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PubMed2000

A randomized trial of 3,4-diaminopyridine in Lambert-Eaton myasthenic syndrome.

OBJECTIVES: The authors report the results of a prospective, placebo-controlled, randomized study to evaluate the effectiveness of 3,4-diaminopyridine (DAP) in patients with Lambert-Eaton myasthenic syndrome (LEMS) and to determine the acute and long-term side effects of DAP. METHODS: Twenty-six patients with LEMS completed a two-arm parallel treatment protocol in which DAP, 20 mg three times daily, or placebo was given blindly for 6 days, and a quantitative examination of muscle strength (the quantitative myasthenia gravis [QMG] score) was used as the primary measure of efficacy. After the blinded study, patients were given open-label DAP and monitored for side effects as long as there was symptomatic improvement. RESULTS: Twelve patients took DAP, and 14 took placebo. There was no difference in the age of LEMS onset, gender distribution, incidence of lung cancer, or baseline muscle strength between the patients who were randomly assigned to receive placebo and those randomly assigned to DAP. Statistical analysis using the Wilcoxon's rank sum test demonstrated that patients who received DAP had a significantly greater improvement in the QMG score and in the summated amplitude of compound muscle action potentials recorded from three sentinel limb muscles. All but one LEMS patient had significant symptomatic improvement from subsequent open-label DAP. Side effects of DAP were negligible, consisting of perioral and digital paresthesia. Laboratory measurements demonstrated no evidence of toxicity affecting liver, renal, hematologic, endocrinologic, encephalographic, or electrocardiologic function acutely or after 6 months of open-label DAP. CONCLUSIONS: This study corroborates previous studies and many years of clinical experience showing that DAP is an effective and safe treatment for LEMS.

4-Aminopyridine↗
PubMed1991

Prolonged effect of a new platelet-activating factor antagonist on ocular vascular permeability in an endotoxin model of uveitis.

Platelet-activating factor (PAF) is a membrane-derived lipid mediator involved in inflammatory responses. In the present study, the effect of a new, synthetic PAF antagonist, BN 50726, on ocular-blood barrier breakdown was investigated in a model of anterior uveitis produced by injection of 5 microL 0.1% endotoxin into the midstroma of rabbit corneas. Severe keratitis and anterior uveitis were induced in 3-4 days. BN 50726 was applied once subconjunctivally and then topically four times daily for 5 days in a blind-designed experiment. Vascular permeability was measured each day with an automated fluorophotometer after injection of fluorescein-conjugated dextran. BN 50726 significantly decreased ocular vascular permeability up to the fifth day of treatment. In another series of animals, slit-lamp observation showed significant reduction in iris erythema and epithelial damage with BN 50726 treatment. These results show that the PAF antagonist reduces early and late responses in uveitis. The possibility that PAF interacts with other inflammatory mediators to affect breakdown of the blood-aqueous barrier is discussed.

Animals↗
PubMed1999

[An epidemiological survey and treatment of blindness in Zhangqiu city of Shandong province].

OBJECTIVE: An epidemiological survey of blindness was carried out in Zhangqiu city of Shandong province. METHODS: According to stratified random sampling rule, 11,884 persons were chosen as the sample (the sampling fraction is 1.27%) in the city. The WHO grading system for blindness was followed in the survey. RESULTS: The prevalence of blindness was found to be 0.31%, resulting chiefly from cataract (45.95%), glaucoma (24.32%) and vitreous retinal disease (13.51%). 1 016 cases of blindness caused by cataract were operated for restoration of vision, that were accounted for 73.89% of all cataract blindness estimated from the result of the survey. The rate of intraocular lens implantation in the restorative operations was 84.15% (855/1,016). After operation, the corrected vision in 64.47% of the blindness was >or= 1.0, in 21.26% between 0.6 - 0.9, in 10.24% between 0.3 - 0.5, and in 4.03% between 0.05 - 0.2. CONCLUSION: The epidemiological results show that the main cause of blindness is cataract. So it is the key objective for surgical restoration of vision in the prevention of the blindness in later days.

Adolescent↗
PubMed1988

Bopindolol in the treatment of moderate hypertension: a dose-response study.

