A clinical evaluation of a blood conservation device in medical intensive care unit patients . OBJECTIVES This study was designed to a ) document the efficacy of a device intended to conserve blood in critically ill patients ; b ) determine the effect of this blood conservation on hemoglobin concentration and the need for blood transfusions ; c ) determine if the blood conservation device resulted in interference with arterial pressure waveforms ; d ) determine if use of the blood conservation device resulted in a difference in the number of accidental needle punctures suffered by healthcare workers . DESIGN Prospective , randomized , controlled trial . A clinical trial using prospective , random allocation of consecutive eligible patients . SETTING The medical intensive care unit ( ICU ) of a university hospital located in a large metropolitan area . PATIENTS A total of 100 patients who were admitted to the medical ICU , required arterial line monitoring for clinical purposes , and were managed by the ICU medical service . Exclusion criteria included active bleeding or chronic renal failure at the time of ICU admission . INTERVENTIONS Patients in the experimental group had a blood conservation device incorporated into the arterial pressure monitoring system , while patients in the control group received a conventional arterial pressure monitoring system . MEASUREMENTS AND MAIN RESULTS Data gathered included : age ; gender ; ICU discharge status ; the duration of ICU stay ; time in the study ; volume of all blood drawn , discarded , or lost due to leakage ; hemoglobin concentrations ; blood transfusions ; and accidental needle injuries . Arterial pressure waveforms were recorded and inspected for dampening or other deformation . Mean hemoglobin concentrations were compared on ICU admission and at 12-hr intervals . Demographic and clinical characteristics of the two groups were not significantly different . The volume of blood drawn and discarded from arterial catheters was significantly lower in the blood conservation group ( blood conservation device : 5.7 +/- 7.5 mL ; control : 96.4 +/- 88.5 mL ; p < .0001 ) , as was the total volume of blood discarded ( blood conservation device : 19.4 +/- 47.4 mL ; control : 103.5 +/- 99.9 mL ; p < .0001 ) . Mean hemoglobin concentration on admission was similar in the two groups ( blood conservation device group : 11.8 +/- 2.5 g/dL ; control group : 12.6 +/- 2.3 g/dL ) . In both groups , the mean hemoglobin concentration declined most rapidly in the first 24 hrs of ICU care and , thereafter , declined more slowly . Although the mean hemoglobin concentration was higher in the blood conservation group after 6 days , statistical significance was not reached until 9.5 days of ICU care . The mean change in hemoglobin concentration ( overall : 1.2 +/- 2.2 g/dL ) during the study represents a statistically significant ( p < .0001 ) decrease of 9.7 % . Hemoglobin concentration during the study decreased by 1.4 +/- 2.2 g/dL in the control group and 1.0 +/- 2.3 g/dL in the blood conservation group ( p = nonsignificant ) . Univariate and multiple regression analysis demonstrated discarded blood volume to be a significant and independent predictor of the decline in hemoglobin concentration . Transfusion requirements were similar in both groups . The blood conservation system did not alter or interfere with pressure waveforms . There were no accidental needle injuries noted . CONCLUSIONS The conservation of blood in critically ill patients must be a high-priority concern of all healthcare workers . Our data indicate that the blood conservation system eliminates a significant factor in the decline in hemoglobin concentration . With devices as described here , there is no reason to continue the practice of wasting the blood of critically ill patients in order to prevent preanalytic error .

blood conservation device

blood conservation system

hemoglobin concentration

need for blood transfusions

hemoglobin concentrations

blood transfusions

accidental needle injuries

Arterial pressure waveforms

Mean hemoglobin concentrations

total volume of blood discarded

hemoglobin concentration

hemoglobin concentration

hemoglobin concentration

hemoglobin concentration

Hemoglobin concentration

blood volume

Transfusion requirements

accidental needle injuries

hemoglobin concentration

medical intensive care unit patients .

critically ill patients ;


A controlled study comparing patients with and without polycystic ovaries undergoing in-vitro fertilization . The outcome of in-vitro fertilization and embryo transfer ( IVF-ET ) was compared in 76 patients with polycystic ovaries ( PCO ) diagnosed on pre-treatment ultrasound scan , and 76 control patients who had normal ovaries and were matched for age , cause of infertility and stimulation regimen . Despite receiving significantly less human menopausal gonadotrophin ( HMG ) , patients with PCO , as compared with controls , had significantly higher serum oestradiol levels on the day of human chorionic gonadotrophin administration ( 5940 +/- 255 versus 4370 +/- 240 pmol/l , P < 0.001 ) , developed more follicles ( 14.9 +/- 0.7 versus 9.8 +/- 0.6 , P < 0.001 ) and produced more oocytes ( 9.3 +/- 0.6 versus 6.8 +/- 0.5 , P = 0.003 ) . However , fertilization rates were reduced in the PCO patients ( 52.8 +/- 3.4 % versus 66.1 +/- 3.4 % , P = 0.007 ) . There was no significant difference in cleavage rates . The pregnancy rate/embryo transfer was 25.4 % in the PCO group and 23.0 % in the group with normal ovaries . There were three high order multiple pregnancies in the PCO group compared with none in the group with normal ovaries . Of the PCO patients , 10.5 % developed moderate/severe ovarian hyperstimulation syndrome ( OHSS ) compared with none of the controls ( P = 0.006 ) . Patients with and without PCO undergoing IVF have comparable pregnancy and livebirth rates . However , it is important to diagnose PCO before ovarian stimulation is initiated as these patients are more likely to develop moderate or severe OHSS following IVF-ET .

human menopausal gonadotrophin ( HMG )

chorionic gonadotrophin

in-vitro fertilization .

serum oestradiol levels

follicles

oocytes

fertilization rates

cleavage rates .

pregnancy rate/embryo transfer

pregnancy and livebirth rates .

polycystic ovaries

polycystic ovaries

control

PCO

PCO

group with normal ovaries

PCO


Comparison of rectal midazolam and diazepam for premedication in pediatric dental patients . Rectally administered midazolam ( 0.35 mg/kg ) and diazepam ( 0.70 mg/kg ) were compared with each other and with placebo for preanesthetic medication in children undergoing dental extractions . All rectal medications were very well accepted , but mask acceptance , improvement in anxiety , and sedation were best in the midazolam group . Improvement in anxiety and sedation were significantly better in the two drug groups than in those patients who had received placebo . Thirty minutes after rectal administration of midazolam , patients showed a decrease in both systolic and diastolic blood pressure and heart rate . Although these decreases differed significantly from the premedication values , they were probably of little clinical importance . Only minor adverse effects were observed in this study . Overall rectally administered midazolam appeared to be somewhat more efficacious than diazepam .

rectal midazolam

diazepam

midazolam

diazepam

placebo

rectal medications

midazolam

placebo

midazolam

midazolam

diazepam

mask acceptance

anxiety

sedation

anxiety

sedation

minor adverse effects

pediatric

dental patients

children

undergoing dental extractions


Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy . BACKGROUND Patients with advanced cancer frequently experience clinically significant anemia , which is often exacerbated by myelosuppressive chemotherapy . Consistent with the anemia of chronic disease , studies have documented serum erythropoietin levels that are inappropriately low for the degree of anemia in cancer patients . Myelosuppressive chemotherapy impairs erythropoiesis , which may not fully recover between treatment cycles . Recombinant human erythropoietin ( rHuEPO ) has been used safely and effectively to treat anemia in AIDS patients receiving zidovudine ( AZT ) and in patients with chronic renal failure . PURPOSE This study was designed to evaluate the clinical role of rHuEPO in reducing symptomatic anemia in patients with advanced cancer who were receiving myelosuppressive chemotherapy ( excluding cisplatin ) . METHODS We studied 153 anemic cancer patients receiving cyclic combination chemotherapy in a prospective multicenter , double-blind , placebo-controlled trial . The patients were randomly assigned to receive either rHuEPO ( 150 U/kg ) or placebo subcutaneously three times a week for a maximum of 12 weeks or until the hematocrit level increased to 38 % -40 % . If the hematocrit reached this target level before 12 weeks , the rHuEPO dose could be reduced to maintain the hematocrit at that level for the duration of the study . Response to rHuEPO therapy was assessed by measuring changes in hematocrit level , transfusion requirements , and quality of life . Quality-of-life assessment was based on patients ' responses to questionnaires before and after the courses of therapy . RESULTS The increase in hematocrit in the rHuEPO-treated group compared with hematocrit in the placebo-treated group was statistically significant ( P = .0001 ) as measured by percentage point of change from baseline to final evaluation , by an increase in hematocrit level of six percentage points or more unrelated to transfusion , and by a rise in hematocrit level to 38 % or more unrelated to transfusion . There was a trend toward the reduction in mean units of blood transfused per patient during months 2 and 3 of therapy combined in rHuEPO-treated patients compared with placebo-treated patients ( 0.91 U versus 1.65 U ; P = .056 ) . In addition , rHuEPO-treated patients experienced a statistically significant improvement in energy level and ability to perform daily activities ( P < or = .05 ) . The two treatment groups showed no statistically significant differences in toxic effects except for increased incidence of diaphoresis ( P < .05 ) and diarrhea ( P = .05 ) in the rHuEPO-treated group . CONCLUSIONS We conclude that rHuEPO is safe and effective for reversing anemia related to advanced cancer or to chemotherapy for cancer .

rHuEPO

placebo

rHuEPO

rHuEPO

rHuEPO-treated

placebo-treated

rHuEPO-treated

rHuEPO-treated

rHuEPO

clinically significant

anemia

symptomatic anemia

hematocrit level

hematocrit

changes in hematocrit level

Quality-of-life

increase in hematocrit

hematocrit

hematocrit

hematocrit level

toxic effects

diaphoresis

diarrhea

anemia

cancer patients

rHuEPO-treated group

placebo-treated

rHuEPO-treated patients

rHuEPO-treated group


Abdominal surgical wound infection is lowered with improved perioperative enterococcus and bacteroides therapy . Perioperative antibiotics decrease surgical wound infection ( SWI ) in trauma patients requiring abdominal exploration . This investigation evaluated 24 hours of cefoxitin or ampicillin/sulbactam used for early therapy in such patients . Patients were randomly assigned to one of two treatment groups . The primary endpoint evaluated was SWI , which was defined as purulent drainage or active wound treatment . Five hundred ninety-two patients were evaluated : 283 received ampicillin/sulbactam and 309 received cefoxitin . The incidence of wound infection among the ampicillin/sulbactam patients was 2 % and among cefoxitin patients it was 7 % ( p < 0.004 ) . The cefoxitin patients with colon injuries were analyzed ( p < 0.007 ) . The major difference between the two groups was an increased incidence of enterococcal infections in the cefoxitin-treated patients . A single broad-spectrum antibiotic given for 24 hour perioperatively effectively controls SWI . Use of ampicillin/sulbactam results in a significantly lower SWI rate than use of cefoxitin , which may be a result of improved enterococcal and Bacteroides coverage .

Perioperative antibiotics

cefoxitin

ampicillin/sulbactam

ampicillin/sulbactam

cefoxitin

surgical wound infection ( SWI )

SWI

incidence of wound infection

incidence of enterococcal infections

SWI rate

enterococcal and Bacteroides coverage .


