol-lowering therapy

placebo

total cholesterol

LDL-cholesterol

apo B

serum triglyceride

HDL-cholesterol

apo A1 levels

Lp ( a )

no significant

no significant change

increase in serum creatinine

statistically significant

urinary protein excretion increased

not associated

significant elevations

liver or muscle enzymes

hypercholesterolaemia

diabetic nephropathy

diabetic nephropathy .

progressive glomerular injury .

non-insulin-dependent diabetes mellitus


A comparison of live and videotape ratings : clomipramine and haloperidol in autism . This study compared live ratings with ratings of videotapes and compared response to clomipramine with response to haloperidol in 8 subjects , mean age 5.62 years , who met criteria for autism . They were consecutive admissions to a pilot study of clomipramine ( n = 4 ) or a double-blind , placebo controlled study of haloperidol ( n = 4 ) . Live ratings were performed by two raters at the end of the pre-treatment placebo baseline period and at the end of the drug treatment period on the CPRS and the CGI and were videotaped . Employing the same instruments , these videotapes were rated by two raters who did not know the subjects and were blind to study design , treatment , and study phase . Ratings of videotapes significantly differed from live ratings . A treatment effect for haloperidol was detected only on live ratings and not on ratings of videotapes . No treatment effect was detected for clomipramine in either live or videotape ratings .

clomipramine

haloperidol

clomipramine

haloperidol

clomipramine

placebo

haloperidol

placebo

clomipramine

Ratings of videotapes

live ratings

live ratings

ratings of videotapes

live

videotape ratings

clomipramine

haloperidol in autism

5.62 years


The effect of iron in formula milk after 6 months of age . Ninety two normal birthweight infants aged 6 months entered a double blind controlled trial which compared a follow on formula milk with no added iron against the same formula milk containing 1.2 mg of iron per 100 ml . There was no significant difference in the social class or demographic characteristics of the two treatment groups or in the proportion of each group completing the trial . There was no difference between the two groups in the quantity of milk taken but the amounts taken lessened between 6 and 18 months of age . There was no difference between the two groups with respect to mean haemoglobin and median serum ferritin at 6 , 9 , 12 , 15 , and 18 months of age . Very few infants developed iron deficiency anaemia in either group but there was a tendency for serum ferritin levels to fall between 6 and 18 months of age in both groups . The results suggest that iron added to follow on milk was not an important source of dietary iron in the infants studied .

iron

formula milk with no added iron

iron

iron

effect

quantity of milk taken

mean haemoglobin

median serum ferritin

iron deficiency anaemia

serum ferritin levels

Ninety two

normal birthweight

infants

6 months


Ebeltoft project : baseline data from a five-year randomized , controlled , prospective health promotion study in a Danish population . BACKGROUND There is increasing political pressure on the medical profession to approach welfare diseases , such as coronary heart disease and diabetes , through prevention . General practitioners are required to offer regular health checks to healthy people , in spite of the lack of scientific evidence for the universal need , usefulness and side effects of such an intervention . Randomized controlled trials are needed . AIM A study was carried out to investigate people 's interest in participating in health checks and in discussions about health with their own general practitioner , participants ' health status , the proportion who received health advice following health checks , and the lifestyle goals they set following discussion with their general practitioner . This study reports the baseline data from a five-year randomized , controlled , prospective , population-based study in general practices in Ebeltoft , Denmark . METHOD All general practitioners from the four practices in Ebeltoft and a random sample of 2000 people aged between 30 and 50 years were invited to participate . Participants were randomly divided into three groups -- one control group and two intervention groups . One intervention group were given a health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner . The other intervention group were also given a health check and written feedback ; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health . RESULTS A total of 1370 people participated in the study ( 69 % response rate ) . Health advice was given to 76 % of 905 participants following health checks . Almost all of the 456 participants ( 96 % ) who were offered the opportunity of discussing their health with their general practitioner took up the offer ; 64 % of the 456 participants reported that they had decided to undertake lifestyle changes . Eleven of those who discussed their health with the doctor were referred to a specialist ( 2 % ) . CONCLUSION There was considerable interest in participating in health promotion . Three out of four of those having a health check were given health advice . Two out of three of those offered a health talk with the general practitioner appeared willing to make relevant lifestyle changes . Long-term follow up is needed to determine effects and side effects of health checks and health talks .

regular health checks

health checks

control

health check and

written feedback

health checks

Health advice

undertake lifestyle changes

referred to a specialist

healthy

30 and 50

Eleven


Effect of six-hour exposure to nitrogen dioxide on early-phase nasal response to allergen challenge in patients with a history of seasonal allergic rhinitis . BACKGROUND Recent studies have suggested that exposure to air pollutants may enhance the airway responsiveness of susceptible individuals to inhaled allergen . METHODS To investigate the effect of exposure to nitrogen dioxide ( NO2 ) on nasal airways resistance ( NAR ) and inflammatory mediators in nasal lavage fluid , eight subjects with a history of seasonal allergic rhinitis , who were tested out of season , were exposed in a randomized single-blind , crossover study to either air or 400 ppb NO2 for 6 hours . The changes in NAR and eosinophil cationic protein ( ECP ) , mast cell tryptase ( MCT ) , neutrophil myeloperoxidase ( MPO ) , and interleukin-8 ( IL-8 ) in nasal lavage fluid before and after exposure were evaluated . Another group of eight subjects with a history of seasonal allergic rhinitis were also randomized to exposure to air or 400 ppb NO2 for 6 hours and then challenged with allergen , before evaluation for changes in NAR and changes in ECP , MCT , MPO , and IL-8 in nasal lavage fluid . RESULTS Exposure to air or NO2 did not alter either NAR or the levels of ECP , MCT , MPO , or IL-8 in nasal lavage fluid . Allergen challenge after exposure to both air and NO2 significantly ( p < 0.05 ) increased levels of MCT , but not MPO and IL-8 in the nasal lavage fluid . In addition , allergen challenge after exposure to NO2 but not air , significantly increased levels of only ECP in nasal lavage fluid ( p < 0.05 ) . CONCLUSIONS These results suggest that acute exposure to NO2 at concentrations found at the curbside in heavy traffic during episodes of pollution , may " prime " eosinophils for subsequent activation by allergen in individuals with a history of seasonal allergic rhinitis .

nitrogen dioxide

nitrogen dioxide ( NO2 )

air

nasal response

changes in NAR

changes in ECP

MCT

MPO

IL-8 in nasal lavage fluid

NAR

levels of ECP , MCT , MPO , or IL-8

MCT

MPO

ECP in nasal lavage

susceptible individuals

eight subjects

Another group of eight


Randomized trial of Sandostatin prophylaxis for preservation injury after pancreas transplantation .

Sandostatin prophylaxis

preservation injury

prophylaxis

preservation injury

pancreas transplantation


Optimized strategy for detection of early stage , curable prostate cancer : role of prescreening with prostate-specific antigen . In 1,002 men aged 45-80 y , 81 % of the cancers detectable by serum prostate-specific antigen ( PSA ) , digital rectal examination ( DRE ) , and transrectal ultrasonography ( TRUS ) were present in a subpopulation ( 19 % of total ) identified by serum PSA above the threshold value of 3.0 micrograms/L . This study was extended to 7,350 men using serum PSA and DRE as first approach , followed by TRUS only when 1 of these 2 tests was abnormal . Because the aim of prostate cancer detection is to find cancers at an early , potentially curable stage , it is of major interest that 71.8 % of evaluable cancers were clinical stage B ; 8.4 % and 10.7 % were stages C1 and C2 , respectively ; only 9.2 % were stage D ( metastatic ) at first visit while none was at stage D at follow-up visits . This study , the first performed in an unselected , unscreened population , shows that serum PSA is the most sensitive technique to identify men at high risk of having prostate cancer and that 12 % more cancers can be found at first visit by doing DRE in addition to PSA . Follow-ups can be done every second year using serum PSA alone , as 97 % of the cancers detected at annual follow-up by DRE + PSA were PSA+ . Cancers are discovered by the present approach at an estimated cost of $ 2,665 per cancer . Such cancers are potentially curable in at least 80 % of cases detected at first visit and in 97 % of cases at follow-up . This strategy offers the possibility to improve markedly morbidity and mortality from prostate cancer , presently the second leading cause of cancer death in North American men .

serum prostate-specific antigen ( PSA )

digital rectal examination ( DRE )

transrectal ultrasonography ( TRUS )

