Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease . The Bypass Angioplasty Revascularization Investigation ( BARI ) Investigators . BACKGROUND Coronary-artery bypass grafting ( CABG ) and percutaneous transluminal coronary angioplasty ( PTCA ) are alternative methods of revascularization in patients with coronary artery disease . We tested the hypothesis that in selected patients with multivessel disease suitable for treatment with either procedure , an initial strategy of PTCA does not result in a poorer five-year clinical outcome than CABG . METHODS Patients with multivessel disease were randomly assigned to an initial treatment strategy of CABG ( n = 914 ) or PTCA ( n = 915 ) and were followed for an average of 5.4 years . Analysis of outcome events was performed according to the intention to treat . RESULTS The respective in-hospital event rates for CABG and PTCA were 1.3 percent and 1.1 percent for mortality , 4.6 percent and 2.1 percent for Q-wave myocardial infarction ( P < 0.01 ) , and 0.8 percent and 0.2 percent for stroke . The five-year survival rate was 89.3 percent for those assigned to CABG and 86.3 percent for those assigned to PTCA ( P = 0.19 ; 95 percent confidence interval of the difference in survival , -0.2 percent to 6.0 percent ) . The respective five-year survival rates free from Q-wave myocardial infarction were 80.4 percent and 78.7 percent . By five years after study entry , 8 percent of the patients assigned to CABG had undergone additional revascularization procedures , as compared with 54 percent of those assigned to PTCA ; 69 percent of those assigned to PTCA did not subsequently undergo CABG . Among diabetic patients who were being treated with insulin or oral hypoglycemic agents at base line , a subgroup not specified by the protocol , five-year survival was 80.6 percent for the CABG group as compared with 65.5 percent for the PTCA group ( P = 0.003 ) . CONCLUSIONS As compared with CABG , an initial strategy of PTCA did not significantly compromise five-year survival in patients with multivessel disease , although subsequent revascularization was required more often with this strategy . For treated diabetics , five-year survival was significantly better after CABG than after PTCA .

coronary bypass surgery

angioplasty

CABG

PTCA

CABG

PTCA

mortality

Q-wave myocardial infarction

stroke

five-year survival rate

revascularization procedures

five-year survival

five-year survival

subsequent revascularization

five-year survival

patients with multivessel disease

patients with coronary artery disease


Tight-fitting underwear and sperm quality .

Tight-fitting underwear

sperm quality .


[ Radiotherapy and/or chemotherapy in children with primitive neuroectodermal tumor ( PNET ) of the pineal region ] .

[ Radiotherapy and/or chemotherapy

children


Effects of a chlorhexidine varnish on the gingival status of adolescents . The purpose of this blind study was to determine the effect of a two-stage chlorhexidine varnish , after three months , on the gingival status of 11- to 15-year-old children attending a school in Rio de Janeiro , Brazil . Subjects participating in the study were randomly allocated to control ( C ) and treatment ( T ) groups , n = 53 and n = 57 , respectively . All subjects were matched at baseline on age , salivary levels of mutans streptococci , and caries scores . After elimination of carious lesions , a prophylaxis was given to both groups . The chlorhexidine varnish was then painted on the entire dentition of Group T subjects only . Prior to caries elimination , and again after three months , the gingival index was used to assess the gingival status of study subjects . An average of 106.6 +/- 8.9 and 107.7 +/- 6.2 gingival sites per subject ( four sites per tooth ) in Groups C and T , respectively , were examined by the same calibrated examiner on two occasions . For statistical purposes , data were dichotomized [ ( 0,1 ) ( 2,3 ) ] for the gingival index . Independent t-tests and paired t-tests were used to analyze the data . The percentage of sites per subject with scores of two or three at the baseline were balanced between study groups ( 3.7 +/- 7.1 for T ; 1.8 +/- 3.2 for C ; p = 0.08 ) . After three months , a statistically significant decrease in the average percentage of sites with scores of two or three was demonstrated in the T group ( 0.7 +/- 2.4 , T , p < 0.0001 ; 1.3 +/- 3.0 , C , p < 0.25 ) . The authors concluded that the application of a chlorhexidine varnish significantly improved the gingival health of T subjects for up to three months . A significant improvement in the gingival health could not be demonstrated in the C group .

chlorhexidine varnish

chlorhexidine varnish

prophylaxis

chlorhexidine varnish

chlorhexidine varnish

gingival status

gingival status

gingival health

gingival health

gingival

adolescents

11- to 15-year-old children


Fludarabine in chronic leukaemia .

Fludarabine

chronic leukaemia .


A phase I study of recombinant human ciliary neurotrophic factor ( rHCNTF ) in patients with amyotrophic lateral sclerosis . The ALS CNTF Treatment Study ( ACTS ) Phase I-II Study Group . Fifty-seven patients with amyotrophic lateral sclerosis ( ALS ) were randomly assigned to receive 0.5 , 1 , 3 , 7 , 10 , or 30 micrograms/kg recombinant human ciliary neurotrophic factor ( rHCNTF ) or placebo subcutaneously 3 times a week for 2 weeks . Dose-limiting toxicity , consisting of febrile reactions in some patients , fatigue , and nonproductive cough , was observed at a dose level of 30 micrograms/kg . Dose-related changes in parameters of the acute-phase response were noted , consistent with the relationship of CNTF and its receptor system to the cytokine interleukin-6 ( IL-6 ) and its receptor . No adverse neurologic consequences of rHCNTF administration were observed . Antibodies to rHCNTF were observed in sera of most patients tested after 2 weeks of continuous treatment and 4 weeks ' withdrawal period . rHCNTF was safe and tolerated within acceptable limits when administered to patients with ALS in this study at doses of up to 30 micrograms/kg 3 times a week for 2 weeks . Further studies to explore the efficacy of rHCNTF in the treatment of human motor neuron diseases are justified .

placebo

CNTF

rHCNTF

rHCNTF

rHCNTF

rHCNTF

Dose-limiting toxicity

fatigue

nonproductive cough

Antibodies to rHCNTF

safe and tolerated

amyotrophic lateral sclerosis

Fifty-seven

amyotrophic lateral sclerosis ( ALS )

ALS


[ Effectiveness of adjuvant hormone therapy in breast cancer ] . A third series of randomized tests was undertaken to evaluate the efficacy of postoperative adjuvant hormone therapy ( tamoxifen , diethylstilbestrol , orimethen amino glutethymide ) in breast cancer patients . Tamoxifen was studied in 176 patients with T1-2N0M0 tumors . Five-year recurrence-free survival was registered in 85.2 % of menopausal patients treated with tamoxifen versus 71.1 % in control ( P < 0.05 ) . Five-year recurrence-free survival in menopausal females with breast tumors , stage IIb , was 71.1 % among those treated with diethylstilbestrol and as low as 57.4 % in the tamoxifen group ( P < 0.05 ) . Untoward side-effect incidence was much higher in the diethylstilbestrol group ( 30.4 % ) as compared with tamoxifen ( 3.5 % ) . No significant difference was found for the relationship between orimethen and tamoxifen treatment with respect to 5-year survival and recurrence-free survival .

adjuvant hormone therapy

adjuvant hormone therapy

tamoxifen

diethylstilbestrol

orimethen amino glutethymide

Tamoxifen

tamoxifen

tamoxifen

tamoxifen

orimethen

tamoxifen

evaluate

efficacy

Five-year recurrence-free survival

Five-year recurrence-free survival

Untoward side-effect incidence

much higher

breast cancer

patients with T1-2N0M0 tumors .


Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis . The aim of this study was to determine the comparative efficacy and safety of intra-articular ( i/a ) triamcinolone . hexacetonide ( TH ) and i/a hyaluronic acid ( HA ) in inflammatory knee osteoarthritis . A randomized double-blind comparative trail was carried out in a rheumatology outpatient department . There were 63 patients ( 24 male , 39 female , mean age 70.5 years ) with bilateral symptomatic knee osteoarthritis with effusion . Each was given five HA injections at weekly intervals ; or 20 mg TH followed by four placebo ( saline ) injections . Patients were examined weekly during the treatment period and then at monthly intervals for a further 6 months . Assessment included recording of : visual analog scores ( VAS ) for pain ; duration of stiffness ; range of movement ; joint effusion ; local heat ; synovial thickening ; joint-line and periarticular tenderness . The principal outcome measure was pain on a self-selected activity assessed by Vas . The two groups were comparable at entry and no significant differences between the groups developed at any time during the treatment period . However , there was a high drop-out rate and intention to treat analysis failed to demonstrate statistically significant differences between the groups . In patients remaining in the study , significantly less pain was experienced by the HA group during the 6 month follow-up period . Other parameters showed a similar trend in favor of experienced by the HA group during the 6 month follow-up period . Other parameters showed a similar trend in favor of HA . We could not , however , demonstrate significant differences between the placebo and active treatments . HA may therefore be a useful additional therapy for symptomatic knee osteoarthritis and may have a long duration of action .

hyaluronic acid

triamcinolone hexacetonide

HA injections

20 mg

TH

placebo ( saline ) injections

HA

HA

HA

HA

visual analog scores ( VAS ) for pain

duration of stiffness

range of movement

joint effusion

local heat

synovial thickening

joint-line and periarticular tenderness

pain

inflammatory knee osteoarthritis

inflammatory knee osteoarthritis

63 patients

24 male

39 female

age 70.5 years

symptomatic knee osteoarthritis


Comparison of regimens of amphotericin B deoxycholate in kala-azar . A total of 288 parasitologically proved patients of kala-azar were randomly allocated to three treatment groups . Patients in groups A , B and C received amphotericin B ( AMB ) in a dose of 1 mg/kg body weight ( bw ) /day , 0.75 mg/kg bw/day and 0.5 mg/kg bw/day for 20 days respectively . Apparent cure ( afebrile at the end of therapy ) occurred in all patients and parasitological cure in 96 ( 100 % ) , 92 ( 96 % ) and 84 ( 88 % ) patients respectively in groups A , B and C. Ultimate cure ( no relapse in six months of follow up ) occurred in 95 ( 99 % ) , 87 ( 91 % ) and 79 ( 82 % ) patients in groups A , B and C respectively . The difference between the ultimate cure in the three groups was significant ( P < 0.05 ) . The incidence of adverse events ( rise in serum creatinine and fall in serum potassium , loss of appetite and shivering , rigor and fever during infusion indicative of renal , GIT and infusion related toxicities respectively ) was similar in the three groups . This study showed that amphotericin B should be given at a dosage of 1 mg/kg bw/day for 20 days for Indian kala-azar patients to minimise relapses and prevent development of drug unresponsiveness .