To determine the optimal antihypertensive dose of bopindolol, we performed a randomized double-blind study in parallel groups. After 15 days of placebo single-blind, 115 hypertensive patients received daily for 28 days one of 4 doses: 0 mg (placebo), 0.5 mg, 1.0 mg, 2.0 mg. The reduction of supine diastolic blood pressure (BP) did not exhibit the pattern of a dose-effect relationship. The effect of 0.5 mg belonged to the plateau of the dose-effect curve (P = 0.1, analysis of variance). The reduction of heart rate (HR) followed a typical dose-effect curve, with a plateau beginning with 1 mg (P = 0.02). A trend toward an increase in the incidence of side-effects with dosage was observed (P = 0.3). Thus, the optimal antihypertensive dose may be 0.5 mg or less. Previous studies not using parallel randomized groups suggested an antihypertensive dose ranging from 2 to 4 mg. This study confirms that the dose-effect curves of beta blockers on HR and BP are dissociated. The dose-effect curve of HR seems unsuitable for assessing the optimal antihypertensive dose of a beta blocker.

Adrenergic beta-Antagonists↗
PubMed1996

Remikiren (Ro 42-5892)--an orally active renin inhibitor in essential hypertension. Effects on blood pressure and the renin-angiotensin-aldosterone system.

Remikiren (Ro 42-5892) is a new orally active renin inhibitor with high potency and specificity in vitro. In the present study, the drug was given in a short-term study in patients with essential hypertension, either as monotherapy or with added hydrochlorothiazide. Following a wash-out period of at least 3 weeks and then 8 days of single-blind placebo, 29 patients with essential hypertension were given remikiren 600 mg orally for 8 days. After 4 days of remikiren, hydrochlorothiazide 12.5 mg or 25 mg or placebo was added in double-blind fashion for the last 4 days. There were no significant changes in blood pressure in patients given remikiren alone. In patients given additional hydrochlorothiazide for 4 days, a marked reduction in blood pressure was observed. Remikiren effectively inhibited the plasma renin activity 24 h post-dose, whereas angiotensin II was reduced only during the first hours after drug administration. It is concluded that remikiren is orally effective. Its antihypertensive effect during short-term administration was not significant, but when given with a diuretic, a marked potentiation occurred. Further studies are needed to establish the long-term effects of remikiren alone and in combination therapy.

Antihypertensive Agents↗
PubMed1984

A double-blind comparison of the efficacy and safety of lorazepam and diazepam in the treatment of the acute alcohol withdrawal syndrome.

The safety and efficacy of lorazepam and diazepam were compared in the treatment of the acute alcohol withdrawal syndrome during a five-day double-blind trial in alcoholic patients. The daily doses of lorazepam and diazepam were tapered from 6 or 8 mg to 2 mg and from 30 or 40 mg to 10 mg, respectively, during the first four days; no medication was given on day 5. Drug efficacy was measured by Total Severity Assessment Scores (TSAS), the three TSAS factor scores, and by the physician's global evaluation. Of the 55 inpatients enrolled, 47 completed the study. There were no statistically significant differences between the treatment groups in any of the efficacy assessment measures. The physical conditions of the majority of the patients treated with lorazepam (57%) and diazepam (59%) improved during therapy. There were no clinically significant differences between the treatment groups in vital signs or laboratory values. The results of this study indicate that lorazepam is as effective as diazepam in reducing the symptoms of acute alcohol withdrawal. When lorazepam and diazepam are compared in terms of their pharmacokinetics, lorazepam may have therapeutic advantages for the management of the acute alcohol withdrawal syndrome.

Adult↗
PubMed2001

Opipramol for the treatment of generalized anxiety disorder: a placebo-controlled trial including an alprazolam-treated group.

Opipramol, a drug widely prescribed in Germany, is a tricyclic compound with no reuptake-inhibiting properties. However, it has pronounced D2-, 5-HT2-, and H1-blocking potential and high affinity to sigma receptors (sigma-1 and sigma-2). In early controlled trials, anxiolytic effects were revealed. However, those studies were performed before the concept of generalized anxiety disorder (GAD) was established. Because of the interesting receptor-binding profile and promising results of the early clinical trials, the authors performed a state-of-the-art placebo-controlled trial using alprazolam as an active control. Three hundred seven outpatients with GAD were included. After a 7-day single-blind placebo washout, patients were randomly assigned to receive either opipramol (final dose, 200 mg/day), alprazolam (2 mg/day), or placebo and were treated for 28 days. The efficacy of both active compounds was higher than the effects with placebo treatment. There were statistically significant differences (p < 0.05, according to the analysis of covariance) in the main outcome criterion (baseline-adjusted final means of an intent-to-treat analysis of the total scores on the Hamilton Rating Scale for Anxiety) and in secondary efficacy parameters, with global improvement of 47% for placebo and significantly more for opipramol (63%) and alprazolam (64%). Regarding safety and tolerability, no substantial differences in the number of adverse events observed between treatment groups were obvious. Sedation seemed more pronounced with alprazolam treatment than with opipramol or placebo. In this trial, it was demonstrated for the first time that opipramol, a strong but nonselective sigma site ligand, possesses anxiolytic efficacy superior to placebo in the treatment of GAD.