PSA

DRE

TRUS

PSA

DRE

PSA

PSA

DRE

PSA

PSA+

serum prostate-specific antigen ( PSA )

digital rectal examination ( DRE )

transrectal ultrasonography ( TRUS )

serum PSA

sensitive technique

risk of having prostate cancer

serum PSA alone

estimated cost

curable


Using repeated measures of symptom score , uroflowmetry and prostate specific antigen in the clinical management of prostate disease . Benign Prostatic Hyperplasia Treatment Outcomes Study Group . Measurements of American Urological Association symptom score , peak urine flow rate and prostate specific antigen ( PSA ) are often followed over time in urological management . However , their interpretation is confounded by within-patient variability due to chance . Data from 2 clinical trials are used to examine the magnitude of this variation . When these measures are repeated at a short interval variation is modest and might easily be misinterpreted as a true change in patient condition . For example , approximately 20 % of patients might be expected to have a chance increase or decrease in symptom score by at least 4.9 points , in peak urine flow rate by at least 4.1 ml . per second or in PSA by at least 1.6 ng./ml . Clinicians can use these data to help interpret repeated measures of these variables in patients , and can consider obtaining paired measurements to decrease the effect of chance variation when they plan on following them over time .

urological management .

peak urine flow rate

prostate specific antigen ( PSA )

prostate disease

Benign Prostatic Hyperplasia


Double-blind comparison of the efficacy and safety of trandolapril 2 mg and hydrochlorothiazide 25 mg in patients with mild-to-moderate essential hypertension . Investigator Study Group . This multicenter international trial recruited 205 patients from 16 investigators . After a 4-week , single-blind placebo run-in , patients were randomized to receive 16 weeks of trandolapril 2 mg/day ( 68 patients ) , hydrochlorothiazide ( HCTZ ) 25 mg/day ( 68 patients ) , or the combination ( 69 patients ) . Morning predosing supine diastolic blood pressure ( DBP ) was the primary efficacy measurement . Intention-to-treat analysis showed significant decreases in all three groups in mean ( +/- SEM ) supine DBP throughout the study , with no significant differences at week 16 between trandolapril ( -10.6 +/- 1.3 mm Hg ) and HCTZ ( -10.9 +/- 1.3 mm Hg ) . The combination gave a significantly greater reduction than either drug alone ( -15.1 +/- 1.13 mm Hg ) . Blood pressure was normalized in the combination group in 67 % of patients , a significantly higher proportion than either trandolapril ( 63 % ) or HCTZ ( 60 % ; p = 0.04 ) . Each treatment was well tolerated . The incidence of adverse events was similar in all three groups . Trandolapril 2 mg once daily is an effective antihypertensive agent , comparable to HCTZ . Furthermore , the combination of the two drugs was shown to enhance the antihypertensive effect of the two compounds alone .

trandolapril

hydrochlorothiazide

single-blind placebo

trandolapril

hydrochlorothiazide ( HCTZ )

or the combination

efficacy and safety

supine DBP

Blood pressure

adverse events

antihypertensive effect


Comparison of autologous bone marrow transplantation with sequential chemotherapy for intermediate-grade and high-grade non-Hodgkin 's lymphoma in first complete remission : a study of 464 patients . Groupe d'Etude des Lymphomes de l'Adulte . PURPOSE Intensive chemotherapy followed by autotransplantation has given promising results in partially responding or sensitive relapsed patients with aggressive non-Hodgkin 's lymphoma . In 1987 , we designed a randomized study to evaluate the potential benefit of a high-dose regimen containing cyclophosphamide , carmustine , and etoposide ( CBV ) followed by autotransplantation over a consolidative sequential chemotherapy ( ifosfamide , etoposide , asparaginase , and cytarabine ) in patients in first complete remission with intermediate- and high-grade non-Hodgkin 's lymphoma . PATIENTS AND METHODS Patients were younger than 55 years and had at least one adverse prognostic factor . Induction treatment was that of the LNH84 protocol with an open randomization on the anthracycline . Patients in complete remission were further randomly assigned to receive either consolidation procedure . RESULTS After induction treatment , 464 patients were assessable for the consolidation phase . With a median follow-up duration of 28 months , the 3-year disease-free survival rate was 52 % ( 95 % confidence interval , 45 % to 59 % ) in the sequential chemotherapy arm and 59 % ( 95 % confidence interval , 52 % to 66 % ) in the autologous transplant arm ( P = .46 , relative risk = 0.90 ) . The 3-year survival rate did not differ between sequential chemotherapy and autotransplantation , at 71 % ( 95 % confidence interval , 64 % to 78 % ) and 69 % ( 95 % confidence interval , 62 % to 76 % ) , respectively ( P = .60 , relative risk = 1.11 ) . CONCLUSION For such a subset of patients , consolidation with the CBV regimen followed by autologous bone marrow transplantation is not superior to sequential chemotherapy .

carmustine

etoposide ( CBV )

ifosfamide

etoposide

asparaginase

cytarabine

anthracycline .

complete remission :

benefit

complete remission

3-year disease-free survival rate

3-year survival rate

superior

younger than 55 years

464 patients


Multicyclic , dose-intensive chemotherapy supported by sequential reinfusion of hematopoietic progenitors in whole blood . PURPOSE To support multicyclic , dose-intensive chemotherapy , we assessed the effects of reinfusing hematopoietic progenitors collected at each cycle in leukapheresis product or whole blood . PATIENTS AND METHODS Twenty-five patients with small-cell lung cancer ( SCLC ) were treated with six cycles of ifosfamide , carboplatin , and etoposide ( ICE ) with granulocyte colony-stimulating factor ( G-CSF ) 300 micrograms/d subcutaneously ( SC ) on days 4 to 15 . Hematopoietic progenitors collected during each cycle were reinfused on day 3 of the next cycle . Cohort 1 ( n = 6 ) was treated every 3 weeks , with leukapheresis after 2 weeks and cryopreservation of the leukapheresis product . Chemotherapy was given if the WBC count was > or = 3 x 10 ( 9 ) /L and platelet count > or = 100 x 10 ( 9 ) /L . Cohort 2 ( n = 7 ) was treated every 2 weeks , with leukapheresis on day 1 of the next cycle and storage of the leukapheresis product at 4 degrees C. Cohort 3 ( n = 12 ) was treated every 2 weeks , with 500 to 750 mL of blood drawn by venesection on day 1 of the next cycle and stored at 4 degrees C. In cohorts 2 and 3 , chemotherapy was given if the WBC count was > or = 3 x 10 ( 9 ) /L and platelet count > or = 30 x 10 ( 9 ) /L . Blood and leukapheresis products were assayed for hematopoietic progenitors . RESULTS ICE chemotherapy with G-CSF was effective in mobilizing blood progenitors ( median , 120-fold ) . Long-term cultures showed no evidence of stem-cell depletion . The cytotoxic dose-intensity of standard every-4-weeks ICE is 100 % . In the first three cycles , it was 134 % ( median ) in cohort 1 and 200 % in cohorts 2 and 3 ( P < .0001 ) . Toxicity and supportive care requirements were not increased . CONCLUSION The dose-intensity of ICE chemotherapy can be doubled by reinfusing hematopoietic progenitors collected by leukapheresis or venesection and stored at 4 degrees C .

hematopoietic progenitors

dose-intensive chemotherapy

reinfusing hematopoietic progenitors

leukapheresis

leukapheresis

leukapheresis product

chemotherapy

ICE chemotherapy

ICE chemotherapy

Blood and leukapheresis products

mobilizing blood progenitors

stem-cell depletion .

cytotoxic dose-intensity

Twenty-five

with small-cell lung cancer ( SCLC )


A randomized study comparing glucagon and hyoscine N-butyl bromide before endoscopic retrograde cholangiopancreatography . BACKGROUND This study tried to resolve whether glucagon is a better premedication for endoscopic retrograde cholangiopancreatography ( ERCP ) . METHODS We first measured the basal blood sugar and amylase levels . Then an endoscope was placed in the duodenum without premedication , and basal pulse and duodenal peristaltic rates were measured . ERCP began after studied subjects were randomly premedicated with either 1 mg glucagon ( n = 38 ) or 40 mg hyoscine N-butyl bromide ( n = 36 ) intravenously . Ten minutes later the variables were measured again . RESULTS Glucagon elicited hyperglycemia whereas hyoscine N-butyl bromide manifested an anticholinergic effect . No difference was found between these two groups with regard to the necessary interval for ERCP ( 20.6 +/- 14.1 min versus 21.4 +/- 14.7 min ; NS ) or the success rate for cholangiopancreatography ( 92.1 % versus 91.7 % ; NS ) . Neither hyperamylasemia nor pancreatitis was preventable when glucagon was used . CONCLUSIONS The two premedications appear equally effective in the performance of ERCP .

glucagon

hyoscine N-butyl bromide

glucagon

1 mg glucagon

40 mg hyoscine N-butyl bromide

Glucagon

hyoscine N-butyl bromide

glucagon

basal blood sugar and amylase levels .

hyperglycemia

anticholinergic effect .