amphotericin B deoxycholate

amphotericin B ( AMB )

amphotericin B

parasitological cure

ultimate cure

drug unresponsiveness

kala-azar

Indian kala-azar patients


The effect of body positioning upon maximal oxygenation of patients with unilateral lung pathology . A quasi-experimental , repeated-measures cross-over design study on the effect of body position on oxygenation ( SaO2 ) blood pressure , respiration and pulse in patients with unilateral lung pathology was conducted . Previous research strongly suggests that positioning with the healthy ( unaffected ) lung in the dependent lateral ( down ) position is related to improved oxygenation , but knowledge about whether this effect is maintained over time is lacking . The purpose of this investigation was to determine : ( 1 ) Is positioning with the unaffected lung in the dependent lateral position related to increased arterial blood saturation levels and decreased blood pressure , pulse and respiration ? ( 2 ) What is the relationship between the dependent variables -- oxygenation saturation levels , blood pressure , pulse and respiration -- and the independent variables -- body position and time in the position ? Thirty-nine patients with unilateral lung pathology were positioned on their sides with the unaffected lung down , on their sides with the affected lung down , and also in semi-Fowler 's position . Arterial ( SaO2 ) blood saturation and vital signs were measured at baseline 0 , 15 and 30 minutes . There was no statistically significant relationship between oxygenation level or systolic blood pressure . Diastolic blood pressure , respiration and pulse did vary significantly with position .

maximal oxygenation

oxygenation ( SaO2 )

unilateral lung pathology

unilateral lung pathology

Thirty-nine

unilateral lung pathology


Randomized trial comparing induction chemotherapy versus induction chemotherapy followed by maintenance chemotherapy in small-cell lung cancer . European Lung Cancer Working Party . PURPOSE AND METHODS The European Lung Cancer Working Party ( ELCWP ) performed a randomized trial with the primary end point to determine if maintenance chemotherapy with 12 courses of etoposide ( 120 mg/m2 on days 1 and 3 ) and vindesine ( 3 mg/m2 on day 3 ) could improve progression-free survival in small-cell lung cancer ( SCLC ) patients who responded to six courses of induction chemotherapy with ifosfamide , etoposide , and an anthracycline ( doxorubicin or epirubicin ) . RESULTS Among 235 eligible patients initially registered , 91 were randomized to receive maintenance therapy , including seven patients who were no longer responding . Among 84 randomized responders , progression-free survival was significantly improved ( P = .003 ) by maintenance therapy , with median durations ( maintenance v follow-up ) of 25 versus 12 weeks after the second randomization , but survival was not significantly increased ( P = .10 ) , with median durations of 48 and 38 weeks . However , in a multi-variate analysis that took into account disease extent , maintenance therapy , Karnofsky performance status ( PS ) , and absolute dose-intensity ( ADI ) of anthracycline given during induction , limited disease ( LD ) and maintenance were found to be independent positive predictors of survival . CONCLUSION We conclude that maintenance chemotherapy in responding patients is beneficial in SCLC .

induction chemotherapy

induction chemotherapy

maintenance chemotherapy

etoposide

vindesine

induction chemotherapy

ifosfamide

etoposide

anthracycline

doxorubicin

epirubicin

progression-free survival

progression-free survival

survival

limited disease ( LD ) and maintenance

survival .

small-cell lung cancer

seven


Removing bee stings . BACKGROUND Conventional advice on immediate treatment of honey-bee stings has emphasised that the sting should be scraped off , never pinched . The morphology of the sting suggested little basis for this advice , which is likely to slow down removal of the sting . METHODS The response to honey-bee stings was assayed with a measurement of the size of the resulting weal . Injection of known quantities of venom showed that this measurement is a good indicator of envenomisation . FINDINGS Weal size , and thus envenomisation , increased as the time from stinging to removal of the sting increased , even within a few seconds . There was no difference in response between stings scraped or pinched off after 2 s. INTERPRETATION These data suggest that advice to patients on the immediate treatment of bee stings should emphasise quick removal , without concern for the method of removal .

Removing bee stings

venom

quick removal

Weal size

stings scraped or pinched off

bee stings

honey-bee stings


[ Clinical early phase II study of bicalutamide ( Casodex ) in patients with prostatic cancer ] . To investigate the efficacy and safety of bicalutamide ( Casodex ) with its clinically recommended dose , the randomized early phase II study was performed in 124 patients with prostatic cancer ( stage C , D ) . The patients were given 50 , 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks ; 122 patients were eligible for evaluation . The overall response rate was 50.0 % ( 20/40 ) , 61.0 % ( 25/41 ) and 53.7 % ( 22/41 ) in the 50 mg , 80 mg and 100 mg groups , respectively . The response rate in prostate lesion , bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups . The proportion of patients showing a response with regard to serum PSA ( CR and PR ) was 84.2 , 92.7 and 97.6 % in the 50 , 80 and 100 mg groups , respectively . The incidence of adverse reactions was 65.0 , 61.0 and 61.0 % in the 50 , 80 and 100 mg groups , respectively , and there was no significant difference in overall safety rating in the three groups . Frequent adverse reactions were gynecomastia and breast pain . Only one patient in the 80 mg group was withdrawn due to shortness of breath . Serum concentrations of LH , testosterone and estradiol increased significantly after treatment . Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer , and its recommended dose was 80 mg once daily .

bicalutamide ( Casodex )

bicalutamide

50 , 80 or 100 mg of bicalutamide

Bicalutamide

efficacy and safety

overall response rate

incidence of adverse reactions

no significant difference

overall safety rating

Frequent adverse reactions

gynecomastia and breast pain .

withdrawn due to shortness of breath .

prostatic cancer

cancer

cancer


Influence of acute myocardial infarction location on in-hospital and late outcome after primary percutaneous transluminal coronary angioplasty versus tissue plasminogen activator therapy . In the Primary Angioplasty in Myocardial Infarction trial , 395 patients with acute myocardial infarction ( AMI ) were prospectively randomized to tissue plasminogen activator ( tPA ) or primary percutaneous transluminal coronary angioplasty ( PTCA ) . In 138 patients with anterior wall AMI , in-hospital mortality was significantly reduced by treatment with PTCA compared with tPA ( 1.4 % vs 11.9 % , p = 0.01 ) . PTCA also resulted in lower rates of death or reinfarction ( 1.4 % vs 18.0 % , p = 0.0009 ) , recurrent myocardial ischemia ( 11.3 % vs 28.4 % , p = 0.01 ) , and stroke ( 0.0 % vs 6.0 % , p = 0.037 ) in anterior wall AMI . The independent beneficial effect of treatment with primary PTCA rather than tPA in anterior wall AMI was confirmed by multivariate analysis and interaction testing . The in-hospital mortality of 257 patients with nonanterior wall AMI was similar after PTCA and tPA ( 3.2 % vs 3.8 % , p = 0.82 ) . Compared with tPA , however , primary PTCA resulted in a markedly lower rate of recurrent myocardial ischemia ( 9.7 % vs 27.8 % , p = 0.0002 ) , fewer unscheduled catheterization and revascularization procedures , and a shorter hospital stay ( 7.0 vs 8.6 days , p = 0.01 ) in nonanterior wall AMI . Thus , compared with tPA , primary PTCA in patients with anterior wall AMI results in significantly improved survival , with lower rates of stroke , reinfarction , and recurrent myocardial ischemia . In nonanterior wall AMI , treatment with PTCA and tPA results in similar early mortality , although PTCA-treated patients have a more stable hospital course characterized by reduced recurrent ischemia , fewer subsequent invasive procedures , and earlier discharge .

tissue plasminogen activator therapy

tissue plasminogen activator ( tPA

in-hospital mortality

rates

death or reinfarction

recurrent myocardial ischemia

stroke

in-hospital mortality

recurrent myocardial ischemia

unscheduled catheterization

revascularization procedures

hospital stay

improved survival

rates of

stroke

reinfarction

recurrent myocardial ischemia

mortality

recurrent ischemia

subsequent invasive procedures

discharge

acute myocardial infarction

AMI


Comparison of diclofenac sodium and morphine sulphate for postoperative analgesia after day case inguinal hernia surgery . Postoperative pain may be a significant reason for delayed discharge from hospital , increased morbidity and reduced patient satisfaction with ambulatory hernia surgery . This study compared two postoperative oral analgesic protocols after day case inguinal hernia repair ; 30 mg morphine sulphate ( MST ) and 10 mg metoclopramide every 8 h for 48 h or 75 mg diclofenac twice daily for 48 h. The pain reported in the MST group was significantly greater on both the day of operation and the first postoperative day ( P < 0.05 , Mann-Whitney U test ) . A significantly higher proportion of patients taking MST complained of nausea on the day of operation and on the 1st postoperative day ( P < 0.05 , chi 2 ) . The time taken to walk , dress and leave home alone were achieved in a significantly shorter duration in patients taking diclofenac . We conclude that diclofenac provides effective analgesia , has a more acceptable side-effect profile than morphine sulphate and is the treatment of choice after ambulatory hernia surgery .

diclofenac sodium and morphine sulphate

30 mg morphine sulphate ( MST )

10 mg metoclopramide

75 mg diclofenac

MST

MST

diclofenac .

diclofenac

morphine sulphate

postoperative analgesia

Postoperative pain

pain reported

nausea

analgesia

inguinal hernia surgery

ambulatory hernia surgery

day case inguinal hernia repair

patients taking MST


Resource utilization and costs of care in the diabetes control and complications trial . OBJECTIVE To describe in detail the resources used and costs incurred in the clinical management of patients with insulin-dependent diabetes mellitus ( IDDM ) in the Diabetes Control and Complications Trial ( DCCT ) . RESEARCH DESIGN AND METHODS The resources used for intensive and conventional therapy and to deal with the side effects of therapy were assessed at each of the 29 DCCT clinics and summarized . Unit costs were derived from the DCCT , manufacturers , and Medicare and chosen to reflect what an item would cost to a single-payer national health system . Costs were calculated as the product of resources used and unit costs . The costs of the research component of the DCCT were not included . RESULTS In the DCCT , the annual cost of intensive therapy ( $ 4,000 and $ 5,800/year for multiple daily injections and continuous subcutaneous insulin infusion , respectively ) was approximately three times the cost of conventional therapy ( $ 1,700/year ) . A large portion of the difference in cost was related to the greater frequency of outpatient visits and the greater resources used in self-care . CONCLUSIONS DCCT intensive therapy is more expensive than conventional therapy , but it offers the hope of cost savings as a result of averted complications .

insulin-dependent

intensive and conventional therapy

costs of care

resources

costs incurred

Costs

costs

annual cost of intensive therapy

cost of conventional therapy

cost

frequency of outpatient visits

resources used in self-care

insulin-dependent diabetes mellitus

IDDM


Pharmacokinetics of adriamycin and adriamycin -- DNA complex in L1210 mice and men .

adriamycin

adriamycin -- DNA complex

Pharmacokinetics

and men


Effect of chronic aerobic exercise and progressive relaxation on motor performance and affect following acute stress . The effects of a 10-week aerobic exercise and progressive relaxation training program on somatic , emotional , and behavioral responses to acute stress , as determined by quality of motor performance and affect , were examined . The participants consisted of 60 unfit male university undergraduate students with no previous training in stress management who were randomly and evenly assigned to engage in one of four treatments over 10 weeks : ( a ) moderate aerobic exercise , ( b ) progressive relaxation , ( c ) a placebo group that engaged in group discussion but did experience acute stress , and ( d ) a nonintervention control group that did not experience stress while performing the motor task . Acute stress consisted of " losing " against a competitor of the opposite sex on the criterion motor task while receiving unpleasant information about their performance over 30 preintervention and 30 postintervention trials . Analyses indicated that aerobic exercisers , in comparisons with the other groups , responded to acute stress with more positive affect , lower stressor task heart rate , reduced systolic ( but not diastolic ) blood pressure , and superior motor performance . Progressive relaxation markedly reduced systolic blood pressure but did not favorably influence performance or affect in response to acute stress . Placebo and control groups were statistically similar on all measures . The findings indicated support for the use of chronic aerobic exercise as a strategy for improved coping with acute stress .