A double-blind comparison of clomipramine , desipramine , and placebo in the treatment of autistic disorder . OBJECTIVE To determine whether clomipramine hydrochloride , a serotonin reuptake blocker with unique anti-obsessional properties , is differentially effective for obsessive-compulsive and stereotyped motor behaviors in autistic disorder compared with placebo and with the noradrenergic tricyclic antidepressant agent , desipramine hydrochloride . DESIGN Following a 2-week , single-blind placebo washout phase , 12 autistic subjects completed a 10-week , double-blind , crossover comparison of clomipramine and placebo , and 12 different subjects completed a similar comparison of clomipramine and desipramine . SETTING Outpatient clinic . PATIENTS A referral sample of 30 male and female autistic patients were enrolled , and 24 completed the study . MEASURES Key outcome measures were the Autism Relevant Subscale of the Children 's Psychiatric Rating Scale , the Modified Comprehensive Psychopathological Rating Scale-Obsessive-Compulsive Disorder Subscale , and the Clinical Global Impressions Scale . RESULTS Clomipramine was superior to both placebo and desipramine on ratings of autistic symptoms ( including stereotypies ) , anger , and compulsive , ritualized behaviors ( P < .05 ) , with no differences between desipramine and placebo . Clomipramine was equal to desipramine and both tricyclic agents were superior to placebo for amelioration of hyperactivity . CONCLUSION Biological links between compulsions and stereotyped , repetitive behaviors in autistic disorder should be explored .

clomipramine

desipramine

placebo

clomipramine hydrochloride

placebo

desipramine hydrochloride

placebo

clomipramine

placebo

clomipramine

desipramine

Clomipramine

desipramine

placebo

Clomipramine

desipramine

Clinical Global Impressions Scale

hyperactivity

autistic disorder .

12 autistic subjects

12 different subjects


Prognostic value of clinical , laboratory , and histological characteristics in multiple myeloma : improved definition of risk groups . Follow-up data of 320 multiple myeloma ( MM ) patients entering the German Myeloma Treatment Group ( GMTG ) trial MM01 were analysed for factors predicting overall ( OAS ) and tumour related survival ( TRS ) . Response to primary induction chemotherapy was relevant for prognosis if a limit of 25 % tumour cell mass ( TCM ) reduction was used to separate responders from non-responders . Furthermore , TCM , histological grading of myeloma cells , degree of bone marrow infiltration , haemoglobin , platelet counts , calcium , creatinine , albumin , beta 2M , and Bence Jones proteinuria correlated to both OAS and TRS . Age was relevant for OAS only . The multivariate analysis revealed histological grading , TCM and platelets as the most reliable prognostic factors . Based on these data the Durie/Salmon classification could be improved by defining poor prognosis patients ( 50 % TRS : 16 months ) characterised by pretreatment platelets of < or = 150,000 and/or poorly differentiated myeloma cell morphology . Patients lacking both risk factors displayed 50 % survival times of 46 months in stage III and 88 months in stage II .

primary induction chemotherapy

poor prognosis

survival times


Metabolic responses to oral surgery under local anesthesia and sedation with intravenous midazolam : the effects of two different local anesthetics . The effects of epinephrine-free and epinephrine-containing local anesthetic solutions on plasma potassium and blood glucose concentrations were investigated in 20 patients undergoing oral surgery with intravenous midazolam sedation . Ten patients were randomly assigned to receive 4.4 mL of 2 % lidocaine with 1:80,000 epinephrine as a local anesthetic and 10 were given 4.4 mL of 3 % prilocaine with 0.03 IU/mL felypressin . There were significant changes from baseline potassium and glucose concentrations both within and between treatments in the early postinjection period . The epinephrine-containing local anesthetic significantly reduced the plasma potassium concentration 10 min after injection , by 0.16 +/- 0.20 mmol/L ( mean +/- SD ) , and increased the blood glucose concentration at 10 , 20 , and 30 min ( by 0.46 +/- 0.37 , 0.63 +/- 0.45 , and 0.56 +/- 0.28 mmol/L , respectively ) . Conversely , plasma potassium increased and blood glucose decreased 10 , 20 , and 30 min following the administration of the epinephrine-free solution . At 30 min potassium was increased by 0.24 +/- 0.16 mmol/L , and glucose was decreased by 0.23 +/- 0.16 mmol/L . It is concluded that epinephrine-free and epinephrine-containing local anesthetics differ in their metabolic effects during oral surgery with midazolam sedation .

oral surgery

local anesthesia

midazolam

local anesthetics

midazolam

epinephrine-free solution

epinephrine-free

midazolam sedation

potassium and glucose concentrations

blood glucose concentration

plasma potassium

blood glucose

30 min potassium

glucose

oral surgery

sedation


Recurrence of condylomata acuminata following cryotherapy is not prevented by systemically administered interferon . OBJECTIVE To determine whether interferon alpha-2a , when utilised as adjuvant chemotherapy following ablation of condylomata acuminata ( genital warts ) by cryotherapy , is effective in the prevention of recurrences . DESIGN Randomised , placebo-controlled , double-blind study . Statistical analysis was by 2-tailed Fisher 's Exact Test . PATIENTS 97 patients with recurrent condylomata acuminata . INTERVENTION 49 patients were treated with cryotherapy plus subcutaneously administered interferon alpha-2a , and 48 received cryotherapy plus placebo . Of these , 36 and 37 patients , respectively , completed the study and were evaluable . MAIN OUTCOME MEASURE Clinical eradication of condylomata for six months following adjuvant chemotherapy . RESULTS By completion of the adjuvant chemotherapy , 10 ( 28 % ) interferon recipients and 16 ( 43 % ) placebo recipients experienced recurrences . At six months follow-up , 25 ( 69 % ) interferon and 27 ( 73 % ) placebo recipients experienced recurrences . In the six months following interferon therapy , only 31 % of interferon and 27 % of placebo recipients remained free of recurrences ( p = 0.99 ) . CONCLUSIONS Interferon alpha-2a administered subcutaneously offers no benefit as a chemotherapeutic adjuvant to cryotherapy when used alone in the therapy of genital warts in this population of patients with recurrent condylomata .

cryotherapy

interferon

interferon alpha-2a

adjuvant chemotherapy

cryotherapy

placebo-controlled

cryotherapy plus placebo

chemotherapy

adjuvant chemotherapy

placebo

interferon

placebo

interferon therapy

interferon

placebo

Interferon alpha-2a

Recurrence of condylomata acuminata

adjuvant chemotherapy

recurrences

experienced recurrences

free of recurrences


Ethanol-induced alterations in electroencephalographic activity in adult males . The present investigation examined the effects of placebo ( P ) , low-dose ( LD ) , and high-dose ( HD ) ethanol on electroencephalographic ( EEG ) activity in 21 healthy , adult males ( X = 22.7 years ) . Only one condition ( P , LD , or HD ) was presented per day and the condition order was randomized . For each subject , blood-alcohol levels measured via breathalyzer and EEG activity , using the entire 10/20 International System , were recorded both prior to and at intervals of 35 , 70 , 105 , and 140 minutes after P , LD , or HD administration . The Fast Fourier Transform was used to calculate power spectral densities for each EEG recording . Measures of the relative areas under the power spectral curve were made for each of the following frequency bands : slow alpha ( 7.5 to 10 Hz ) ; fast alpha ( 10.5 to 13.0 Hz ) ; slow beta ( 13.5 to 19.5 Hz ) ; and fast beta ( 20 to 26 Hz ) at electrodes F3 , F4 , C3 , C4 , P3 , P4 , O1 , and O2 . Repeated-measures multivariate analysis of variance performed on normalized relative area values revealed that ethanol had significant effects on EEG activity at anterior sites : frontal ( F3 , F4 ) and central ( C3 , C4 ) that presented as increased activity in the slow alpha frequency band . These results suggest a differential responsivity of both cortical region and EEG frequency band to the effects of ethanol ingestion .

placebo ( P )

ethanol

electroencephalographic activity

electroencephalographic ( EEG

EEG activity

EEG activity at anterior sites

cortical region and EEG frequency band

adult males .


0.1 % bupivacaine does not reduce the requirement for epidural fentanyl infusion after major abdominal surgery . BACKGROUND AND OBJECTIVES Although local anesthesia has been demonstrated to potentiate spinal morphine analgesia in animal studies , results comparing epidural local anesthesia/opioid mixtures with opioid alone are contradictory in clinical studies . The hypothesis was that , although the concentration of bupivacaine ( 0.1 % ) was low to minimize its adverse effects , if the infusion rate of a fentanyl/bupivacaine solution was closely adjusted according to need , the presence bupivacaine would reduce the requirement for epidural fentanyl . METHODS Forty patients were randomly assigned to receive either fentanyl ( 10 micrograms/mL ) or a fentanyl/bupivacaine ( 0.1 % ) mixture epidurally corresponding to the dermatome of the surgical incision in a double-blind fashion for the first 18 hours after major abdominal surgery . The infusion was titrated for each patient to the rate required for pain relief during forced inspiration ( pain score < or = 2 , maximum 10 ) . Pain scores , the fentanyl doses required , plasma concentrations of fentanyl at 18 hours , and the incidence and severity of adverse effects were recorded . RESULTS Patients reported similar median pain scores and were equally satisfied with pain relief in both groups . The mean required post-operative fentanyl infusion rate ( 57.7 +/- 19.5 micrograms/h ) and the plasma concentrations ( 0.84 +/- 0.36 ng/mL ) in the fentanyl group were comparable to the infusion rate ( 54.4 +/- 19.2 micrograms/h ) and the plasma concentrations ( 0.86 +/- 0.36 ng/mL ) in the fentanyl/bupivacaine group . Respiratory and cardiovascular functions were preserved , and the incidence of nausea , pruritus , and periods of drowsiness or sleep were similar in both groups . CONCLUSIONS In low concentrations ( 0.1 % ) , bupivacaine did not reduce the titrated dose of epidural fentanyl required for adequate pain relief during forced inspiration after major abdominal surgery . The incidence and severity of adverse effects were also comparable whether or not low-dose bupivacaine infusion was used .

bupivacaine

bupivacaine

fentanyl/bupivacaine

fentanyl ( 10 micrograms/mL )

fentanyl/bupivacaine ( 0.1 % )

major abdominal surgery

pain relief

bupivacaine

bupivacaine

adverse effects

median pain scores

pain relief

plasma concentrations

infusion rate

plasma concentrations

after major abdominal surgery

Forty

after major abdominal surgery


Lack of interaction between pantoprazole and digoxin at therapeutic doses in man . Substituted benzimidazole inhibitors of the gastric H+/K+ATPase may interact with the cytochrome P450 enzyme system and alter the pharmacokinetics of coadministered drugs . On the other hand , changes in intragastric pH might alter the absorption of other drugs . The primary aim of the present study was to determine whether pantoprazole modifies the steady-state serum concentrations of orally administered digoxin . Secondary aims were the influence of digoxin on the pharmacokinetics of pantoprazole as well as safety and tolerability . Eighteen healthy volunteers received a single oral dose of pantoprazole ( 40 mg ) and serum concentrations were determined . Three to 10 days later , subjects received in a single-blind , randomized , crossover fashion oral beta-acetyldigoxin ( 0.2 mg ) twice daily and concomitant oral pantoprazole ( 40 mg ) or placebo once daily for 5 days . Serum concentrations of pantoprazole and digoxin were determined on day 5 . Primary characteristics for confirmative assessment of no interaction were AUC and Cmax of digoxin . Lack of interaction in the sense of equivalence was concluded for both digoxin ( with and without pantoprazole ) and pantoprazole ( with and without digoxin ) as the 90 % -confidence intervals of the respective AUC- and Cmax-ratios were within the equivalence range of 0.8-1.25 . Pantoprazole did not influence the characteristic ECG modifications ( T-wave ) caused by digoxin . Both drugs were well tolerated and no adverse events or clinically relevant alterations in vital signs or clinical laboratory parameters were observed during treatment . In conclusion , pantoprazole and digoxin may be administered concomitantly without the need for dose adjustment .

pantoprazole and digoxin

Substituted benzimidazole inhibitors

pantoprazole

digoxin

digoxin

pantoprazole

oral dose of pantoprazole ( 40 mg )

beta-acetyldigoxin

concomitant oral pantoprazole

placebo

pantoprazole

digoxin

digoxin

pantoprazole

pantoprazole

digoxin

Pantoprazole

pantoprazole

digoxin

AUC and Cmax of digoxin .