necessary interval for ERCP

hyperamylasemia nor pancreatitis

performance of ERCP


Randomised , placebo-controlled , double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia . Beta-sitosterol Study Group . Medical treatments have become available for benign hypertrophy of the prostate , including alpha-receptor blocking agents and 5-alpha-reductase inhibitors . Drugs derived from plants , for which no precise mechanism of action has been described , are widely used for this purpose in Europe . In a randomised , double-blind , placebo-controlled multicentre study , 200 patients ( recruited between April and October 1993 ) with symptomatic benign prostatic hyperplasia were treated with either 20 mg beta-sitosterol ( which contains a mixture of phytosterols ) three times per day or placebo . Primary end-point was a difference of modified Boyarsky score between treatment groups after 6 months ; secondary end-points were changes in International Prostate Symptom Score ( IPSS ) , urine flow , and prostate volume . Modified Boyarsky score decreased significantly with a mean of -6.7 ( SD 4.0 ) points in the beta-sitosterol-treated group versus -2.1 ( 3.2 ) points in the placebo group p < 0.01 . There was a decrease in IPSS ( -7.4 [ 3.8 ] points in the beta-sitosterol-treated group vs -2.1 [ 3.8 ] points in the placebo group ) and changes in urine flow parameters : beta-sitosterol treatment resulted in increasing peak flow ( 15.2 [ 5.7 ] mL/s from 9.9 [ 2.5 ] mL/s ) , and decrease of mean residual urinary volume ( 30.4 [ 39.9 ] mL from 65.8 [ 20.8 ] mL ) . These parameters did not change in the placebo group ( p < 0.01 ) . No relevant reduction of prostatic volume was observed in either group . Significant improvement in symptoms and urinary flow parameters show the effectiveness of beta-sitosterol in the treatment of benign prostatic hyperplasia .

placebo-controlled

beta-sitosterol

placebo-controlled

20 mg beta-sitosterol

phytosterols )

placebo .

Boyarsky score

urine flow

prostate volume

Modified Boyarsky score

IPSS

urine flow parameters

peak flow

mean residual urinary volume

prostatic volume

symptoms and urinary flow parameters

Beta-sitosterol Study Group .


Abdominoperineal resection and anterior resection in the treatment of rectal cancer : results in relation to adjuvant preoperative radiotherapy . The outcome of patients with rectal cancer treated by abdominoperineal or anterior resection , with or without preoperative radiotherapy , was assessed to detect any differences attributable to the operative method and interactions between radiotherapy and type of surgery . The study was based on 1292 patients included in two consecutive controlled randomized trials of preoperative radiotherapy in operable rectal carcinoma . The outcome was not related to surgical method . Radiotherapy increased postoperative mortality and complications and reduced local and distant recurrence , but had no effect on overall survival . Effects of radiotherapy were similar irrespective of the type of surgery , except that the increase in postoperative mortality in irradiated patients was greater in those treated with abdominoperineal resection . Sphincter-saving procedures appear to have no adverse effects on outcome of rectal cancer , but the optimum use of radiotherapy is still to be defined .

Abdominoperineal resection

anterior resection

adjuvant preoperative radiotherapy

preoperative radiotherapy

radiotherapy

Sphincter-saving procedures

postoperative mortality

complications

local and distant recurrence

overall survival

postoperative mortality

rectal cancer


Active treatment programs for patients with chronic low back pain : a prospective , randomized , observer-blinded study . Several new studies have indicated that an active approach to patients with chronic disabling low back pain ( LBP ) seems effective . Some of these studies emphasize the importance of dealing with the patient 's total situation in comprehensive multidisciplinary programs -- the bio-psycho-social model . However , these programs are expensive . The aim of this study was to evaluate the rehabilitation outcome from three different active programs in terms of : ( 1 ) return-to-work rate , ( 2 ) days of sick leave , ( 3 ) health-care contacts , ( 4 ) pain and disability scores , and ( 5 ) staying physically active . The subjects included 132 patients randomized to the study , of whom 123 started one of the treatment programs . They had all had at least 6 months of chronic LBP . The patients were randomized into one of three programs : group 1 -- a full-time , intensive 3-week multidisciplinary program , including active physical and ergonomic training and psychological pain management , followed by 1 day weekly for the subsequent 3 weeks ; group 2 -- active physical training , twice a week for 6 weeks , for a total of 24h ; group 3 -- psychological pain management combined with active physical training , twice a week for 6 weeks , also for a total of 24h . The results presented here are based on data collected 4 months following treatment , which shows an 86 % response rate . The initial examination and the follow-up evaluation were performed by a blinded observer . The results show that 4 months after treatment , the intensive multidisciplinary program is superior to the less intensive programs in terms of return-to-work rate , health-care contacts , pain and disability scores , and staying physically active . ( ABSTRACT TRUNCATED AT 250 WORDS )

Active treatment programs

psychological pain management

2 -- active physical training

return-to-work rate

days of sick leave

health-care contacts

pain and

disability scores

staying physically active

patients with chronic low back pain :


Pharmacokinetics and pharmacodynamics of the monoamine oxidase B inhibitor mofegiline assessed during a phase I dose tolerance trial . The safety , pharmacokinetics , and pharmacodynamics of single oral doses of up to 48 mg and daily ( for 28 days ) doses of up 24 mg mofegiline were investigated in healthy male volunteers . Plasma pharmacokinetics indicated rapid absorption and elimination : time to reach maximum concentration occurred at about 1 hour ; half-life ranged from 1 to 3 hours . Maximal plasma concentration and area under the plasma concentration-time curve increased and oral clearance decreased disproportionately with dose . Mofegiline rapidly and markedly inhibited platelet monoamine oxidase B ( MAOB ) activity , which returned to baseline within 14 days . Urinary excretion of phenylethylamine increased proportionately with doses up to 24 mg. No changes in urinary elimination of catecholamines , blood pressure , heart rate , or ECG were observed . A classic maximum tolerated dose was not achieved in these studies . However , the 48 mg single dose and the 24 mg multiple daily dose far exceeded the dose ( 1 mg ) that was associated with > 90 % platelet MAOB inhibition .

mofegiline

Mofegiline

Urinary excretion of phenylethylamine

urinary elimination of catecholamines

blood pressure

heart rate

ECG

maximum tolerated dose


Antipyrine clearance and response to interferon treatment in patients with chronic active hepatitis C. To determine whether hepatic metabolic function affects the response to interferon treatment , we measured antipyrine clearance ( APC ) in 85 patients with chronic active hepatitis C and compared the results with treatment outcome . Among 55 patients who responded to interferon by normalization of alanine transaminase ( ALT ) , median APC before treatment was 0.47 ( range , 0.12 to 0.98 ; normal range , 0.34 to 1.02 mL/min/kg body wt ) , a value that was significantly greater than in 30 nonresponders ( 0.23 ; 0.08 to 0.67 mL/min/kg body wt , P < .001 ) . APC was closely associated with response to interferon . The response rate among cases with values > 0.25 mL/min/kg body weight was 79 % , the same as in cases without cirrhosis . Cases without cirrhosis and with APC of > 0.25 mL/min/kg body weight had an 85 % chance of responding to interferon ; this was unlikely a simple reflection of histological activity , because the correlation with Scheuer score was poor in this subgroup ( r = -.31 , P < .05 ) . A second , independent group of 43 patients was used to test the predictive value of APC ( using 0.25 mL/min/kg body wt as a cut-off ) for response to interferon treatment . In this group , APC correctly predicted positive response to interferon in 75 % of cases . APC was also used to measure the effects of treatment on hepatic metabolic function . Regardless of outcome , there was no change in APC at the end of a 6-month course of interferon treatment . Six months later , however , improvement in APC ( 14 % ; P < .05 ) was evident among responders but not in those who had failed to respond to interferon . ( ABSTRACT TRUNCATED AT 250 WORDS )

interferon

treatment

interferon

treatment

interferon

interferon

interferon

interferon

interferon

interferon

Antipyrine clearance and

response to interferon treatment

response to interferon treatment

antipyrine clearance ( APC )

response to interferon

response rate

responding to interferon

Scheuer score

predictive value of APC

positive response to interferon

hepatic metabolic function

APC

chronic active hepatitis C.

chronic active hepatitis C


A two-filter model for frequency discrimination . In this paper , we explore a two-filter model , the simplest version of multi-channel models for frequency discrimination of simple tones . According to this model , frequency discrimination is based on a change in the relative output levels of two auditory filters , one centered below and the other above the frequency of the tone . This idea can explain the experimental results that frequency discrimination is relatively unaffected by randomization of stimulus level . Moreover , it suggests a close relationship between the ability of listeners to perform frequency discrimination of simple tones and spectral-shape discrimination of two-tone complexes . The ability of three listeners to perform these two tasks was measured at six frequencies ( from 0.25 to 8 kHz ) . The results from the spectral-shape-discrimination task were used to predict frequency-difference limens . There was a high correlation between obtained and predicted values .

two-filter model

two-filter model

six frequencies ( from 0.25 to 8 kHz )

frequency discrimination

frequency discrimination

frequency discrimination .