chronic aerobic exercise

progressive relaxation

aerobic exercise

progressive relaxation

one of four treatments over 10 weeks

moderate aerobic exercise

progressive relaxation

motor performance

systolic blood pressure

male


A double-blind comparative study of ofloxacin otic drops versus neomycin-polymyxin B-hydrocortisone otic drops in the medical treatment of chronic suppurative otitis media . Active chronic suppurative otitis media poses a management problem when patients are being considered for surgical treatment . Topical antibiotics have demonstrated varying degrees of success in the management of discharging ears . The introduction of quinolones has revived interest in these topical agents . This double-blind study compares two antibiotics , namely ofloxacin and neomycin-polymyxin B , with similar in vitro sensitivities to Gram positive and Gram negative organisms . Fifty-two patients were selected randomly and the results show that ofloxacin eardrops have marginal benefits in symptomatic improvement ( 89 per cent versus 79 per cent , p = 0.27 ) and bacterial eradication ( 81 per cent versus 75 per cent , p = 0.81 ) in active chronic suppurative otitis media . Significantly fewer patients ( seven per cent versus 29 per cent , p = 0.04 ) in the ofloxacin group had active disease at the end of the two-week treatment . We recommend the use of ofloxacin eardrops in managing active chronic suppurative otitis media since it has high clinical efficacy , contains no steroid component and has no demonstrated risk of ototoxicity .

ofloxacin otic drops

antibiotics

ofloxacin

neomycin-polymyxin B

ofloxacin eardrops

ofloxacin eardrops

symptomatic improvement

bacterial eradication

active chronic suppurative otitis media

disease

clinical efficacy

risk of ototoxicity

chronic suppurative otitis media

Active chronic suppurative otitis media

discharging ears

Fifty-two

chronic suppurative otitis media

active chronic suppurative otitis media


Accuracy of pelvic radiotherapy : prospective analysis of 90 patients in a randomised trial of blocked versus standard radiotherapy . The aim of this study was to assess the accuracy of pelvic radiotherapy during a trial of blocked radiotherapy at the Royal Marsden Hospital , UK . Prospective evaluation was performed on 90 patients receiving CT planned pelvic radiotherapy using weekly anterior-posterior and lateral portal films . Field placement errors ( FPEs ) were calculated by comparing field centres of each film with a designated point of interest . Data was evaluated to calculate the overall treatment simulator differences , the number of error free treatments , and mean treatment-simulator position and to evaluate the role of systematic versus random errors . Age , weight , disease site , position of treatment , fractionation , blocked versus conventional techniques were assessed for their effect on treatment accuracy . The mean absolute error between treatment and simulator films was anterior right-left ( ARL ) 0.25 cm , anterior superior-inferior ( ASI ) 0.32 cm , lateral anterior-posterior ( LAP ) 0.42 cm , and lateral superior-inferior ( LSI ) 0.28 cm . On average the field centre was displaced by 0.66 cm ( standard deviation , S.D . = 0.34 ) from that intended . On each treatment day 29 % of anterior films and 45 % of lateral films had at least one 0.5 cm error . Overall 59 % of treatments had at least one 0.5 cm error and 9 % a 1.0 cm error . The field centre was more than 0.5 cm from the position intended in 66 % of treatments and over 1 cm for 14 % of treatments . Analysis of variance showed that both random and systematic errors occurred in all directions . Though random errors were of similar magnitude in all direction ( variance sigma 2 = 0.06-0.09 cm2 ) ; systematic errors showed a 4-fold variation being greatest in the LAP direction ( sigma 2 = 0.19 cm2 ) and least the ARL direction ( sigma 2 = 0.048 cm2 ) . No factor consistently predicted for worse outcome in all directions . Hypofractionated treatments were less accurate in the LSI direction ( P > 0.05 ) . Systematic errors were associated in the ARL direction with hypofractionation ( P < 0.01 ) and , in the LSI direction with weight ( P < 0.03 ) and age ( P < 0.05 ) . We conclude that significant random and systematic errors can occur during pelvic radiotherapy especially in the LAP direction . These results suggest that in the absence of a customised immobilisation device , to cover 95 % of errors , margins of 0.6 cm for RL and SI directions and 0.9 cm for AP direction should be allowed between the planning and clinical target volumes . However , ideally , each centre should determine their own margin requirements according to local clinical practice .

radiotherapy

radiotherapy

CT planned pelvic radiotherapy

radiotherapy

accuracy

Field placement errors ( FPEs )

mean absolute error

accurate

Systematic errors

pelvic radiotherapy

pelvic radiotherapy


[ Intraoperative continuous epidural block influences postoperative changes in breathing pattern and thoracoabdominal movement associated with upper abdominal surgery ] . We have examined the changes in breathing pattern and thoracoabdominal movement associated with upper abdominal surgery in order to evaluate the possible influences of nociceptive input on respiration . Sixteen patients scheduled for gastrectomy were studied . Continuous epidural block was instituted prior to the induction of anesthesia and maintained throughout the surgery in 8 of 16 patients ( Group 1 ) while it was instituted upon the peritoneal closure and maintained thereafter in the remaining 8 patients ( Group 2 ) . Breathing pattern and thoracoabdominal motion were determined before and after surgery while the patients awake by respiratory inductance plethysmography ( Respisomnography , Chest MI ) . Breathing frequency and minute ventilation increased significantly while tidal volume was unchanged after the operation regardless of the intraoperative epidural block . Furthermore , there were identical shortening of inspiratory time and prolongation of duty ratio ( inspiratory time/duration of a breath ) in the two groups . Contribution of rib cage movement on tidal volume increased significantly postoperatively in all the patients . However , the changes were significantly smaller in patients receiving intraoperative epidural block . These results indicate that the causes of tachypnea and increased minute ventilation are different from the mechanism responsible for the alteration of thoracoabdominal partitioning of ventilation after upper abdominal surgery . The former may be related to the metabolic changes and , conceivably , unaffected by continuous epidural block . While the latter may be the consequence of the reflex inhibition of the diaphragmatic function that can be , at least partially , modified by continuous epidural block .

Continuous

epidural block

surgery

Sixteen

scheduled for gastrectomy


Risperidone in the treatment of negative symptoms of schizophrenia : a meta-analysis . Risperidone has antiserotonergic and antidopaminergic properties that may make it more effective than conventional antipsychotic agents in the treatment of the negative symptoms of schizophrenia . Clinical trials in chronic schizophrenic patients have shown trends in favor of risperidone in the control of negative symptoms compared with haloperidol , perphenazine or zuclopenthixol , but the differences were not consistently statistically significant . A meta-analysis of the pooled results from six double-blind trials showed that risperidone at doses ranging from 4 to 8 mg/day had a significantly ( p < 0.004 ) higher negative symptom response rate , defined as the percentage of patients with a 20 % or more reduction in scores on the negative subscale of the Positive and Negative Syndrome Scale , than patients receiving active controls . The combined patient population treated with 4-8 mg/day of risperidone was 1.43 times more likely to have had a clinical response on the negative symptom subscale than the combined population treated with haloperidol , perphenazine or zuclopenthixol .

Risperidone

Risperidone

risperidone

haloperidol

perphenazine

zuclopenthixol

risperidone

risperidone

haloperidol

perphenazine

zuclopenthixol

negative symptoms

negative symptoms

negative symptoms

negative symptom response rate

schizophrenia :

schizophrenia .


Measuring the impact of patient counseling in the outpatient pharmacy setting : the research design of the Kaiser Permanente/USC patient consultation study . This article describes the research method used to measure the impact of three alternative models of patient counseling in the outpatient pharmacy setting . The study was conducted in pharmacies operated by the Southern California region Kaiser Permanente Medical Care Program . Both random assignment and large-scale geographic area research designs were used . The presentation of the research design includes discussions of data collection and patient sampling methods ; the measurement of patient outcomes , including measures of health care costs and utilization , patient functional status , and quality of life . Demographic data are presented for the study population , including an analysis of potential biased selection of patients electing to participate in random assignment . Data are also presented documenting potential selection bias across geographically determined treatment groups in the geographic area design arm . Finally , the article presents the analysis plan for the study and discusses study limitations .

patient counseling

patient counseling

patient outcomes

patient functional status

quality of life


Prediction of the infarct-related artery in acute myocardial infarction by a scoring system using summary ST-segment and T-wave changes . We developed a scoring system to predict the artery responsible for an acute myocardial infarction ( AMI ) using ST-segment and T-wave changes on the initial electrocardiogram ( ECG ) using data from 228 patients ( development set ) with symptoms compatible with AMI and tested in a similar group of 223 patients ( test set ) from the Thrombolysis and Angioplasty in Myocardial Infarction ( TAMI-5 ) Trial . Using stepwise logistic regression we were able to accurately predict the left anterior descending ( LAD ) , right , or left circumflex ( LC ) coronary artery as the infarct-related artery using 2 variables : ( 1 ) the summation of the ST-segment elevation in leads V1 to V4 ; and ( 2 ) the summation of the T-wave negativity in leads I , aVL , and V5 . In the development set , these 2 variables demonstrated respective sensitivity and specificity of 98 % and 90 % for LAD lesions , 82 % and 85 % for right narrowings , and 82 % and 84 % for LC narrowings . In the test set , the sensitivity and specificity were 97 % and 95 % for LAD lesions , 85 % and 86 % for right lesions , and 73 % and 60 % for LC coronary artery lesions . Information easily obtained on the ECG can accurately predict the likelihood of the LAD , right , or LC artery as the infarct-related artery . This may be useful in the decision to administer thrombolytic treatment .

summary ST-segment and T-wave changes

ST-segment and T-wave changes

initial electrocardiogram ( ECG )

sensitivity and specificity

sensitivity and specificity

LC coronary artery lesions

AMI


Continuous and cyclical clodronate therapies and bone density in postmenopausal bone loss . OBJECTIVE To evaluate the effectiveness of different clodronate regimens in postmenopausal osteoporosis . METHODS In groups of 20 , 60 women were randomly assigned to one of three treatments : oral calcium , 1000 mg/day ; oral calcium plus oral clodronate , 400 mg/day ; oral calcium plus oral clodronate , 400 mg/day for 30 days , followed by a 60-day period of calcium supplement alone . This last regimen was repeated four times in the 12-month study period . RESULTS Patients who received calcium alone showed a decline in spinal bone mass , both after 6 and 12 months ( P < .03 and P < .005 , respectively ) ; femoral density in this group also decreased after 6 and 12 months ( P < .002 and P < .05 , respectively ) . On the other hand , both clodronate-treated groups had increased levels of lumbar bone mass compared with controls , both after 6 and 12 months of therapy . However , at the end of the study , patients treated with cyclical clodronate had higher spinal bone mass compared with those treated continuously ( 3.32 +/- 0.71 versus 0.43 +/- 0.89 % , P < .02 ) . After 6 months , femoral bone density was significantly higher both in subjects treated with clodronate , both cyclically and continuously ( P < .01 ) , compared with controls . Continuous clodronate treatment resulted in a clear fall in biochemical indices of bone resorption , together with a consequent decrease in osteocalcin at 6 ( P < .02 ) and 12 months ( P < .003 ) and a significant increase in parathyroid hormone after 12 months ( P < .001 ) of therapy . CONCLUSION One-year treatment with clodronate induces a gain in bone mass , especially in the spine . The continuous regimen does not result in any further benefit in lumbar bone density over the cyclical one , probably because of a greater suppression of bone turnover .