AUC- and Cmax-ratios

tolerated

adverse events

in

man

Eighteen


Differential effects on bone density of progestogen-only methods for contraception in premenopausal women . The question of differential effects on bone density by two different types of progestogen-only methods for contraception in premenopausal women was addressed . Data from a prospective randomized clinical trial among 22 premenopausal women , age 32.6 ( range 20-45 years ) , who were randomly assigned to either of two treatments with continuous progestogens for contraception were analyzed ; depot-medroxyprogesterone acetate ( DMPA ) or continuous levonorgestrel treatment with subdermal implants ( Norplant ) , respectively . Forearm bone density ( BMDprox ) increased with 2.94 % ( p = 0.006 ) in women who were prescribed levonorgestrel , which was in contrast to stable values in those prescribed depot-medroxy-progesterone acetate ; group difference at 6 months for BMDprox 3.4 % ( 95 % CI 1.3 , 5.5 ; p = 0.025 ) and BMDdist 4.1 % ( 95 % CI - 1.3 , 9.6 ; p = 0.077 ) . The changes in bone density were consistent with the changes in biochemical indices for bone metabolism ; DMPA users showed signs of increased bone turnover and users of levonorgestrel showed increased bone formation with increased levels of both alkaline phosphatase ( p = 0.004 ) and osteocalcin ( p = 0.007 ) . The findings suggest an increase in bone density during treatment with levonorgestrel and stable values during short-term administration of DMPA , in standard clinical doses for contraception .

progestogen-only

progestogen-only

continuous progestogens

depot-medroxy-progesterone acetate

DMPA

levonorgestrel

DMPA

bone density

Forearm bone density ( BMDprox )

BMDprox

BMDdist

bone density

biochemical indices for bone metabolism

bone turnover

increased bone formation

bone density

premenopausal women .


Effect of dietary supplementation with n-3 fatty acids on coronary artery bypass graft patency . Epidemiologic and experimental data suggest that a high dietary intake of long-chain polyunsaturated n-3 fatty acids may reduce the risk of atherothrombotic disease . In a randomized , controlled study , 610 patients undergoing coronary artery bypass grafting were assigned either to a fish oil group , receiving 4 g/day of fish oil concentrate , or to a control group . All patients received antithrombotic treatment , either aspirin or warfarin . Their diet and serum phospholipid fatty acid profiles were monitored . The primary end point was 1-year graft patency , which was assessed by angiography in 95 % of patients . Vein graft occlusion rates per distal anastomoses were 27 % in the fish oil group and 33 % in the control group ( odds ratio 0.77 , 95 % confidence interval , 0.60 to 0.99 , p = 0.034 ) . In the fish oil group , 43 % of the patients had > or = 1 occluded vein graft ( s ) compared with 51 % in the control group ( odds ratio 0.72 , 95 % confidence interval , 0.51 to 1.01 , p = 0.05 ) . Moreover , in the entire patient group , there was a significant trend to fewer patients with vein graft occlusions with increasing relative change in serum phospholipid n-3 fatty acids during the study period ( p for linear trend = 0.0037 ) . Thus , in patients undergoing coronary artery bypass grafting , dietary supplementation with n-3 fatty acids reduced the incidence of vein graft occlusion , and an inverse relation between relative change in serum phospholipid n-3 fatty acids and vein graft occlusions was observed .

n-3 fatty acids

fish oil group

4 g/day of fish oil concentrate

control group

antithrombotic treatment

aspirin

warfarin

fish oil

fish oil

n-3 fatty acids

graft patency

> or = 1 occluded vein graft ( s )

serum phospholipid n-3 fatty acids

coronary artery bypass graft

coronary artery bypass grafting

antithrombotic treatment

coronary artery bypass grafting


Direct analysis of resistance in the cutaneous microflora during treatment of acne vulgaris with topical 1 % nadifloxacin and 2 % erythromycin .

topical 1 % nadifloxacin

2 % erythromycin

resistance in the cutaneous microflora

acne vulgaris


The effect of liquid fibre on feeding behaviour .

liquid fibre

feeding behaviour .

feeding behaviour .


Long-term efficacy of subcutaneous sumatriptan using a novel self-injector . An open , multicenter study investigated the long-term efficacy , tolerability , and acceptability to patients of subcutaneous sumatriptan 6 mg , administered using a novel cartridge system self-injector , for the acute treatment of migraine . Eighty patients treated all migraine attacks for 6 months at home with a subcutaneous injection of sumatriptan 6 mg. A second injection could be taken after 1 to 24 hours if relief was inadequate , or if the headache recurred , and rescue medication could be taken 1 hour after the second injection . The primary end point was the percentage of attacks in which headache improved from severe or moderate before treatment to mild or absent at 1 hour after the first injection . A total of 1566 attacks were treated by the 80 patients and 69 patients completed 6 months of treatment . Headache relief was reported 1 hour after the first injection in a mean of 78 % of attacks ( 83 % in the first 3 months and 76 % in the second 3 months ) . A second injection was required in a mean of 40 % of attacks , and headache was mild or absent 1 hour after the second injection in a mean of 77 % of attacks . Rescue medication was required after the second injection in a mean of 14 % of attacks . At the end of the study , 87 % of patients said that they would take the medication again , and at each clinic visit over 80 % said that they found the injector easy to use . Adverse events were similar to those reported previously with sumatriptan and were mostly mild to moderate in intensity , short-lived , and resolved spontaneously . Subcutaneous sumatriptan 6 mg is an effective , well tolerated , and well accepted , long-term , acute treatment for migraine when self-injected by patients using the novel self-injector .

subcutaneous sumatriptan

sumatriptan

injection of sumatriptan 6 mg.

sumatriptan

sumatriptan

headache

Headache relief

headache

Rescue medication

migraine

Eighty

migraine

sumatriptan


Effects of interaction of RRR-alpha-tocopheryl acetate and fish oil on low-density-lipoprotein oxidation in postmenopausal women with and without hormone-replacement therapy . We evaluated the effects of RRR-alpha-tocpheryl acetate ( alpha-tocopheryl acetate ) and hormone-replacement therapy ( HRT ) on the oxidative susceptibility of low-density lipoprotein ( LDL ) in postmenopausal women consuming a fish oil supplement . The independent effect of fish oil was also assessed . Forty-eight women , equally divided between women using and not using HRT , participated in a double-blind crossover trial . Each of the four periods lasted 5 wk and was followed by a 4-wk washout interval . During each period all subjects were given a 15-g supplement of fish oil and either 0 ( placebo ) , 100 , 200 , or 400 mg alpha-tocopheryl acetate daily . LDL resistance to oxidative modification was assessed by calculating lag time , propagation rate , and maximum production of conjugated dienes . Supplementation with fish oil and placebo shortened lag time and slowed propagation rate in women both using and not using HRT . After subjects consumed fish oil , supplementation with alpha-tocopheryl acetate increased plasma and LDL alpha-tocopherol contents significantly and lengthened lag time ( at even the lowest concentration ) but had no significant effect on propagation rate or maximum production compared with values measured after consumption of fish oil alone . Women not using HRT had faster propagation rates and higher maximum production than women using HRT ; after supplementation with fish oil and alpha-tocopheryl acetate these differences prevailed . Supplements as low as 100 mg alpha-tocopheryl acetate/d increase the resistance of LDL to oxidation when fish oil supplements are used . HRT and fish oil supplements may independently affect LDL oxidative susceptibility .

RRR-alpha-tocopheryl acetate

fish oil

hormone-replacement therapy

hormone-replacement therapy ( HRT )

fish oil supplement

HRT

( placebo )

alpha-tocopheryl acetate

placebo

alpha-tocopheryl

effect

lag time

propagation rate

maximum production of conjugated dienes

lag time

propagation rate

lengthened lag time

propagation rate

maximum production

propagation rates

maximum production

resistance of LDL to oxidation

LDL oxidative susceptibility

postmenopausal

women

hormone-replacement therapy

postmenopausal

women

Forty-eight

women

women

HRT


A community-based randomized trial of praziquantel to control schistosomiasis morbidity in schoolchildren in Zambia . A community-based , double-blind , randomized trial of praziquantel was carried out in an area of Zambia endemic for schistosomiasis . The aim of the study was to assess the impact of the treatment on Schistosoma mansoni morbidity . A total of 377 infected children , aged seven to 19 years , was randomized into two groups : one of 190 ( group A ) and one of 187 ( group B ) . All children were treated with 40 mg praziquantel/kg at the start of the study . Six months later , the children in group A were re-treated with the same dose of praziquantel , while the children in group B were given placebos . All children were followed up three , six and 12 months after the initial treatment , morbidity being clinically evaluated at the six- and 12-month follow-ups . The results show that , in both groups of children , there were significant reductions in splenomegaly , hepatomegaly , and subjective symptoms of morbidity six and 12 months after initial treatment . However , there were no significant differences , between the two groups , in the prevalences of these symptoms of morbidity . It therefore appears that once-yearly treatment of children , in this and similar endemic areas , is sufficient to reduce schistosomiasis morbidity to , and maintain it at , a tolerable level .