Adolescent↗
PubMed2000

A fenfluramine-activated FDG-PET study of borderline personality disorder.

BACKGROUND: Impulsive aggression in patients with personality disorders is associated with diminished levels of cerebrospinal fluid (CSF) 5-HIAA, blunted neuroendocrine responses to serotonergic agonists, and decreased glucose utilization in the prefrontal cortex. We tested the hypothesis that impulsive aggression in borderline personality disorder (BPD) may be associated with diminished serotonergic regulation in the prefrontal cortex, using positron-emission tomography (PET) neuroimaging during pharmacologic challenge with d,l fenfluramine (FEN). METHODS: A 2-day, single-blind, placebo-controlled FEN challenge study was conducted in five patients with BPD (and no Axis I MDD) and eight healthy control participants. On Day 1, 4 mCi [(18)F]-fluorodeoxyglucose (FDG) was injected 3 hours after ingestion of placebo; on Day 2, FDG was injected 3 hours after ingestion of.8 mg/kg to 60 mg of d,l fenfluramine. After 30 min, a 45-min emission scan was acquired on the Siemans/CTI 951r/31 scanner. PET data were aligned to MR images and analyzed by Statistical Parametric Mapping (SPM96). RESULTS: In response to placebo, uptake of FDG was greater in control participants than patients in large areas of the prefrontal cortex including medial and orbital regions bilaterally (BA 10-11), left superior temporal gyrus, and right insular cortex. There were no areas in which patients had greater relative regional uptake than control participants. In response to FEN, relative regional uptake of FDG (relative to placebo) was greater in control participants compared to patients in medial and orbital regions of right prefrontal cortex (BA 10), left middle and superior temporal gyri (BA 22-23), left parietal lobe (BA 40), and left caudate body. CONCLUSIONS: Patients with BPD have diminished response to serotonergic stimulation in areas of prefrontal cortex associated with regulation of impulsive behavior.

Adolescent↗
PubMed1979

Evaluation of blood culture procedures in a pediatric hospital.

To determine optimal clinical laboratory techniques for detecting pediatric bacteremia, we studied 7,768 consecutive blood cultures in a 1-year period. Blood was inoculated into one vented 50-ml bottle of brucella broth with 0.05% sodium polyanetholsulfonate and one unvented 50-ml bottle of Columbia broth with 0.05% sodium polyanetholsulfonate and 0.05% cysteine. Bottles were visually examined for growth on days 1 through 7 and blindly subcultured aerobically and anaerobically on days 1, 2, and 7. There were 724 (9.3%) positive cultures, and 484 (6.2%) were clinically significant. The most frequent isolates from bacteremic patients were Haemophilus influenzae (24%) and Streptococcus pneumoniae (17%). Growth was noted in only one bottle in 25% of clinically significant isolates. Bottles inoculated with greater than or equal to 1 ml of blood became positive earlier than bottles inoculated with less than 1 ml. After 1 day of incubation, 48% of the clinically significant cultures showed growth on visual examination, whereas 85% showed growth on subculture. Only 19% of Haemophilus isolates were detected visually on day 1, whereas 88% were recovered on subculture. By day 7, 3.5% of all isolates (including 18% of pneumococcal isolates and 1% of Haemophilus isolates) could no longer be recovered on subculture. We conclude that a two-bottle blood culture system and blind subculture within 24 h will optimize detection of pediatric bacteremia.

Bacteria↗
PubMed1983

A multicenter, double-blind comparison of oxaprozin, phenylbutazone, and placebo therapy in patients with tendinitis and bursitis.