cyclical clodronate therapies

clodronate

calcium alone

clodronate-treated

cyclical clodronate

Continuous clodronate treatment

clodronate

spinal bone mass

spinal bone mass

femoral bone density

bone resorption

parathyroid hormone

postmenopausal bone loss

postmenopausal osteoporosis

women

received calcium


Effects of glucocorticoids on energy metabolism and food intake in humans . The effect of glucocorticoid administration on energy metabolism and food intake was studied in 20 healthy , nondiabetic Caucasian male volunteers [ 27 +/- 5 ( SD ) yr , 72 +/- 9 kg , 20 +/- 7 % body fat ] randomly and blindly assigned to glucocorticoid ( methylprednisolone , METH ; n = 10 ) or placebo ( PLAC ; n = 10 ) treatment . Each subject was studied twice : during a weight maintenance diet and during ad libitum food intake . Energy metabolism was measured by indirect calorimetry and food intake by an automated food-selection system . Twenty-four-hour urinary norepinephrine excretion ( 24-h NE ) was used as an estimate of sympathetic nervous system activity . During weight maintenance , METH intravenous infusion ( 125 mg/30 min ) increased energy expenditure compared with PLAC , and after 4 days of oral therapy , METH ( 40 mg/day ) decreased 24-h NE and increased energy expenditure compared with PLAC . During ad libitum food intake , after 4 days of METH ( 40 mg/day ) or PLAC oral therapy , both groups increased their energy intake over weight maintenance , but the increase was significantly larger in the METH group compared with the PLAC group ( 4,554 +/- 1,857 vs. 2,867 +/- 846 kcal/day ; P = 0.04 ) . Our data suggest that therapeutic doses of glucocorticoids induce obesity mostly by increasing energy intake , an effect which may be related to the ability of glucocorticoids to act directly or indirectly on the central regulation of appetite .

glucocorticoids

glucocorticoid

placebo ( PLAC ;

energy metabolism

food intake

energy metabolism

food intake

Energy metabolism

food intake

urinary norepinephrine excretion

sympathetic nervous system activity

energy expenditure

energy expenditure

energy intake

energy intake


Comparison of analgesic effect of locally and systemically administered ketorolac in mastectomy patients . BACKGROUND Ketorolac is a parenteral nonsteroidal antiinflammatory drug ( NSAID ) . Two features have limited its clinical utility : tendency to elicit kidney failure and inability to produce complete analgesia . Because most NSAIDs are weak acids ( pKa 3-5 ) and become concentrated in acidic tissues , such as injured and inflamed tissues , we hypothesized that local administration may enhance its analgesic efficacy while lowering the potential for systemic complications . METHODS We conducted a randomized , placebo-controlled study of 60 group I-II ( American Society of Anesthesiology criteria ) mastectomy patients , 20 in each group . Near the end of surgery and every 6 h postoperatively , 20 ml of the study solution containing normal saline with or without 30 mg of ketorolac were administered simultaneously either via a Jackson-Pratt drain or intravenously in a double-blind fashion . The quality of pain control , the amount and character of the drain fluid , incidence of nausea and vomiting , length of stay in the postoperative care unit , and amount of morphine used for treatment of break-through pain were recorded . RESULTS Intraoperative administration of ketorolac resulted in better quality of pain control in the immediate postoperative period regardless of route of administration . The incidence of nausea was significantly higher in the placebo group , and drain output in the ketorolac groups did not exceed the output in the placebo group . CONCLUSION Analgesic of the locally administered ketorolac is equally effective to the efficacy of ketorolac administered intravenously .

ketorolac

Ketorolac

placebo-controlled

ketorolac

ketorolac

placebo

ketorolac

ketorolac

quality of pain control

incidence of nausea

drain output

effective

efficacy


Deep vein thrombosis after major reconstructive spinal surgery . STUDY DESIGN A prospective study was performed . OBJECTIVES The goals of the study were to determine the incidence of deep vein thrombosis after major adult spinal surgery and the optimal mode of prophylaxis in this surgical population . SUMMARY OF BACKGROUND DATA Few studies have evaluated deep vein thrombosis incidence and prophylaxis after major adult spinal surgery . Incidence rates have ranged from 0.9-14 % . METHODS Three hundred twenty-nine patients were evaluated . One hundred ten patients were randomized to 3 different deep vein thrombosis prophylaxis groups . These patients had duplex doppler scans between the fifth and seventh postoperative days . The remaining 219 patients formed a nonrandomized group and received either thrombosis embolic deterrent stockings alone or thrombosis embolic deterrent stockings and pneumatic compression boots for deep vein thrombosis prophylaxis . The type of deep vein thrombosis prophylaxis in this group was based on surgeon preference . All 329 patients were followed for clinical signs and symptoms of thromboembolic disease . Patients were followed clinically for a minimum of 1 year . RESULTS All 110 prophylaxis study group patients were clinically asymptomatic and 109 duplex scans were normal . One scan was indeterminate and a follow-up venogram was negative . Two patients in the coumadin group ( 5.7 % ) experienced excessive blood loss . One of the 219 patients from the nonrandomized group developed a clinically detectable proximal deep vein thrombosis which was confirmed by duplex ultra-sonography . The overall clinical incidence of deep vein thrombosis was 0.3 % ( 1 in 329 patients ) . CONCLUSIONS This low 0.3 % rate is in agreement with recent studies that focus on thromboembolic disease . Given the low incidence , routine screening for asymptomatic thrombi appears unwarranted . In addition , mechanical prophylaxis with graduated compression stockings and pneumatic compression boots is preferable to anticoagulation therapy .

duplex doppler scans

Deep vein thrombosis

deep vein thrombosis

deep vein thrombosis

prophylaxis

deep vein thrombosis prophylaxis

duplex doppler scans

asymptomatic

duplex scans

excessive blood loss

duplex ultra-sonography

deep vein thrombosis

thromboembolic disease

Deep vein thrombosis

major reconstructive spinal surgery

deep vein thrombosis

major adult spinal surgery

major adult spinal surgery

Three hundred twenty-nine

One hundred ten


MRI signal hyperintensities in geriatric depression . OBJECTIVE The authors rated periventricular and subcortical signal hyperintensities on magnetic resonance imaging ( MRI ) scans in elderly patients with depression and in normal subjects with similar demographic features to examine whether such changes discriminate patients with depression from normal subjects and whether they are associated with any clinical variables . METHOD Two established hyperintensity rating systems were used to compare the MRI brain scans of 48 elderly patients with depression diagnosed according to DSM-III-R with the scans of 39 normal elderly subjects . RESULTS Elderly depressed patients manifested significantly more severe hyperintensity ratings in the subcortical gray matter than age-matched comparison subjects . Significant differences were not identified between patients with similar current ages and cerebrovascular disease risk who had early-onset or late-onset depression . CONCLUSIONS These findings support those of neuroimaging studies implicating the basal ganglia in depression and geriatric depression . The data suggest that the relationship observed in some reports between late-onset depression and MRI hyperintensities is most likely a function of cerebrovascular disease risk and age .

MRI signal

magnetic resonance imaging ( MRI )

MRI brain scans

MRI

hyperintensity ratings

geriatric depression .


The effects of chronic naltrexone treatment in young autistic children : a double-blind placebo-controlled crossover study . In a double-blind placebo-controlled crossover trial 23 autistic children , aged 3-7 years , were treated with a mean daily dosage of 1 mg/kg naltrexone for 4 weeks . Drug effects were monitored with behavior checklists rated by parents and teachers , and ethological playroom observations . On average , parents ' checklists and playroom data could not differentiate between naltrexone treatment and placebo treatment ; however , teachers significantly favored naltrexone treatment . They reported a decrease in hyperactivity and irritability . No effects of naltrexone on social and stereotypic behavior could be demonstrated .

naltrexone

naltrexone

naltrexone

hyperactivity and irritability .

young autistic

children

23 autistic

children

, aged 3-7 years


Metabolic and hormonal responses to induced hypotension for middle ear surgery . We have investigated in 30 patients the metabolic and hormonal responses to middle ear surgery using induced hypotension to a mean arterial pressure of 55 mm Hg . A standardized anaesthetic technique of propranolol , thiopentone-vecuronium-isoflurane was used in all patients and hypotension induced with sodium nitroprusside , trimetaphan camsylate or additional isoflurane . All patients showed a classic stress response with an increase in circulating blood glucose , cortisol and growth hormone concentrations . Blood lactate and plasma uric acid concentrations changed little during operation , suggesting that tissue oxygenation was adequate . However , the former declined after operation , possibly as a result of the concomitant use of propranolol . There were no significant differences between the three hypotensive techniques in their effects on the hormonal and metabolic response , although the increase in blood glucose concentration in the trimetaphan group was obtunded . We conclude that induced hypotension for middle ear surgery induced an endocrine and metabolic response of small magnitude and short duration .

induced hypotension

induced hypotension

stress response

increase in circulating blood glucose

cortisol

growth hormone

concentrations

blood glucose concentration

middle ear surgery

hypotension


Randomized controlled trial of acellular diphtheria , pertussis and tetanus vaccines in southern Ghana . A randomized controlled trial of acellular diphtheria/pertussis/tetanus ( ADPT ) freeze-dried and liquid vaccines in infants was conducted in a peri-urban community ( Ashaiman ) in southern Ghana . Immunogenicity of the acellular vaccines , persistence of antibodies and adverse reactions were compared with those achieved with a whole-cell diphtheria-pertussis-tetanus ( DPT ) vaccine . The incidence of pertussis in the vaccine groups and prevalence of pertussis in children under 5 years of age in the study area were also determined . The acellular vaccines produced significantly fewer local and systemic reactions . Local reactions such as swelling and redness were observed in 2 % ( 8/399 ) to 2.3 % ( 9/385 ) of the acellular vaccine recipients as against 31 % ( 122/394 ) in the whole-cell vaccine group . Fever ( > or = 37.5 degrees C ) occurred in 7.27 % ( 29/399 ) to 9.8 % ( 38/385 ) in the acellular vaccine groups compared with 36.6 % ( 145/394 ) in the whole-cell vaccine group . Geometric mean titres ( GMTs ) , measured by ELISA , to pertussis toxin ( PT ) and filamentous haemagglutinin ( FHA ) were significantly higher in the acellular vaccine groups than in the whole-cell DPT ( WCDPT ) group . There were no significant differences in the GMTs of tetanus and diphtheria antitoxins between the two groups after each vaccination . Twelve months after primary vaccination , GMTs to PT in the freeze-dried , liquid ADPT groups and the WCDPT group have fallen from 56.23 , 62.63 and 44.97 ELISA U/ml to 6.08 , 6.18 and 11.30 ELISA U/ml , respectively . GMTs to FHA in all the vaccine groups also dropped during the same period from 49.94 , 41.73 and 20.74 ELISA U/ml to 7.26 , 7.72 and 5.91 ELISA U/ml , respectively . In this comparative controlled trial , the ADPT vaccines were more immunogenic , with less local and systemic reactions , than the WCDPT vaccine but there was a considerable drop in antibody titres in all the vaccine groups 12 months after primary vaccination . However , the levels of titres of anti-PT and anti-FHA antibodies in all the three vaccines that confer protection are not known . Further studies are necessary to provide this information in order to assess the need for subsequent booster doses after primary immunization with both ADPT and WCDPT vaccines .

