Efficacy of colchicine versus placebo for the treatment of pericardial effusion after open-heart surgery : A randomized , placebo-controlled trial . BACKGROUND Pericardial effusion ( PE ) , a common complication after open-heart surgery , accounts for 50 % to 85 % of patients . Although reversible in most of the cases , it could be life threatening in the occurrence of tamponade in large effusions . We aimed to determine the therapeutic efficacy of colchicine on PE after open-heart surgery . METHODS The study is a prospective , randomized , triple-blind , placebo-controlled single-center trial at Tehran Heart Center . A total of 149 patients with mild or moderate PE in transthoracic echocardiography were randomly assigned to receive 1 mg/d colchicine ( n = 74 ) or 1 tablet of placebo ( n = 75 ) for 2 weeks and then underwent follow-up echocardiography . RESULTS Baseline and clinical characteristics were not significantly different between the 2 study groups except for age ( P = .02 ) and graft numbers ( P = .005 ) . There was no significant difference in pretreatment and posttreatment PE sizes between the 2 study groups ( P = .440 and .844 , respectively ) . Median ( 25th-75th percentiles ) of effusion changes was 5 mm ( 1-7.6 mm ) in the colchicine group and 5 mm ( 1-6.6 mm ) in the placebo group ( P = .932 ) . Intervention had no significant impact on pretreatment and posttreatment effusion values and changes in isolated coronary artery bypass graft surgery patients ( P = .607 , .539 , and .628 , respectively ) . After adjustment for possible confounders , there was still no significant difference in postoperative PE between the 2 study groups ( t = -0.285 , P = .776 ) . CONCLUSION We concluded that prescription of colchicine does not seem to be effective in treatment of asymptomatic postoperative PE . This could be justified in case that the etiology of most of the PEs might be contribution of noninflammatory factors which are better to be dealt with observational approaches .

colchicine

placebo

placebo-controlled

1 mg/d colchicine ( n = 74 )

placebo

echocardiography

colchicine

placebo

colchicine

Pericardial effusion ( PE )

PE

PE sizes

effusion changes

PE

asymptomatic postoperative PE .

pericardial effusion

open-heart surgery

Pericardial effusion ( PE )

PE

open-heart surgery

mild or moderate PE

PE

PEs


Cost-effectiveness analysis of a communication-focused therapy for pre-school children with autism : results from a randomised controlled trial . BACKGROUND Autism is associated with impairments that have life-time consequences for diagnosed individuals and a substantial impact on families . There is growing interest in early interventions for children with autism , yet despite the substantial economic burden , there is little evidence of the cost-effectiveness of such interventions with which to support resource allocation decisions . This study reports an economic evaluation of a parent-mediated , communication-focused therapy carried out within the Pre-School Autism Communication Trial ( PACT ) . METHODS 152 pre-school children with autism were randomly assigned to treatment as usual ( TAU ) or PACT + TAU . Primary outcome was severity of autism symptoms at 13-month follow-up . Economic data included health , education and social services , childcare , parental productivity losses and informal care . RESULTS Clinically meaningful symptom improvement was evident for 53 % of PACT + TAU versus 41 % of TAU ( odds ratio 1.91 , p = 0.074 ) . Service costs were significantly higher for PACT + TAU ( mean difference £4,489 , p < 0.001 ) , but the difference in societal costs was smaller and non-significant ( mean difference £1,385 , p = 0.788 ) due to lower informal care rates for PACT + TAU . CONCLUSIONS Improvements in outcome generated by PACT come at a cost . Although this cost is lower when burden on parents is included , the cost and effectiveness results presented do not support the cost-effectiveness of PACT + TAU compared to TAU alone . TRIAL REGISTRATION Current Controlled Trials ISRCTN58133827 .

communication-focused therapy

treatment as usual ( TAU

PACT

TAU

Cost-effectiveness analysis

follow-up

Economic data included health

education and social services

childcare

p = 0.074

Service

but the difference

pre-school children

autism

pre-school children

autism


Pembrolizumab versus docetaxel for previously treated , PD-L1-positive , advanced non-small-cell lung cancer ( KEYNOTE-010 ) : a randomised controlled trial . BACKGROUND Despite recent advances in the treatment of advanced non-small-cell lung cancer , there remains a need for effective treatments for progressive disease . We assessed the efficacy of pembrolizumab for patients with previously treated , PD-L1-positive , advanced non-small-cell lung cancer . METHODS We did this randomised , open-label , phase 2/3 study at 202 academic medical centres in 24 countries . Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1 % of tumour cells were randomly assigned ( 1:1:1 ) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg , pembrolizumab 10 mg/kg , or docetaxel 75 mg/m ( 2 ) every 3 weeks . The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50 % of tumour cells . We used a threshold for significance of p < 0.00825 ( one-sided ) for the analysis of overall survival and a threshold of p < 0.001 for progression-free survival . This trial is registered at ClinicalTrials.gov , number NCT01905657 . FINDINGS Between Aug 28 , 2013 , and Feb 27 , 2015 , we enrolled 1034 patients : 345 allocated to pembrolizumab 2 mg/kg , 346 allocated to pembrolizumab 10 mg/kg , and 343 allocated to docetaxel . By Sept 30 , 2015 , 521 patients had died . In the total population , median overall survival was 10.4 months with pembrolizumab 2 mg/kg , 12.7 months with pembrolizumab 10 mg/kg , and 8.5 months with docetaxel . Overall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel ( hazard ratio [ HR ] 0.71 , 95 % CI 0.58-0.88 ; p=0.0008 ) and for pembrolizumab 10 mg/kg versus docetaxel ( 0.61 , 0.49-0.75 ; p < 0.0001 ) . Median progression-free survival was 3.9 months with pembrolizumab 2 mg/kg , 4.0 months with pembrolizumab 10 mg/kg , and 4.0 months with docetaxel , with no significant difference for pembrolizumab 2 mg/kg versus docetaxel ( 0.88 , 0.74-1.05 ; p=0.07 ) or for pembrolizumab 10 mg/kg versus docetaxel ( HR 0.79 , 95 % CI 0.66-0.94 ; p=0.004 ) . Among patients with at least 50 % of tumour cells expressing PD-L1 , overall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel ( median 14.9 months vs 8.2 months ; HR 0.54 , 95 % CI 0.38-0.77 ; p=0.0002 ) and with pembrolizumab 10 mg/kg than with docetaxel ( 17.3 months vs 8.2 months ; 0.50 , 0.36-0.70 ; p < 0.0001 ) . Likewise , for this patient population , progression-free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel ( median 5.0 months vs 4.1 months ; HR 0.59 , 95 % CI 0.44-0.78 ; p=0.0001 ) and with pembrolizumab 10 mg/kg than with docetaxel ( 5.2 months vs 4.1 months ; 0.59 , 0.45-0.78 ; p < 0.0001 ) . Grade 3-5 treatment-related adverse events were less common with pembrolizumab than with docetaxel ( 43 [ 13 % ] of 339 patients given 2 mg/kg , 55 [ 16 % ] of 343 given 10 mg/kg , and 109 [ 35 % ] of 309 given docetaxel ) . INTERPRETATION Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated , PD-L1-positive , advanced non-small-cell lung cancer . These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection . FUNDING Merck & Co .

Pembrolizumab

docetaxel

pembrolizumab

pembrolizumab

pembrolizumab

docetaxel

pembrolizumab

docetaxel

pembrolizumab

pembrolizumab

docetaxel

pembrolizumab

pembrolizumab

pembrolizumab

pembrolizumab

docetaxel

pembrolizumab

docetaxel

Pembrolizumab

pembrolizumab

survival and progression-free survival

median overall survival

Overall survival

Median progression-free survival

overall survival

progression-free survival

overall survival

advanced non-small-cell lung cancer

1034 patients


Amiprilose hydrochloride for rheumatoid arthritis . STUDY OBJECTIVE To assess the safety and efficacy of amiprilose hydrochloride ( HCl ) , a novel synthetic carbohydrate with anti-inflammatory and immunomodulatory properties , in patients with rheumatoid arthritis . DESIGN Prospective , multicenter , randomized , parallel group , double-blind placebo-controlled 12-week trial . PATIENTS Two hundred and one functional class I and II patients with definite or classic rheumatoid arthritis , previously untreated with disease modifying antirheumatic drugs . INTERVENTIONS Patients were withdrawn from nonsteroidal anti-inflammatory drug therapy . Those who flared were randomly assigned to amiprilose HCl , 6 g/d , or placebo for 12 weeks . No concomitant anti-inflammatory or antirheumatic drug therapy was permitted during the study . Combination acetaminophen and propoxyphene napsylate was the only supplemental analgesic medication allowed . MEASUREMENTS AND MAIN RESULTS The number of painful joints and swollen joints , joint pain and joint swelling indices , left and right grip strength , investigator global assessment , and patient global assessment returned to baseline for the amiprilose group and showed statistically significant ( P less than 0.05 ) differences from the placebo group within 4 to 6 weeks . The protocol criteria for overall therapeutic response were satisfied by 41 % of the amiprilose patients , compared with 21 % of the placebo group ( P = 0.003 ) . Approximately 0.5 tablet per day less analgesic medication was taken by the amiprilose group ( P less than 0.05 at weeks 6 and 12 ) . There were no statistically significant differences in morning stiffness , walking time , erythrocyte sedimentation rate , C-reactive protein , or rheumatoid factor between the groups . A similar number of adverse experiences were reported by the patients on amiprilose ( 67 % ) and on placebo ( 63 % ) . One patient on amiprilose developed thrombocytopenia of unknown cause ; no other reported adverse effects were serious . CONCLUSIONS Amiprilose HCl has significant anti-inflammatory activity and a favorable safety profile when used as the sole antirheumatic therapy in patients with active rheumatoid arthritis . Synthetic carbohydrates may represent an important new class of drugs for the treatment of inflammatory , autoimmune diseases .