Effect of perception of mechanical loading on human respiratory pattern regulation . We applied external flow resistive ( R ) and elastic ( E ) mechanical loads over the entire respiratory cycle to five normal subjects by using a pseudorandom loading protocol . Loads ranged in magnitude from imperceptible ( R0/E0 ) through just perceptible ( R1/E1 ) to large ( R2/E2 ) and resulted in respiratory pattern responses that were due to reflex responses alone ( R0/E0 ) or to a combination of reflex responses and behavioral reactions to the perception of impeded breathing ( R1/E1 and R2/E2 ) . Pattern regulation dynamics were estimated from the computed impulse responses of tidal volume and inspiratory and expiratory durations . We anticipated that emergence of behavioral contributions would be marked by increased variability in response strategies and by increased nonlinearity in the observed responses . Regarding the immediate pattern response to loading , there was a tendency for increased qualitative variation across subjects as the load size increased , but the within-subject variability ( coefficient of variation ) was unaffected . We found no evidence for increased nonlinearity as loads became perceptible . The emergence of behavioral control in some instances seemed to be marked by reduction of complexity of the impulse response to one dominated by the zeroth-order lag , leading to dynamically simpler responses compared to control .

imperceptible

just perceptible

large

human respiratory pattern

Pattern regulation dynamics

variability in response strategies

nonlinearity

qualitative variation

five

normal


Lisinopril administration improves insulin action in aged patients with hypertension . Thirty elderly , mildly hypertensive patients were enrolled for a single-blind , randomised cross-over placebo controlled trial in which placebo and lisinopril ( 20 mg/day before breakfast ) were given for 4 and 8 weeks , respectively . A wash-out period of 3 weeks between placebo and lisinopril was observed . In each patient a euglycaemic glucose clamp with simultaneous indirect calorimetry allowed us to determine whole body glucose disposal and substrate oxidation . Changes in morning SBP and DBP were also determined . Lisinopril vs. placebo significantly improved whole body glucose disposal ( 40.4 +/- 0.4 vs. 30.3 +/- 0.4 mumol/kg LBM x min ; P < 0.01 ) , non-oxidative glucose metabolism ( 18.1 +/- 0.7 vs. 10.9 +/- 0.6 mumol/kg LBM x min ; P < 0.01 ) and fasting plasma potassium levels ( 4.8 +/- 3 vs. 4.4 +/- 0.4 mmol/l ; P < 0.05 ) . SBP ( 175 +/- 3.3 vs. 160 +/- 3.0 mm Hg ; P < 0.001 ) and DBP ( 106 +/- 2.3 vs. 95 +/- 2.0 mm Hg ; P < 0.001 ) were significantly reduced by lisinopril administration . After ACE inhibition , fasting plasma potassium levels correlated with the decline in mean arterial BP ( r = -0.71 ; P < 0.006 ) . In conclusion , lisinopril administration reduces arterial BP and improves insulin sensitivity in elderly hypertensive patients .

Lisinopril

placebo

placebo

lisinopril

placebo

lisinopril

Lisinopril

placebo

lisinopril

lisinopril

insulin action

whole body glucose disposal

substrate oxidation

Changes

morning SBP and DBP

whole body glucose disposal

non-oxidative glucose metabolism

fasting plasma potassium levels

SBP

DBP

fasting plasma potassium levels

decline in mean arterial BP

arterial BP

improves insulin sensitivity

aged

patients with hypertension .

Thirty

elderly

mildly hypertensive

elderly

hypertensive


Hemostatic function of aspirin-treated platelets vulnerable to cardiopulmonary bypass . Altered shear-induced pathway . The impaired hemostasis of aspirin-treated patients is an annoying problem during and after cardiopulmonary bypass . The hemostatic function of platelets comprises two mechanisms : the shear-induced and the cyclooxygenase pathways . Because the latter is inhibited in aspirin-treated patients , the hemostatic function depends mainly on the former pathway . To investigate the effect of cardiopulmonary bypass on the shear-induced pathway , a double-blind study of preoperative aspirin treatment ( 325 mg ) and placebo was conducted in 40 patients undergoing coronary artery bypass grafting . Postoperative blood loss was higher in the aspirin-treated patients than in the placebo-treated patients ( p < 0.05 ) . The shear-induced hemostasis was monitored by the in vitro bleeding test ( Thrombostat ) , which mimics bleeding through an injured arteriole . The shear-induced pathway of aspirin-treated platelets was not affected before cardiopulmonary bypass , but it was impaired more during the operation ( p < 0.01 ) and remained worse afterward ( p < 0.05 ) , compared with that of placebo-treated platelets . The inhibitory effects of aspirin on thromboxane production and on collagen-induced platelet aggregation remained throughout the operation . In aspirin-treated platelets , the aggregation capacity induced by adenosine diphosphate was inhibited before the operation ( p < 0.05 ) and showed substantial recovery during the operation ( p < 0.05 ) . These results suggest that the shear-induced pathway of aspirin-treated platelets is more vulnerable to cardiopulmonary bypass than the pathway in normal platelets and causes severe impairment of hemostasis afterward .

aspirin-treated

aspirin-treated

aspirin-treated

aspirin

placebo

coronary artery bypass grafting

aspirin-treated

aspirin-treated

placebo-treated

aspirin

aspirin-treated

aspirin-treated

Hemostatic function

hemostatic function

Postoperative blood loss

shear-induced hemostasis

thromboxane production

collagen-induced platelet aggregation

aggregation capacity

aspirin-treated

cardiopulmonary bypass

aspirin-treated

coronary artery bypass grafting

aspirin-treated


Reducing the risk of coronary events : evidence from the Scandinavian Simvastatin Survival Study ( 4S ) . The Scandinavian Simvastatin Survival Study ( 4S ) was designed to evaluate the effects of cholesterol reduction with simvastatin on mortality and morbidity in patients with coronary artery disease ( CAD ) . A total of 4,444 patients with angina pectoris or previous myocardial infarction and serum cholesterol levels of 213-310 mg/dl ( 5.5-8.0 mmol/liter ) while treated with a lipid-lowering diet were randomly assigned to double-blind treatment with simvastatin or placebo . Over the 5.4 years of median follow-up , simvastatin produced changes in total cholesterol , low density lipoprotein ( LDL ) cholesterol , and high density lipoprotein ( HDL ) cholesterol of -25 % , -35 % , and +8 % , respectively , with minimal adverse effects . A total of 256 patients ( 12 % ) in the placebo group died compared with 182 ( 8 % ) in the simvastatin group , a risk reduction of 30 % ( p = 0.0003 ) attributable to a 42 % reduction in the risk of coronary death . Noncardiovascular causes accounted for 49 and 46 deaths in the placebo and simvastatin groups , respectively . Major coronary events were experienced by 622 patients ( 28 % ) in the placebo group and 431 patients ( 19 % ) in the simvastatin group , corresponding to a risk reduction of 34 % ( p < 0.00001 ) . This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged > or = 60 years . Other benefits of treatment included a 37 % reduction ( p < 0.00001 ) in the risk of undergoing myocardial revascularization procedures . Simvastatin was beneficial regardless of whether patients had a history of myocardial infarction or whether they were smokers or had hypertension . ( ABSTRACT TRUNCATED AT 250 WORDS )

simvastatin

lipid-lowering diet

simvastatin

placebo

mortality

morbidity

adverse effects .

died

Noncardiovascular causes

deaths

Major coronary events

risk reduction

coronary artery disease ( CAD ) .

angina pectoris

myocardial infarction

serum cholesterol levels

women

both sexes


Why are there sometimes concreteness effects in memory for prose ? Four experiments explored on-line encoding strategies and memory for high imagery and low imagery texts . Results consistently indicated that concreteness effects in memory for text depend on how materials are presented in several different respects . Most importantly , the experiments clarified apparently contradictory results of previous studies by indicating that concreteness effects generally do not occur in memory for prose when imageability is manipulated between-subjects , and that their occurrence when imageability is manipulated within-subjects depends on the order occurrence when imageability is manipulated within-subjects depends on the order of presentation . In addition , moving window analyses of text processing strategies indicated that differential strategies observed in previous studies when subjects listened to high vs low imagery text do not generalize to reading of the same materials . Potential explanations for the pattern of results are evaluated , and implications for theories of mental imagery and memory are considered .