acellular vaccine

acellular vaccine

acellular vaccine

whole-cell DPT ( WCDPT )

ADPT vaccines

WCDPT vaccine

vaccines

Immunogenicity

local and systemic reactions .

swelling and redness

Fever

Geometric mean titres ( GMTs )

ELISA

GMTs to PT

GMTs to FHA

immunogenic

antibody titres

anti-PT and anti-FHA antibodies

diphtheria/pertussis/tetanus

infants

pertussis

children

2 %

2.3 %

31 %


Serum bactericidal activities and comparative pharmacokinetics of meropenem and imipenem-cilastatin . The pharmacokinetics and serum bactericidal activities ( SBAs ) of imipenem and meropenem were investigated in a randomized crossover study . Twelve healthy male volunteers received a constant 30-min infusion of either 1 g of imipenem plus 1 g of cilastatin or 1 g of meropenem . The concentrations of the drugs in serum and urine were determined by bioassay and high-pressure liquid chromatography . Pharmacokinetic parameters were based on an open two-compartment model and a noncompartmental technique . At the end of infusion , the mean concentrations of imipenem and meropenem measured in serum were 61.2 +/- 9.8 and 51.6 +/- 6.5 mg/liter , respectively ; urinary recoveries were 48.6 % +/- 8.2 % and 60.0 % +/- 6.5 % of the dose in 12 h , respectively ; and the areas under the concentration-time curve from time zero to infinity were 96.1 +/- 14.4 and 70.5 +/- 10.3 mg.h/liter , respectively ( P < or = 0.02 ) . Imipenem had a mean half-life of 66.7 +/- 10.4 min ; that of meropenem was 64.4 +/- 6.9 min . The volumes of distribution at steady state of imipenem and meropenem were 15.3 +/- 3.3 and 18.6 +/- 3.0 liters/70 kg , respectively , and the mean renal clearances per 1.73 m2 were 85.6 +/- 17.6 and 144.6 +/- 26.0 ml/min , respectively . Both antibiotics were well tolerated in this single-dose administration study . The SBAs were measured by the microdilution method of Reller and Stratton ( L. B. Reller and C. W. Stratton , J. Infect . Dis . 136:196-204 , 1977 ) against 40 clinically isolated strains . Mean reciprocal bactericidal titers were measured 1 and 6 h after administration . After 1 and 6 h the median SBAs for imipenem and meropenem , were 409 and 34.9 and 97.9 and 5.8 , respectively , against Staphylococcus aureus , 19.9 and 4.4 and 19.4 and 4.8 , respectively , against Pseudomonas aeruginosa , 34.3 and 2.2 and 232 and 15.5 , respectively , against Enterobacter cloacae , and 13.4 and 2.25 and 90.7 and 7.9 , respectively , against Proteus mirabilis . Both drugs had rather short biological elimination half-lives and a predominantly renal route of elimination . Both carbapenems revealed high SBAs against clinically important pathogens at 1 h ; meropenem had a higher SBA against E. cloacae and P. mirabilis , and the SBA of imipenem against S. aureus was greater than the SBA of meropenem .

imipenem

meropenem

imipenem plus 1 g of cilastatin

1 g of meropenem

bioassay

high-pressure liquid chromatography

two-compartment model

noncompartmental technique

Serum bactericidal activities

comparative pharmacokinetics

pharmacokinetics

serum bactericidal activities ( SBAs )

urinary recoveries

SBAs

Mean reciprocal bactericidal titers

SBAs

half-lives

SBA

SBA

Twelve healthy male volunteers


Warfarin for atrial fibrillation . The patient 's perspective . OBJECTIVE To determine the minimal clinically important difference ( MCID ) of warfarin therapy for the treatment of nonvalvular atrial fibrillation from the perspective of patients using 2 different elicitation methods . DESIGN All patients completed 2 face-to-face interviews , which were 2 weeks apart . For each interview , they were randomized to receive 1 of 2 elicitation methods : ping-ponging or starting at the known efficacy . SETTING The practices of 2 university-affiliated family medicine centers ( 8 physicians each ) , 14 community-based family physicians , and 2 cardiologists . PATIENTS Sixty-four patients with nonvalvular atrial fibrillation who were initiated with warfarin therapy at least 3 months before the study . INTERVENTION During each interview , the patients ' MCIDs were determined by using ( 1 ) a pictorial flip chart to describe atrial fibrillation ; the consequences of a minor stroke , a major stroke , and a major bleeding episode ; the chance of stroke if not taking warfarin ; the chance of a major bleeding episode if taking warfarin ; examples of the inconvenience , minor side effects , and costs of warfarin therapy ; and then ( 2 ) 1 of the 2 elicitation methods to determine their MCIDs ( the smallest reduction in stroke risk at which the patients were willing to take warfarin ) . Patients ' knowledge of their stroke risk , acceptability of the interview process , and factors determining their preferences were also assessed . MAIN RESULTS Given a baseline risk of having a stroke in the next 2 years , if not taking warfarin , of 10 of 100 , the mean MCID was 2.01 of 100 ( 95 % confidence interval , 1.60-2.42 ) . Fifty-two percent of the patients would take warfarin for an absolute decrease in stroke risk of 1 % over 2 years . Before eliciting their MCIDs , patients showed poor knowledge of their stroke risk , which improved afterward . The interview process was well accepted by the patients . The MCID using the ping-ponging elicitation method was 1.015 of 100 smaller compared with use of the starting at the known efficacy method ( P = .01 ) . CONCLUSIONS We were able to determine the MCID of warfarin therapy for the prevention of stroke from the perspective of patients with nonvalvular atrial fibrillation . Their MCIDs were much smaller than those that have been implied by some experts and clinicians . The interview process , using the flip chart approach , appeared to improve the patients ' knowledge of their disease and its consequences and treatment . The method used to elicit the patients ' MCIDs can have a clinically important effect on patient responses . The method used in our study can be generalized to other conditions and , thus , could be helpful in 3 ways : ( 1 ) from a clinical decision-making perspective , it could facilitate patient-physician communication ; ( 2 ) it could clarify the patient perspective when interpreting the results of previously completed trials ; and ( 3 ) it could be used to derive more clinically relevant sample sizes for randomized treatment trials .

Warfarin

warfarin therapy

warfarin

warfarin

warfarin therapy

minor side effects

costs of warfarin therapy

stroke risk

knowledge of their stroke risk

MCID

MCID

MCIDs

atrial fibrillation

nonvalvular atrial fibrillation

Sixty-four

nonvalvular atrial fibrillation

nonvalvular atrial fibrillation


Prospective evaluation of the macrolide antibiotic dirithromycin for the treatment of Helicobacter pylori . BACKGROUND Macrolide antibiotics are active in vitro and in vivo against Helicobacter pylori . We assessed a newer macrolide , dirithromycin , for the treatment of H. pylori in two separate studies . METHODS Volunteers with H. pylori infection ( by 13C-urea breath test ) were randomly assigned to 2-week treatment regimens . Study 1 : dirithromycin 500 mg q.d.s. , dirithromycin 500 mg q.d.s . plus omeprazole 40 mg q.d.s. , or dirithromycin 500 mg q.d.s . plus metronidazole 500 mg t.d.s . Study 2 : dirithromycin 500 mg q.d.s . plus omeprazole 20 mg b.d. , dirithromycin 1000 mg q.d.s . plus omeprazole 20 mg b.d. , or amoxycillin 500 mg q.d.s . plus omepirazole 20 mg b.d . Four weeks after the completion of therapy a repeat 13C-urea breath test was done to assess for cure . RESULTS No patient taking dirithromycin alone ( n = 6 ) or in combination with omeprazole ( n = 26 ) achieved cure of their infection . Eradication of H. pylori was seen in one of seven patients taking dirithromycin plus metronidazole . Five of 10 patients taking omeprazole-amoxycillin dual therapy had their H. pylori infection cured ( P = 0.0007 vs. patients taking dirithromycin plus omeprazole ) . Eleven ( 47 % ) of 32 patients taking dirithromycin alone or combined with omeprazole reported side-effects , but only two ( 6 % ) stopped therapy prematurely as a result of side-effects . CONCLUSION No subject taking dirithromycin alone or in combination with omeprazole had their H. pylori infection cured . Dirithromycin , in the regimen used , shows little promise in the treatment of patients with H. pylori infection .

macrolide antibiotic dirithromycin

Macrolide antibiotics

macrolide , dirithromycin

dirithromycin 500 mg q.d.s.

dirithromycin

omeprazole

dirithromycin

metronidazole .

omeprazole-amoxycillin

dirithromycin

omeprazole )

dirithromycin

omeprazole

dirithromycin

omeprazole

Dirithromycin

cure of their infection

Eradication of H. pylori

pylori infection cured

reported side-effects

side-effects

cured

Helicobacter pylori

Helicobacter pylori

H. pylori

H. pylori


The influence of nonhandicapped peers on the social interactions of children with a pervasive development disorder . This study investigated whether or not children with autism or a related pervasive developmental disorder ( PDD ) can benefit from regular opportunities to interact with a normally developing peer , matched as to sex and age . An experimental design with random assignment of subjects to treatment and control groups was used to demonstrate the impact of this peer-mediated intervention . In the treatment group , we found significant improvements in the social behavior of the children with PDD . Several gains were also generalized to interactions with an unfamiliar nonhandicapped peer , to interactions with another child with PDD , and to the large school setting . In the untreated control group , no positive changes were observed . Results suggest that children with PDD can develop peer relations if appropriate social contexts are made available for them .

nonhandicapped peers

peer-mediated intervention

social interactions

benefit

impact

social behavior

gains

large school setting

positive changes

peer relations

children

pervasive development disorder

children

autism

children

PDD


The long-term effects of auditory training on children with autism . Eighty children , 3-17 years of age , with autism or Asperger syndrome and mild to severe distress in the presence of some sounds , were randomly allocated to two groups . The experimental group received auditory training and the control group listened to the same unmodified music under the same conditions . Significant improvements in behavior and severity of autism were maintained for 12 months by both groups . Informal data suggested that a range of abnormal responses to sound and other sensory abnormalities may also have improved . Verbal and performance IQ increased significantly 3 to 12 months after interventions . Findings suggest that some aspect of both auditory training and listening to selected unmodified music may have a beneficial effect on children with autism and sound sensitivity , and indicate a need for further research into the effects that led to these changes and the mechanisms involved in the sensory abnormalities commonly associated with autism .