Amiprilose hydrochloride

amiprilose hydrochloride ( HCl )

placebo-controlled

amiprilose HCl , 6 g/d

amiprilose

placebo

amiprilose

placebo

amiprilose

placebo

amiprilose

Amiprilose HCl

safety

efficacy

number of painful joints

swollen joints

joint pain

joint swelling indices

left and right grip strength

investigator global assessment

patient global assessment

overall therapeutic response

analgesic medication

C-reactive protein

rheumatoid factor

adverse experiences

thrombocytopenia

anti-inflammatory activity

favorable safety profile

rheumatoid arthritis .

rheumatoid arthritis

Two hundred and one

rheumatoid arthritis

active rheumatoid arthritis


Effect of direct current pulse stimulating acupoints of JiaJi ( T10-13 ) and Ciliao ( BL 32 ) with Han 's Acupoint Nerve Stimulator on labour pain in women : a randomized controlled clinical study . OBJECTIVE To assess the clinical effect and safety of direct current ( DC ) pulse produced by Han 's Acupoint Nerve Stimulator in reduction ( HANS ) of labor pain . METHODS Totally 120 participants were enrolled in this clinical trial , and were randomly divided into 4 groups including : HANS group , patient controlled intravenous analgesia ( PCIA ) group , patient-controlled epidural analgesia ( PCEA ) group and control group . The HANS group was treated by stimulating the acupoints of JiaJi ( T10-L3 ) and Ciliao ( BL 32 ) with DC pulse of 100 Hz and 15-30 mA produced by a portable battery-powered Han 's Acupoint Nerve Stimulator for 30 min . The PCIA group was intravenously infused Ondansetron ( 8 mg ) for 5 min , then tramadol injection ( 1.5 mg/kg ) was slowly dripped by using BaxterAP II electronic pump with 50 mL tramadol ( 0.70 % ) + ondansetron ( 8 mg ) , background infusion 2 mL/h , PCA dose of 2 mL , lockout interval of 10 min . In PCEA group , women received intrathecal injection ropivacaine ( 3 mg ) in L2-3 , and epidural catheter was connected to BaxterAP II electronic pump , with 100 mL Ropivacaine ( 0.1 % ) and Sufentanil ( 50 ug ) , background infusion 5 mL , Patient controlled analgesia ( PCA ) dose of 5 mL , lockout interval of 10 min . The control group was not received analgesia . The visual analogue scale ( VAS ) , stage and manner of labor , Apgar score of newborn , neonatal weights , oxytocin dosage , postpartum hemorrhage and side effects were monitored in all groups . RESULTS The vital signs were all stable in the four analgesic groups . After analgesia , there was statistical difference in VAS score between HANS group and control group , between PCEA group and the control group , between PCIA group and control group . The analgesic effect in the PCEA group was significantly better than that of other two groups . The second stage of labor in the PCEA group was longer than the other three groups , showing significant difference between them . The Apgar score of newborn 1 min after birth in the PCIA group was slightly lower than that of the other two groups , showing significant difference between them . The neonatal weights between four groups were not significantly different . The rate of cesarean section in the control group was significantly higher than that of the labor analgesia group , there was statistically difference in four groups . The number of PCIA group that used oxytocin was lower than that of other three groups . There was no significant difference in postpartum hemorrhage between four groups . The side effects of the PCEA group were itching , uroschesis and neonatal asphyxia and PCIA group were nausea and vomiting and neonatal asphyxia . However , fewer side-effects were observed in the HANS group . CONCLUSION The DC pulse produced by HANS may be a non-pharmacological alternative to labor pain with fewer side effects .

Han 's Acupoint Nerve Stimulator

HANS group

HANS

acupoints of JiaJi

Ciliao

DC pulse

PCIA

Ondansetron

tramadol injection

tramadol

ondansetron

PCEA

injection ropivacaine

Ropivacaine

Sufentanil

Patient controlled analgesia ( PCA )

HANS

control

PCEA

control

PCIA

control

PCEA

PCEA

PCIA

PCIA

PCEA

PCIA

HANS

HANS

labour pain

labor pain .

The

visual analogue scale ( VAS )

postpartum hemorrhage and side effects

VAS score

analgesic effect

neonatal weights

rate of cesarean section

used oxytocin

postpartum hemorrhage

side-effects

labour pain

women


Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder : A Randomized Trial . OBJECTIVES To determine safety and efficacy of the 5HT1A serotonin partial agonist buspirone on core autism and associated features in children with autism spectrum disorder ( ASD ) . STUDY DESIGN Children 2-6 years of age with ASD ( N = 166 ) were randomized to receive placebo or 2.5 or 5.0 mg of buspirone twice daily . The primary objective was to evaluate the effects of 24 weeks of buspirone on the Autism Diagnostic Observation Schedule ( ADOS ) Composite Total Score . Secondary objectives included evaluating the effects of buspirone on social competence , repetitive behaviors , language , sensory dysfunction , and anxiety and to assess side effects . Positron emission tomography measures of tryptophan metabolism and blood serotonin concentrations were assessed as predictors of buspirone efficacy . RESULTS There was no difference in the ADOS Composite Total Score between baseline and 24 weeks among the 3 treatment groups ( P = .400 ) ; however , the ADOS Restricted and Repetitive Behavior score showed a time-by-treatment effect ( P = .006 ) ; the 2.5-mg buspirone group showed significant improvement ( P = .003 ) , whereas placebo and 5.0-mg buspirone groups showed no change . Children in the 2.5-mg buspirone group were more likely to improve if they had fewer foci of increased brain tryptophan metabolism on positron emission tomography ( P = .018 ) or if they showed normal levels of blood serotonin ( P = .044 ) . Adverse events did not differ significantly among treatment groups . CONCLUSIONS Treatment with 2.5 mg of buspirone in young children with ASD might be a useful adjunct therapy to target restrictive and repetitive behaviors in conjunction with behavioral interventions . TRIAL REGISTRATION ClinicalTrials.gov : NCT00873509 .

Low-Dose Buspirone

placebo

buspirone

buspirone

buspirone

buspirone

buspirone

placebo

buspirone

buspirone

buspirone

social competence

repetitive behaviors

language

sensory dysfunction

anxiety

side effects

ADOS Composite Total Score

Young Children

Autism Spectrum Disorder

children

autism spectrum disorder ( ASD )

Children 2-6 years of age

ASD

young children

ASD


Covariance analysis in generalized linear measurement error models . We summarize some of the recent work on the errors-in-variables problem in generalized linear models . The focus is on covariance analysis , and in particular testing for and estimation of treatment effects . There is a considerable difference between the randomized and non-randomized models when testing for an effect . In randomized studies , simple techniques exist for testing for a treatment effect . In some instances , such as linear and multiplicative regression , simple methods exist for estimating the treatment effect . In other examples such as logistic regression , estimating a treatment effect requires careful attention to measurement error . In non-randomized studies , there is no recourse to understanding and modelling measurement error . In particular ignoring measurement error can lead to the wrong conclusions , for example the true but unobserved data may indicate a positive effect for treatment , while the observed data indicate the opposite . Some of the possible methods are outlined and compared .

Covariance analysis


Prospective trial of timing of bacillus Calmette-Guérin vaccination in Canadian Cree infants . We studied 184 Cree Indian infants in randomized , prospective fashion to assess the effect of age on lymphocyte sensitization to purified protein derivative ( PPD ) before and after and without bacillus Calmette-Guérin ( BCG ) vaccination . Lymphocyte responses to PPD , Candida , and streptokinase were measured at birth and at intervals later . The mean response of paired values from 26 infants without BCG vaccination rose for the PPD stimulation index ( SI ) from 2.7 at birth to 3.9 before 2 yr of age . The SI for both Candida and streptokinase for this group of infants rose significantly in the first 2 yr ( p less than 0.05 ) . In 66 infants who received BCG in the first 7 days of life , the PPD-SI rose from 3.1 to 35.3 ( p less than 0.001 ) . In 17 infants who received the vaccine later but before 9 months , it rose from 3.1 at birth to 24.9 , and in 14 who received it between 9 months and 2 yr , it rose from 2.2 to 52.9 . The lymphocyte responses to PPD after BCG in these two groups were significantly different ( p less than 0.05 ) . There was no evidence in the older infants that a raised PPD-SI before BCG vaccination affected lymphocyte sensitization by the vaccine . We conclude that increasing the age at vaccination with BCG from birth to more than 9 months enhances immunologic sensitization to PPD significantly in this population .

bacillus Calmette-Guérin vaccination

lymphocyte responses

lymphocyte sensitization


Auditory evoked potential modifications according to clinical and biochemical responsiveness to fenfluramine treatment in children with autistic behavior . Evoked potentials to auditory stimulations varying in intensity were studied in 13 children with autistic behavior treated with fenfluramine . Modifications of both amplitude and single-trial potential variability were considered according to the clinical and biochemical responsiveness to this drug . Six children ( responders ) were clinically improved by the treatment . Electrophysiological data were affected according to the clinical and biochemical responsiveness to fenfluramine : the auditory evoked potential amplitude increased , and the single-trial potential variability decreased at each intensity level only in responders whose dopaminergic metabolism was significantly modified by fenfluramine treatment . No modification was found in nonresponders . Both biochemical and electrophysiological results argued for an amphetamine-like action of fenfluramine in those autistic children whose attention deficits are associated with motor disturbances including hyperactivity .

fenfluramine treatment

fenfluramine

fenfluramine

fenfluramine

Modifications of both amplitude

single-trial potential variability

auditory evoked potential amplitude

single-trial potential variability

dopaminergic metabolism

children

autistic

autistic behavior

fenfluramine .


[ EMLA cream ( lidocaine/prilocaine ) versus infiltration analgesia with carbocaine ( mepivacaine ) in vasectomy ] . The analgesic efficacy of EMLA cream was compared with infiltration with 1 % carbocaine in 13 bilateral vasectomies . Twelve patients preferred infiltration analgesia . EMLA analgesia was only effective in the skin , and had to be supplemented as the incision reached subcutaneous tissue .

EMLA cream ( lidocaine/prilocaine )

EMLA cream

infiltration with 1 % carbocaine

EMLA analgesia

analgesic efficacy

only effective in the skin

had to be supplemented


The Effects of Valsartan and Amlodipine on the Levels of Irisin , Adropin , and Perilipin . BACKGROUND Hypertension and obesity are two major threats for public health . Up to the present , antihypertensive medications have been used to lower blood pressure , which seem to provide a better life with lower morbidity and mortality rates . Their effect on etiopathogenesis of hypertension is now an area of developing research . The association between hypertension and obesity also suggests the link between antihypertensive agents and energy hemostasis . We aimed to investigate the effects of antihypertensive treatment on the irisin , adropin , and perilipin levels in patients with essential hypertension and to compare them with healthy volunteers in terms of their effect on energy hemostasis . METHODS In total , 85 newly diagnosed patients with untreated essential hypertension were admitted to the outpatient clinic . Patients were randomized to one of the following treatment protocols : amlodipine or valsartan for a 12 week period . 42 patients were randomized into the valsartan group and 43 patients into the amlodipine group . Serum perilipin , irisin , and adropin levels were measured before and after drug treatment by ELISA kits . RESULTS We discovered that the hypertensive patients have lower levels of perilipin and higher levels of adropin compared with the control group . Both amlodipine and valsartan increased the levels of perilipin , irisin , and adropin after 12 weeks of treatment . CONCLUSIONS In conclusion , in regulating energy balance , perilipin , irisin , and adropin , could be of pathogenic importance in obesity-induced hypertension . Hence , ongoing trials need to elucidate this mechanism .

Valsartan

Amlodipine

Irisin

Adropin

Perilipin

amlodipine

valsartan

valsartan

amlodipine

ELISA kits

amlodipine

valsartan

levels of perilipin

levels of adropin


Oxidized Regenerated Cellulose Reduces the Amount of Fluid Drainage after Liver Resection : A Randomized Prospective Clinical Trial . BACKGROUND/AIMS Oxidized regenerated cellulose ( ORC ) has been registered as adjuncts to stimulate hemostasis in liver surgery . However , most previous studies were primarily designed to study the intra-operative hemostatic efficacy , and the effect on prophylactic application was never studied as a primary endpoint . This randomized prospective clinical trial was undertaken to evaluate whether ORC is safe and effective when used as a prophylactic agent covering the raw cut surface during the hepatectomy to reduce the volume and duration of drainage . METHODOLOGY Between June 2011 and August 2012 , a total of 40 patients undergoing major hepatectomy were randomly assigned to ORC or control groups ( 20 in each group ) . Patient characteristics , resection-related factors , debit of drainage and postoperative complications were compared between the two groups . RESULTS The two groups were comparable in terms of demographics , indications for surgery , extent of hepatectomy , and intraoperative blood loss . The amount of drainage after operation was significantly less in the ORC group compared with the control group ( 406.9 ± 308.1 vs. 627.0 ± 301.6 ml , P = 0.028 ) . CONCLUSIONS Application of ORC covering the raw cut surface during the hepatectomy can significantly decrease the amount of drainage .