praziquantel

praziquantel

praziquantel/kg

praziquantel

placebos

morbidity

morbidity

schoolchildren

schistosomiasis

children , aged seven to 19 years

children

children

children

children

children


Correlation of quantitative measures with the modified Ashworth scale in the assessment of plantar flexor spasticity in patients with traumatic brain injury . This study of plantar flexor spasticity describes relationships among a traditional qualitative spasticity scale , three potential quantitative spasticity measures and a measure of voluntary ankle muscle function . Thirty-four volunteer adult patients with traumatic brain injuries participated . There were 28 males and 6 females ; the mean age was 30.3 years . A battery of five randomly sequenced tests was performed for each subject on one ankle . Tests were : modified Ashworth scale ( MAS ) scoring ; H-reflex testing with and without Achilles tendon vibration ; H-reflex testing with and without dorsiflexor contraction ; reflex threshold angle and timed toe tapping ( TTT ) . Twenty-six subjects returned to have the second ankle tested , resulting in 60 ankles for the analyses . Spearman 's coefficients for correlation of quantitative spasticity measures with MAS scores ranged from 0.39 to 0.49 with associated probabilities < or = 0.002 . Pearson coefficients for correlation of quantitative spasticity measures with TTT scores were lower but also significant ( P < or = 0.07 ) . Multiple correlation for the set of quantitative measures yielded R = 0.614 ( P < 0.001 ) with MAS scores and R = 0.365 ( P = 0.045 ) with TTT scores . These findings reveal statistically significant relationships of low to moderate strength among potential quantitative spasticity measures , a traditional qualitative spasticity scale and a simple measure of voluntary ankle muscle function . Understanding these relationships is an essential part of the ongoing search for quantitative spasticity measures .

modified Ashworth scale

Ashworth scale ( MAS )

modified Ashworth scale ( MAS )

reflex threshold angle

timed toe tapping ( TTT )

MAS scores

TTT scores

MAS scores

potential quantitative spasticity

voluntary ankle muscle function

plantar flexor spasticity

traumatic brain injury

Thirty-four

Twenty-six


Low-dose naltrexone effects on plasma chemistries and clinical symptoms in autism : a double-blind , placebo-controlled study . The effect of month-long naltrexone ( NTX ) treatment at a daily oral dose of 0.5 mg/kg/day was contrasted with placebo ( PLC ) in a double-blind study with conjoint clinical and biochemical evaluations of therapeutic effects . Modest clinical benefits were achieved with both PLC and NTX , with marginally better overall results following NTX , and degree of improvement appeared to be related to plasma chemical profiles . Massively elevated levels of beta-endorphin were observed in all children with assays using C-terminal antibody but not with an N-terminal antibody assay . In addition , 70 % of the children exhibited abnormally low levels of adrenocorticotropic hormone , and smaller subsets exhibited elevated norepinephrine ( 60 % ) , arginine-vasopressin ( 50 % ) , and serotonin ( 20 % ) . The best clinical responders exhibited the clearest normalization of the elevated plasma chemistries , especially in C-terminal-beta-endorphin and serotonin . There was some evidence of therapeutic carry-over effects in both clinical and biochemical measures in those children who received NTX before PLC . The results suggest that NTX only benefits a subgroup of autistic children , who may be identified by the presence of certain plasma abnormalities . These results suggest a possible linkage between abnormal plasma chemistries , especially those related to the pro-opiomelanocortin system , and autistic symptoms .

naltrexone

naltrexone ( NTX )

placebo

PLC

NTX

NTX

PLC

NTX

beta-endorphin

adrenocorticotropic hormone

norepinephrine

arginine-vasopressin

serotonin

plasma chemistries

autism

children

children

autistic

children


Placebo-controlled acute dosage naltrexone study in young autistic children . In a double-blind , placebo-controlled crossover trial 23 autistic children were treated with a single 40-mg dose of the opiate antagonist naltrexone . Drug effects were monitored by detailed playroom observations , actometers , and parents ' checklist ratings ( Aberrant Behavior Checklist , social items and target behaviors ) . Naltrexone treatment failed to produce significant changes in social behavior , but it did reduce irritability and target scores on behavior checklists . The playroom data indicated that naltrexone significantly affected indices of activity and attention .

Placebo-controlled

naltrexone

placebo-controlled

naltrexone

Naltrexone

naltrexone

significant changes

social behavior

activity and attention

young autistic children .

23 autistic children


Lung function measurement in general practice : a comparison of the Escort spirometer with the Micromed turbine spirometer and the mini-Wright peak flow meter . It is important that new types of spirometer for widespread clinical use are pragmatically evaluated in primary care . This study compared measurements taken by a new portable Fleisch pneumotachograph spirometer ( known as the Escort ) with those of the commonly used mini-Wright peak flow meter and the Micromed Pocket turbine spirometer . A pragmatic study was conducted in two phases during routine surgeries at Aldermoor Health Centre , Southampton . Phase I compared the new spirometer with the mini-Wright peak flow meter and Phase 2 compared the new spirometer and the turbine spirometer . One hundred patients aged 5-88 years ( 56 patients with a history of chronic respiratory complaints and 44 patients without ) entered Phase 1 , and 100 patients aged 6-82 years ( 62 patients with a history of chronic respiratory complaints and 38 patients without ) entered Phase 2 . Each patient contributed only once to each phase , but some entered both phases on separate occasions . Ninety-five percent limits of agreement ( mean +/- SD ) were wide for all comparisons . Graphical plots revealed trends towards higher Escort values as mean values rose compared with both mini-Wright and turbine readings for peak expiratory flow rate and forced expiratory volume in one second . Possible over-reading of peak expiratory flow rate with the mini-Wright meter at low mean values was also seen . Readings taken with these different types of meter can not be interchanged with confidence in clinical practice . The clinical significance of the theoretically more accurate measures of lung function produced with the new meter , and indeed of spirometry itself , needs further investigation .

Escort spirometer

Micromed turbine spirometer

mini-Wright peak flow meter

spirometer

new portable Fleisch

pneumotachograph spirometer

mini-Wright peak flow meter

Micromed Pocket turbine spirometer

spirometer

mini-Wright peak flow meter

spirometer

turbine spirometer .

mini-Wright meter

Escort values

peak expiratory flow rate

measures of lung function

One hundred

5-88 years

56 patients

chronic respiratory complaints

44 patients

100 patients

6-82 years

62 patients

chronic respiratory complaints

38 patients


No effect of beta-carotene supplementation on the susceptibility of low density lipoprotein to in vitro oxidation among hypercholesterolaemic , postmenopausal women . The effect of beta-carotene on the susceptibility of low density lipoprotein ( LDL ) to oxidative modification was investigated in a double-blind , randomized placebo-controlled study . Hypercholesterolaemic , postmenopausal women were given 30 mg beta-carotene per day ( n = 15 subjects ) or placebo capsules ( n = 15 subjects ) for 10 weeks . They were instructed to follow the American Heart Association Step One diet . LDL , isolated before and after treatment was subjected to copper-catalysed lipid peroxidation . There were no significant differences between LDL from the beta-carotene and placebo groups , as assessed by measuring the lag time for formation of conjugated dienes ; the rate of formation and the amount of conjugated dienes formed ; the amount of lipid peroxides generated ; and the relative electrophoretic mobility , at baseline and after treatment . Dietary records showed that the subjects were consuming similar amounts and types of fat . No significant differences were found in the lipid composition and fatty acid pattern of LDL from the two groups . In conclusion , the results indicated that supplementation with beta-carotene in non-smoking , hypercholesterolaemic , postmenopausal women had no protective effect on the susceptibility of LDL to copper-catalysed modification in vitro .

beta-carotene supplementation

beta-carotene

30 mg beta-carotene per day

placebo capsules

beta-carotene

placebo

beta-carotene

in vitro oxidation

LDL

rate of formation

the amount of conjugated dienes formed

amount of lipid peroxides generated

electrophoretic mobility

protective effect

hypercholesterolaemic

postmenopausal

women

Hypercholesterolaemic

postmenopausal women

non-smoking

hypercholesterolaemic

postmenopausal women


[ Evaluating an interactive , multi-media learning system for the study of primary open angle glaucoma ] . Using the interactive multimedia learning system for studying open-angle glaucoma [ 3 ] a prospective , randomized , case-controlled study was carried out to determine the value of this new form of learning in terms of acceptance and the imparting of knowledge . This article describes details of the study and presents their results . Results were established on the basis of targeted questions asked prior to and after the learning phase , followed by an analysis of frequencies and significance testing by the Chi squared method . It was shown that the imparting of knowledge is significantly improved when this learning system is employed . In addition , after its first use , acceptance of this new medium rose dramatically .

interactive multimedia learning system

learning system

imparting of knowledge

acceptance of this new medium

study of primary open angle glaucoma


Chronopharmacology of enalapril in hypertensive patients . The pharmacokinetics and pharmacodynamics of enalapril , an angiotensin converting enzyme inhibitor , are reported to vary with the time of administration . The present study was undertaken to examine whether the effect of enalapril on plasma bradykinin ( BK ) , substance P and prostaglandin E2 ( PGE2 ) , which are likely to be involved in the mechanism of enalapril-induced cough , might also be affected by its time of administration . Enalapril 5 mg or placebo was given orally at 10:00 h ( day trial ) or 22:00 h ( night trial ) to 12 patients with essential hypertension . Serum concentrations of total drug ( enalapril + enalaprilat , its active metabolite ) during the day and night trials did not differ significantly at any time . However , serum enalaprilat tended to be higher and its maximum concentration greater in the day trial than in the night trial . Blood pressure 24 h after administration of enalapril was reduced at 22:00 h , but not at 10:00 h. Plasma BK tended to increase following enalapril administration at 10:00 h , but not at 22:00 h. Remarkable increases in plasma BK were observed in two patients in the day trial and one of them also complained of cough . However , no such increase in plasma BK or subsequent adverse effect were recorded in the night trial . Plasma substance P and PGE2 did not change significantly following enalapril administration either in the day or night trial . The results suggest that the response of BK to enalapril is affected by the time of administration . In patients who complain of cough during treatment with enalapril during the daytime , this adverse effect might be diminished or eliminated by a switch to night-time administration .

enalapril

enalapril

enalapril

Enalapril

placebo

enalapril

enalaprilat

serum enalaprilat

enalapril

enalapril

enalapril

enalapril

enalapril

serum enalaprilat

Blood pressure 24 h

Plasma BK

plasma BK

plasma BK

adverse effect

Plasma substance P

cough

hypertensive patients .


Synthetic serum substitute ( SSS ) : a globulin-enriched protein supplement for human embryo culture . OBJECTIVE The purpose of the present study was to evaluate whether an IVF protein supplement prepared from human serum albumin ( HSA ) and human globulins would retain performance characteristics equivalent to those reported for the commercial plasma expanders , Plasmatein ( Alpha Therapeutics , Los Angeles , California ) and Plasmanate ( Cutter Biological , Miles Inc. , Elkhart , Indiana ) . METHODS Pronuclear-stage human embryos were randomly divided and cultured in human tubal fluid medium ( HTF ) supplemented with either HSA ( 5 mg/mL ) or Plasmatein ( 10 % , v/v ; 5 mg/ml ) as a means of indirectly assessing the effect alpha- and beta-globulins have on embryonic development . Those results coupled with the known composition characteristics of Plasmatein were used as the starting basis to formulate test lots of synthetic serum substitute ( SSS ) . RESULTS Significantly ( P < 0.05 ) more of the human embryos cultured in Plasmatein supplemented medium reached the four-cell or greater stage by 40 hr postinsemination than a comparable group cultured in HSA alone . Lot 1 of SSS , formulated with HSA ( 84 % of total protein ) and human globulins ( 16 % of total protein ) and an aqueous lipoprotein fraction derived from human plasma ( Excyte IV ; Miles Diagnostics , Kankakee , Illinois ) , produced accelerated early embryonic growth relative to control murine embryos grown in the presence of Plasmatein , however , the percentage of the embryos reaching the hatched blastocyst stage was decreased ( 45 vs 100 % ) . Human embryos from seven patients , randomized to HTF medium supplemented with Plasmatein or lot 1 of SSS , showed equivalent growth at 36-40 hr postinsemination . A microprecipitate developed in media supplemented with lot 1 after several days of culture . The Excyte IV concentration was reduced and , ultimately , eliminated from the subsequent and final prototype lots of SSS . Murine embryos grown in the presence of lipoprotein free SSS showed significantly accelerated ( P < 0.01 ) growth at 17 hr postthaw compared to Plasmatein and all embryos progressed to hatching by 41 hr . Human embryos , randomized to either Plasmatein or lot 3 of SSS , showed significantly accelerated growth ( P < 0.01 ) when scored at 38 hr following insemination . CONCLUSION Synthetic serum substitute provides a convient , standardized means of adding protein to media used in assisted reproductive technology ( ART ) procedures .