auditory training

auditory training

the control group listened to the same

unmodified music

under the same conditions

auditory training

listening

behavior and severity of autism

range of abnormal responses

sound

other sensory abnormalities

Verbal and performance IQ

beneficial effect

children

autism

Eighty

children

autism

Asperger syndrome

children

autism

sound sensitivity


Relation of total homocysteine and lipid levels in children to premature cardiovascular death in male relatives . We assessed the relative importance of lipid , apo B , lipoprotein ( a ) [ Lp ( a ) ] , and total homocysteine ( tHcy ) levels in children in relation to premature cardiovascular disease in family members . Parents of 381 girls and 375 boys age 8-12 y completed family history questionnaires . Nonfasting serum lipid and lipoproteins and plasma tHcy and cysteine levels were measured in the children . Serum folate and vitamin B12 levels were determined in a random subsample of 23 % of the children , who participated in a food frequency interview . Children whose parents reported hypercholesterolemia had higher total and non-HDL cholesterol and apo B levels than the rest , but these levels were not associated with cardiovascular disease . tHcy levels were similar in girls and boys . tHcy was higher in children whose father , grandfather , or uncle died at age < or = 55 y of myocardial infarction or sudden cardiac arrest ( n = 42 ) than in control children [ 5.92 mumol/L ( 95 % confidence interval [ CI ] of 5.47-6.36 ) versus 5.25 mumol/L ( 95 % CI , 5.16-5.34 ) ] , also after adjustment for socioeconomic group . Intake and serum levels of vitamin B12 and folate were within recommended or reference ranges . In a stepwise multiple regression analysis , serum folate ( negative correlation ) , plasma creatinine , and sugar intake as percent of dietary energy ( positive correlations ) were significantly associated with tHcy ( multiple r = 0.44 , adjusted r2 = 18 % ; 95 % CI , 5-30 % ) . Our data show that a modest elevation in tHcy in children was related to premature cardiovascular death in their male relatives and may partly account for the contribution of family history to risk of cardiovascular disease . tHcy may be modifiable through the diet , even in children with apparently adequate vitamin nutriture .

homocysteine

lipid levels

lipid

homocysteine

family history questionnaires

tHcy

tHcy

tHcy

Serum folate and vitamin B12 levels

tHcy levels

tHcy

tHcy

tHcy

premature cardiovascular death

tHcy

children

male relatives

children

Parents

girls

boys

age 8-12 y


Intraumbilical vein injection of prostaglandin F2 alpha in retained placenta . A randomized protocol was used to study the effect of intraumbilical prostaglandin F2 alpha ( Hembate , Upjohn ) and oxytocin injection in women with retained placenta . Prostaglandin F2 alpha , 20 mg , diluted to 20 ml in normal saline solution ( 10 women , group 1 ) , 30 IU of oxytocin , diluted to 20 ml in normal saline solution ( 11 women , group 2 ) , or 20 ml of normal saline solution alone ( 7 women , group 3 ) , were injected into the umbilical vein 1 h after delivery . Nine women ( group 4 , controls ) underwent manual removal of the retained placenta . In group 1 , placental expulsion occurred in all patients and the duration of the placental expulsion after prostaglandin F2 alpha injection was 6.8 +/- 1.36 ( mean +/- SE ) min : in group 2 , six placental expulsions occurred after 13.3 +/- 1.97 min ( mean +/- SE ) ; and in group 3 , no effect was recorded after intraumbilical saline injection . We suggest that intraumbilical vein injection of prostaglandin F2 alpha might be a beneficial , non-surgical method for treating retained placenta . Oxytocin might reduce the incidence of manual lysis of the placenta and achieve partial success .

prostaglandin F2 alpha

intraumbilical prostaglandin F2 alpha

Hembate

Upjohn

oxytocin injection

Prostaglandin F2 alpha

30 IU of oxytocin

20 ml of normal saline solution alone

prostaglandin F2 alpha

prostaglandin F2 alpha

Oxytocin

placental expulsion

placental expulsions

retained placenta .

women

10 women ,

11 women

7 women

Nine

women


The use of a water extract from the bark of Choerospondias axillaris in the treatment of second degree burns . Burns are common in Vietnam , and because of economic constraints and limited resources for the import of appropriate treatments , the health authorities are obliged to rely on traditional herbal remedies . It is therefore essential to evaluate current drugs , one of which is the water extract of the bark of the tree Choerospondias axillaris . It has been used for many years in the Vietnam-Sweden hospital at Uong Bi in northern Vietnam . We assessed the efficacy of the remedy in an open , randomised controlled clinical trial , in which 20 patients with second degree burns were treated with the extract of the Choerospondias axillaris and 19 with saline gauze . The mean healing time was significantly shorter for patients treated with Choerospondias axillaris ( 11 days ) compared with patients treated with saline gauze ( 17 days ) ( p < 0.01 ) , and the number of wound infections was significantly lower in the Choerospondias axillaris group ( 7/20 compared with 16/19 , p = 0.003 ) . The bark extract was easy to apply and additional wound care was not usually necessary , while the treatment with saline gauze was laborious for both patients and staff and was much more expensive . The extract from Choerospondias axillaris is a convenient treatment for second degree burns in both children and adults .

extract of the Choerospondias axillaris

saline gauze .

Choerospondias axillaris

saline gauze

Choerospondias axillaris

bark extract

saline gauze

extract from Choerospondias axillaris

efficacy

mean healing time

number of wound infections

expensive

treatment of second degree burns .

children

adults


One quadrant sub-Tenon 's capsule anesthesia in anterior segment surgery . Reports of complications associated with local anesthesia in ophthalmic surgery have increased conspicuously in recent years . Sub-Tenon 's capsule anesthesia for anterior segment surgery avoids the risks of retrobulbar and peribulbar injections . This study compared sub-Tenon 's and retrobulbar anesthesia . Patients undergoing various anterior segment surgery were randomly assigned to sub-Tenon 's or retrobulbar anesthesia ; 300 were operated with 1-quadrant sub-Tenon 's anesthesia ( 1-QST ) and the results were compared with 270 patients operated with retrobulbar anesthesia . Retrobulbar anesthesia consisted of a 2.5 ml injection of a 1:1 mixture of 2 % lidocaine without epinephrine and 0.5 % bupivacaine . Sub-Tenon 's anesthesia involved direct transconjunctival infiltration of the same local anesthetic directly into the sub-Tenon 's space , in the inferior-nasal quadrant , using a blunt 23-gauge cannula . Patients undergoing various anterior segment surgery procedures were randomly assigned to 1-QST or retrobulbar anesthesia ; 300 patients were operated with 1-QST and the results were compared with 270 patients operated with retrobulbar anesthesia . Preinjection mean ( +/- SD ) IOP wer 12.9 +/- 3.7 mmHg in the retrobulbar and 13.4 +/- 3.2 mmHg in the 1-QST patients . Preoperative intraocular pressures were 8.7 +/- 3.0 mmHg in the retrobulbar and 9.2 +/- 3.2 mmHg in 1-QST patients . Pre- and postinjection IOP for retrobulbar and 1-QST patients were similar . Pain scores for delivery of the anesthetic , using a numerical rating scale , produced a median score of 1 for 1-QST and 2 for the retrobulbar technique . For the subsequent operative procedure , the median score was 1 for 1-QST and 2 for the retrobulbar patients . Complete akinesia was achieved in 41 % with 1-QST and in 69 % of retrobulbar patients . 1-QST patients with incomplete akinesia most often had lateral muscle function which did not interfere with the operation . We found the use of a blunt cannula to deliver anesthetic into the sub-Tenon 's space as a simple , safe and effective alternative approach to traditional retrobulbar anesthesia in anterior segment surgery .

Sub-Tenon 's capsule anesthesia

sub-Tenon 's

retrobulbar anesthesia .

sub-Tenon 's or retrobulbar anesthesia

retrobulbar anesthesia

Retrobulbar anesthesia

Sub-Tenon 's anesthesia

retrobulbar anesthesia

retrobulbar

retrobulbar

retrobulbar

retrobulbar

retrobulbar anesthesia

Preinjection mean ( +/- SD ) IOP

Preoperative intraocular pressures

Pre- and postinjection IOP

Complete akinesia

incomplete akinesia

lateral muscle function

anterior segment surgery

ophthalmic surgery

anterior segment surgery

270 patients

retrobulbar anesthesia

anterior segment surgery


Regular replacement of extended wear rigid gas permeable contact lenses . PURPOSE While the benefits of planned replacement of soft contact lenses have been investigated , the question of whether there are any clinical benefits to planned replacement of rigid gas permeable ( RGP ) lenses does not appear to have been addressed experimentally . We aimed to determine the benefits of regular replacement of extended wear RGP contact lenses . METHODS We conducted a prospective , single-center , controlled , double-masked study of 39 RGP lens wearers . The subjects were divided into two groups and wore extended wear Quantum 2 lenses ( Dk = 120 ) for 12 months . Subjects in Group I replaced lenses every 3 months , whereas those in Group II were not scheduled to replace their lenses . The integrity of the lenses and the ocular responses to lens wear were monitored in both groups every three months . RESULTS Compared to lenses worn by subjects in Group I , lenses worn by Group II subjects showed significantly more mucous coating , lens binding , and corneal staining over time ( P < 0.05 ; ANCOVA ) . There was no difference in microcystic or tarsal conjunctiva response , lens comfort , refractive change , or visual acuity between the two groups . CONCLUSIONS We advocate that to maintain optimal lens integrity and ocular health , RGP lenses used for extended wear should be replaced every 3 to 6 months .

soft contact lenses

rigid gas permeable ( RGP ) lenses

regular replacement

extended wear RGP contact lenses

wore extended wear Quantum 2 lenses

replaced lenses every 3 months

not scheduled to replace their lenses

integrity of the lenses

ocular responses

mucous coating

lens binding

corneal staining

lens comfort

refractive change

visual acuity

optimal lens integrity

ocular health

RGP lens wearers


Clonidine increases the sweating threshold , but does not reduce the gain of sweating . We tested the hypothesis that clonidine produces a dose-dependent increase in the sweating threshold but does not reduce the gain of sweating . Six healthy male volunteers were evaluated , each on three separate days in random order . In one , saline was administered ; in another , a 2-micrograms/kg bolus of clonidine was followed by an infusion at 2 micrograms.kg-1.h-1 , and on a third day , a 4-micrograms/kg bolus was followed by an infusion at 4 micrograms.kg-1.h-1 . Core temperature was measured at the tympanic membrane and mean skin temperature was determined from four sites . A chest sweating rate of 40 g.m-2.h-1 was considered significant . The core temperature triggering sweating , adjusted to a designated mean skin temperature of 34 degrees C , identified the threshold for this response . Gain was defined by the adjusted core temperature increase required to augment sweating from 100 to 300 g.m-2.h-1 . degree C-1 . Plasma clonidine concentrations were 0.8 +/- 0.1 and 1.6 +/- 0.2 ng/mL on the small- and large-dose days , respectively . Clonidine administration increased the sweating threshold approximately 0.4 degree C ( P < 0.05 ) , but the increase was comparable at each dose . The gain of sweating was approximately 0.2 degree C and was not influenced by clonidine administration . The thermoregulatory effects of clonidine thus resemble those of volatile anesthetics , opioids , and propofol . These data suggest that the antishivering effect of clonidine results from central thermoregulatory inhibition rather than a specific peripheral action on thermogenic muscular activity . Unlike other sedatives and anesthetics , the concentration-dependence of clonidine demonstrates a ceiling beyond which the administration of an additional drug fails to enhance the effect , suggesting that the thermoregulatory effect of clonidine may be limited , even at high plasma concentrations . The gain of sweating was well preserved indicating that this response remains effective in the presence of sedatives and anesthetics .