The effects of 1,200 mg of oxaprozin once daily, 100 mg of phenylbutazone four times daily, and placebo were compared in the treatment of 125 patients with acute tendinitis and bursitis in a seven-day double-blind study at six clinical sites. Patients in all three treatment groups showed significant (P less than 0.05) improvement as early as the third treatment day. Both the oxaprozin- and phenylbutazone-treated patients frequently showed significantly (P less than 0.05) greater improvement than those in the placebo group in both physician and patient efficacy assessments. The most frequently reported adverse effects were nausea, vomiting, and headache. The results of this study indicate that oxaprozin is as effective and safe as phenylbutazone and superior to placebo in the treatment of patients with acute tendinitis and bursitis.

Acute Disease↗
PubMed1993

[Diclofenac vs nimesulide in arthrosis. Plasma levels and clinical efficacy].

Diclofenac and nimesulide are non-steroidal antiinflammatory agents advocated for use in painful and inflammatory rheumatic and certain non rheumatic conditions. In Uruguay, these drugs are administered in doses of 100 mg and 200 mg once a day, respectively. Diclofenac is an effective and safe analgesic and antiinflammatory drug. There are scarce data available on the pharmacokinetic profile of nimesulide. These facts encouraged us to undertake the present study on clinical efficacy, tolerance and pharmacokinetics of nimesulide, controlled with sustained release diclofenac. Twenty patients with osteoarthritis, stage II-III, according to a clinical-radiological evaluation, were selected for the study. Patients were assigned at random to treatment A (Voltaren sustained release, 100 mg) or B (Nodo regular formulation, 200 mg) once a day. A double blind study with active drug and controlled parallel groups was designed. After a washout period of one week patients were treated with active medication during 84 days, and clinical controls every 14 days ensued. Experienced rheumatologists assessed pain and other clinical symptoms. Blood samples were drawn on days 7, 49 and 91 of the study, ten hours after the morning dose, and plasma diclofenac and nimesulide concentrations were measured. On day 7 and 91, blood counts and biochemical laboratory studies were performed (namely, hemoglobin, RBC, WBC, leucocyte differential count, platelet count, alkaline phosphatase, ASAT, ALAT, creatinine, etc.) Already two weeks after the study had begun, significant improvements in clinical parameters assessed were seen for both treatments. A trend to accumulation of diclofenac and nimesulide along the three months of treatment was observed.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2001

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial.

OBJECTIVE: Baclofen is known for the alleviation of signs and symptoms of spasticity. Reports from our previous study have suggested that it may be at least as effective as clonidine in the management of physical symptoms of opiate withdrawal syndromes and superior to clonidine in the management of mental symptoms. We now report on a randomized double-blind comparison of baclofen vs. clonidine in view of side-effects profile. METHODS: A total of 62 opiates addicts were randomly assigned to treatment with baclofen or clonidine during a 14-day, double-blind clinical trial. All patients met the DSM IV criteria for opioid dependence. Maximum daily doses were 40 mg for baclofen and 0.8 mg for clonidine. This trial medication was given three times per day in divided doses. The severity of side-effects was measured in days 0, 1, 2, 3, 4, 7 and 14. RESULTS: There was no significant difference between two treat7ments in terms of retention in treatment (dropout) and overall side-effect. Nevertheless, significantly more problems relating to hypotension were encountered with subjects on clonidine. CONCLUSION: We conclude that, the low incidence of hypotension with baclofen suggests that the drug may be suitable for outpatient ambulatory treatment of withdrawal from opiates.

Adult↗
PubMed1983

Parathion alters incubation behavior of laughing gulls.

One member of each pair of incubating laughing gulls at 9 nests was trapped, orally dosed with either 6 mg/kg parathion in corn oil or corn oil alone, and marked about the neck with red dye. Each nest was marked with a numbered stake and the treatment was recorded. A pilot study with captive laughing gulls had determined the proper dosage of parathion that would significantly inhibit their brain AChE activity (about 50% of normal) without overt signs of poisoning. After dosing, birds were released and the nests were observed for 2 1/2 days from a blind on the nesting island. The activities of the birds at each marked nest were recorded at 10-minute intervals. Results indicated that on the day of treatment there was no difference (P greater than 0.05, Chi-square test) in the proportion of time spent on the nest between treated and control birds. However, birds dosed with 6 mg/kg parathion spent significantly less time incubating on days 2 and 3 than did birds receiving only corn oil. By noon on the third day, sharing of nest duties between pair members in the treated group had approached normal, indicating recovery from parathion intoxication. These findings suggest that sublethal exposure of nesting birds to an organophosphate (OP) insecticide, such as parathion, may result in decreased nest attentiveness, thereby making the clutch more susceptible to predation or egg failure. Behavioral changes caused by sublethal OP exposure could be especially detrimental in avian species where only one pair member incubates or where both members are exposed in species sharing nest duties.