text processing strategies

concreteness effects in memory

concreteness effects in memory for text

concreteness effects

memory

Four

memory

high imagery

low imagery


The European Myocardial Infarction Project : an assessment of pre-hospital thrombolysis . The use of thrombolytic agents in patients with suspected myocardial infarction has been shown to reduce early and long-term mortality by about 20 % , and it has been suggested that since time is an important factor , pre-hospital treatment would give better results . However , health deciders need reliable data on which to base future policies concerning this . The European Myocardial Infarction Project was a European Economic Community-supported double-blind study designed to evaluate the efficacy and safety of pre-hospital early thrombolytic treatment in patients with suspected myocardial infarction compared with the same treatment given later in a hospital setting . A total of 5469 patients in 16 countries were randomised by 198 mobile emergency units to receive either pre-hospital treatment with anistreplase , the thrombolytic agent used , followed by placebo after hospital admission ( pre-hospital group ; 2750 patients ) , or placebo followed by anistreplase ( hospital group ; 2719 patients ) . The median time delay between the injections was 55 min . A non-significant decrease in 30-day mortality was observed in favour of the pre-hospital group ( 13 % : P = 0.08 ) , whereas the decrease in cardiac death observed , also in favour of the pre-hospital group , was on the borderline of significance ( 16 % ; P = 0.049 ) . Although some complications occurred more frequently in the pre-hospital group in the pre-hospital period , the overall incidence for serious complications was similar for both groups . These results show that the pre-hospital thrombolytic strategy in patients with suspected myocardial infarction is both effective and safe when performed by well-equipped well-staffed mobile emergency units .

thrombolytic agents

anistreplase

followed by placebo

placebo followed by anistreplase

pre-hospital thrombolytic strategy

median time delay

30-day mortality

decrease in

cardiac death

some complications

thrombolytic strategy

myocardial infarction

effective and safe

thrombolysis

myocardial infarction

myocardial infarction

5469 patients


Quantifying the extent of osteonecrosis of the femoral head . A new method using MRI . In a randomised trial comparing core decompression with conservative treatment we tested the hypothesis that the extent of necrosis at the initial MRI predicts the subsequent risk of collapse of the femoral head . After the initial clinical evaluation , including plain radiography and MRI , 37 hips with early-stage osteonecrosis ( ON ) in 33 patients were randomly assigned to a core-decompression group or a conservatively-treated group . All were followed regularly by clinical evaluation , plain radiography and MRI at intervals of three months . The extent of ON was estimated on the basis of abnormal signal intensity in the weight-bearing portion of the femoral head as determined from a combination of coronal and sagittal MRIs . The arc of the necrotic portion in the mid-coronal image ( A ) and that in the mid-sagittal image ( B ) were used to quantify the extent of necrosis by the formula : ( A/180 ) x ( B/180 ) x 100 . There was a strong correlation between this index and the risk of collapse before and after adjustment for age , gender , stage and treatment group . We conclude that the extent of the necrotic portion ascertain by this method is a major predictor of future collapse . We propose a systematic method of determining the index of the necrotic portion which may be clinically useful in the management of early-stage ON of the femoral head .

MRI

MRI

plain radiography

MRI

core-decompression

conservatively-treated

plain radiography

MRI

index and the risk of collapse

extent of the necrotic portion

necrotic portion

osteonecrosis of the femoral head .


The efficacy of a herbal-based toothpaste on the control of plaque and gingivitis . A double-blind controlled clinical trial with parallel groups was designed to investigate the effectiveness of a herbal-based toothpaste in the control of plaque and gingivitis as compared with a conventional dentifrice . 70 subjects with gingivitis completed the 6-week study . All participants had at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index of 2 or more at baseline . At baseline , both groups were balanced for the parameters measured : plaque index , plaque vitality , gingival index , bleeding on probing and gingival crevicular fluid flow . At the end of the trial , there were reductions within both groups , however , there were no significant differences between the groups . It was concluded that the herbal based toothpaste was as effective as the conventionally formulated dentifrice in the control of plaque and gingivitis .

herbal-based toothpaste

herbal-based toothpaste

conventional dentifrice .

herbal based toothpaste

conventionally formulated dentifrice

plaque and gingivitis .

70 subjects

gingivitis


Effect of fats high in individual saturated fatty acids on plasma lipoprotein [ a ] levels in young healthy men . Plasma lipoprotein [ a ] ( Lp [ a ] ) is associated with atherogenesis and thrombogenesis . We examined how plasma Lp [ a ] in healthy young men was affected by fats high in stearic ( C18 ) , palmitic ( C16 ) , and lauric+myristic ( C12+ C14 ) acid ( experiment I , 15 subjects ) , and by fats high in myristic ( C14 ) and palmitic ( C16 ) acid ( experiment II , 12 subjects ) . Strictly controlled isocaloric diets with 36 % of energy from test fats were served in random order for 3 weeks separated by wash-out period ( s ) . Diets high in C18 gave significantly higher levels of Lp [ a ] ( 51 ( 12-560 ) mg/L ) than diets high in C16 ( 38 ( 12-533 mg/L ) ( P = 0.020 ) and C12 + C14 ( 34 ( 12-534 ) mg/L ) ( P = 0.002 ) . These differences were observed in several of the subjects in experiment I . In experiment II we saw no difference in plasma Lp [ a ] after diets high in C16 and C14 . Our observations suggest that a fat high in stearic acid might affect Lp [ a ] in a different way than fats high in palmitic and myristic+lauric acid . Lp [ a ] concentrations were not associate with changes in tissue-plasminogen activator ( t-PA ) activity , factor VII coagualant activity , or plasma LDL cholesterol .

fats

isocaloric diets

Diets high in C18

high in C16

plasma lipoprotein [ a ] levels

Plasma lipoprotein [ a ] ( Lp [ a ] )

levels of Lp [ a ]

differences

plasma Lp [ a ]

Lp [ a ]

Lp [ a ] concentrations

factor VII coagualant activity

plasma LDL cholesterol

young

healthy

men

experiment I , 15 subjects

experiment II , 12 subjects


Cisplatin plus etoposide with and without ifosfamide in extensive small-cell lung cancer : a Hoosier Oncology Group study . PURPOSE To determine whether the addition of ifosfamide to cisplatin plus etoposide improves the response rate , time to disease progression , or overall survival in previously untreated patients with extensive-stage small-cell carcinoma of the lung ( SCLC ) . PATIENTS AND METHODS Patients with extensive SCLC with a Karnofsky performance score ( KPS ) > or = 50 and adequate renal function and bone marrow reserve were eligible . Patients with CNS metastases were eligible and received concurrent whole-brain radiotherapy . Patients were randomized to receive cisplatin ( 20 mg/m2 ) plus etoposide ( 100 mg/m2 ) ( VP ) both given intravenously ( i.v . ) on days 1 to 4 or cisplatin ( 20 mg/m2 ) , ifosfamide ( 1.2 g/m2 ) , and etoposide ( 75 mg/m2 ) ( VIP ) all given i.v . on days 1 to 4 . Cycles were repeated every 3 weeks for four cycles . RESULTS From May 1989 through March 1993 , 171 patients were randomized ( 84 to VP and 87 to VIP ) . The median follow-up duration is 26 months . All patients were assessable for survival ; 163 were fully assessable for response and 162 for toxicity . Myelosuppression was greater with VIP . Objective responses were observed in 55 of 82 ( 67 % ) and 59 of 81 ( 73 % ) assessable patients treated with VP and VIP , respectively ( difference not significant ) . The difference in the median time to progression was statistically different ( P = .039 ) . The median survival times on VP and VIP were 7.3 months and 9.0 months , respectively ( P = .045 for survival curves by stratified log-rank test ) with 2-year survival rates of 5 % versus 13 % , respectively . CONCLUSION VIP combination chemotherapy is associated with an improved time to progression and overall survival over VP therapy in patients with extensive SCLC .

Cisplatin plus etoposide

ifosfamide

ifosfamide

cisplatin plus etoposide

cisplatin

etoposide

cisplatin

ifosfamide

etoposide

response rate

time to disease progression

overall survival

survival

assessable for response

toxicity

Myelosuppression

greater

Objective responses

median time to progression

median survival times

2-year survival rates

time to progression

overall survival

lung cancer


Hemodynamic effects during induction , laryngoscopy , and intubation with eltanolone ( 5 beta-pregnanolone ) or propofol . A study in ASA I and II patients . STUDY OBJECTIVE To evaluate the cardiovascular changes following induction of anesthesia , laryngoscopy , and intubation in patients receiving a bolus dose of either eltanolone or propofol . DESIGN Randomized , controlled , blind , prospective clinical study . SETTING General operating theaters of a university hospital . PATIENTS 40 ASA status I and II patients scheduled for elective surgery . INTERVENTIONS Patients were premedicated with oral temazepam 20 mg. Anesthesia was induced with either eltanolone 0.58 mg/kg or propofol 1.7 mg/kg , neuromuscular blockade was achieved with vecuronium 0.1 mg/kg , and anesthesia was maintained with enflurane 0.5 % to 1.0 % in nitrous oxide ( 67 % ) . MEASUREMENTS AND MAIN RESULTS Blood pressure was measured using an automatic oscillometric technique , heart rate ( HR ) was derived from the ECG , oxygen saturation was measured by pulse oximetry , and cardiac output ( Q ) was measured by a thoracic bioimpedance technique . Induction of anesthesia with either drug , eltanolone or propofol , decreased arterial systolic ( SAP ) and diastolic ( DAP ) blood pressure , Q , and stroke volume ( SV ) . HR increased . Systemic vascular resistance ( SVR ) was unaltered . After laryngoscopy and intubation , SAP and DAP increased secondary to an increase in SVR . HR also increased ; SV decreased in patients receiving eltanolone . Side effects ( e.g. , apnea occurring for more than 30 seconds , involuntary movements , limb hypertonus ) occurred at a similar incidence with both treatments , but pain following injection was greater with propofol ( 59 % vs. 9 % ) . CONCLUSIONS Patients receiving either eltanolone or propofol showed similar cardiovascular changes to induction of anesthesia , although there were greater increases in arterial pressure and HR in those patients receiving eltanolone .