Synthetic serum substitute ( SSS )

Plasmatein

Plasmanate

human tubal fluid medium ( HTF )

HSA ( 5 mg/mL )

( 10 % , v/v ; 5 mg/ml )

Plasmatein

Plasmatein

HSA

Plasmatein

SSS

SSS

Plasmatein

Plasmatein

SSS

Synthetic serum substitute

performance characteristics

four-cell or greater stage

early embryonic growth

growth

Excyte IV concentration

accelerated ( P < 0.01 ) growth

hatching

accelerated growth

seven


Hypertension and non-insulin-dependent diabetes . A comparison between an angiotensin-converting enzyme inhibitor and a calcium antagonist . The effects of the angiotensin-converting enzyme lisinopril were compared with those of the calcium antagonist nifedipine in 162 non-insulin-dependent diabetic hypertensive patients for a 24-week period . In 83 and 79 patients , respectively , lisinopril and slow-release nifedipine produced similar reductions in blood pressure ( systolic/diastolic : -16/-13 mmHg supine and -14/-11 mmHg standing after lisinopril ; -15/-12 mmHg supine and -14/-11 mmHg standing nifedipine ) . Fasting and post-prandial plasma glucose , glycosylated haemoglobin and plasma lipids appeared to be unaffected by either agent . Also , 28 % of the patients on lisinopril and 30 % of those on nifedipine presented microalbuminuria . Both drugs induced a reduction in the albumin excretion rate ( AER ) . The geometric mean x : tolerance factor of the reduction in AER among the 23 microalbuminuric patients on lisinopril ( -10.0 x:1.3 micrograms/min ) was greater , though not significantly so , than that observed in the 26 on nifedipine ( -0.9 x 1.2 micrograms/min ) . Moreover , lisinopril appeared to be better tolerated than nifedipine in our study population . Microalbuminuria is an important risk factor for cardiovascular mortality in non-insulin-dependent diabetic patients as well as in the general population . To what extent a reduction in the AER could ameliorate diabetic patients is , at present , unknown . Finally , both lisinopril and nifedipine showed a similar antihypertensive effect in these patients which was not associated with significant differences in plasma glucose , insulin or lipid concentrations . The clinical consequences of the insignificant differences in AER remain unclear .

angiotensin-converting enzyme inhibitor

calcium antagonist .

calcium antagonist nifedipine

lisinopril and slow-release nifedipine

lisinopril

nifedipine

lisinopril

nifedipine

lisinopril

nifedipine

lisinopril

nifedipine

reductions in blood pressure

glycosylated haemoglobin

plasma lipids

albumin excretion rate

reduction in AER

tolerated

AER

antihypertensive effect

AER

Hypertension

non-insulin-dependent diabetes

non-insulin-dependent diabetic


A randomised controlled trial comparing two schedules of antenatal visits : the antenatal care project . OBJECTIVE To compare the clinical and psychological effectiveness of the traditional British antenatal visit schedule ( traditional care ) with a reduced schedule of visits ( new style care ) for low risk women , together with maternal and professional satisfaction with care . DESIGN Randomised controlled trial . SETTING Places in south east London providing antenatal care for women receiving shared care and planning to deliver in one of three hospitals or at home . SUBJECT 2794 women at low risk fulfilling the trial 's inclusion criteria between June 1993 and July 1994 . MAIN OUTCOME MEASURES Measures of fetal and maternal morbidity , health service use , psychosocial outcomes , and maternal and professional satisfaction . RESULTS Pregnant women allocated to new style care had fewer day admissions ( 0.8 v 1.0 ; P=0.002 ) and ultrasound scans ( 1.6 v 1.7 ; P=0.003 ) and were less often suspected of carrying fetuses that were small for gestational age ( odds ratio 0.73 ; 95 % confidence interval 0.54 to 0.99 ) . They also had some poorer psychosocial outcomes ; for example , they were more worried about fetal wellbeing antenatally and coping with the baby postnatally , and they had more negative attitudes to their babies , both in pregnancy and postnatally . These women were also more dissatisfied with the number of visits they received ( odds ratio 2.50 ; 2.00 to 3.11 ) . CONCLUSIONS Patterns of antenatal care involving fewer routine visits for women at low risk may lead to reduced psychosocial effectiveness and dissatisfaction with frequency of visits . The number of antenatal day admissions and ultrasound scans performed may also be reduced . For the variables reported , the visit schedules studied are similar in their clinical effectiveness . Uncertainty remains as to the clinical effectiveness of reduced visit schedules for rare pregnancy problems .

schedules of antenatal visits

antenatal care

( traditional care )

antenatal care

new style care

antenatal care

visits

reduced visit schedules

health service use

psychosocial outcomes

maternal and professional satisfaction

day admissions

ultrasound scans

poorer psychosocial outcomes

fetal wellbeing antenatally

coping with the baby postnatally

attitudes

dissatisfied with the number of visits

psychosocial effectiveness

dissatisfaction

antenatal day admissions

ultrasound scans performed

women

women

women

Pregnant

women


Around-the-clock intraocular pressure reduction with once-daily application of latanoprost by itself or in combination with timolol . OBJECTIVE To determine whether once-daily , in the morning , topical application of the new ocular hypotensive prostaglandin analogue , latanoprost , yields nocturnal intraocular pressure ( IOP ) reduction similar to its diurnal IOP reducing efficacy . STUDY DESIGN AND PATIENTS Placebo- controlled , randomized , and double-masked study on hospitalized patients with ocular hypertension or glaucoma . Patients in group 1 ( n=9 ) were maintained on twice-daily applications of 0.5 % timolol maleate . Patients in group 2 ( n=10 ) terminated their timolol treatment 3 weeks before the beginning of the study . In both groups the test drug ( 0.005 % latanoprost ) and its vehicle ( placebo ) was applied by hospital staff every morning for 9 days . MEASUREMENTS After 4 days of ambulatory treatment , patients were hospitalized , and IOP values were obtained in the supine and sitting positions with a handheld electronic tonometer ( Tono-Pen XL , Bio-Rad , Glendale , Calif ) and a Goldmann 's applanation tonometer , covering every 2-hour interval , around the clock , but not more than at four time points per day during a 5-day period . RESULTS The mean nocturnal IOPs ( Goldmann 's applanation tonometer ) collected for 5 days were mean +/-SEM 17.9+/-0.6 vs 20.2+/-0.6 mm Hg and 16.8+/-0.3 vs 20.6+/-0.5 mm Hg for the study vs the control eyes in group 1 and group 2 , respectively . These nocturnal IOP reductions were statistically significant ( P < .001 , two-tailed paired Student 's t test ) . The differences between diurnal and nocturnal IOP reductions ( handheld electronic or Goldmann 's applanation tonometer ) were minimal ( > 0.3 mm Hg ) and statistically not significant ( P > .31 , two-tailed paired Student 's t test ) . CONCLUSION Once-daily latanoprost treatment provides uniform circadian ( around-the-clock ) IOP reduction by itself , or in combination with timolol .

latanoprost

combination with timolol

latanoprost

timolol maleate

timolol

latanoprost

placebo

latanoprost

timolol

intraocular pressure reduction

IOP values

nocturnal IOP reductions

diurnal and nocturnal IOP reductions

IOP reduction


Concentration of inhaled amiloride in cystic fibrosis .

inhaled amiloride

cystic fibrosis .


Five-year follow-up of the Fluorouracil Filtering Surgery Study . The Fluorouracil Filtering Surgery Study Group . PURPOSE To determine the efficacy and safety of subconjunctival 5- fluorouracil injections after trabeculectomy in patients with poor prognoses , to determine risk factors for surgical failure and to examine the relationship of intraocular pressure and visual function . METHODS In this multicenter clinical trial , 213 patients with previous cataract surgery or previous failed filtering surgery were randomly assigned to receive either trabeculectomy alone or trabeculectomy with postoperative subconjunctival 5-fluorouracil injections . Measurements of intraocular pressure , visual acuity , and visual fields were performed throughout the five years , with the clinician masked to the treatment group . Failure was defined as a reoperation to control intraocular pressure or an intraocular pressure greater than 21 mm Hg at or after the first-year examination . RESULTS Fifty-four ( 51 % ) of the 105 eyes in the 5-fluorouracil group and 80 ( 74 % ) of the 108 eyes in the standard filtering surgery group were classified as failures ( P < .001 , Mantel-Cox survival analysis ) . Risk factors for failure include high intraocular pressure , a short time interval after the last procedure involving a conjunctival incision , the number of procedures with conjunctival incisions , and Hispanic ethnicity . Patients in both treatment groups with controlled intraocular pressures were more likely to maintain visual acuity . Patients in the 5-fluorouracil group had a higher risk of late-onset bleb leaks ( 9 % nine of 105 ) than those in the standard filtering surgery group ( 2 % two of 108 ) ( P = .032 , Fisher 's exact test ) . CONCLUSIONS We recommend the use of subconjunctival 5-fluorouracil after trabeculectomy in eyes after previous cataract surgery or unsuccessful filtering surgery , but caution against its routine use in patients with good prognoses .