Oxidized Regenerated Cellulose

Oxidized regenerated cellulose ( ORC )

ORC

ORC

control groups

debit of drainage

postoperative complications

indications for surgery

hepatectomy

intraoperative blood loss

amount of drainage after operation

hepatectomy

40 patients

hepatectomy

hepatectomy


West Midlands Oncology Association trials of adjuvant chemotherapy in operable breast cancer : results after a median follow-up of 7 years . I . Patients with involved axillary lymph nodes . The aim of this study was to test the effectiveness of a regimen of combination chemotherapy known to be active in advanced breast cancer when given as an adjuvant treatment after mastectomy . A total of 569 patients with cancer of the breast and involvement of axillary lymph nodes were randomised , after simple mastectomy with axillary sampling , to receive either no adjuvant treatment or intravenous adriamycin 50 mg , vincristine 1 mg , cyclophosphamide 250 mg , methotrexate 150 mg and fluorouracil 250 mg ( AVCMF ) every 21 days for eight cycles . Randomisation was stratified according to menopausal status and tumour size . Treatment was started within 14 days of surgery in 94 % of patients . Eighty-eight per cent of patients received at least seven cycles of chemotherapy with no dose reduction . The median relapse-free survival was prolonged by 14 months in patients treated with AVCMF ( chi2 1 = 11.7 ; P = 0.0006 ) . In the premenopausal group this period was 17 months ( chi2 1 = 8.8 ; P = 0.003 ) compared with 8 months in the post-menopausal group ( chi2 1 = 3.3 ; P = 0.07 ) . Neither overall survival nor survival in these subgroups was significantly influenced by treatment .

adjuvant chemotherapy

regimen of combination chemotherapy

no adjuvant treatment

intravenous adriamycin

vincristine

cyclophosphamide

methotrexate

fluorouracil

( AVCMF )

AVCMF

median relapse-free survival

overall survival nor survival

breast cancer :

involved axillary lymph nodes

premenopausal

post-menopausal


The Relaxation Inventory : self-report scales of relaxation training effects . The development of a self-report measure to assess the effects of relaxation training was examined . A rigorous statistical method of scale construction consisting of a modification of the scale discrimination technique was employed , resulting in a 45-item questionnaire representing three orthogonally derived scales . The three scales , Physiological Tension , Physical Assessment , and Cognitive Tension , demonstrated adequate internal consistency with KR20 reliability coefficients of .89 , .95 , and .81 , respectively . In a second study of predictive validity , 40 individuals were randomly assigned to one of four conditions : relaxation training , tension inducement , pre-postcontrol , or postcontrol . Univariate analysis of variance indicated significant findings for each of the three dimensions of the inventory . The Physiological Tension Scale detected significant increases in tension following tension inducement , whereas the Physical Assessment Scale and Cognitive Tension Scale detected increases in relaxation following relaxation training . Recommendations were made for future research on the inventory .

relaxation training effects

45-item questionnaire

relaxation training

tension inducement

, pre-postcontrol , or postcontrol .

relaxation training

tension

relaxation


[ Are there indications for adjuvant chemotherapy after excision of colorectal cancer ? ] .

adjuvant chemotherapy after

excision of colorectal cancer


Dacarbazine versus dacarbazine-vindesine in disseminated malignant melanoma : a randomized phase II study . In a phase II study 119 patients with disseminated malignant melanoma were randomized to receive treatment with dacarbazine alone or in combination with vindesine . The study was designed to reveal an additive response rate when the drugs were combined . Dacarbazine was given i.v . at 250 mg m-2 per day X V every 4 weeks . In the combination regimen vindesine given at 3 mg m-2 per week was included . One hundred and ten patients were available for evaluation of response . With dacarbazine 4/51 patients obtained a complete remission ( 8 % ) and 5/51 patients a partial remission ( 10 % ) . Overall response rate was 18 % . With dacarbazine-vindesine 8/59 patients obtained a complete remission ( 13 % ) and 7/59 patients a partial remission ( 12 % ) . Overall response rate was 25 % . The difference in response rates observed between the treatment arms is not statistically significant . Median response duration was 123 days for dacarbazine patients and 171 days for patients receiving dacarbazine-vindesine ( difference not statistically significant ) .

Dacarbazine

dacarbazine-vindesine

dacarbazine

Dacarbazine was given i.v

vindesine

dacarbazine

dacarbazine-vindesine

complete remission

partial remission

Overall response rate

complete remission

partial remission

Overall response rate

response rates

119 patients

disseminated malignant melanoma

One hundred and ten


Low power laser therapy of shoulder tendonitis . 30 patients with supraspinatus or bicipital tendonitis were randomly allocated to active infrared laser therapy at 904 nm three times weekly for 2 weeks , dummy laser or drug treatment for 2 weeks . Objectively maximum active extension , flexion and abduction of the shoulder , and subjectively pain stiffness movement and function were measured at 0 and 2 weeks . Significant improvement of active over dummy laser was noted for all seven assessments . Active laser therapy produced significant improvement over drug therapy for all three objective measures and pain . Naproxen sodium significantly improved only movement and function compared to dummy laser . These results demonstrate the effectiveness of laser therapy in tendonitis of the shoulder .

Low power laser therapy

active infrared laser therapy

dummy laser

or drug treatment

Naproxen sodium

shoulder tendonitis .


Methods for assessing treatment efficacy in trials for adjuvant therapy for breast cancer .

adjuvant therapy

treatment efficacy

breast cancer


Chlorthalidone does not increase the hypotensive effect of nifedipine in essential hypertensives : a crossover multicentre study . To determine whether the combination of nifedipine + chlorthalidone exerts an additive antihypertensive effect when compared with single-drug treatment , we studied 66 uncomplicated essential hypertensives , with diastolic blood pressure of greater than 100 and less than 115 mmHg . At the end of a 1-month washout placebo period , using a double-blind crossover design , the patients were randomly allocated to nifedipine ( 20 mg twice a day ) , chlorthalidone ( 25 mg once a day ) , the two drugs combined at the same doses and the corresponding placebo . Compared with the randomly allocated placebo , the three active treatments significantly reduced blood pressure without changing the heart rate or body weight . Both the absolute and percentage decreases in mean blood pressure induced by nifedipine and the combination compared with placebo were similar and significantly greater than those induced by chlorthalidone . Taken together , these data show that the combination of nifedipine + chlorthalidone does not exert any additive antihypertensive effect compared with nifedipine alone . This finding indicates that the combination of a dihydropyridine calcium antagonist + a thiazide diuretic is probably devoid of any particular clinical significance in the treatment of uncomplicated essential hypertensives .

Chlorthalidone

nifedipine

nifedipine + chlorthalidone

placebo

nifedipine

chlorthalidone

placebo

nifedipine

placebo

chlorthalidone

nifedipine + chlorthalidone

nifedipine

hypotensive effect

additive antihypertensive effect

blood pressure

heart rate or body weight .

mean blood pressure

additive antihypertensive effect

clinical significance

crossover multicentre study .


[ Cannulation of the internal jugular vein using 2 ultrasonic technics . A comparative controlled study ] . The internal jugular vein ( IJV ) is a common access route to the central venous system . Anatomical landmarks ( group I ) are normally used for localization of the IJV . We have compared this method with two other methods based on ultrasonic waves to identify the IJV and the carotid artery ( CA ) ( even in atypical positions ) . We employed an ultrasound Doppler device in group II and a real-time ultrasonograph in group III . Central venous catheters were placed into the right IJV by the Seldinger technique . The IJV could be located in all patients with both ultrasound methods , but the course of the IJV could only be identified by ultrasonography . For this reason , the direction of the IJV was classified as " typical " in 80 % of group I , in 85 % of group II , but in only 45 % of group III . No intergroup differences were found with respect to the number of punctures ( mean value 1.6 +/- 0.83 ) and the incidence of complications . The time required to locate the site and direction of puncture increased with technical sophistication . There was , however , no difference in the total time for catheter placement , because puncture was performed faster when aided by sonography . In four patients in groups I and II , in whom attempts to puncture the IJV had not been successful , this could subsequently be achieved with ultrasonographic aid . One patient ( group I ) displayed a hematoma following inadvertent puncture of the CA . In one patient in group II the IJV and CA could not be distinguished as one was overlying the other . The echocamera provided improved localization of the IJV and the CA in comparison with the Doppler ultrasound . ( ABSTRACT TRUNCATED AT 250 WORDS )

IJV

IJV

number of punctures

incidence of complications

time required to locate the site

direction of puncture

total time for catheter placement

hematoma


[ PLACE REMAXOL AS A HEPATOPROTECTOR IN INTENSIVE THERAPY OF PERVASIVE PERITONITIS ] . UNLABELLED PERPOSE OF RESEARCH : to evaluate the effectiveness of Remaxol in patients with pervasive peritonitis . MATERIALS AND METHODS assessed the effectiveness of a balanced infusion of the drug ( Remaxol ) in the treatment of 44 patients agedfrom 18 to 50 years . Patients were devided into 2 groups by the method of envelopes . All patients received a comprehensive differential therapy : 21 patient 1 group consisting of infusion therapy in the postoperative period received Remaxol at a dose of 800 mg/day for 7 days . RESULTS the comporative assessment of indicators of systemic hemodinamics , oxygen transport , asid base status , glucose , lactose and free radical oxydation . Patients on the first background was used Remaxol have experiensed a more rapid relief of metabolic disorders , endotoxemia and hepatic dysfunction compared with the indices of the 2 group patients . Noted earlier stabilization of rudicators of systemic hemodynamics and oxygen transport . This has reduced the duration of respiratory and vasopressor suppot , early start ofparenteral intreduction in case the power ( p < 0.05 ) . CONCLUSIONS this study shows that use of the drug for the purpose of relief Remaxol hepatic dysfunction and prevention of drug liver toxicity in conditions ofperitonitis , after 48 hours of operation , provides a positive dynamics and stabilization ofparameters of central hemodynamics , contributing to the abolition of vasopressor support , and contributes to the effective utilization of oxygen , while providing antioxidant effect .