eltanolone ( 5 beta-pregnanolone )

propofol .

eltanolone

propofol .

eltanolone

propofol

Blood pressure

automatic oscillometric technique

heart rate ( HR )

oxygen saturation

cardiac output ( Q )

arterial systolic ( SAP )

diastolic ( DAP ) blood pressure , Q

stroke volume ( SV )

HR

Systemic vascular resistance ( SVR )

SAP

DAP

SVR

HR

SV

ASA I and II patients

scheduled for elective surgery


Brief report : a pilot study of auditory integration training in autism .

auditory integration training

autism .


A randomized , controlled trial of the efficacy of a heparin and vancomycin solution in preventing central venous catheter infections in children . OBJECTIVE To determine whether adding vancomycin to central venous catheter ( CVC ) flush solution would significantly reduce the incidence of bacteremia attributable to luminal colonization with vancomycin-susceptible organisms . STUDY DESIGN Fifty-five children with cancer and eight children given total parenteral nutrition by the surgery or nutrition support services were randomly assigned to receive a heparin CVC flush solution ( n = 31 ) or a heparin-vancomycin CVC flush solution ( n = 32 ) . RESULTS During 9158 catheter days , 6.5 % of the patients in the heparin group and 15.6 % of the patients in the heparin-vancomycin group had bacteremia attributable to luminal colonization with vancomycin-susceptible organisms ( p = 0.43 ) . The mean rates of bacteremia attributable to luminal colonization with vancomycin-susceptible organisms were 0.6/1000 catheter days in the heparin group and 1.4/1000 catheter days in the heparin-vancomycin group ( p = 0.25 ) . There was no significant difference between the groups when the time to the first episode of bacteremia attributable to luminal colonization with a vancomycin-susceptible organism was compared by means of Kaplan-Meier survival estimates . Streptococcus viridans infection was not attributable to luminal colonization . CONCLUSION The addition of vancomycin to heparin CVC flush solution did not reduce bacteremia with vancomycin-susceptible organisms . Bacteremia with Streptococcus viridans was not related to the use of a CVC .

heparin

vancomycin solution

vancomycin

central venous catheter ( CVC ) flush

heparin CVC flush solution

heparin-vancomycin CVC flush solution

efficacy

central venous catheter infections

mean rates of bacteremia

time to the first episode of bacteremia

Streptococcus viridans infection

bacteremia

Bacteremia

central venous catheter infections

children

Fifty-five

children

cancer

eight

children


Prospective trial of intraoperative mitomycin C in the treatment of primary pterygium . AIMS A prospective , randomised , double blind , placebo controlled study of intraoperative mitomycin C as adjunctive treatment of primary pterygium was conducted . METHODS A total of 66 eyes of 54 patients with primary pterygium were treated with excision , with or without a single intraoperative application of mitomycin C ( 0.1 mg/ml for 5 minutes ) to evaluate the efficacy and toxicity of this adjunctive treatment . The mean follow up was 14.1 months ( range 12-23 months ) . RESULTS Of the 36 eyes that underwent simple excision , 14 ( 38.8 % ) exhibited recurrences whereas only one of 30 eyes ( 3.33 % ) treated with excision and intraoperative application of mitomycin C had recurrence ( p = 0.0006 ) . Neither serious ocular complications nor systemic toxicity were noted in the mitomycin C treated group . CONCLUSION Intraoperative mitomycin C appears to be an effective and safe adjunctive treatment of primary pterygium .

intraoperative mitomycin C

placebo

intraoperative mitomycin C

mitomycin C

mitomycin C

mitomycin C

efficacy and toxicity

recurrences

recurrence

primary pterygium


Primary care-based ambulatory opioid detoxification : the results of a clinical trial . OBJECTIVE To determine the feasibility of primary care-based ambulatory opioid detoxification ( AOD ) using two protocols : clonidine and clonidine plus naltrexone . SETTING The Central Medical Unit ( CMU ) -- a freestanding primary care medical clinic staffed by physicians and nurse practitioners . PATIENTS Injection drug users ( IDUs ) seeking substance abuse treatment between the ages of 18 and 50 years who were addicted to opioids ( e.g. , heroin ) and not currently in drug treatment . INTERVENTIONS In the clonidine protocol , clonidine was administered every 4 hours " as needed " for up to 12 days . In the clonidine plus naltrexone protocol , clonidine was administered and naltrexone was administered in increasing doses over five days . Both protocols included " adjuvant " medications for muscle cramps , insomnia , and vomiting . Successfully detoxified patients were referred to ongoing drug treatment . DESIGN A prospective nonrandomized clinical trial . MEASUREMENTS AND MAIN RESULTS One hundred forty opioid-addicted IDUs were referred to the medical clinic for AOD . Among the 125 patients who enrolled in the study , 57 selected clonidine and 68 selected clonidine/naltrexone . The treatment groups ( clonidine vs clonidine/naltrexone ) were similar at baseline with respect to : age at first heroin use ( 21 years vs 23 years ) , mean admission opioid craving score ( 45/100 vs 49/100 ) , and withdrawal symptom score ( 19/72 vs 18/72 ) . Overall , 70 % ( 88/125 ) of the AODs were successful , including 42 % ( 24/57 ) for clonidine and 94 % ( 64/68 ) for clonidine/naltrexone ( p < 0.001 ) . CONCLUSIONS This study suggests that primary care-based AOD can be safely and effectively carried out by primary care providers and that clonidine/naltrexone may be more effective in this setting than is clonidine alone . Ambulatory opioid detoxification can give internists a larger role in initiating drug treatment for IDUs who are addicted to opioids .

clonidine

clonidine plus naltrexone

clonidine

clonidine plus naltrexone

naltrexone

feasibility

mean admission opioid craving score

withdrawal symptom score

AODs

substance abuse

18 and 50 years

One hundred forty

addicted to opioids


Effect of postmenopausal hormonal replacement therapy on mammographic density and parenchymal pattern . PURPOSE To measure changes and predictors of change in mammograms obtained in postmenopausal women undergoing continuous combined hormonal replacement therapy ( HRT ) . MATERIALS AND METHODS Mammograms of 41 postmenopausal women obtained before and 1 year after the initiation of HRT were evaluated blindly according to the quantitative density percentage method and the Wolfe classification system . RESULTS Mammographic densities increased compared with baseline values in 73 % of subjects ( mean increase , 6.7 % ; 95 % confidence interval , 2.5 % , 11.0 % ; P = .003 ) . A shift in Wolfe classification from lower to greater parenchymal density was noted in 24 % of subjects ( P = .016 ) . Multivariate analysis results indicated that the lower the tissue density percentage before treatment , the greater the increase in density percentage after treatment . CONCLUSION An increase in mammographic density was demonstrated in most subjects undergoing continuous combined HRT and was most pronounced in subjects with a lower baseline density percentage .

hormonal replacement therapy ( HRT )

Mammograms

HRT

mammographic density

parenchymal pattern

Mammographic densities

lower to greater parenchymal density

tissue density percentage

increase in density percentage

mammographic density


A controlled trial of cisapride in anorexia nervosa . To determine the efficacy of cisapride , 10 mg three times daily , in improving gastric emptying , reducing distress during meals , and facilitating weight gain in anorexia nervosa , we conducted an 8-week , randomized , double-blind , placebo-controlled trial on 29 inpatients . Measures included scintigraphic gastric emptying studies at 0 , 2 , 4 , and 8 weeks ; subjective distress during meals measured by visual analogue scales ; self-rating of degree of global improvement in symptoms associated with eating at end of study ; and weight measured weekly . Gastric emptying improved significantly but equally in both groups over the study period . Yet subjective measures were better in the cisapride group ; they rated themselves as more hungry ( p = .02 ) and more improved on the global measure of change in symptoms ( p = .02 ) . Even so , the cisapride group did not gain more weight . The correlation between gastric emptying and weight gain was modest ( r = .30 ; p = .11 ) , and between gastric emptying and the subjective measures , virtually absent .