Fluorouracil Filtering Surgery

Fluorouracil Filtering Surgery

trabeculectomy

trabeculectomy

subconjunctival 5-fluorouracil

efficacy

safety

intraocular pressure

visual function

intraocular pressure

visual acuity

visual fields

intraocular pressure

intraocular pressure

high intraocular pressure

visual acuity

late-onset bleb leaks


Prevention of venous thromboembolism after knee arthroplasty . A randomized , double-blind trial comparing enoxaparin with warfarin . OBJECTIVE To compare the effectiveness and safety of fixed-dose enoxaparin and adjusted dose warfarin in preventing venous thromboembolism after knee arthroplasty . DESIGN A randomized , double-blind controlled trial . SETTING 8 university hospitals . PATIENTS 670 consecutive patients who had knee arthroplasty . INTERVENTION Patients were randomly assigned to receive enoxaparin ( 30 mg subcutaneously every 12 hours ) or adjusted-dose warfarin ( international normalized ratio , 2.0 to 3.0 ) . Both regimens were started after surgery . MEASUREMENTS The primary end point was the incidence of deep venous thrombosis in patients with adequate bilateral venograms ; the secondary end point was hemorrhage . RESULTS Among the 417 patients with adequate venograms , 109 of 211 warfarin recipients ( 51.7 % ) had deep venous thrombosis compared with 76 of 206 enoxaparin recipients ( 36.9 % ) ( P = 0.003 ) . The absolute risk difference was 14.8 % in favor of enoxaparin ( 95 % Cl , 5.3 % to 24.1 % ) Twenty-two warfarin recipients ( 10.4 % ) and 24 enoxaparin recipients ( 11.7 % ) had proximal venous thrombosis ( P > 0.2 ) . The absolute risk difference was 1.2 % in favor of warfarin ( Cl , -7.2 % to 4.8 % ) . The incidence of major bleeding was 1.8 % ( 6 of 334 patients ) in the warfarin group and 2.1 % ( 7 of 336 patients ) in the enoxaparin group ( P > 0.2 ) . The absolute risk difference was 0.3 % in favor of warfarin ( Cl , -2.4 % to 1.8 % ) . CONCLUSIONS A postoperative , fixed-dose enoxaparin regimen is more effective than adjusted-dose warfarin in preventing deep venous thrombosis after knee arthroplasty . No differences were seen in the incidence of proximal venous thrombosis or clinically overt hemorrhage .

enoxaparin

warfarin .

fixed-dose enoxaparin

adjusted dose warfarin

warfarin

enoxaparin

enoxaparin

warfarin

enoxaparin

warfarin

enoxaparin

warfarin

effectiveness and safety

incidence of deep venous thrombosis

hemorrhage .

deep venous thrombosis

absolute risk difference

absolute risk difference

major bleeding

absolute risk difference

knee arthroplasty

after knee arthroplasty

knee arthroplasty

adequate bilateral venograms

adequate venograms

after knee arthroplasty


Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2 : a randomized , double-blind , placebo-controlled trial . OBJECTIVE Our purpose was to determine whether a protocol for outpatient induction is safe and effective for initiating labor . STUDY DESIGN A randomized , double-blind , placebo-controlled trial was performed with 100 low-risk patients having well-dated pregnancies . Women with a Bishop score < or = 6 at 38 to 40 weeks ' gestation were administered either 2 mg of intravaginal prostaglandin E2 gel or placebo for 5 consecutive days as outpatients while undergoing fetal monitoring . RESULTS The median interval from randomization to delivery was 4 days in the prostaglandin E2 group ( range 0 to 28 days ) versus 10 days in the placebo group ( range 0 to 26 days , p = 0.002 ) . Twenty-seven of 50 patients ( 54 % ) in the prostaglandin E2 group were admitted for labor during the dosing interval compared with 10 placebo-treated patients ( 20 % , p = 0.001 ) . The mean gestational age at delivery was significantly reduced in the treatment group ( 39.9 +/- 1.0 weeks vs 40.5 +/- 0.99 weeks , p = 0.003 ) as was the incidence of postdates pregnancy ( 40 % vs 66 % , p = 0.016 ) . Hyperstimulation was observed in one prostaglandin E2-treated patient , but no intervention was required . CONCLUSIONS Outpatient low-dose prostaglandin E2 gel administration is effective for initiating labor in patients with an unfavorable cervix and appears safe if performed with adequate monitoring .

prostaglandin E2 :

placebo-controlled

placebo-controlled

prostaglandin E2

placebo

prostaglandin E2

prostaglandin E2-treated

prostaglandin E2 gel

Efficacy

interval from randomization to delivery

mean gestational age at delivery

incidence of postdates pregnancy

Hyperstimulation

effective

initiating labor

pregnancies

Bishop score < or = 6

38 to 40 weeks ' gestation

unfavorable cervix


Effect of marine oils supplementation on coagulation and cellular activation in whole blood . A study was performed to explore the effects of supplemental intake of various marine oils known to be part of the Eskimo diet . Healthy men and women ( 134 ) were randomly selected to consume 15 mL/d of oil from blubber of seal , cod liver , seal/cod liver , blubber of Minke whale , or no oil for ten weeks . Total cholesterol was unchanged in the oil groups , whereas high density lipoprotein cholesterol increased 7 % in the seal/cod liver oil ( CLO ) group ( P < 0.05 ) and 11 % in the whale oil group ( P < 0.005 ) . Triacylglycerol was significantly reduced in the CLO group only . The concentration of prothrombin fragment 1 + 2 was reduced 25 % ( P < 0.05 ) after whale oil supplementation . No change in fibrinogen or factor VIIc was detected . Tumor necrosis factor generation in lipopolysaccharide ( LPS ) -stimulated blood was 30 % reduced after whale oil ( P < 0.05 ) , but was unaffected by intake of seal or CLO . The LPS-induced tissue factor activity in monocytes was reduced to a significant degree only in the seal/CLO group ( 34 % ) and whale oil group ( 35 % ) ( P < 0.05 ) . The most dramatic change in thromboxane B2 in LPS-stimulated blood was seen after whale oil intake with 44 % reduction ( P < 0.01 ) . Supplementation of a regular diet with a combination of seal oil and CLO and especially with whale oil seems to have beneficial effects on several products thought to be associated with cardiovascular and thrombotic diseases .

marine oils supplementation

blubber of Minke whale

no oil

seal/cod liver oil

whale oil

Total cholesterol

high density lipoprotein cholesterol

Triacylglycerol

fibrinogen or factor VIIc

thromboxane B2

Eskimo diet

men and women


The sequencing of chemotherapy and radiation therapy after conservative surgery for early-stage breast cancer . BACKGROUND Patients with early-stage breast cancer who are at substantial risk for systemic metastases are increasingly treated with breast-conserving therapy and adjuvant chemotherapy . However , the optimal sequencing of chemotherapy and radiation therapy is not clear . METHODS Two hundred forty-four patients with stage I or II breast cancer who were at substantial risk for distant metastases were randomly assigned to receive a 12-week course of chemotherapy either before or after radiation therapy . All had had breast-conserving surgery . The median length of follow-up in surviving patients was 58 months ( range , 10 to 124 ) . RESULTS The five-year actuarial rates of cancer recurrence at any site and of distant metastases in the radiotherapy-first group and the chemotherapy-first group were 38 percent and 31 percent ( P = 0.17 ) and 36 percent and 25 percent ( P = 0.05 ) , respectively . Overall survival was 73 percent and 81 percent ( P = 0.11 ) , respectively . The five-year crude rates of first recurrence according to site in the radiotherapy-first and chemotherapy-first groups , respectively , were 5 percent and 14 percent for local recurrence and 32 percent and 20 percent for distant or regional recurrence or both . This difference in the pattern of recurrence was of borderline statistical significance ( P = 0.07 ) . CONCLUSIONS This study suggests that for patients ar substantial risk for systemic metastases , it is preferable to give a 12-week course of chemotherapy followed by radiation therapy , rather than radiation therapy followed by chemotherapy .

breast-conserving therapy

adjuvant chemotherapy

chemotherapy

radiation therapy

radiotherapy-first

chemotherapy-first

radiotherapy-first

chemotherapy-first

radiation therapy

Overall survival

pattern of recurrence

breast cancer

breast cancer

metastases

Two hundred forty-four

breast cancer

metastases

metastases


Measurement of health-related quality of life in multiple myeloma . Nordic Myeloma Study Group . When a randomized trial ( NMSG 4/90 ) comparing treatment with melphalan/prednisone to melphalan/ prednisone + interferon alpha-2b in newly diagnosed multiple myeloma was initiated in 1990 , a quality-of-life assessment was integrated into the study . We used the questionnaire ( QLQ-C30 ) developed by the European Organization of Research and Treatment of Cancer ( EORTC ) Study Group on Quality of Life . The QLQ-C30 incorporates five functional scales , three symptom scales , a global health and quality-of life scale and some single symptom measures . The questionnaire was completed prior to treatment and after 1 , 6 , 12 , 24 , 36 and 48 months . 524 ( 90.2 % ) of 581 patients enrolled in the NMSG 4/90 completed the first questionnaire , and 484 ( 83.3 % ) completed all questionnaires given to them . All but one of the scales met the minimum criteria of reliability ( Cronbach 's alpha > / 0.70 ) . Validity was shown by ( 1 ) the ability of the scales to discriminate clearly between patients differing in clinical status as defined by pretreatment W.H.O . performance index and Durie & Salmon stage , and ( 2 ) the sensitivity to changes in objective disease status ( response and relapse ) . This is the first report of the measurement of health-related quality of life in a prospective clinical trial in multiple myeloma . The results demonstrate that the QLQ-C30 is a reliable and valid instrument for the measurement of quality of life in these patients . The data will be used for a cost-utility analysis of the results of the NMSG 4/90 trial .

melphalan/prednisone

health-related quality of life

quality-of-life

assessment

Quality of Life

quality-of life scale

health-related quality of life

quality of life

multiple myeloma

multiple myeloma


Iobitridol 300 compared to iopromide 300 -- a double-blind randomized phase-III study of clinical tolerance in total body CT. UNLABELLED PURPOSE , MATERIAL AND METHODS : The clinical safety of iobitriodol 300 mg I/ml and iopromide 300 mg I/ml were compared in a randomized double blind phase-III study conducted on 60 patients undergoing abdominal CT for a variety of indications . Each examination was rated as diagnostic or nondiagnostic and the image quality was noted . Nature , onset , intensity as well as outcome of each adverse reaction were recorded . RESULTS There was no significant difference in imaging quality and side effects between the contrast media . In this study , both iobitridol and iopromide provided excellent image quality and a low rate of side effects . CONCLUSION Iobitridol is a safe and effective nonionic contrast agent for contrast-enhanced body CT .

Iobitridol 300

iopromide 300 -- a

iobitridol

iopromide

Iobitridol

onset

adverse reaction

imaging quality

side effects

excellent image quality

low rate of side effects

safe

effective nonionic contrast agent

total body CT.