REMAXOL

Remaxol

drug ( Remaxol )

infusion therapy

Remaxol

Remaxol

Remaxol


Internet-based Mindfulness Meditation for Cognition and Mood in Older Adults : A Pilot Study . CONTEXT Older adults are at risk for greater chronic stress and cognitive decline . Training in mindfulness meditation ( MM ) may help reduce stress and , thus , cognitive decline in older adults , but little research has explored that hypothesis . OBJECTIVE The current study 's primary aim was to evaluate the feasibility and acceptability for use by older adults of the Internet Mindfulness Meditation Intervention ( IMMI ) , a program that had been developed by the research team , as well as of an Internet-based health-and-wellness education program , the control . The secondary aim was to collect preliminary pre- and postintervention data on mood and cognitive function . DESIGN The study was a randomized , controlled trial ( RCT ) , a pilot study , with participants randomized either to the meditation group or the education group . SETTING Participants obtained access to the programs from their homes , and the baseline and endpoint assessments occurred in their homes as well . PARTICIPANTS Older adults aged 65-90 y were recruited from the Portland , OR , metropolitan area . Twenty-one people enrolled in the study . INTERVENTION Participants in both groups took part in a 1-h online session each week for 6 wk , with 30 min of daily home practice . OUTCOME MEASURES Feasibility and acceptability were assessed through measures of adherence to the protocol and a client satisfaction questionnaire . Mood and cognitive outcomes were also evaluated before and after the interventions . RESULTS Sixteen participants completed the study , 8 in each group , and 5 dropped out , for a 76 % completion rate . Participants ' mean age was 76.2 y ; 88 % were Caucasian , and 50 % were female . Acceptability was high for the interventions , based on above-average scores on the client satisfaction questionnaire . The IMMI participants completed ( 1 ) 4.25 ± 2.4 sessions , with a range of 0-6 ; ( 2 ) 604 ± 506 home-practice minutes , with a range 0-1432 ; and ( 3 ) 21.3 ± 15.5 d of practice , with a range of 0-46 . The education group completed ( 1 ) 4.75 ± 1.8 sessions , with a range of 2-6 ; ( 2 ) 873 ± 395 home-practice minutes , with a range of 327-1524 ; and ( 3 ) 25.6 d of practice , with a range of 11-35 . The intervention and control formats were both feasible , and the control group was appropriate . As expected due to the pilot nature of the study , no differences existed between groups for the mood or cognitive outcomes . CONCLUSIONS Administering interventions via the Internet to older adults is feasible . The 2 interventions were acceptable to participants and equal with regard to perceived credibility and acceptability . Future RCTs are planned to evaluate the clinical efficacy of the 2 interventions .

Internet-based Mindfulness Meditation

mindfulness meditation ( MM )

meditation

education

IMMI

education

Mood

chronic stress

cognitive decline .

stress

cognitive decline

feasibility and acceptability

mood

cognitive function .

Feasibility and acceptability

client satisfaction

Mood

cognitive outcomes

Acceptability


Effects of heat and cold on the perineum after episiotomy/laceration . The Redness Edema Ecchymosis Discharge Approximation ( REEDA ) tool , devised to evaluate postpartum healing of the perineum following an episiotomy/laceration , was used to evaluate the effects of heat and cold on the perineum during the first 24 hours after delivery . Ninety patients were randomly assigned to one of three treatment groups . Treatment consisted of 30 subjects applying a warm perineal pack , 30 applying a cold perineal pack , and 30 taking a warm sitz bath . Analysis of variance indicated no difference in the REEDA score before or two hours after treatment . A Pearson r correlation indicated the REEDA score was associated with a laceration and not with infant weight . Although these findings do not support assumptions from the literature , this study provides baseline data and trends for future study .

heat and cold

episiotomy/laceration

heat and cold

warm perineal pack

cold perineal pack

warm sitz bath

REEDA

laceration and not with infant weight

episiotomy/laceration

Ninety


[ Dose-reduced antihypertensive agents -- use in complex nonmedicamentous therapy of hypertension ] . In order to estimate the influence of a non-medicamentous therapy ( CNT ) on the consumption of medicaments and coronary risk in high blood pressure 73 hypertensives of a medicamentously stabilized CNT-group were examined in comparison to a group of the same size of patients with hypertension who were managed exclusively medicamentously for behaviour of blood pressure , need of antihypertensive drugs and changes of hypertension-associated risk factors . After an exactly controlled 6-month treatment hypertensives with additionally recommended far-reaching CNT showed an economization of medicaments by scarcely the half in comparison to the reference group . By means of suitable control methods a causal non-medicamentously conditioned decrease of blood pressure could be excluded . A different need of antihypertensive drugs was simulated by the exacter intake of medicaments in the index-patients . Notwithstanding the metabolic effects of the additional therapy have induced a positive change of atherogenic lipids . The examinations indicate in general the difficulty of the judgement of efficacy of non-medicamentous therapeutic measures in connection with a rational dose-reduced long-term therapy with antihypertensive drugs .

antihypertensive agents -- use

nonmedicamentous

non-medicamentous therapy ( CNT )

antihypertensive drugs

non-medicamentously

antihypertensive drugs

non-medicamentous therapeutic

blood pressure

atherogenic lipids .

hypertensives

hypertension

hypertensives


[ Diabetic constipation treated with acupoint embedding therapy and forlax : a randomized controlled trial ] . OBJECTIVE To compare the difference among the combined method of oral administration of forlaxand acupoint embedding therapy , the simple acupoint embedding therapy and the simple oral administration of for-lax in the clinical efficacy on diabetic constipation . METHODS One hundred and fifty patients were randomized intoa comprehensive group , an acupoint embedding group and a forlax group , 50 cases in each one . In the acupointembedding group , the embedding therapy was applied to bilateral Tianshu ( ST 25 ) , Daheng ( SP 15 ) , Shangjuxu ( ST 37 ) and Dachangshu ( BL 25 ) , once a week . In the forlax group , forlax ( polyethylene glycol ) was prescribedfor oral administration , once a day , 10 g each time . In the comprehensive group , the acupoint embedding therapyand forlax were combined and the methods were the same as the first two groups . The treatment for 4 weeks wasas one session , and 2 sessions were required in the three groups . Separately , in 4 weeks , 8 weeks of treatment and2 months after treatment , the constipation symptom scores were compared among the three groups . At the end of2 sessions of treatment , the clinical efficacy and adverse reactions were compared among the three groups . In2 months after treatment , the recurrence rate was compared among the three groups . RESULTS The total effectiverate was 98 . 0 % ( 49/50 ) in the comprehensive group , better than 86 . 0 % ( 43/50 ) in the acupoint embeddinggroup and 78 . 0 % ( 11/50 ) in the forlax group ( both P < 0 . 01 ) . In the 4 weeks and 8 weeks of treatment , the con-stipation symptom scores were reduced significantly as compared with those before treatment in the three groups ( all P < 0 . 05 ) . The results in the comprehensive group were lower than those in the other two groups ( all P < 0 . 05 ) . In the 4 weeks of treatment , the scores were not different significantly between the acupoint embedding group and the forlax group ( P > 0.05 ) . In 8 weeks of treatment and 2 months after treatment , the scores in the acupoint embedding group were better tan those in the forlax group ( all p < 0.05 ) . There were 2 cases of drug adverse reaction in the comprehensive group , 6 cases in the forlax group and 0 case in the acupoint embedding group . The recurrence rate was 8.1 % ( 4/49 ) in the comprehensive group , lower than 32.6 % ( 14/43 ) in the acupoint embedding group and 59.0 % ( 23/39 ) in the forlax group ( both P < 0.01 ) . CONCLUSION the combined therapy of acupoint embedding and forlax achieves the better clinical efficacy on diabetic constipation and constipation symptom scores as compared with the simple acupoint embedding therapy and the oral administration of forlax the short-term efficacy of the simple acupoint embedding therapy is not different significantly from the simple forlax medication , but the long-term efficacy and safety are better than those of simple forlax medicaiton .

simple acupoint embedding therapy

simple oral administration of for-lax

acupointembedding group

embedding therapy

bilateral Tianshu ( ST 25 )

Daheng ( SP 15 )

Shangjuxu ( ST 37 )

Dachangshu

acupoint embedding

therapyand forlax

simple acupoint embedding therapy

oral administration of forlax

clinical efficacy

adverse reactions

total effectiverate

con-stipation symptom scores

recurrence rate

constipation symptom scores

[ Diabetic constipation

diabetic constipation .

One hundred and fifty

diabetic constipation


A comparison of high and low fat meals on postprandial esophageal acid exposure . Fatty foods have been identified as precipitating factors in symptomatic gastroesophageal reflux ( GER ) . A fat meal has also been found to decrease lower esophageal sphincter pressure ( LESP ) in normal subjects . We used the ambulatory 24-h pH monitor to assess esophageal acid exposure in 10 normal subjects and 10 GER patients following low and high fat meals eaten in two body positions . The meals had nearly identical protein content , volumes , and calories . On successive days , patients ingested one of the meals twice , followed by random assignment to 3 h upright and 3 h recumbent position . Acid exposure for each hour over a 3-h postprandial ( PP ) period was assessed as the percent time pH less than 4.0 . Increased upright acid exposure occurred in normals after the high fat ( 6.2 +/- 2.1 % ; mean +/- SE ) compared with the low fat meal ( 1.5 +/- 0.5 % ; p less than 0.05 ) . GER patients had greater ( p less than 0.05 ) acid exposure than normals in all study periods , but no differences were found between low and high fat meals in either study position . High fat meals induce upright GER in normals , but do not significantly affect the abnormal amount of GER in patients . In addition , progressive increases in acid exposure were found over the 3 postprandial hours in GER patients in a recumbent position . The findings are consistent with prior data showing decreased LESP with a fat meal in normals .

high and low fat meals

low and high fat meals

two body positions

meals

upright and

recumbent position

esophageal sphincter pressure ( LESP )

Acid exposure for each hour

upright acid exposure

acid exposure

upright GER

acid exposure

LESP

postprandial esophageal

gastroesophageal reflux

GER


A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis . BACKGROUND Primary biliary cholangitis ( formerly called primary biliary cirrhosis ) can progress to cirrhosis and death despite ursodiol therapy . Alkaline phosphatase and bilirubin levels correlate with the risk of liver transplantation or death . Obeticholic acid , a farnesoid X receptor agonist , has shown potential benefit in patients with this disease . METHODS In this 12-month , double-blind , placebo-controlled , phase 3 trial , we randomly assigned 217 patients who had an inadequate response to ursodiol or who found the side effects of ursodiol unacceptable to receive obeticholic acid at a dose of 10 mg ( the 10-mg group ) , obeticholic acid at a dose of 5 mg with adjustment to 10 mg if applicable ( the 5-10-mg group ) , or placebo . The primary end point was an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range , with a reduction of at least 15 % from baseline , and a normal total bilirubin level . RESULTS Of 216 patients who underwent randomization and received at least one dose of obeticholic acid or placebo , 93 % received ursodiol as background therapy . The primary end point occurred in more patients in the 5-10-mg group ( 46 % ) and the 10-mg group ( 47 % ) than in the placebo group ( 10 % ; P < 0.001 for both comparisons ) . Patients in the 5-10-mg group and those in the 10-mg group had greater decreases than those in the placebo group in the alkaline phosphatase level ( least-squares mean , -113 and -130 U per liter , respectively , vs. -14 U per liter ; P < 0.001 for both comparisons ) and total bilirubin level ( -0.02 and -0.05 mg per deciliter [ -0.3 and -0.9 μmol per liter ] , respectively , vs. 0.12 mg per deciliter [ 2.0 μmol per liter ] ; P < 0.001 for both comparisons ) . Changes in noninvasive measures of liver fibrosis did not differ significantly between either treatment group and the placebo group at 12 months . Pruritus was more common with obeticholic acid than with placebo ( 56 % of patients in the 5-10-mg group and 68 % of those in the 10-mg group vs. 38 % in the placebo group ) . The rate of serious adverse events was 16 % in the 5-10-mg group , 11 % in the 10-mg group , and 4 % in the placebo group . CONCLUSIONS Obeticholic acid administered with ursodiol or as monotherapy for 12 months in patients with primary biliary cholangitis resulted in decreases from baseline in alkaline phosphatase and total bilirubin levels that differed significantly from the changes observed with placebo . There were more serious adverse events with obeticholic acid . ( Funded by Intercept Pharmaceuticals ; POISE ClinicalTrials.gov number , NCT01473524 ; Current Controlled Trials number , ISRCTN89514817 . ) .