cisapride

cisapride

placebo-controlled

cisapride

efficacy

gastric emptying

distress during meals

weight gain

subjective distress during meals

visual analogue scales

weight

Gastric emptying

hungry

change in symptoms

weight

gastric emptying

weight gain

gastric emptying

anorexia nervosa

anorexia nervosa

both

cisapride

cisapride


Synthesis of interleukin-1 beta in primary biliary cirrhosis : relationship to treatment with methotrexate or colchicine and disease progression . Primary biliary cirrhosis ( PBC ) is a chronic , progressive , cholestatic liver disease . Interleukin-1 beta ( IL-1 beta ) may play a role in the pathogenesis of PBC by contributing to altered immune function and fibrosis . Colchicine or methotrexate has some beneficial effects in the treatment of PBC , and also affects interleukin-1 ( IL-1 ) . Therefore , we prospectively studied the synthesis of IL-1 beta by peripheral blood mononuclear cells ( PBMC ) from 42 patients with PBC entered into a randomized , double-blind , double-dummy controlled trial of colchicine and methotrexate . PBMC obtained at entry , 6 , 12 , 18 , and 24 months were stimulated to produce IL-1 beta with phytohemagglutinin ( PHA ) , lipopolysaccharide ( LPS ) , Staphylococcus epidermidis , recombinant IL-2 , or mitochondrial antigen . Patients in the two treatment groups did not differ at entry in biochemical measures or liver histological stage . Over 24 months in both groups , serum bilirubin and histologic stage remained stable and alkaline phosphatase decreased significantly . For all patients , synthesis of IL-1 beta increased constitutively and in response to immune-mediated stimulants ( PHA , IL-2 , and mitochondrial antigen ) but not the bacterial stimulants LPS or S epidermidis . Compared with levels of IL-1 beta at entry , PHA induced increases for patients treated with methotrexate ( 12 , 18 , and 24 months ) or colchicine ( 18 and 24 months ) . At 24 months , IL-2-induced IL-1 beta synthesis was increased in patients treated with methotrexate , whereas S epidermidis-induced IL-1 beta was enhanced in colchicine-treated patients . Before treatment , IL-1 beta production did not relate to severity of disease except in response to S epidermidis . ( ABSTRACT TRUNCATED AT 250 WORDS )

methotrexate

colchicine

Colchicine

methotrexate

colchicine

methotrexate

methotrexate

colchicine-treated

Interleukin-1 beta ( IL-1 beta )

interleukin-1 ( IL-1 ) .

IL-1 beta

serum bilirubin and histologic stage

alkaline phosphatase

synthesis of IL-1 beta

IL-2-induced IL-1 beta synthesis

S epidermidis-induced IL-1 beta

primary biliary cirrhosis

Primary biliary cirrhosis ( PBC )

liver disease

PBC


Comparison of non-invasive methods for the assessment of haemodynamic drug effects in healthy male and female volunteers : sex differences in cardiovascular responsiveness . 1 . The study was performed to determine the sensitivity and short-term and day-to-day variability of a novel technique based on laser interferometry of ocular fundus pulsations and of non-invasive methods for the quantification of haemodynamic drug effects . An additional aim was to assess sex differences in haemodynamic responsiveness to cardiovascular drugs in male and female healthy volunteers . 2 . Ten males and nine females ( age range 20-33 years ) were studied in a double-blind , randomized , cross-over trial . Simultaneous measurements from systemic haemodynamics , laser interferometry of ocular fundus pulsations , systolic time intervals from mechanocardiography , a/b ratio from oxymetric fingerplethysmography and Doppler sonography of the radial artery were used to describe the haemodynamic effects of cumulative , stepwise increasing intravenous doses of phenylephrine , isoprenaline , sodium nitroprusside and of placebo . 3 . Laser interferometry detected the isoprenaline-effects at the lowest dose level of 0.1 micrograms min-1 with a high signal-to-noise ratio . The reproducibility of measurements under baseline was high , no changes were observed after systemically effective doses of phenylephrine or sodium nitroprusside . Systolic time intervals were sensitive and specific for isoprenaline-induced effects , PEP and QS2c-measurements had high reproducibility . Fingerplethysmography proved a sensitive measurement for the detection of the vasodilating effects of sodium nitroprusside , but was not specific , and showed low reproducibility . Measurements from Doppler sonography had lower reproducibility and sensitivity compared with the other applied methods . 4 . There was a significant sex difference for several of the haemodynamic parameters under baseline conditions ; however , the responsiveness to the drugs under study was not different , when drug effects were expressed as % -change from the baseline . 5 . Laser interferometry is a valuable non-invasive , highly sensitive and specific approach for the detection of pulse pressure changes . A battery of non-invasive tests appears useful for the characterization of cardiovascular drugs . Gender differences may not pose a relevant problem for the study of acute haemodynamic effects of cardiovascular drugs .

non-invasive methods

haemodynamic

non-invasive methods

haemodynamics

mechanocardiography

oxymetric fingerplethysmography

Doppler sonography

intravenous doses of phenylephrine

isoprenaline

sodium nitroprusside

placebo

Laser interferometry

reproducibility and sensitivity

Ten

males

nine

females


In vivo assessment of catheter-tip PO2 sensor : sampling lumen fabrication . Fabrication of the sampling lumen of an intra-arterial PO2 sensor is performed in standard catheters mechanically or by laser . Clinical evaluation is performed with respect to catheter insertion , complications , accuracy of oxygen sensor data and fibrin deposition on the catheter surface . The success rate for catheter insertion is 57 % for 138 standard and 50 % for 74 laser-cut catheters studied . The proportion of catheter failures ( blocked or non-reading ) is 14 % in laser-cut compared with 30 % in standard . These differences are not statistically significant at the 5 % level . There is no clinically significant difference in sensor accuracy , with 37.5 % of results within +/- 0.05 kPa and 80 % within +/- 2.0 kPa of simultaneous blood gas values . Drift is within +/- 0.3 kPa h-1 for 78 % of monitoring time . Significant errors of recalibration occur in 6 % of calibrations . Scanning electron micrographs demonstrate a much smaller sampling lumen in the laser-cut group , but no reduction in fibrin deposition at the site of the sampling hole . The low success rate for catheter insertion is a problem because of cost implications . The accuracy of the system is usually sufficient for clinical purposes , provided the calibration is checked every 4 h .

catheter-tip PO2 sensor :

intra-arterial PO2 sensor

catheter

assessment

success rate for catheter insertion

sensor accuracy

Drift

Significant errors of recalibration

sampling lumen

fibrin deposition

success rate for catheter insertion

accuracy

catheter-tip

catheters

catheter

catheter

138 standard

74 laser-cut

catheters


A randomized trial of exercise therapy in patients with acute low back pain . Efficacy on sickness absence . STUDY DESIGN A randomized , placebo-controlled trial in which patients received either usual care by a general practitioner ( information and analgesics ) , or placebo physiotherapy given by a physiotherapist , or exercise therapy given by a physiotherapist . OBJECTIVE To assess the efficacy of exercise therapy on sickness absence from work in patients with acute low back pain . SUMMARY OF BACKGROUND DATA Exercise therapy during the nonchronic phase of back pain is considered to reduce sickness absence , but this opinion is controversial . METHODS Patients with acute nonspecific low back pain and a paid job were included for analysis . Sickness absence ( number of days ) was checked monthly during the 1-year follow-up period and compliance was also assessed . RESULTS From 40 general practices 363 patients who were gainfully employed were included . In the exercise therapy group the percentage of patients with sickness absence was higher and the duration of absence was longer than in the placebo and usual care groups , but these differences were not significant . Indications of more absence in the exercise therapy group appeared to be based largely on a greater number of patients with absences during the first 3 months . Patients in the exercise group who had not reported sick at entry had more sickness absences during the follow-up year than patients in the usual care and placebo group . Good compliance did not affect the results . CONCLUSIONS Exercise therapy for patients with acute low back pain does not reduce sickness absence .

exercise therapy

placebo-controlled

usual care

placebo physiotherapy

exercise therapy

exercise therapy

Exercise therapy

exercise therapy

placebo

usual care

exercise therapy group

exercise group

usual care

placebo

Exercise therapy

sickness absence

sickness absence from work

sickness absence

Sickness absence ( number of days )

compliance

sickness absence

duration of absence

absence

sickness absences

compliance

sickness absence

acute low back pain

acute nonspecific low back pain

paid job


Paracervical anesthesia for outpatient hysteroscopy . One hundred seventy-seven women aged 41 +/- 8 ( mean +/- SD ) years , referred for evaluation of excessive uterine bleeding , were enrolled in an open-label randomized trial to evaluate the efficacy of local anesthesia before hysteroscopy in an outpatient population . The patients underwent hysteroscopy and endometrial biopsy with paracervical block by 10 mL of 1 % mepivacaine hydrochloride solution ( n = 87 ) or no local anesthesia ( n = 90 ) and assessed lower abdominal and pelvic pain according to a 10-point linear analog scale . The mean +/- SD pain score was 4.5 +/- 2.0 at hysteroscopy and 5.2 +/- 2.1 at endometrial biopsy in the 87 subjects given a paracervical block versus 4.9 +/- 2.2 and 5.7 +/- 2.4 in the 90 women not given local anesthesia , without statistically significant differences . Paracervical anesthesia for routine outpatient hysteroscopy in premenopausal women may be superfluous .