Clonidine

clonidine

saline

clonidine

sweating threshold

gain of sweating .

increase in the sweating threshold

reduce the gain of sweating .

Core temperature

mean skin temperature

chest sweating rate

sweating

core temperature

Plasma clonidine concentrations

gain of sweating

thermoregulatory effects

sweating threshold


Long-term results regarding the use of recombinant interferon alpha-2b in the treatment of II type mixed essential cryoglobulinemia . Thirty-three patients with II type mixed essential cryoglobulinemia ( MEC ) were randomized into two groups : one to receive combined therapy including prednisone plus interferon , the other to receive prednisone therapy . Interferon was administered as induction treatment ( 3 Mu/day ) and then as maintenance therapy ( 3 Mu three times a week ) . 83 % of the combined therapy patients responded as opposed to 27 % of the prednisone treated patients . Among the patients that responded to combined therapy , nine of them had a complete response , four a partial response , and two a minor response . None of the patients treated with prednisone therapy responded completely but only two had a partial and two a minor response . Four patients ( three of combined therapy and one of prednisone therapy ) showed proteinuria before the treatment which improved at the end of the induction therapy . Ten patients showed anti-HCV positivity which remained unchanged after the treatment . Three patients showed liver involvement secondary to cryoglobulinemia and an improvement of histological pattern after the induction with combined therapy . One patient showed an improvement of peripheral neuropathy after induction with the combined therapy . These data suggest the effectiveness of interferon given as induction and as maintenance treatment in the therapy of II type mixed essential cryoglobulinemia .

recombinant interferon alpha-2b

prednisone

Interferon

prednisone

combined therapy

prednisone

combined therapy .

interferon

proteinuria

anti-HCV positivity

liver involvement

histological pattern

peripheral neuropathy


Effects of ORG-2766 on brain event-related potentials of autistic children . A double-blind , placebo-controlled study examined the effects of 6 weeks of treatment with the adrenocorticotropin4-9 analogue ORG-2766 ( 40 mg/day ) on brain event-related potentials ( ERPs ) of autistic children . In visual and auditory oddball paradigms ( with task and nontask conditions ) , standard ( 80 % ) , target ( 10 % ) , and unexpected novel stimuli ( 10 % ) were presented . ORG-2766 ( a ) increased the occipital P3 component of the ERP to visual targets , ( b ) decreased the occipital P3 component of the ERP to auditory targets , ( c ) did not affect visual and auditory parietal target P3 components , and ( d ) also did not affect the A/Pcz/300 to auditory novel stimuli . In addition , ORG-2766 treatment increased the N1 component of the ERP to task-irrelevant auditory stimuli .

autistic children .


Inhibition of epidural morphine-induced pruritus by intravenous droperidol . The effect of increasing the doses of morphine and of droperidol . BACKGROUND AND OBJECTIVES Because the mechanism of inhibition of epidural morphine-induced pruritus by droperidol is not clear , this study was undertaken to determine the effects of larger doses of droperidol or morphine , or both . METHODS A double-blind study was performed in 210 ASA I or II patients undergoing cesarean delivery , who were randomly assigned to six groups . All patients received epidural anesthesia with 0.5 % bupivacaine containing 1:200,000 epinephrine , to which 2 mg ( groups 1 , 2 , and 3 ) or 4 mg ( groups 4 , 5 , and 6 ) morphine sulfate was added . Just after delivery , 2.5 mg droperidol was given intravenously to groups 2 and 5 , and 5 mg was given to groups 3 and 6 . During the postoperative period , the patients were assessed for the occurrence and severity of pruritus ( classified as absent , mild , moderate , or severe ) or other untoward symptoms . The groups were compared for the incidence of pruritus by the Mann-Whitney nonparametric test . RESULTS The incidence of pruritus was significantly reduced only when the control group . ( no droperidol ) was compared with the group that received 2.5 mg droperidol , both when 2 mg and when 4 mg morphine was used . A 5-mg dose of droperidol had no inhibitory effect . There was no difference in the incidence of pruritus between use of 2 mg and 4 mg morphine . Other untoward effects of morphine either could not be observed or occurred with an incidence unaffected by either dose of droperidol . CONCLUSION Pruritus caused by epidural use of 2 or 4 mg of morphine is inhibited by the intravenous use of 2.5 mg droperidol but not by a larger dose .

morphine

droperidol

droperidol

morphine

epidural anesthesia

bupivacaine

epinephrine

morphine sulfate

droperidol

morphine

morphine

droperidol

epidural morphine-induced pruritus

occurrence and severity of pruritus

other untoward symptoms

incidence of pruritus

incidence of pruritus

inhibitory effect

incidence of pruritus

untoward effects

Pruritus

randomly assigned to six groups


Effect of practice on laterality in a mental rotation task . The purpose of the present study was to investigate the effect of practice on the lateralization of mental rotation skills . Forty-six females and 46 males completed four blocks of 64 trials in a lateralized mental rotation task . Results revealed a reduction in reaction time and error rate across blocks , thus demonstrating a practice effect . A shift from a right hemisphere advantage to a left hemisphere advantage across blocks of trials was also found . The results are discussed in terms of their implication for hypotheses linking laterality and training . Practical implications for laterality research are also discussed .

mental rotation task

lateralized mental rotation task

reaction time

error rate

mental rotation task

Forty-six

females

males


The comparative safety and diagnostic accuracy of adenosine myocardial perfusion imaging in women versus men . STUDY OBJECTIVE To determine if the diagnostic accuracy and safety of intravenous adenosine myocardial perfusion imaging is significantly different in men compared with women . DESIGN Prospective , comparative , open-label clinical trial . SETTING Nuclear medicine laboratory in a university-affiliated hospital . PATIENTS Consecutive patients who were referred for evaluation of known or suspected coronary artery disease . Patients were judged not to be able to exercise adequately . INTERVENTIONS Coronary angiography was conducted within 6 weeks of an adenosine thallium-201 myocardial perfusion imaging study . MEASUREMENTS AND MAIN RESULTS Diagnostic accuracy is shown in the table . [ table : see text ] Overall , side effects from adenosine were not different between men and women . The frequencies of ST depression and chest pain were significantly greater in women than men , although their etiologies are unknown . The frequency of severe side effects such as heart block and hypotension was not different between men and women . CONCLUSIONS The diagnostic accuracy and safety of adenosine thallium-201 myocardial perfusion imaging are generally similar in women and men .

adenosine myocardial perfusion imaging

adenosine myocardial perfusion imaging

safety

diagnostic accuracy

Diagnostic accuracy

side effects

ST depression

chest pain

severe side effects

heart block and hypotension

women versus men .


Cost-effectiveness analysis of serum vancomycin concentration monitoring in patients with hematologic malignancies . OBJECTIVE This study evaluates the cost-effectiveness of vancomycin serum concentration monitoring in patients with hematologic malignancies . METHODS The study was designed as a prospective randomized study . Seventy immunocompromised febrile patients with hematologic malignancies were randomly assigned to either a vancomycin therapeutic drug monitoring group ( TDM group ; n = 37 ) or to a control group ( n = 33 ) . Intervention in the TDM group involved patient follow-up by a clinical pharmacist to obtain and pharmacokinetically interpret serum vancomycin concentrations for dosage individualization . RESULTS Evaluation of all patients included global clinical response and nephrotoxicity , as well as the economic costs and effectiveness derived from the vancomycin monitoring program . There were no significant differences between the TDM and control groups in the outcome measures , except for the incidence of nephrotoxicity : the rates of minor nephrotoxicity were 33.3 % and 13.5 % in the control and TDM groups , respectively . The corresponding figures for moderate nephrotoxicity were 9.1 % and 0 % . Logistic regression analysis confirmed that TDM independently reduced the incidence of nephrotoxicity in this patient population . On the basis of this reduced nephrotoxicity , a incremental cost of $ 435 per case of nephrotoxicity prevented was found for vancomycin serum concentration monitoring . CONCLUSIONS A decreased incidence of nephrotoxicity provides evidence of a real clinical benefit to patient management in patients with hematologic malignancies . The TDM for vancomycin therapy in this high-risk population has been shown to be a cost-effective procedure .

serum vancomycin

vancomycin

vancomycin

control group

vancomycin

vancomycin

vancomycin

vancomycin

global clinical response

nephrotoxicity

economic costs and effectiveness

moderate nephrotoxicity

incidence of nephrotoxicity

nephrotoxicity

incremental cost

decreased incidence of nephrotoxicity

hematologic malignancies

hematologic malignancies

Seventy

immunocompromised febrile

hematologic malignancies


Levels of recombinant human granulocyte colony-stimulating factor in serum are inversely correlated with circulating neutrophil counts . Recombinant human granulocyte colony-stimulating factor ( rhG-CSF ) is effective in countering chemotherapy-induced neutropenia . However , serum rhG-CSF levels can not be maintained throughout the course of rhG-CSF therapy . The drop in serum rhG-CSF levels may vary with the duration of rhG-CSF administration or with the circulating neutrophil counts . We investigated the relationship between serum G-CSF levels and circulating neutrophil counts and the pharmacokinetics of rhG-CSF for patients with lung cancer who had been treated with myelosuppressive chemotherapy and then with subcutaneous rhG-CSF ( lenograstim , 2 micrograms per kg of body weight per day ) . Twelve patients were randomly assigned to four groups with different rhG-CSF therapy schedules . Serum G-CSF levels were measured by an enzyme immunoassay method . Serum G-CSF levels during the rhG-CSF therapy greatly exceeded endogenous G-CSF levels and were mainly due to the presence of exogenous rhG-CSF rather than increased levels of endogenous G-CSF . Despite the duration of rhG-CSF administration , serum G-CSF levels during rhG-CSF therapy were inversely correlated with circulating neutrophil counts ( r2 = 0.73 , P < 0.0001 ) . The value for the area under the concentration-time curve of rhG-CSF on the day of neutrophilia was lower than that on the day of neutropenia ( P < 0.05 ) . Our results suggest that the fall in serum G-CSF levels during rhG-CSF therapy may result from increased clearance and/or decreased absorption of rhG-CSF , two processes related to circulating neutrophil counts .

rhG-CSF

rhG-CSF therapy .

rhG-CSF

rhG-CSF

rhG-CSF

rhG-CSF therapy schedules

rhG-CSF therapy

rhG-CSF

rhG-CSF

rhG-CSF therapy

rhG-CSF

rhG-CSF therapy

rhG-CSF

serum rhG-CSF levels

serum rhG-CSF levels

serum G-CSF levels

circulating neutrophil counts

Serum G-CSF levels

Serum G-CSF levels

endogenous G-CSF levels

serum G-CSF levels

concentration-time curve

rhG-CSF

serum G-CSF levels

Twelve


An occupation based physical activity intervention program : improving fitness and decreasing obesity . The purpose of this quasi-experimental study was to determine the effectiveness of an occupation based health and fitness program . Subjects were 1,504 police trainees ( 85 % male , 15 % female ) with an ethnic distribution of 82 % white , 16 % African American , and 2 % other . Data were collected at 25 sites across the state of North Carolina . The sites were randomly assigned to either the experimental group ( implemented the intervention ) or the control group ( continued usual training ) . As compared with controls , subjects at the experimental sites improved significantly in cardiovascular fitness ( aerobic power ) , general muscular strength ( number of sit ups per minute ) , and flexibility , and lowered their body fat . The intervention required minimal equipment and was taught primarily by peers who received a 1 week training program . This occupational approach to improving health could be particularly useful in occupations with many workers who seldom engage in leisure time physical activity .