Obeticholic Acid

ursodiol

placebo

obeticholic acid

placebo

ursodiol

alkaline phosphatase level

bilirubin level .

alkaline phosphatase level

total bilirubin level


An evaluation of sealing ability of calcium hydroxide sealers . Solid core filling material such as gutta-percha has been used to fill the root canal in conjunction with a sealer to prevent apical leakage . The purpose of this study was to compare apical seal of five different root canal sealers . Sixty roots of maxillary central incisors were cleansed and shaped and randomly assigned to one of six groups of ten roots each . The root canals were obturated with gutta-percha and one of the sealers by the lateral-vertical condensation technique . Groups I , II , III , IV , and V consisted of roots in which the canal was filled with gutta-percha along with either Roth 's sealer , AH26 , Sealapex , CRCS , or Nogenol sealer , respectively . Group VI was filled with gutta-percha and without sealer to serve as a control . The access opening was filled with amalgam . Each tooth was then placed in a capped vial containing 2 X 2 inch gauze pads saturated with distilled water , and the sealer was allowed to set at 37 degrees C in the humidor for 48 hours . The roots , except for the apical 2 mm , were coated with two layers of nail polish . The roots were stained with india ink , decalcified , dehydrated , and then placed in methylsalicylate to make them transparent . The leakage was measured with a filar micrometer eyepiece under a dissecting microscope . The mean apical leakage of six groups was as follows : I = 0.45 mm , II = 0.277 mm , III = 0.343 mm , IV = 0.263 mm , V = 0.336 mm , and VI = 2.310 mm . Results showed no significant difference in the apical seal produced by gutta-percha and the tested root canal sealers . ( ABSTRACT TRUNCATED AT 250 WORDS )

calcium hydroxide sealers

apical seal

root canal sealers

gutta-percha

sealers

amalgam

sealing ability

mean apical leakage


Randomized clinical trial comparing systemic interferon with diathermocoagulation in primary multiple and widespread anogenital condyloma . Two hundred three patients ( median age 26 years ; range 18-45 ) with untreated multiple and widespread anogenital condyloma were randomly assigned to one of four study arms in order to compare the efficacy , toxicity , and tolerability of recombinant interferon alpha-2b with those of diathermocoagulation . Of 200 evaluable patients , 51 were treated intramuscularly ( IM ) with 3 x 10 ( 6 ) U ( 3 MU ) /m2 daily for 3 weeks ( total dose 63 MU/m2 ) , 50 received subcutaneous thrice-weekly injections of 3 MU/m2 for 4 weeks ( total dose 36 MU/m2 ) , 51 underwent diathermocoagulation , and 48 were not treated and were used as a control group . Six months after the end of treatment , the overall response rate ( complete and partial responses ) was 70 % : 57 and 82 % for patients receiving interferon alpha-2b ( IM and subcutaneously ) and diathermocoagulation , respectively , and 8 % for the control group . After 6 months from therapy , no significant differences in complete response were found among the different types of treatment : 20 , 20 , and 35 % for the two interferon groups and the diathermocoagulation group , respectively . Fifteen and two complete responders in the cauterization and interferon groups , respectively , experienced disease recurrence ( P less than .01 ) . All patients given interferon therapy complained of flu-like symptoms , which declined progressively after the first week of treatment . Fatigue , lasting as long as patients received interferon , was the most prevalent chronic side effect . We conclude that systemic recombinant interferon alpha-2b is active in treating patients with primary condyloma lesions and does so as well as cauterization . ( ABSTRACT TRUNCATED AT 250 WORDS )

interferon

diathermocoagulation

recombinant interferon alpha-2b

diathermocoagulation

intramuscularly

diathermocoagulation

interferon alpha-2b

diathermocoagulation

diathermocoagulation

interferon therapy

interferon

efficacy

toxicity

tolerability

complete response

disease recurrence

flu-like symptoms

Fatigue

side effect


[ Preventive use of Pentaglobin in intensive care treatment of trauma patients ] . Basing on 50 posttraumatic intensive-care patients with medium grade lesions ( ISS criteria ) , the prophylactic effect of an intravenously applicable IgM preparation ( Pentaglobin ) against nosocomial infections was investigated . The prophylaxis group received on the 3rd , 4th and 5th day a daily dose of 10 g each . At the same times the controls were given 12.5 g human albumin each . Whereas no difference was seen between both groups regarding the definitive outcome of the treatment , the prophylaxis group clearly showed fewer infection pointers during the clinical course . In particular , the incidence and magnitude of febrile temperatures were significantly lower between the 4th and 8th days of treatment . Our results indicate , however , that the prophylactic use those patients who are at particularly high infection exposure risk , e.g . through reintervention surgery , haemorrhage complications or extensive diagnostic interventions .

Pentaglobin

Pentaglobin

12.5 g human albumin

infections

infection pointers

extensive diagnostic interventions

trauma

posttraumatic intensive-care

lesions

ISS criteria

infection

reintervention surgery

haemorrhage complications

diagnostic interventions


Cardiovascular and behavioral effects of aerobic exercise training in healthy older men and women . The cardiovascular and behavioral adaptations associated with a 4-month program of aerobic exercise training were examined in 101 older men and women ( mean age = 67 years ) . Subjects were randomly assigned to an Aerobic Exercise group , a Yoga and Flexibility control group , or a Waiting List control group . Prior to and following the 4-month program , subjects underwent comprehensive physiological and psychological evaluations . Physiological measures included measurement of blood pressure , lipids , bone density , and cardiorespiratory fitness including direct measurements of peak oxygen consumption ( VO2 ) and anaerobic threshold . Psychological measures included measures of mood , psychiatric symptoms , and neuropsychological functioning . This study demonstrated that 4 months of aerobic exercise training produced an overall 11.6 % improvement in peak VO2 and a 13 % increase in anaerobic threshold . In contrast , the Yoga and Waiting List control groups experienced no change in cardiorespiratory fitness . Other favorable physiological changes observed among aerobic exercise participants included lower cholesterol levels , diastolic blood pressure levels , and for subjects at risk for bone fracture , a trend toward an increase in bone mineral content . Although few significant psychological changes could be attributed to aerobic exercise training , participants in the two active treatment groups perceived themselves as improving on a number of psychological and behavioral dimensions .

aerobic exercise

aerobic exercise training

Aerobic Exercise

group

Yoga

and

Flexibility control

group

Waiting List control group

aerobic exercise

Yoga

Waiting List

aerobic exercise

older

men and women

older


Milk intolerance in children with persistent sleeplessness : a prospective double-blind crossover evaluation . From July 1986 to July 1988 , 146 children less than 5 years of age were referred by their physicians to our university sleep clinic for continual waking and crying during sleep hours . For 85 children ( 58.2 % ) , the sleeplessness was attributed to inappropriate sleep habits . For 17 children ( 11.6 % ) , no explanation was found for the sleep difficulties in spite of an extensive workup . Their median age at referral was 13.5 months ( range 2.5 to 29 months ) . Their persistent sleeplessness was tentatively attributed to an undiagnosed intolerance to cow 's milk . Cow 's milk was excluded from their diet . In 15 children sleep normalized after 5 weeks ( range 4 to 6 weeks ) . As seen from the parents ' logs , the median time needed by the children to fall asleep decreased from 15 minutes ( range 15 to 60 minutes ) to 10 minutes ( range 10 to 15 minutes , P = .001 ) . The number of complete arousals decreased from 5 ( range 1 to 12 ) to less than 1 per night ( range 0 to 2 ) ( P = .001 ) . Total sleep time per 24 hours increased from 5.5 hours ( range 3 to 8.5 hours ) to 13.0 hours ( range 10 to 14.5 hours , P = .001 ) . Sleep normalized in one child who continued to receive no cow 's milk only after the hydrolyzed hypoallergenic diet was discontinued . In every child , a double-blind crossover challenge was conducted involving a control diet containing no cow 's milk and a diet containing cow 's milk . The challenge induced the reappearance of insomnia and agitated behavior in all except one child . The child 's initial sleep difficulties were retrospectively attributed to inappropriate sleep habits . ( ABSTRACT TRUNCATED AT 250 WORDS )

control diet containing no cow 's milk

diet containing cow 's milk

Milk intolerance

number of complete arousals

Total sleep time per 24 hours

Sleep


A comparison of sclerotherapy with staple transection of the esophagus for the emergency control of bleeding from esophageal varices . We compared two procedures for the emergency treatment of bleeding esophageal varices in patients who did not respond to blood transfusion and vasoactive drugs . We randomly assigned 101 patients with cirrhosis of the liver and bleeding esophageal varices to undergo either emergency sclerotherapy ( n = 50 ) or staple transection of the esophagus ( n = 51 ) . Four patients assigned to sclerotherapy and 12 assigned to staple transection did not actually undergo those procedures , but all analyses were made on an intention-to-treat basis . Total mortality did not differ significantly between the two groups ; the relative risk of death for staple transection as compared with sclerotherapy was 0.88 ( 95 percent confidence interval , 0.51 to 1.54 ) . Mortality at six weeks was 44 percent among those assigned to sclerotherapy and 35 percent among those assigned to staple transection . Complication rates were similar for the two groups . An interval of five days without bleeding was achieved in 88 percent of those assigned to staple transection and in 62 percent of those assigned to sclerotherapy after a single injection ( P less than 0.01 ) and 82 percent after three injections . In only 2 of the 11 patients who received a third sclerotherapy injection was bleeding controlled for more than five days , and 9 died . We conclude that staple transection of the esophagus is as safe as sclerotherapy for the emergency treatment of bleeding esophageal varices and that it is more effective than a single sclerotherapy procedure . We currently recommend surgery after two injection treatments have failed .