local anesthesia

hysteroscopy and endometrial biopsy

no local anesthesia

Paracervical anesthesia

outpatient hysteroscopy .

hysteroscopy

hysteroscopy

mean +/- SD pain score

outpatient hysteroscopy

One hundred seventy-seven

women

41 +/- 8

excessive uterine bleeding

premenopausal


Are PRO discharge screens associated with postdischarge adverse outcomes ? OBJECTIVE We evaluate whether patient outcomes may be affected by possible errors in care at discharge as assessed by Peer Review Organizations ( PROs ) . DATA SOURCES/STUDY SETTING The three data sources for the study were ( 1 ) the generic screen results of a 3 percent random sample of Medicare beneficiaries age 65 years or older who were admitted to California hospitals between 1 July 1987 and 30 June 1988 ( n = 20,136 patients ) ; ( 2 ) the 1987 and 1988 California Medicare Provided Analysis and Review ( MEDPAR ) data files ; and ( 3 ) the American Hospital Association ( AHA ) 1988 Annual Survey of Hospitals . STUDY DESIGN Multivariate logistic regression analysis was used to evaluate the association between the results of generic discharge administered by the PROs and two patient outcomes : mortality and readmission within 30 days . The analysis was adjusted for other patient characteristics recorded on the uniform discharge abstract . PRINCIPAL FINDINGS Four discharge screens indicated an increased risk of an adverse outcome-absence of documentation of discharge planning , elevated temperature , abnormal pulse , and unaddressed abnormal test results at discharge . The other three discharge screens examined-abnormal blood pressure , IV fluids or drugs , and wound drainage before discharge-were unrelated to postdischarge adverse outcomes . CONCLUSIONS Generic discharge screens based on inadequate discharge planning , abnormal pulse , increased temperature , or unaddressed abnormal tests may be important indicators of substandard care . Other discharge screens apparently do not detect errors in care associated with major consequences for patients .

PRO discharge screens

generic screen results

Generic discharge screens

elevated temperature

abnormal pulse

unaddressed abnormal test results

examined-abnormal blood pressure

IV fluids or drugs

wound drainage

abnormal pulse

increased temperature

unaddressed abnormal tests


Does tetanus immune globulin interfere with the immune response to simultaneous administration of tetanus-diphtheria vaccine ? A comparative clinical trial in adults . In the management of wounds , sometimes it is recommended to give an adult-type tetanus-diphtheria ( Td ) vaccine dose plus tetanus immune globulin ( TIG ) . Sixty and 59 healthy young adults previously immunized against tetanus ( T ) and diphtheria ( D ) were randomized to receive intramuscularly either Td vaccine alone ( group 1 ) or Td vaccine plus 500 IU of TIG ( group 2 ) simultaneously . Antitoxin response was assessed after 4 weeks and 4 months . Circulating antibodies were measured by enzyme-linked immunosorbent assay ( ELISA ) . The cutoff of these tests was 0.1 IU/mL . Titers of 0.1 IU/mL or greater were considered protective . For geometric mean titers ( GMT ) , antibody titers below the cutoff of the assay were given , arbitrarily , 0.05 IU/mL . At 4 weeks , 98 % or more of the subjects in group 1 had circulating T and D antitoxin levels of 0.1 IU/mL or higher ; in group 2 , 95 % and 90 % of the subjects had titers above this limit for T and D , respectively . At 4 months , these percentages were 98 % and 95 % for T antitoxin levels in groups 1 and 2 , respectively ; whereas 96 % and 88 % of the subjects in groups 1 and 2 had D antitoxin levels of 0.1 IU/mL or higher , respectively . Significantly ( P < .05 ) higher GMTs were seen at the 4-week assessment ( but not at 4 months ) in group 1 , as compared with group 2 , in both T and D antitoxin levels ( 9.91 IU/mL versus 5.60 IU/mL for T antitoxin , and 2.86 IU/mL versus 1.45 IU/mL for D antitoxin ) . This finding resulted from those participants with low ( < 0.1 IU/mL ) prevaccination antibody titers . ( ABSTRACT TRUNCATED AT 250 WORDS )

tetanus immune globulin

tetanus-diphtheria vaccine

tetanus-diphtheria ( Td ) vaccine

tetanus immune globulin ( TIG )

Td vaccine alone

( group 1 )

Td vaccine plus 500 IU of TIG

immune response

Antitoxin response

antibody titers

circulating T and D antitoxin levels

T antitoxin levels

D antitoxin levels

adults

Sixty and 59

healthy

young adults


Failure of naltrexone hydrochloride to reduce self-injurious and autistic behavior in mentally retarded adults . Double-blind placebo-controlled studies . BACKGROUND It is hypothesized that self-injurious behavior ( SIB ) and symptoms of autism may be due to overactivity in some opioid systems in the brain . We examined the efficacy and safety of naltrexone hydrochloride , an opioid antagonist , in the treatment of SIB and autism in mentally retarded adults . METHOD Thirty-three mentally retarded adults with autism and/or SIB participated in double-blind , placebo-controlled crossover studies . Active treatment was first a single 100-mg dose of naltrexone hydrochloride . Subsequently , 19 subjects were treated with 50 mg/d and 14 with 150 mg/d of naltrexone hydrochloride for 4 weeks . The outcome was assessed by means of direct observations ( n = 11 ) and on the basis of scores on a list of target behaviors , the Aberrant Behavior Checklist , and the Clinical Global Impression Scale . RESULTS Thirty-two subjects ( seven with autism , 16 with autism and SIB , and nine with SIB ) completed the trial . Naltrexone treatment failed to have therapeutic effects on SIB and autism . On the contrary , naltrexone increased the incidence of stereotypic behavior on the Aberrant Behavior Checklist , and the care staff evaluated the effect of the 50-mg/d treatment as being significantly worse than that of the placebo treatment as measured by the Clinical Global Impression Scale . CONCLUSION Our findings suggest that naltrexone has no clinical value for a broad group of mentally retarded subjects with SIB and/or autism .

naltrexone hydrochloride

placebo-controlled

naltrexone hydrochloride

placebo-controlled

naltrexone hydrochloride

naltrexone hydrochloride

Naltrexone

naltrexone

efficacy and safety

failed

significantly worse

Clinical Global Impression Scale

SIB and autism

Thirty-three

adults


Movement-related potentials in Parkinson 's disease . Presence and predictability of temporal and spatial cues . Activity of the supplementary motor area may be inferred from movement-related potentials ( MRPs ) which are associated with the preparation and execution of voluntary , or internally determined movements . Supplementary motor area activity may be abnormal in Parkinson 's disease since its major input from the basal ganglia is disrupted . Investigation of the abnormalities in supplementary motor area activity associated with movement deficits in Parkinson 's disease may therefore reveal functions of the basal ganglia and the supplementary motor area . Movement-related potentials associated with sequential movements were investigated under various cueing conditions in Parkinson 's disease subjects and age-matched controls . In controls , MRPs revealed involvement of the supplementary motor area in movements which can be internally determined ( non-cued and externally cued , predictable movements , but not unpredictable movements ) . In Parkinson 's disease , however , the supplementary motor area was only involved in movements which must be internally determined ( non-cued movements , but not externally cued movements ) ; therefore impaired internal control mechanisms , operating via the supplementary motor area , are bypassed when external cues are given . As a result , Parkinson 's disease patients are more reliant on external cues and are unable to use predictive models to internally guide movement . Supplementary motor area involvement also relied on the predictability ( in controls ) or presence ( in Parkinson 's disease ) of timing cues and not spatial cues , indicating a role of the supplementary motor area and basal ganglia in the temporal organizations of sequential movement rather than the programming of specific movements . For non-cued movements , abnormalities in MRPs for Parkinson 's disease subjects consisted of delayed MRP onset and peak times , and prolonged cortical activity following movement . These observations led to a proposed model of the interaction between the basal ganglia and the supplementary motor area , involving the temporal organization of voluntary and internally determined sequential movements .

Movement-related potentials

movement-related potentials ( MRPs )

Movement-related potentials

controls

non-cued

externally cued

predictable

not unpredictable

not externally cued

timing cues

delayed MRP onset

peak times

Parkinson 's disease

Parkinson 's disease

Parkinson 's disease

Parkinson 's disease