( implemented the intervention )

( continued usual training )

occupational approach

improving fitness

decreasing obesity

general muscular strength

number of sit ups per minute

flexibility

lowered their body fat

obesity .

male

female


Counselling of postnatal depression : a controlled study on a population based Swedish sample . In a two-stage screening procedure using the Edinburgh Postnatal Depression Scale ( EPDS ) at 8 and 12 weeks postpartum and the Montgomery-Asberg Depression Rating Scale ( MADRS ) and DSM-III-R at about 13 weeks postpartum , 41 women identified as depressed were randomly allocated to a study and a control group . The women in the study group received 6 weekly , counselling visits by the Child Health Clinic nurse and the control group received routine primary care . Twelve ( 80 % ) of 15 women with major depression in the study group were fully recovered after the intervention compared to 4 ( 25 % ) of 16 in the control group . Counselling by health nurses is helpful in managing postnatal depression and seems to work well within the Swedish Primary Health Care system .

Counselling

Counselling

DSM-III-R

fully recovered

population based Swedish sample .


Prospective comparison of nasal versus oral insertion of a thin video endoscope in healthy volunteers . BACKGROUND AND STUDY AIMS Attempts have been made to improve patient 's tolerance of upper gastrointestinal endoscopy and to decrease the need for sedation , using thinner endoscopes and a nasal introduction route . We prospectively compared the oral and nasal routes in volunteers , using a thin prototype video endoscope . METHODS Ten healthy volunteers underwent two upper gastrointestinal endoscopies in a random order on two different days , with the procedure being carried out by a single experienced endoscopist . Parameters assessed were the tolerance of scope insertion and the assessment of the entire procedure ( 0-10 scale ) , the method of insertion preferred by the volunteers , the completeness of the examination ( assessed by an independent endoscopist ) , and the time required for the procedure . RESULTS In one patient , nasal insertion failed , and she was excluded from further analysis . The insertion of the scope was easier via the oral route , as reflected in a shorter examination time ( mean 165 vs. 210 seconds , p = 0.017 ) and patients ' tolerance for the scope insertion ( mean score : 8 for oral vs. 4 for nasal route ; p = 0.03 ) . On the other hand , gagging occurred more frequently during oral endoscopy ( 6/9 vs 1/9 , p = 0.05 ) . Three of the volunteers in each case preferred the oral or the nasal route , and three were not decided , in case of a repeated endoscopy . Similarly , the overall tolerance for the procedure did not between the two groups . CONCLUSION Thin-diameter gastroscopes seem to improve patient 's tolerance . In this small study in volunteers , nasal introduction showed no overall benefit over oral introduction . Modifications of the scope to achieve better nasal passage are necessary .

nasal versus oral insertion

video endoscope

upper gastrointestinal endoscopy

oral and nasal routes

oral endoscopy

tolerance of scope insertion

assessment of the entire procedure

completeness of the examination

time required for the procedure .

nasal insertion

insertion of the scope

examination time

gagging

overall tolerance for the procedure

patient 's tolerance

healthy volunteers .


Secondary caries formation in vitro around glass ionomer-lined amalgam and composite restorations . The aim of this in vitro secondary caries study was to examine the glass-ionomer liner 's effect on wall-lesion inhibition when a conventional and a light-cured glass ionomer liner was placed under amalgam and composite resin restorations . Class V preparations in extracted upper premolars were used and ten restorations were used for each of the following groups : ( i ) two layers of copal varnish and amalgam ; ( ii ) conventional glass-ionomer and amalgam ; ( iii ) light-cured glass-ionomer and amalgam ; ( iv ) bonding agent and light-cured composite resin ; ( v ) conventional glass-ionomer , bonding agent and light-cured composite resin ; ( vi ) light-cured glass-ionomer , extended 0.3 mm short of the enamel margin bonding agent and light-cured composite resin ; and ( vii ) light-cured glass-ionomer , extended 1 mm short of the enamel margin , bonding agent and light-cured composite resin . The teeth were thermocycled and artificial caries were created using an acid-gel . The results of this study showed that artificial recurrent caries can be reduced significantly ( P < 0.05 ) with a glass-ionomer liner under amalgam restorations . The results also showed that when the light-cured glass-ionomer liner was placed 0.3 mm from the cavosurface margin under composite resin restoration , the artificial recurrent caries reduced significantly ( P < 0.05 ) .

glass-ionomer liner 's

glass ionomer liner

artificial caries

glass-ionomer

artificial recurrent caries

artificial recurrent caries reduced


A component analysis of cognitive-behavioral treatment for depression . The purpose of this study was to provide an experimental test of the theory of change put forth by A. T. Beck , A. J . Rush , B. F. Shaw , and G. Emery ( 1979 ) to explain the efficacy of cognitive-behavioral therapy ( CT ) for depression . The comparison involved randomly assigning 150 outpatients with major depression to a treatment focused exclusively on the behavioral activation ( BA ) component of CT , a treatment that included both BA and the teaching of skills to modify automatic thoughts ( AT ) , but excluding the components of CT focused on core schema , or the full CT treatment . Four experienced cognitive therapists conducted all treatments . Despite excellent adherence to treatment protocols by the therapists , a clear bias favoring CT , and the competent performance of CT , there was no evidence that the complete treatment produced better outcomes , at either the termination of acute treatment or the 6-month follow-up , than either component treatment . Furthermore , both BA and AT treatments were just as effective as CT at altering negative thinking as well as dysfunctional attributional styles . Finally , attributional style was highly predictive of both short- and long-term outcomes in the BA condition , but not in the CT condition .

cognitive-behavioral treatment

cognitive-behavioral therapy ( CT )

BA

full CT treatment

CT

CT

efficacy

depression .

automatic thoughts ( AT )

core schema

effective

altering negative thinking

dysfunctional attributional styles .

attributional style

short- and long-term outcomes

depression

major depression


Relationship of the dose of intravenous gammaglobulin to the prevention of infections in adults with common variable immunodeficiency . The objective was to assess clinical efficacy of 3 dosages of intravenous gammaglobulins to prevent infectious episodes in adult common variable immunodeficiency . We designed a randomized , double blind , dose-assessing study . The setting was at University Hospital , Out-patient Clinic . Our patients were twenty-one adult patients with common variable immunodeficiency . The measurements were comparative study of the number and severity of infections using 3 various dosages of intravenous gammaglobulins , each given monthly for M least 6 months . Results indicated four hundred and eighty-four infectious episodes occurred while giving 305 infusions of IVIG 200 mg/kg ; 205 infectious episodes while giving 170 infusions of 400 mg/kg and 436 infectious episodes while giving 247 infusions of 600 mg/kg . The morbidity scores ( infection/infusion ) were 1.59 , 1.21 and 1.77 respectively ( p - N/S ) . There was no significant difference in the severity of infections on the above 3 dosages , and no difference in the duration of infection-free intervals . The conclusions resulted in no significant differences in morbidity in adult patients with common variable immunodeficiency treated in cross-over pattern with IVIG 200 mg/kg , 400 mg/kg and 600 mg/kg . Thus , high dosages of IVIG are not conferring better protection against infections in such patients .

gammaglobulin

intravenous gammaglobulins

gammaglobulins

IVIG 200 mg/kg

number and severity of infections

infectious episodes

morbidity scores ( infection/infusion )

severity of infections

duration of infection-free intervals

morbidity

immunodeficiency

twenty-one


Effects of enflurane and isoflurane on splanchnic oxygenation in humans . STUDY OBJECTIVES To determine the effects of enflurane and isoflurane on hepatic venous oxygen saturation ( ShvO2 ) and splanchnic oxygen ( O2 ) extraction . To measure hemodynamic parameters and ShvO2 , mixed venous , and arterial lactate concentrations during enflurane and isoflurane anesthesia . DESIGN Randomized , prospective study . SETTING University hospital . PATIENTS 20 ASA physical status I , II , and III adults , who underwent major abdominal surgery requiring mechanical ventilation a few hours postoperatively . INTERVENTIONS After placement of catheters in the pulmonary artery , radial artery , peripheral and right hepatic vein , one hour postoperatively either enflurane or isoflurane was applied at different minimum alveolar concentration ( MAC ) of 0.5 , 1.0 , and 1.5 in a randomized order . MEASUREMENTS AND MAIN RESULTS Before and 10 minutes after administration of each desired end-expiratory anesthetic concentration , the following parameters were determined : hemodynamic parameters , arterial ( SaO2 ) , mixed venous ( SvO2 ) , and hepatic venous oxygen saturations , systemic and splanchnic O2 extraction , arterial , mixed venous , and hepatic venous lactate concentrations . Cardiac output ( CO ) and mean arterial pressure ( MAP ) decreased in a dose dependent manner . SaO2 , SvO2 , and systemic O2 extraction remained unchanged with enflurane and isoflurane anesthesia . In the enflurane group , but not in the isoflurane group , ShvO2 decreased with increasing inhalational concentrations . This decrease in ShvO2 reflected an increase in splanchnic O2 extraction with enflurane ; in contrast to isoflurane . CONCLUSIONS Enflurane causes a decrease in ShvO2 , which indicates an impairment of splanchnic perfusion corresponding to the reduction in CO and MAP in a dose-dependent manner . Isoflurane maintains splanchnic perfusion in contrast to enflurane .

enflurane

isoflurane

enflurane

isoflurane

enflurane

isoflurane

enflurane

isoflurane

enflurane

enflurane

isoflurane

Enflurane

Isoflurane

enflurane

splanchnic oxygenation

hemodynamic parameters

hepatic venous oxygen saturations

systemic O2 extraction

splanchnic O2 extraction

splanchnic perfusion

CO

MAP

splanchnic perfusion

splanchnic oxygenation

adults