sclerotherapy

staple transection of the esophagus

undergo either emergency sclerotherapy

staple transection of the esophagus

sclerotherapy

sclerotherapy

sclerotherapy

sclerotherapy

sclerotherapy

control of bleeding

bleeding

Total mortality

relative risk of death

Mortality

Complication rates

interval of five days without bleeding

bleeding controlled

safe as sclerotherapy

emergency treatment of bleeding

bleeding from esophageal varices

101 patients


Rate-modulated cardiac pacing based on transthoracic impedance measurements of minute ventilation : correlation with exercise gas exchange . The relation of pacing rate to physiologic variables of metabolic demand was examined in 10 consecutive patients with a minute ventilation-sensing , rate-modulating ventricular pacemaker implanted for complete heart block . All patients had paroxysmal ( seven patients ) or chronic ( three patients ) atrial fibrillation and were referred for catheter ablation of the atrioventricular junction . Treadmill exercise testing with measurement of expired gas exchange and respiratory flow was performed before ablation and 4 weeks after pacemaker implantation , with the pacemaker programmed to both the fixed-rate VVI and rate-modulating minute ventilation VVIR pacing modes in random sequence . The relation of pacing rate to oxygen consumption ( VO2 ) , expired carbon dioxide concentration ( VCO2 ) , respiratory quotient , tidal volume , respiratory rate and minute ventilation was determined during exercise in the rate-modulating minute ventilation pacing mode . Pacing rate was highly correlated with minute ventilation ( r = 0.89 ) , respiratory quotient ( r = 0.89 ) , VCO2 ( r = 0.87 ) , tidal volume ( r = 0.87 ) , VO2 ( r = 0.84 ) and respiratory rate ( r = 0.84 ) . The mean exercise duration increased from 8.3 +/- 2.8 min in the fixed rate pacing mode to 10.2 +/- 3.4 min in the rate-modulating , minute ventilation mode ( p = 0.0001 ) . The maximal VO2 increased from 13.4 +/- 3.4 to 16.3 +/- 4.1 cc/kg per min ( p = 0.0004 ) . The maximal heart rate achieved in the minute ventilation pacing mode was 136 +/- 9.7 beats/min , similar to that observed in the patient 's intrinsic cardiac rhythm before ablation ( 134.9 +/- 30.1 beats/min , p = NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS )

Treadmill exercise testing

respiratory quotient

tidal volume

respiratory rate and minute ventilation

Pacing rate

minute ventilation

respiratory quotient

tidal volume

respiratory rate

mean exercise duration

maximal VO2

paroxysmal

seven

three

atrial fibrillation


Combined action of enalapril or timolol with hydrochlorothiazide plus amiloride in hypertension . 59 mild to moderate hypertensives were treated for four weeks with 50 mg hydrochlorothiazide plus 5 mg of amiloride , then concomitantly with these diuretics with either enalapril ( 10-20 mg ) or timolol ( 10-20 mg ) in two parallel treatment groups for an additional 12 weeks in an open study . Addition of these drugs lowered the blood pressure by 25 +/- 3/16 +/- 2 mm Hg and 15 +/- 3/14 +/- 1 mm Hg , respectively . The difference of the reduction of the systolic blood pressure between enalapril and timolol group at the end of the combined treatment was statistically significant ( p less than 0.01 ) . The mean serum potassium was elevated by 0.3 mmol/l after addition of enalapril to the diuretic treatment , but none of the patients developed hyperkalaemia . No adverse effects on other routine laboratory values were observed . Both drug combinations can be considered efficient , well tolerated and safe in the treatment of mild to moderate hypertension .

enalapril

timolol

hydrochlorothiazide plus amiloride

hydrochlorothiazide

amiloride

enalapril

timolol

blood pressure

systolic blood pressure

mean serum potassium

hyperkalaemia

adverse effects

tolerated and safe

hypertension

mild to moderate hypertensives


Intranasal recombinant alfa-2b interferon treatment of naturally occurring common colds . In a double-blind , placebo-controlled study , patients with naturally occurring common colds of less than or equal to 48 h duration were randomly assigned to receive nasal sprays of recombinant alfa-2b interferon at 10 or 20 MU/day or placebo four times per day for 5 days . The 10-MU ( n = 74 ) , 20-MU ( n = 74 ) , and placebo ( n = 72 ) groups had comparable frequencies of documented rhinovirus colds ( 50 to 65 % ) and mean durations of pretreatment symptoms ( 26 to 27 h ) . The median duration of colds tended to be longer in the 20-MU group ( 10 days ) than the 10-MU group ( 8 days ) or placebo group ( 8 days ) ( P = 0.06 ) . In those with proven rhinovirus colds treated within 24 h , the median duration was significantly longer in the 20-MU group ( 9 days ) than in the placebo group ( 6 days ) . No differences favoring interferon treatment were found in respiratory symptom scores or resolution of specific symptoms . On days 5 and 7 , nasal washings from compliant subjects with proven rhinovirus colds yielded rhinoviruses more often in placebo ( 47 and 48 % , respectively ) than in interferon ( 15 and 16 % , respectively ) recipients ( P less than 0.02 ) , but no differences in new respiratory illness occurrence were observed in household contacts . Interferon recipients had significantly higher frequencies of blood in nasal mucus ( 16 to 18 % ) than did placebo recipients ( 4 % ) during treatment . Antibiotics for presumed secondary infections were given more often in the 20-MU group ( 11 % ) than in the placebo group ( 0 % ) ( P less than 0.01 ) . Nasal sprays of recombinant alfa-2b interferon were not an effective treatment for natural colds and were associated with toxicity .

alfa-2b interferon

recombinant alfa-2b interferon

placebo

placebo

placebo

placebo

nasal washings

placebo

interferon

Interferon

placebo

Antibiotics

placebo

alfa-2b interferon

naturally occurring common colds

median duration of colds

median duration

respiratory illness occurrence

in nasal mucus

Antibiotics

effective treatment for natural colds

toxicity

common colds

naturally occurring common colds


Strategies for dietary and anti-smoking advice . Practical experiences from the Oslo Study . One of the 2 controlled preventive trials within the Oslo Study was a non-drug trial on the effect of diet and smoking intervention on coronary heart disease in 1232 middleaged , normotensive , healthy men . All had elevated serum cholesterol and 4 out of 5 smoked every day . The participants in the intervention group met every 6 months during the 5-year study for clinical examination and for dietary and smoking counselling . The effect on serum cholesterol was a 13 % lowering ( i.e . 10 % net reduction compared with control group ) , and about a 50 % reduction in cigarette consumption . The effect on coronary heart disease ( fatal and non-fatal myocardial infarction or sudden death ) was a 47 % lowering of the 5-year incidence in the intervention group compared with the control group ( p = 0.02 , 2-sided ) . The main intervention strategies were : information about the risk factor concept to participant and spouse ( in groups ) individual diet and anti-smoking counselling after finishing an extensive clinical and electrocardiographic examination , including exercise-ECG basis and background for the counselling strategy : the total situation of the participant . Some of the most important items : personality , motivation , diet history , bodyweight , blood lipids and blood sugar anti-smoking advice given individually to all smokers in the intervention group advice that smoking cessation was expected to be of special importance for those with elevated blood lipids .

diet

smoking intervention

dietary

smoking counselling

effect of diet

smoking intervention

dietary and smoking counselling

effect on serum cholesterol

cigarette consumption .

effect on

coronary heart disease


Effect of acebutolol on left ventricular performance . The effect of acebutolol on left ventricular performance was examined by various noninvasive means in three studies . M-mode echocardiographic measurements were made in 21 patients with coronary artery disease who were receiving placebo , acebutolol , and propranolol in a double-blind , randomized , crossover study . In these patients with normal or near-normal resting left ventricular function , neither drug induced depression of left ventricular function . In 26 patients with chronic angina pectoris receiving acebutolol under double-blind , placebo-controlled conditions , gated ( equilibrium ) myocardial blood pool imaging using red blood cells labeled with technetium 99m showed acebutolol to have no clinically significant negative effect on left ventricular performance at rest or during supine bicycle exercise . Acebutolol at effective antianginal doses modestly improved resting global and regional myocardial function . In 13 patients with stable angina pectoris , single-pass studies of left ventricular function with indium 113 under double-blind , placebo-controlled conditions similarly showed acebutolol to have no clinically significant negative inotropic effects . In conclusion , acebutolol is safe for use in patients with coronary disease and a wide range of ejection fractions but , as with all beta blockers , should be used cautiously in patients with markedly reduced resting left ventricular function .

acebutolol

acebutolol

placebo

acebutolol

propranolol

acebutolol

placebo-controlled

acebutolol

Acebutolol

acebutolol

acebutolol


Primary hypothyroidism associated with interferon therapy of breast cancer .

interferon

Primary hypothyroidism

Primary hypothyroidism

interferon therapy of breast cancer .


Use of transdermal glyceryl trinitrate to reduce failure of intravenous infusion due to phlebitis and extravasation . Self-adhesive patches which release glyceryl trinitrate at a slow continuous rate or placebo patches were applied to the skin of patients distal to intravenous infusion sites in a double-blind manner . The frequency of infusion failure was three times lower with the glyceryl trinitrate than with placebo patches . The decrease was of similar magnitude whether failure was due to extravasation or phlebitis . Headaches were more common in patients with active patches but were relieved by simple analgesics .

transdermal glyceryl trinitrate

glyceryl trinitrate

placebo patches

glyceryl trinitrate

placebo patches

analgesics

failure of intravenous infusion

Headaches

phlebitis and extravasation


Comparison of the efficacy and safety of esmolol , a short-acting beta blocker , with placebo in the treatment of supraventricular tachyarrhythmias . The Esmolol vs Placebo Multicenter Study Group . The efficacy and safety of esmolol , a short-acting intravenous beta-adrenergic-blocking agent , and placebo were compared in patients with supraventricular tachyarrhythmias ( heart rate greater than 120 bpm ) in a multicenter , double-blind , partial-crossover study . Seventy-one patients were randomized to receive either esmolol ( n = 36 ) or placebo ( n = 35 ) as initial treatment . Therapeutic failures were crossed over to the other study medication . Therapeutic response was defined as greater than or equal to 20 % reduction in heart rate , heart rate less than 100 bpm , or conversion to normal sinus rhythm . The therapeutic response to esmolol during the initial treatment period ( 72 % ) was similar to that obtained when esmolol was given as a second agent . The average esmolol dosage producing a therapeutic response was 97.5 micrograms/kg/min . Four patients ( 6 % ) converted to normal sinus rhythm during esmolol infusion . In the majority of patients ( 80 % ) , therapeutic response was lost within 30 minutes following discontinuation of esmolol infusion , a finding indicative of rapid reversal of beta-adrenoceptor blockade . The most prevalent adverse effect during esmolol infusion was hypotension which occurred in eight patients ( 12 % ) . Hypotension and associated symptoms resolved within 30 minutes after discontinuation of esmolol infusion , which is consistent with the short duration of action of esmolol ( elimination half-life of 9.2 minutes ) .

esmolol

placebo

Esmolol

Placebo

esmolol

placebo

esmolol

placebo

esmolol

esmolol

esmolol

esmolol

esmolol

efficacy

safety

efficacy

safety

Therapeutic response

heart rate

heart rate less than 100 bpm

conversion to normal sinus rhythm

The therapeutic response

normal sinus rhythm

therapeutic response

adverse effect

hypotension

Hypotension and associated symptoms

supraventricular tachyarrhythmias .