Processing familiar and unfamiliar auditory stimuli during general anesthesia . We tested memory priming for auditory stimuli presented during general propofol-sufentanil anesthesia in 58 patients undergoing day-case arthroscopic surgery . Stimuli were presented via headphones and consisted of common facts ( Group A , 29 patients ) , or familiar or unfamiliar full names of fictitious people ( GRoup B , 29 patients ) . Group A was expected to give more correct answers to questions about the common facts than Group B , when tested postoperatively , and Group B to attribute more fame to presented names than Group A ( famous names test ) . Because the process for learning new or unfamiliar stimuli ( elaboration ) in particular may be impaired under general anesthesia , more memory priming was expected for familiar than for unfamiliar material . No significant differences were demonstrated between the two groups in performance on common facts or in fame attributed to the names . The amount of memory priming , however , was positively related to one of two measures of preoperative anxiety .

auditory stimuli

general propofol-sufentanil anesthesia

day-case arthroscopic surgery

performance on common facts

fame

amount of memory priming

preoperative anxiety

general anesthesia

general propofol-sufentanil anesthesia

day-case arthroscopic surgery

Group A , 29

GRoup B , 29

general anesthesia


Recovery profile after desflurane with or without ondansetron compared with propofol in patients undergoing outpatient gynecological laparoscopy . We studied the effect of combining prophylactic ondansetron ( 4 mg intravenously [ IV ] ) to desflurane-based anesthesia in 90 ASA grade I or 11 women undergoing outpatient gynecological laparoscopy . Recovery after anesthesia , with special focus on postoperative nausea and vomiting ( PONV ) , was assessed . Control groups received a similar desflurane anesthetic ( placebo ) or a propofol-infusion-based ( active control ) anesthetic . The study design was randomized , controlled , and double-blind ( regarding ondansetron ) and single-blind ( regarding the anesthetic technique ) . Early recovery ( eye opening , orientation , following commands , sitting ) was similar in the three groups . However , overall home readiness ( toleration of oral fluids , walking , pain tolerable by oral analgesics , no or only mild nausea ) was achieved faster in the desflurane group receiving ondansetron ( 109 [ 21-937 ] min , P < 0.01 ) and in the propofol group ( 110 [ 33-642 ] min , P < 0.001 ) when compared to the desflurane only group ( 372 [ 45-723 ] min ) ( median [ range ] ) . The total incidence of PONV in the desflurane-only group was 80 % ( P < 0.01 ) , compared to 40 % and 20 % in the desflurane group receiving ondansetron and the propofol group , respectively . The postoperative antiemetic requirements were consistently and significantly ( P < 0.01 ) higher in the desflurane-only group compared to the other two groups . Postoperative sedation , analgesic requirements , and psychomotor recovery ( assessed by the Maddox Wing and the Digit Symbol Substitution Tests ) were similar in the three groups . Our results suggest that in order to achieve a propofol-like recovery profile in patients with a high likelihood of PONV , desflurane should be combined with a potent antiemetic ( e.g. , ondansetron ) .

desflurane with or without ondansetron

propofol

prophylactic ondansetron

desflurane-based anesthesia

gynecological laparoscopy

desflurane anesthetic ( placebo )

ondansetron

ondansetron

desflurane

desflurane-only

desflurane

propofol

desflurane-only

propofol-like

desflurane

home readiness

PONV

postoperative antiemetic requirements

propofol-like recovery profile

outpatient gynecological laparoscopy

women


Antihistaminics in idiopathic dystonia .

Antihistaminics

idiopathic dystonia .


Comparison of synemol cream and other topical corticosteroid creams using the vasoconstrictor bioassay . The human vasoconstrictor bioassay was used to assess the potency of open applications of Synemol cream ( 0.025 % ) , Diprosone cream ( 0.05 % ) , Aristocort-A cream ( 0.5 % ) , and Valisone cream ( 0.1 % ) . Intensity of vasoconstriction was determined eight , twenty-four , and thirty-two hours after application . Results obtained from the average intensity scores of the three determinations indicated that Synemol cream ( 0.025 % ) is actually a more active compound than are Diprosone cream ( 0.05 % ) , Aristocort-A cream ( 0.5 % ) , and Valisone cream ( 0.1 % ) , and that its activity is longer acting .

synemol cream

topical corticosteroid creams

Synemol cream

Diprosone cream ( 0.05 % )

Aristocort-A cream

Valisone cream ( 0.1 % )

Synemol cream

Diprosone cream

Aristocort-A cream

Valisone cream

intensity scores


Antibiotic strategy after the empiric phase in patients treated for a hematological malignancy . Empiric broad-spectrum antibiotic therapy has become a generally accepted strategy in the treatment of febrile neutropenic patients . Particularly in patients with prolonged neutropenia , subsequent adaptation of such a regimen will be the rule rather than exception . Since there are no uniformly accepted guidelines for the modification of antibiotic therapy during the post-empiric phase , we assessed the impact of a set of rules that evolved during the first randomized trials . Evaluation of the clinician 's compliance with these rules in 1951 febrile neutropenic episodes was the subject of the present analysis . Treatment was modified in 761 ( 39 % ) cases , and these changes were made according to the rules in 76 % . For 75 % of the alterations in treatment during the evening and night shifts , no reasonable explanation was established , while 93 % of the modifications during the normal working hours were made for objective reasons . The empiric regimen was more frequently changed in patients with a clinical focus of infection at the onset of fever than in patients who showed fever as the only symptom of a possible infection . The perceived need for modification amounted to 69 % in pulmonary infections , to 51 % in skin and soft-tissue infections , to 44 % in patients with abdominal complaints , and to 37 % in upper respiratory tract infections . Glycopeptides constituted 22 % of modifications , particularly in patients with a central venous catheter , and systemically active antifungals were administered in 16 % of cases . Especially inexperienced clinicians tend to adjust antibiotic therapy , in spite of the fact that persistence of fever alone seldom reflects inadequate treatment when the clinical condition of the patient is stable or improving . On the other hand , the development of subsequent infectious events emphasizes that a genuine need for modification does frequently exist .

Antibiotic strategy

antibiotic therapy

antibiotic therapy

hematological malignancy

febrile neutropenic

prolonged neutropenia


Antifungal pulse therapy for onychomycosis .

Antifungal pulse therapy

onychomycosis .


Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment : a controlled clinical trial . Few controlled clinical trials of psychological interventions for cancer pain relief exist in spite of frequent support for their importance as adjuncts to medical treatment . This study compared oral mucositis pain levels in 4 groups of cancer patients receiving bone marrow transplants ( BMT ) : ( 1 ) treatment as usual control , ( 2 ) therapist support , ( 3 ) relaxation and imagery training , and ( 4 ) training in a package of cognitive-behavioral coping skills which included relaxation and imagery . A total of 94 patients completed the study which involved two training sessions prior to treatment and twice a week 'booster ' sessions during the first 5 weeks of treatment . Results confirmed our hypothesis that patients who received either relaxation and imagery alone or patients who received the package of cognitive-behavioral coping skills would report less pain than patients in the other 2 groups . The hypothesis that the cognitive-behavioral skills package would have an additive effect beyond relaxation and imagery alone was not confirmed . Average visual analogue scale ( VAS ) report of pain within the therapist support group was not significantly lower than the control group ( P = 0.103 ) nor significantly higher than the training groups . Patient reports of relative helpfulness of the interventions for managing pain and nausea matched the results of VAS reports . From these results , we conclude that relaxation and imagery training reduces cancer treatment-related pain ; adding cognitive-behavioral skills to the relaxation with imagery does not , on average , further improve pain relief .

treatment as usual control

pain

cancer pain relief

pain

pain

nausea

cancer treatment-related pain

pain relief


The individual responsiveness to growth hormone ( GH ) treatment in GH-deficient adults is dependent on the level of GH-binding protein , body mass index , age , and gender . The aim of the present trial was to study the individual responsiveness to GH treatment in terms of body composition and to search for possible predictors of the response in GH-deficient adults . Sixty-eight patients ( 44 men and 24 women ) with a mean age of 44.3 ( 1.2 ) yr and verified GH deficiency participated in a 2-phase treatment trial with an initial randomized , double blind , placebo-controlled , 6-month period , followed by an open treatment period , thereby ensuring all patients 12 months of GH treatment . Recombinant human GH was administered sc daily at bedtime , with a target dose of 12 micrograms/kg x day . GHBP was measured by ligand-mediated immunofunctional assay , and serum insulin-like growth factor I ( IGF-I ) was determined by RIA after acid-ethanol extraction , using a truncated IGF-I analog as the radioligand . Lean body mass ( LBM ) and body fat ( BF ) were determined by dual energy x-ray absorptiometry , and total body water ( TBW ) was determined by bioelectrical impedance . During the placebo control period , serum IGF-I , LBM , and TBW increased ( P < 0.001 ) , whereas BF decreased ( P < 0.001 ) and serum GHBP was unchanged in the group treated with GH compared with the patients treated with placebo . After 12 months of GH treatment , the individual changes in BF ranged from -12.5 to 4.3 kg and from -4.5 to 10.1 kg in LBM . Age ( P < 0.05 ) and baseline GHBP level ( P < 0.01 ) were inversely correlated with the increase in LBM . The GH-induced increment in IGF-I and TBW was greater in men than in women ( P < 0.01 ) , whereas the decreases in BF were similar in men and women . This trial demonstrates the variability in responsiveness to GH administration in GH-deficient adults . The best response to GH was obtained in younger patients with low GHBP levels . Furthermore , men responded better than women .

growth hormone ( GH ) treatment

GH treatment

placebo-controlled

Recombinant human GH

GH

body mass index

Lean body mass ( LBM )

body fat ( BF )

serum IGF-I

LBM

TBW

BF

serum GHBP

BF

baseline GHBP level

GH-induced increment in IGF-I and TBW

BF

GH-deficient

adults

Sixty-eight

men

24 women

mean age of 44.3 ( 1.2 ) yr

verified GH deficiency


The effects of amantadine and pemoline on cognitive functioning in multiple sclerosis . BACKGROUND Amantadine hydrochloride and pemoline , both frequently used to treat the fatigue of multiple sclerosis ( MS ) , may also improve attention and other cognitive functions in MS. To our knowledge , these agents have never been compared in a placebo-controlled trial of patients with MS . OBJECTIVE To evaluate the effects of amantadine and pemoline on cognitive functioning in MS. METHODS A total of 45 ambulatory patients with MS and severe fatigue were treated for 6 weeks with amantadine , pemoline , or placebo using a parallel group design . They underwent comprehensive neuropsychological testing to determine treatment effects on cognitive functioning . Primary outcome measures were tests of attention ( Digit Span , Trail Making Test , and Symbol Digit Modalities Test ) , verbal memory ( Selective Reminding Test ) , nonverbal memory ( Benton Visual Retention Test ) , and motor speed ( Finger Tapping Test ) . RESULTS Fatigue did not significantly correlate with any of the neuropsychological outcome measures at baseline or after treatment . All three treatment groups improved on tests of attention ( P < .003 ) , verbal memory ( P < .001 ) , and motor speed ( P < .002 ) . There were no significant differences between amantadine , pemoline , and placebo . CONCLUSIONS Cognitive functioning in MS is independent of fatigue . Neither amantadine nor pemoline enhances cognitive performance in MS compared with placebo .

amantadine

pemoline

Amantadine hydrochloride

pemoline

amantadine and pemoline

amantadine , pemoline

placebo

amantadine

pemoline

placebo .

motor speed ( Finger Tapping Test )

Fatigue

tests of attention

verbal memory

motor speed

patients with MS .