Animals↗
PubMed1989

[Evaluation of the effectiveness and tolerance of cicletanine in patients with essential hypertension treated with beta-blockers].

The effectiveness and safety of cicletanine hydrochloride, the first representative of the furopyridine family, were evaluated in a 90-day double-blind study involving 120 patients with moderate essential hypertension poorly controlled after at least one month of treatment with a beta-blocker. After a 30-day pre-inclusion period during which a placebo capsule was given together with a stable dose of the beta-blocker, the patients were randomised to one of three therapeutic groups: group 1 (placebo, n = 40), group 2 (cicletanine 50 mg/day, n = 41), group 3 (cicletanine 100 mg/day, n = 39). All three groups were matched in every respect. Eight patients in group I were excluded (5 for ineffectiveness, 2 for unexpected effect, 1 for intercurrent disease) as was 1 patient in group 3 for unexpected effect. On entering the active phase of treatment, supine blood pressures were 171.3 +/- 13.6/103.9 +/- 6.1 mmHg in group 1, 173.5 +/- 12.7/103.6 +/- 5.2 mmHg in group 2 and 171.8 +/- 15.4/104.5 +/- 5.9 mmHg in group 3. A significant (p less than 0.0001) treatment effect on SBP was found in groups 2 and 3 and on DBP in all three groups. The improvement observed in both SBP and DBP was similar in groups 2 and 3 and highly significant when compared with group 1 (p 0.001). At the end of the trial, 5% of group 1 patients, 51.2% of group 2 patients and 74.4% of group 3 patients had normal blood pressure values. The drug was well tolerated clinically and biochemically.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗
PubMed1997

Dose-dependent enhancements by interferon-gamma on functional responses of neutrophils from chronic granulomatous disease patients.

Interferon-gamma (IFN-gamma) is recommended as prophylaxis against infections in patients with chronic granulomatous disease (CGD). However, since the optimal dose, the dosing interval, and the mechanisms of action are not well-defined, we studied the effects on CGD neutrophil (PMN) functions ex vivo of interferon-gamma (IFN-gamma). Evaluations were made on oxidative capacity, measured by superoxide anion production and chemiluminescence after stimulation with f-met-leu-phe (f-MLP) or phorbol-myristate-acetate, the killing of Aspergillus fumigatus hyphae (assessed as conversion of the tetrazolium salt MTT to formazan), and on the expression of Fc gammaRI receptor (CD64). After randomization, 9 CGD patients (4 with gp91phox, 3 with p47phox, 1 with p67phox deficiency and 1 with unspecified CGD) were given IFN-gamma, either 50 or 100 microg/m2 subcutaneously on 2 consecutive days after double blinded randomization. Furthermore, one female hyperlyonized X-linked carrier with a CGD phenotype was also studied separately after IFN-gamma treatment. Evaluations were made the day before and on days 1, 3, 8, and 18 after IFN-gamma administration. The killing of A fumigatus hyphae, being close to zero before IFN-gamma, was enhanced on day 3, being 36% higher than pretreatment values in the high-dose CGD group and 17% in the low-dose group. The expression of Fc gammaRI on PMN increased 3.7-fold in the high-dose and 2.3-fold in the low-dose CGD group, being maximal on day 1. Oxidative functions were raised in only selected patients represented by different subtypes of CGD. The hyperlyonized carrier of X-linked CGD responded to IFN-gamma with more enhanced oxidative responses and Aspergillus killing of her PMNs than the other patients. This study suggests that a higher dose of IFN-gamma than currently recommended confers transient enhancements of certain PMN functions in CGD patients.

Adolescent↗
PubMed1976

Alternate-day prednisone: preliminary report of a double-blind controlled study.

Thirteen patients with moderately severe myasthenia gravis participated in a double-blind study using either 100 mg of prednisone or an equivalen numbder of placebo tablets on alternate days. Anticholinesterase therapy was continued on a demand basis. At the end of 6 months the code was broken. Seven patients were on placebo and three of these had improved to such a degree that steroid therapy was not indicated. Four of these patients ultimately were started on prednisone and improved. Of the six patients on prednisone, three showed no improvement and three were improved. At the end of 2 years, the seven patients still taking prednisone were on maintenance dosage of this drug. Three of this group had experienced relapses when the dosage was cut to 15 to 25 mg on alternate days, and they again improved when the prednisone dosage was increased. No statistical evaluation is possible because of the small number of patients. It can be stated that seven patients improved with steroid therapy. Conversely, not all patients treated with alternate-day prednisone improved. Finally, any evaluation of treatment of myasthenia gravis must take into consideration the potential for spontaneous improvement, as demonstrated by three of the patients treated with placebo.