supraventricular tachyarrhythmias

Seventy-one


[ Potentiation of the effect of non-depolarizing muscle relaxants by acylaminopenicillins . Studies on the example of vecuronium ] . In a prospective controlled clinical study interactions between nondepolarizing muscle relaxants and acylaminopenicillins were investigated electromyographically . Six patients in each group received either apalcillin , azlocillin , mezlocillin or piperacillin during the operation . Muscle relaxation was maintained using the short acting nondepolarizing relaxant vecuronium , which shows no cumulative effect within clinical dosages . The intra-individual comparison with the control period ( 100 % ) showed a significant prolongation of the duration of action after a fixed dose of vecuronium . The mean increase was +26 % following apalcillin , +46 % after piperacillin , +38 % following mezlocillin and +55 % following azlocillin . The shortest time of the control periods was 8.6 min and the maximum time was 32.6 min . We also found a significant depression of the EMG-response . No significant differences could be detected between the four antibiotics . The method described here has proven to be sensitive enough to detect clinically relevant interactions with muscle relaxants . As a result of our study , caution seems to be necessary if acylaminopenicillins are administered in the early postoperative period .

acylaminopenicillins

nondepolarizing muscle relaxants

acylaminopenicillins

acylaminopenicillins

Muscle relaxation

prolongation of the duration of action

mean increase

shortest time

depression

EMG-response

clinically relevant interactions

muscle relaxants

Six


Propranolol in acute myocardial infarction : the MILIS experience . The results of the propranolol limb of the Multicenter Investigation of the Limitation of Infarct Size are reviewed . A total of 269 patients , who presented with symptoms and electrocardiographic signs suggesting acute myocardial infarction were randomized to acute intravenous and subsequent oral therapy with propranolol ( n = 134 ) or placebo ( n = 135 ) . Eligibility for acute beta-blocker therapy was determined on the basis of readily available , noninvasive tests . Therapy was started at an average time of 8.5 hours after onset of symptoms . The full induction dose of intravenous propranolol ( 0.1 mg/kg ) was tolerated by 90 % of treated patients , and oral maintenance therapy was being continued in 82 % of treated patients on the second hospital day . There was a significant reduction in heart rate throughout maintenance therapy with propranolol , which continued through the tenth hospital day . There was no significant difference in the incidence of congestive heart failure between propranolol- and placebo-treated groups . There was also no significant difference between the 2 groups in infarct size estimated by measurement of serum CK-MB , planimetry of infarct area on technetium pyrophosphate myocardial scintigrams or R-wave measurements in patients with transmural anterior and inferior infarcts . There was no significant difference in mortality between the 2 groups during an average of 36 months ' follow-up . Although propranolol can be administered safely to patients with acute myocardial infarction who are selected on the basis of simple clinical criteria , there is no evidence of reduction of infarct size when beta blockade is begun 8.5 hours after the onset of symptoms .

Propranolol

propranolol

propranolol

placebo

propranolol

propranolol-

placebo-treated

propranolol

heart rate

incidence of congestive heart failure

infarct size

mortality

infarct size

acute myocardial infarction :

acute myocardial infarction


Protective effect of high-dose medroxyprogesterone acetate ( HD-MPA ) on hematological toxicity induced by chemotherapy for advanced solid tumors : a multicentric controlled clinical trial . MPA-Hematology Italian Cooperative Group . A multicenter , randomized , controlled trial was conducted comparing active treatment with placebo in 227 patients with breast , colorectal , lung and other solid forms of cancer . Combination therapy , ( CT ) conventionally employed for the various types of tumor involved , was associated with MPA ( 117 patients ) or placebo ( 110 patients ) . MPA was given orally as tablets , as a dose of 500 mg b.i.d . for 6 months . The results were , briefly , as follows : The incidence of leukopenia was significantly lower in the groups receiving MPA in patients with breast and colorectal cancer ( P less than 0.02 ) . Tumors of the lung and other solid forms showed no such difference . The incidence of thrombocytopenia was the same in all disease groups . Objective responses ( CR + PR ) were observed in 23/46 ( 50 % ) of breast cancer patients treated with CT + MPA , and in 13/47 ( 28 % ) of those given CT + placebo . The difference was significant ( P less than 0.02 ) . Subjective parameters also showed more improvement in the MPA group than in the patients given CT alone . No significant differences were found for the other types of tumor , but the numbers in this population were very limited . In a group of 45 patients , antithrombin III a ( % ) , antithrombin III R : Ag ( % ) , plasminogen ( mg/dl ) , alpha-2 macroglobulin ( % ) , factor VIII C ( % ) , factor VIII R : Ag ( % ) and factor IX C ( % ) were determined . The most interesting post-treatment findings were an increase in anti-thrombin III ( activity and antigen level ) and in plasminogen . This suggests that MPA does not increase the risk of thrombosis , and might even , to some extent , impede tumor-induced thrombophilia . ( ABSTRACT TRUNCATED AT 250 WORDS )

chemotherapy

placebo

Combination therapy , ( CT )

MPA

placebo

MPA

CT + MPA

CT + placebo

MPA

hematological toxicity

incidence of leukopenia

incidence of thrombocytopenia

Objective responses ( CR + PR )

Subjective parameters


Antibiotic elimination of group-B streptococci in urine in prevention of preterm labour . The presence of group-B streptococci in the urine of pregnant women seems to be associated with preterm labour . Urine samples from 4122 women at 27-31 weeks ' gestation were examined for bacteria . Group-B streptococci were found in the urine of 69 women . In a double-blind , controlled study these patients were given either penicillin ( 10 ( 6 ) IU three times daily for 6 days ; 37 patients ) or placebo ( 32 patients ) . The rates of primary rupture of the membranes ( 11 % v 53 % ; p less than 0.001 ) and preterm labour ( 5.4 % v 38 % ; p less than 0.002 ) were significantly lower in the penicillin group than in the placebo group . These results suggest that treatment and follow-up to prevent recolonisation in pregnant women with group-B streptococci in the urine may reduce the frequency of preterm labour in these patients .

penicillin

placebo

penicillin

placebo

preterm labour

primary rupture of the membranes

preterm labour

frequency of preterm labour

preterm labour

pregnant

women

pregnant

group-B streptococci


Bronchial carcinoma . II . Quantitative measurements of the quality of survival . A prospective randomized study of the result of therapy in inoperable patients with advanced disease . Forty-eight bronchial carcinoma patients in clinicoanatomical stage 4 of the disease ( advanced disease ) were randomly assigned to groups for radiotherapy , chemotherapy ( cyclophosphamide ) and placebo treatment , respectively . The results were assessed by the survival time and quality of survival . The median survival time was 4.7 months for radiotherapy , 4.7 months for cyclophosphamide and 1.7 months for placebo . The median total sum of vitagram points was 28.1 for radiotherapy , 20.7 for cyclophosphamide and 6.8 for placebo . When calculated per month , the median sum of vitagram points was 5.9 for radiotherapy , 5.7 for cyclophosphamide and 4.8 for placebo . Statistically the results give no reason to believe that placebo is better than radiotherapy , but it can not be excluded that radiotherapy patients could have a much longer survival . As for cyclophosphamide versus radiotherapy , the differences are to uncertain for any conclusion to be drawn .

radiotherapy

chemotherapy ( cyclophosphamide )

placebo

radiotherapy

cyclophosphamide

placebo

radiotherapy

cyclophosphamide

placebo

radiotherapy

cyclophosphamide

placebo

placebo

radiotherapy

radiotherapy

cyclophosphamide

radiotherapy

quality of survival

survival time

quality of survival

median survival time

median total sum of vitagram points

median sum of vitagram points

survival

Bronchial carcinoma

Forty-eight

bronchial carcinoma


Comparison of endotracheal and peripheral intravenous adrenaline in cardiac arrest . Is the endotracheal route reliable ? Twelve patients presenting to an accident and emergency department in asystolic cardiac arrest were randomly allocated to treatment with endotracheal adrenaline ( five patients ) or peripheral intravenous adrenaline ( seven patients ) . Femoral-artery blood samples were taken for assay of adrenaline and noradrenaline . After intravenous adrenaline there was a good clinical and biochemical response , but after endotracheal adrenaline there was no change in serum adrenaline and no measurable clinical response . The endotracheal route of adrenaline administration is not reliable in out-of-hospital cardiac arrest .

endotracheal adrenaline

peripheral intravenous adrenaline

adrenaline

noradrenaline

adrenaline

adrenaline

clinical and biochemical response

no change in serum adrenaline

measurable clinical response

cardiac arrest .

Twelve


Lithium and granulocytopenia during induction therapy of acute myelogenous leukemia . Twenty-seven patients receiving a standard cytosine arabinoside and daunorubicin regimen as induction of reinduction therapy of acute myelogenous leukemia were randomly assigned to receive lithium carbonate , 300 mg t.i.d. , or no lithium . Treatment groups were comparable with respect to age and baseline granulocyte counts . All patients developed granulocyte nadirs below 100/cu mm . By actuarial analysis , the median duration of granulocytopenia , less than 1000/cu mm , was 16.0 days in the lithium group and 24.6 days in the no-lithium group , p = 0.013 . The median duration of granulocytes less than 500/cu mm also favored the lithium group but only approached statistical significance : 14.0 days versus 20.5 days , p = 0.054 . Lithium levels between 0.5 and 1.0 meq/liter were easily maintained in 11 of 12 patients receiving lithium , 300 mg t.i.d. , and toxicity directly attributable to lithium was not observed . Despite the shortened duration of neutropenia , the incidence of infections and the rate of remission were not affected .

Lithium

standard cytosine arabinoside

daunorubicin regimen

lithium carbonate , 300 mg t.i.d.

no lithium

lithium

no-lithium

lithium

Lithium

lithium

lithium

granulocyte nadirs

median duration of granulocytopenia

median duration of granulocytes

toxicity

shortened duration of neutropenia

acute myelogenous leukemia .