Fadrozole HCL ( CGS-16949A ) versus megestrol acetate treatment of postmenopausal patients with metastatic breast carcinoma : results of two randomized double blind controlled multiinstitutional trials . BACKGROUND Breast cancer patients with prior response to endocrine therapy achieve subsequent benefit from additional endocrine therapies . The efficacy and safety of an aromatase inhibitor , fadrozole HCL , were compared with megestrol acetate in post menopausal patients who had disease progression after receiving antiestrogen therapy either for metastatic disease or as adjuvant therapy . METHODS In 2 multiinstitutional prospective trials , 683 postmenopausal patients were randomized to receive either fadrozole HCL , 1 mg twice daily , or megestrol acetate , 40 mg 4 times daily , in a double blind fashion after progression on first-line hormonal therapy . Objective response rates , time to progression , survival and safety of the two regimens were compared . RESULTS Results of intent-to-treat analyses are presented in this study . No significant differences were detected between the two treatment groups in time to progression , objective response rates , duration of response , and survival in either trial . There were no clinically meaningful differences between the treatment groups in the incidence and severity of adverse experiences , except that weight gain , fluid retention , and dyspnea were observed in more patients in the megestrol acetate group compared with those receiving fadrozole HCL , whereas nausea and vomiting were observed in more patients in the fadrozole HCL group compared with those receiving megestrol acetate . CONCLUSIONS Fadrozole HCL was as efficacious as megestrol acetate in postmenopausal patients with metastatic breast carcinoma after one hormonal therapy . Adverse experiences were mild with both therapies , but megestrol acetate was associated wiht a higher frequency of weight gain , fluid retention and dyspnea , whereas fadrozole HCL was associated with a higher frequency of nausea and vomiting .

Fadrozole HCL ( CGS-16949A )

megestrol acetate

fadrozole HCL

fadrozole HCL , 1 mg twice daily

megestrol acetate , 40 mg 4 times daily

first-line hormonal therapy

Fadrozole HCL

fadrozole HCL

Objective response rates

time to progression

survival

safety

time to progression

objective response rates

duration of response

survival

adverse experiences

weight gain

fluid retention

dyspnea

nausea and vomiting

efficacious

nausea and vomiting

postmenopausal

metastatic breast carcinoma

Breast cancer

postmenopausal

metastatic breast carcinoma


Comparative efficacy of intravenous ibutilide versus procainamide for enhancing termination of atrial flutter by atrial overdrive pacing . This study compares the influence of intravenous ibutilide , a class III antiarrhythmic agent , with procainamide , a class IA antiarrhythmic agent , and with placebo on its ability to terminate atrial flutter using rapid atrial pacing . Fifty-nine episodes of atrial flutter in 54 patients who failed to terminate with an intravenous infusion of ibutilide , procainamide , or placebo alone underwent attempts at pacing termination using a standard protocol of burst atrial overdrive pacing . Atrial flutter cycle length and atrial monophasic action potential duration recorded from the right atrium during atrial flutter were measured at baseline and following infusion of ibutilide , procainamide , or placebo . Both ibutilide and procainamide significantly enhanced ( p < 0.001 ) pacing-induced termination of atrial flutter compared with placebo . Pacing converted 2 of 11 patients ( 18 % ) who received placebo , 13 of 15 patients ( 87 % ) who received ibutilide , and 29 of 33 patients ( 88 % ) who received procainamide to sinus rhythm . Ibutilide and procainamide compared with placebo markedly reduced ( p < 0.001 ) the incidence of pacing-induced atrial fibrillation . The atrial flutter cycle length was prolonged significantly less ( p < 0.001 ) , and the atrial monophasic action potential duration was increased significantly more ( p < 0.001 ) by ibutilide than by procainamide . Although the electrophysiologic changes induced by these antiarrhythmic agents contributed to facilitating pacing-induced termination , neither tachycardia cycle length nor action potential duration were useful predictors of the ability of pacing to terminate atrial flutter . In conclusion , despite differing electrophysiologic effects , the use of intravenous ibutilide or procainamide enhances the termination of atrial flutter by atrial overdrive pacing .

ibutilide

procainamide

ibutilide

procainamide

placebo

ibutilide

procainamide

placebo

ibutilide

procainamide

placebo .

ibutilide

procainamide

placebo .

placebo

ibutilide

procainamide

Ibutilide

procainamide

placebo

ibutilide

procainamide .

ibutilide

procainamide

sinus rhythm .

atrial flutter


Effect of n-3 polyunsaturated fatty acid intake on phospholipid fatty acid composition in plasma and erythrocytes . To characterize the time course of plasma and red blood cell ( RBC ) changes after n-3 polyunsaturated fatty acid ( PUFA ) supplementation , 20 healthy male volunteers were randomly assigned to receive either four 1-g capsules of n-3 PUFA ethyl esters or four 1-g capsules of olive oil ( as placebo ) for a period of 4 mo , followed by a 3-mo washout period . Fatty acids of plasma and RBC phospholipid fractions were analyzed at 0 , 2 , and 4 mo of treatment and at 1 , 2 , and 3 mo of washout . During n-3 PUFA supplementation , accumulations of eicosapentaenoic ( EPA ) , docosapentaenoic ( DPA ) , and docosahexaenoic ( DHA ) acids were marked after 2 mo with differences among different fractions of plasma and RBCs in further accumulation up to 4 mo . During the first and second months of the washout , slight differences were observed in changes of various fatty acids among different phospholipid fractions , but after 3 mo of washout , only minor alterations were still detectable with respect to pretreatment values . These data confirm the complex relations among different fatty acid pools after n-3 PUFA supplementation .

n-3 polyunsaturated fatty acid intake

n-3 PUFA supplementation

n-3 PUFA supplementation

Fatty acids of plasma

RBC phospholipid fractions

eicosapentaenoic ( EPA )

docosapentaenoic ( DPA )

docosahexaenoic ( DHA ) acids

different fatty acid pools


Pentoxifylline therapy in HIV seropositive subjects with elevated TNF . Tumor necrosis factor-alpha ( TNF-alpha ) is thought to induce cachexia in subjects infected with human immunodeficiency virus ( HIV ) , and it has been suggested that HIV-seropositive patients would benefit from treatment with pentoxifylline , a known suppressor of TNF-alpha production . The purpose of the present study was to examine how pentoxifylline at a dose of 800 mg thrice daily would influence the cellular immune system in HIV-seropositive persons with elevated TNF-alpha . Six HIV-seropositive subjects with elevated amounts of TNF-alpha in plasma at least at two occasions were included in an open , controlled , randomized , cross-over study consisting of a 6 week treatment period and a 6 week control period . Blood samples were collected before and at the end of each period . Pentoxifylline treatment did not influence the concentration of plasma-TNF-alpha , subpopulations of blood mononuclear cells , the proliferative responses nor the natural killer ( NK ) , and lymphokine activated killer ( LAK ) cell activities . Furthermore , pentoxifylline treatment did not influence the weight , temperature , well being , or tiredness of the subjects . However , the patients frequently reported gastrointestinal side effects . In vitro , however , pentoxifylline at suprapharmacological concentrations inhibited the blood mononuclear cell ( BMNC ) proliferative responses , NK , and LAK cell activities .

Pentoxifylline

pentoxifylline

6 week control period

cellular immune system

gastrointestinal side effects .

NK

LAK cell activities

HIV seropositive

HIV-seropositive

Six

HIV-seropositive


Feedlot performance and carcass characteristics of Holstein steers as affected by source of dietary protein and level of ruminally protected lysine and methionine . The objective of this study was to determine the effects of source of dietary CP and level of ruminally protected lysine and methionine ( RPLM ) on feedlot performance and carcass characteristics of Holstein steers during a growing-finishing trial ( 266 d ) . A total of 168 Holstein steers ( 182.7 +/- 27.5 kg ) were used in a completely randomized design experiment ( eight treatments ; three pens of seven steers/treatment ) . Steers were given ad libitum access to high-concentrate diets ( 13 % CP ) containing 71 % whole shelled corn , 10 % corn silage , 4 % condensed distillers solubles , and 15 % protein supplements ( DM basis ) . Treatments were arranged as a 2 x 4 factorial . The main factors were two sources of dietary CP and four levels of RPLM . The sources of dietary CP were soybean meal ( SBM ) or SBM and urea ( SBM-U ) . Urea-N replaced 50 % of SBM-N in the SBM-U diet . The levels of RPLM were 0 , 5 , 10 , and 15 g per steer daily . No interactions ( P > .10 ) between source of dietary CP and level of RPLM were observed for feedlot performance or carcass characteristics . Feedlot performance showed an advantage ( P < .10 ) to feeding SMB during the first 84 d of the trial and an advantage to feeding SBM-U during the last 98 d of the trial . However , feedlot performance for the whole trial and carcass characteristics ( except for fat thickness ) were not affected ( P > .10 ) by the source of dietary CP . Steers fed diets containing SBM-U had 12 % less ( P < .10 ) fat thickness than those fed diets containing SBM . Supplementation of diets with increasing levels of RPLM did not affect ( P > .10 ) ADG or carcass characteristics . However , DMI and gain : feed showed cubic ( P < .10 ) responses to increasing dietary level of RPLM . Supplementation of RPLM at the 10 g/d level improved gain : feed by 12 % during the last 98 d of the trial , and this was a direct response to the cubic effects of RPLM on DMI . Results suggest a cost advantage for replacing 50 % of SBM-N with that from urea in high-corn diets without negative effects on feedlot performance or carcass characteristics of growing-finishing Holstein steers with extended feeding periods ( 266 d ) . These types of diets seem to meet the amino acid requirements and are not limiting in lysine and methionine .

( 13 % CP )

effects

feedlot performance

and

carcass characteristics

dietary CP

Urea-N

dietary CP and level of RPLM

carcass characteristics

Feedlot performance

feedlot performance

fat thickness

fat thickness

cubic ( P < .10 ) responses

gain : feed

Holstein

steers

Holstein steers

Holstein steers

182.7 +/- 27.5 kg

Holstein steers


Effectiveness of erythromycin in the treatment of acute bronchitis . BACKGROUND Clinical trials have not shown a consistent benefit of treating bronchitis with antibiotics . Many physicians , however , treat acute bronchitis with antibiotics because of the possibility of Mycoplasma pneumoniae or other pathogens . The objectives of this study were to determine the effectiveness of erythromycin treatment in patients with acute bronchitis and to determine whether a newly developed rapid M pneumoniae antibody test is useful in predicting which patients will respond to therapy . METHODS We conducted a randomized , double-blind , placebo-controlled clinical trial at three primary care centers in North Carolina . A convenience sample of 140 patients presenting with acute bronchitis were tested for M pneumoniae , 91 of whom were treated with either erythromycin 250 mg four times daily for 10 days or an identical-appearing placebo . RESULTS Patients treated with erythromycin missed an average of only 0.81 +/- 1.1 days of work compared with 2.16 +/- 3.2 days for placebo-treated patients ( P < .02 ) . There were no significant differences in cough , use of cough medicine , general feeling of well-being , or chest congestion between the erythromycin and placebo groups . Twenty-five percent of the patients tested positive for M pneumoniae . There were no differences in response to erythromycin based on whether the patient had a positive test for M pneumoniae . CONCLUSIONS Erythromycin is effective in significantly reducing lost time from work , but it is not effective in reducing cough or other symptoms in patients with acute bronchitis , regardless of the outcome of the M pneumoniae antibody test .

erythromycin

erythromycin

erythromycin

erythromycin

placebo-treated

erythromycin

placebo

erythromycin

Erythromycin

days of work

cough

use of cough medicine

general feeling of well-being

chest congestion