Adrenocorticotropic Hormone↗
PubMed2001

Oxcarbazepine (Trileptal) as monotherapy in patients with partial seizures.

OBJECTIVE: To evaluate the efficacy and safety of oxcarbazepine (OXC) as monotherapy for patients with uncontrolled partial seizures. METHODS: A multicenter, double-blind, randomized, parallel-group, dose-controlled monotherapy trial compared OXC at 2400 mg/day with OXC at 300 mg/day in patients with uncontrolled partial-onset seizures previously receiving carbamazepine (CBZ) monotherapy. During a 28-day open-label conversion phase, patients were tapered off CBZ and titrated to OXC 2400 mg/day. After a 56-day open-label baseline phase on OXC 2400 mg/day, patients entered a 126-day double-blind treatment phase in which they were randomized to continue OXC at 2400 mg/day or were down titrated over 6 weeks to OXC at 300 mg/day. Patients met the efficacy endpoint by completing the double-blind treatment phase or by meeting one of four predefined exit criteria. The primary efficacy variable was time to meeting one of the exit criteria. The secondary efficacy variable was the percentage of patients meeting one of the exit criteria in each of the two treatment groups. RESULTS: Of the 143 patients enrolled, 96 were randomized in the double-blind treatment phase. Time to meeting an exit criterion was significantly in favor of the OXC 2400 mg/day group (p = 0.0001). The median time to meeting an exit criterion was 68 days for the OXC 2400 mg/day Group and 28 days for the OXC 300 mg/day Group. In addition, the percentage of patients meeting one of the exit criteria was significantly lower for the OXC 2400 mg/day Group (p = 0.0001). Overall, OXC was well tolerated with the most common adverse events consisting of fatigue, nausea, ataxia, and headache. CONCLUSION: This trial demonstrated that OXC at 2400 mg/day is well tolerated and efficacious when administered as monotherapy in patients with uncontrolled partial onset seizures.

Adolescent↗
PubMed1999

Monitoring changes in fat-free mass in HIV-positive men with hypotestosteronemia and AIDS wasting syndrome treated with gonadal hormone replacement therapy.

OBJECTIVE: To compare methods for assessing changes in body composition during gonadal hormone replacement therapy in a group of HIV-positive men with AIDS wasting syndrome. DESIGN: The study included a 21-day, double-blind, randomized, placebo-controlled inpatient intervention and a 12-week open-label intervention. The inpatient intervention included 18 men who were confined to a metabolic ward. Days 1-7 comprised weight stabilization and body composition measures followed by 14 days of nandrolone decanoate at either 65 or 195 mg weekly, or placebo, and repeat testing. The open-label intervention comprised 12 weeks of 200 mg nandrolone decanoate fortnightly with measurements of fat-free mass at 6 and 12 weeks. METHODS: The inpatient intervention measured nitrogen balance from 24 h urine and fecal collections and fat-free mass by dual energy x-ray absorptiometry (DEXA), bioimpedance spectroscopy (BIS) and D2O dilution. Nitrogen balance was calculated as the difference between dietary intake and urinary and fecal nitrogen excretion. Nitrogen was converted to fat-free mass using the constant of 32.5 g. Repeated measures analysis of variance was used to determine which methods were significantly different from the reference nitrogen balance technique. RESULTS: Nitrogen accretion of lean tissue was 0.55 and 0.85 kg weekly for low and high-dose groups, respectively. Estimated nitrogen retention during the open-label study was 0.42 kg weekly. Body weight increased with the estimated lean tissue accretion. DEXA, BIS and D2O methods demonstrated improvements in fat-free mass, although the BIS estimate of fat-free mass most closely matched the results of the nitrogen retention method. CONCLUSION: DEXA, BIS and D2O techniques demonstrated increases in fat-free mass. The BIS method is less costly, more convenient to use, and had results that more closely matched those from nitrogen balance and retention methods. BIS may be the preferred method to monitor changes in fat-free mass in AIDS patients and patients with malnutrition.

Anabolic Agents↗