Methotrexate/nitrous-oxide toxic interaction in perioperative chemotherapy for early breast cancer .

perioperative chemotherapy

toxic interaction


Noradrenergic mechanisms in akathisia : treatment with propranolol and clonidine .

propranolol

clonidine

akathisia

propranolol and clonidine


Cardiovascular effects of non-depolarizing neuromuscular blockers in patients with aortic valve disease . To compare haemodynamic responses associated with equipotent doses of neuromuscular blockers and high-dose fentanyl ( 50 micrograms.kg-1 ) , 40 patients with aortic valve stenosis ( AS ) and 20 patients with aortic insufficiency ( AI ) were randomized to four study groups to receive the following : ( 1 ) pancuronium 0.12 mg.kg-1 , ( 2 ) vecuronium 0.12 mg.kg-1 , ( 3 ) atracurium 0.4 mg.kg-1 , or ( 4 ) pancuronium-metocurine mixture ( 0.4 mg + 1.6 mg/ml ) : 1 ml/10 kg ) . Neuromuscular blockers were injected at the same time with the fentanyl ; haemodynamics were recorded with the patients awake ( baseline ) , at two minutes post-induction , and at two and five minutes after intubation . In patients with AS , pancuronium increased heart rate more than vecuronium or atracurium ; heart rates were also higher with the pancuronium-metocurine mixture than with vecuronium . Although there were no ECG signs of ischaemia , one patient given pancuronium developed severe hypotension associated with tachycardia . Reductions in SVR after atracurium allowed small but significant ( p less than 0.01 ) decreases in MAP which were well tolerated ; one patient , however , did develop severe hypotension . Intubation resulted in significant ( p less than 0.01 ) increases in MAP in the pancuronium-metocurine mixture group . Vecuronium permitted the most stable overall haemodynamic course at all measurement times . In contrast , patients with AI showed stable haemodynamics after vecuronium , pancuronium and the pancuronium-metocurine mixture ; one patient became tachycardic following vecuronium . Atracurium caused unexplained elevations in diastolic and mean arterial pressures which were significant when compared to vecuronium ( p less than 0.01 ) . These results in increases in PCWP ; mean PA pressures and CVP were also increased . These effects of atracurium inpatients with Al need further evaluation .

non-depolarizing neuromuscular blockers

neuromuscular blockers

fentanyl

( 3 ) atracurium 0.4 mg.kg-1

( 4 ) pancuronium-metocurine mixture

Neuromuscular blockers

fentanyl

pancuronium

vecuronium

atracurium

pancuronium-metocurine mixture

vecuronium

pancuronium-metocurine

Vecuronium

vecuronium

pancuronium

pancuronium-metocurine mixture

vecuronium

Atracurium

vecuronium

atracurium

heart rate

heart rates

ECG signs of ischaemia

SVR

MAP

well tolerated

severe hypotension

MAP

overall haemodynamic course

stable haemodynamics

tachycardic

PCWP

mean PA pressures

CVP

increased


Mexiletine for treatment of chronic painful diabetic neuropathy . Sixteen of nineteen patients completed a randomised double-blind crossover trial to assess the effect of oral mexiletine ( 10 mg/kg bodyweight daily ) on the symptoms and signs of chronic painful diabetic neuropathy . The median age of the sixteen patients was 50 years ( range 30-64 ) . Assessment with a five-item clinical symptom scale showed significant improvement during the mexiletine phase compared with the placebo phase . Pain was reduced during mexiletine but not during placebo , as assessed by a visual analogue rating scale . Mexiletine treatment had no effect on tendon reflexes , vibration threshold levels , beat-to-beat variation in heart rate during deep breathing , and postural blood pressure response . Mild side-effects were seen in three of the sixteen patients during mexiletine treatment .

Mexiletine

oral mexiletine

placebo

mexiletine

placebo

Mexiletine

five-item clinical symptom scale

Pain

tendon reflexes

vibration threshold levels

postural blood pressure response

Mild side-effects


Multicenter trial of cryotherapy for retinopathy of prematurity : preliminary results . Cryotherapy for Retinopathy of Prematurity Cooperative Group . We report the preliminary 3-month outcome of a multicenter randomized trial of cryotherapy for treatment of retinopathy of prematurity ( ROP ) . Transscleral cryotherapy to the avascular retina was applied to one randomly selected eye when there was threshold disease ( defined as five or more contiguous or eight cumulative 30 degree sectors [ clock hours ] of stage 3 ROP in zone 1 or 2 in the presence of " plus " disease ) . An unfavorable outcome was defined as posterior retinal detachment , retinal fold involving the macula , or retrolental tissue . At this writing , 172 infants had been examined 3 months after randomization . An unfavorable outcome was significantly less frequent in the eyes undergoing cryotherapy ( 21.8 % ) compared with the untreated eyes ( 43 % ) . While the surgery was stressful , no unexpected complications occurred during or following treatment . These data support the efficacy of cryotherapy in reducing by approximately one half the risk of unfavorable retinal outcome from threshold ROP .

cryotherapy

Cryotherapy

cryotherapy

Transscleral cryotherapy

cryotherapy

cryotherapy

posterior retinal detachment

retinal fold involving the macula

retrolental tissue

unexpected complications

efficacy

retinopathy of prematurity :


5-Fluorouracil , adriamycin , cyclophosphamide ( FAC ) vs. 5-fluorouracil , epirubicin , cyclophosphamide ( FEC ) in metastatic breast cancer . 94 evaluable patients with metastatic breast cancer were randomly assigned to 5-fluorouracil , adriamycin , and cyclophosphamide ( FAC ) or 5-fluorouracil , epirubicin , and cyclophosphamide ( FEC ) , with cycles repeated every 3 weeks . The objective response rate to FAC was 46 % versus 44 % to FEC . There was no significant difference in the median duration of response and median survival for the two regimens . Toxicity was more frequent and more pronounced in patients receiving FAC . Results indicate therapeutic equivalence of the two regimens and reduced toxicity of the epirubicin arm .

FAC

FEC

FAC

objective response rate

median duration of response and

median survival

Toxicity

metastatic breast cancer


Motion aftereffects with horizontally moving sound sources in the free field . A horizontally moving sound was presented to an observer seated in the center of an anechoic chamber . The sound , either a 500-Hz low-pass noise or a 6300-Hz high-pass noise , repeatedly traversed a semicircular arc in the observer 's front hemifield at ear level ( distance : 1.5 m ) . At 10-sec intervals this adaptor was interrupted , and a 750-msec moving probe ( a 500-Hz low-pass noise ) was presented from a horizontal arc 1.6 m in front of the observer . During a run , the adaptor was presented at a constant velocity ( -200 degrees to +200 degrees/sec ) , while probes with velocities varying from -10 degrees to +10 degrees/sec were presented in a random order . Observers judged the direction of motion ( left or right ) of each probe . As in the case of stimuli presented over headphones ( Grantham & Wightman , 1979 ) , an auditory motion aftereffect ( MAE ) occurred : subjects responded " left " to probes more often when the adaptor moved right than when it moved left . When the adaptor and probe were spectrally the same , the MAE was greater than when they were from different spectral regions ; the magnitude of this difference depended on adaptor speed and was subject-dependent . It is proposed that there are two components underlying the auditory MAE : ( 1 ) a generalized bias to respond that probes move in the direction opposite to that of the adaptor , independent of their spectra ; and ( 2 ) a loss of sensitivity to the velocity of moving sounds after prolonged exposure to moving sounds having the same spectral content .

horizontally moving sound

500-Hz low-pass noise

6300-Hz high-pass noise

moving probe

auditory motion aftereffect ( MAE )

MAE

MAE


Chemotherapy of large bowel carcinoma -- fluorouracil ( FU ) + hydroxyurea ( HU ) vs. methyl-CCNU , oncovin , fluorouracil , and streptozotocin ( MOF-Strep ) . An Eastern Cooperative Oncology Group study . In this prospective randomized study of initial chemotherapy for advanced measurable metastatic large bowel carcinoma , the response rate was 6/32 ( 19 % ) for FU + HU and 5/32 ( 16 % ) for MOF-Strep ; the estimated median survival is 43 weeks for both treatments . Patients who received MOF-Strep experienced substantially greater vomiting and hematologic toxicity than patients who received FU + HU ( p less than 0.001 ) .

bowel carcinoma

response rate

median survival

vomiting and hematologic toxicity

large bowel carcinoma


Comparative efficacy of oral erythromycin versus oral tetracycline in the treatment of acne vulgaris . A double-blind study . The efficacy of erythromycin base ( E-Mycin tablets , 333 mg ) and the efficacy of tetracycline hydrochloride ( Panmycin tablets ) were compared in this double-blind , randomized study . Two hundred patients with moderate to moderately severe acne vulgaris were randomly assigned to the study . One hundred patients received 1 gm of erythromycin base by mouth per day for 4 weeks , followed by 333 mg/day for 8 weeks , plus placebo for tetracycline . The second group of patients received 1 gm of tetracycline by mouth per day for 4 weeks , followed by 500 mg/day for 8 weeks , plus placebo for erythromycin . Both drugs reduced acne severity to the same extent . Pustules , papules , and open comedo counts decreased significantly over the 12-week period . Seventy-seven percent of the erythromycin-treated patients and 89 % of the tetracycline-treated patients stated that their acne was markedly improved or improved by week 12 . Most of the side effects in patients treated with erythromycin were gastrointestinal symptoms . Among the side effects in patients treated with tetracycline were Candida vaginitis in one patient and pseudotumor cerebri in one patient .

oral erythromycin

oral tetracycline

erythromycin base

tetracycline hydrochloride

1 gm of erythromycin base

placebo

tetracycline

tetracycline

placebo

erythromycin

acne vulgaris .

efficacy

efficacy

tetracycline hydrochloride

acne severity

acne

gastrointestinal symptoms .

Candida vaginitis

pseudotumor cerebri

Two hundred patients


Comparison of ketanserin and pindolol in hypertension . The antihypertensive effects of ketanserin ( 40 mg twice daily ) and pindolol ( 5 mg twice daily ) as monotherapy were compared in a crossover , double-blind trial in 17 patients with essential hypertension . Both ketanserin and pindolol decreased supine systolic and diastolic blood pressure significantly ( P less than 0.01 for systolic and P less than 0.001 for diastolic ) when evaluated at the end of the 2-month treatment periods . There was no significant difference between the two drugs . No significant changes in heart rate were observed on either drug . Both drugs were well tolerated .

ketanserin

pindolol

ketanserin

pindolol

ketanserin

pindolol

systolic and P

heart rate

hypertension .


Prevention of subsequent exercise-induced periinfarct ischemia by emergency coronary angioplasty in acute myocardial infarction : comparison with intracoronary streptokinase . To compare the efficacy of emergency percutaneous transluminal coronary angioplasty and intracoronary streptokinase in preventing exercise-induced periinfarct ischemia , 28 patients presenting within 12 hours of the onset of symptoms of acute myocardial infarction were prospectively randomized . Of these , 14 patients were treated with emergency angioplasty and 14 patients received intracoronary streptokinase . Recatheterization and submaximal exercise thallium-201 single photon emission computed tomography were performed before hospital discharge . Periinfarct ischemia was defined as a reversible thallium defect adjacent to a fixed defect assessed qualitatively . Successful reperfusion was achieved in 86 % of patients treated with emergency angioplasty and 86 % of patients treated with intracoronary streptokinase ( p = NS ) . Residual stenosis of the infarct-related coronary artery shown at predischarge angiography was 43.8 +/- 31.4 % for the angioplasty group and 75.0 +/- 15.6 % for the streptokinase group ( p less than 0.05 ) . Of the angioplasty group , 9 % developed exercise-induced periinfarct ischemia compared with 60 % of the streptokinase group ( p less than 0.05 ) . Thus , patients with acute myocardial infarction treated with emergency angioplasty had significantly less severe residual coronary stenosis and exercise-induced periinfarct ischemia than did those treated with intracoronary streptokinase . These results suggest further application of coronary angioplasty in the management of acute myocardial infarction .

emergency coronary angioplasty

intracoronary streptokinase

intracoronary streptokinase

emergency angioplasty

intracoronary streptokinase

emergency angioplasty

streptokinase

streptokinase

coronary angioplasty

exercise-induced periinfarct ischemia

Periinfarct ischemia

Successful reperfusion

exercise-induced periinfarct ischemia

severe residual coronary stenosis

exercise-induced periinfarct ischemia

acute myocardial infarction :

acute myocardial infarction

acute myocardial infarction

acute myocardial infarction