The efficacy of oxymetholone in combination with erythropoietin on hematologic parameters and muscle mass in CAPD patients.

OBJECTIVES: To determine the efficacy of oxymetholone, an androgenic steroid, in combination with rHuEPO on hematologic and muscle mass in CAPD patients. METHODS: A double-blinded, placebo-controlled experimental study was conducted for 6 months and 24 CAPD patients were divided into two groups. The treatment group (n = 11) received rHuEPO plus oral oxymetholone (50 mg/tablet twice daily). The placebo group (n = 13) received rHuEPO plus a placebo twice daily. The evolution of the patients' hematologic parameters and the impact of the drugs on their muscle mass were evaluated. RESULTS: After 6 months of therapy, hematocrit and hemoglobin values of the treatment group were significantly different from those of the placebo group (38.1 ± 1.0% and 32.8 ± 0.9%, p = 0.001; 12.9 ± 0.3 g/dl and 11.0 ± 0.3 g/dl, p = 0.001 for hematocrit and hemoglobin, respectively). The increase in hematocrit and hemoglobin values observed in treatment group was statistically greater than those of the placebo group (p < 0.01). After 6 months, none of anthropometric parameters, albumin, protein or lean body mass levels, were significantly different from baseline in the placebo group. Conversely, most of the anthropometric parameters, albumin and lean body mass levels were significantly increased in the oxymetholone group (p < 0.05). The mean weight of subjects in the oxymetholone group changed from 63.82 ± 2.71 to 67.02 ± 3.26 kg (p = 0.001). The subjective global assessment score for 7 patients in the treatment group (63.6%) changed in a positive manner. A rise in liver enzymes was the main side effect observed in the treatment group. CONCLUSIONS: Oxymetholone significantly enhances the erythropoietic effects of rHuEPO and improves the nutritional status of CAPD patients. However, significant increases in liver enzymes need to be monitored closely.

Oxymetholone ameliorates insulin sensitivity in maintenance hemodialysis patients: a randomized controlled trial.

AIMS: To investigate the beneficial effects of oral oxymetholone on IR in hemodialysis (HD) patients by increasing skeletal muscle function and stimulating myocyte glucose uptake and metabolism. METHODS: In a randomized, controlled double-blind study, 44 patients were randomly assigned to one of two groups: a treatment group that received oxymetholone 50 mg orally twice daily and a control group that received placebo twice daily for 24 weeks. IR was calculated by using HOMA, and dual-energy X-ray absorptiometry was used to determine body composition. All patients were encouraged to walk at least one kilometer daily and were monitored by the Barthel index activity score. RESULTS: 25 men (57%) and 19 women (43%) were studied. 23 subjects were in the control group, and 21 subjects were in the treatment group. The mean age of patients and the duration of dialysis were 43.5 +/- 9.9 years and 92.8 +/- 37.8 months, respectively. After treatment, the HOMA index and body fat mass (FM) were significantly decreased in the treatment group compared to those in the control group (10.8 +/- 16.4 vs. 3.1 +/- 4.5; p < 0.05 and 1.73 +/- 2.77 vs. 0.40 +/- 1.12 kg; p < 0.05, respectively). Concurrently, the mean change of fat free mass (FFM) in the treatment group was higher than that in the control group (3.24 +/- 1.74 vs. 0.65 +/- 1.21 kg, p < 0.05). Two patients in the treatment group experienced an elevation in serum liver enzymes (9.52%). CONCLUSION: HD patients treated with short-term oral oxymetholone showed an increase in insulin sensitivity when compared to the placebo group, and this effect depended on changes in FFM and FM.

Pseudallescheria boydii brain abscess in a renal transplant recipient: first case report in Southeast Asia.

Pseudallescheria boydii and its asexual form, Scedosporium apiospermum, are ubiquitous filamentous fungi that rarely cause central nervous system (CNS) infection. Brain abscess caused by P. boydii is a highly lethal infection, usually seen in organ transplant recipients who receive a number of immunosuppressive agents. We have presented a case of a 48-year-old man 6 years after renal transplantation who received methylprednisolone followed by antithymocyte globulin for treatment of acute cellular rejection. Eight weeks later, he developed fever, headache, and left-sided hemiparesis. Further investigation with magnetic resonance imaging of the brain showed multiple ring-enhancing hypodense lesions with marked edema which were compatible with brain abscesses. Following surgical drainage, multiple fungal elements were initially described as Aspergillus species. The patient failed to improve and died from rapidly progressive infection despite treatment with amphotericin B. Later a diagnosis was finally made by the isolation of P. boydii in pus culture. The specific diagnosis is difficult to rapidly make, because P. boydii mimics other fungi morphologically in tissue sections and may produce infections clinically similar to other mycoses. Culture of the organism is required for definitive diagnosis. P. boydii infections are important complications of transplantation. They are difficult to treat due to resistance to amphotericin B. Physicians should consider P. boydii a possible cause of brain abscess in organ transplant recipients, especially with heavy immunosuppressive agents. This is the first case report of CNS infection due to P. boydii in a renal transplant patient in Southeast Asia.

Pharmacokinetics of single-dose rosiglitazone in chronic ambulatory peritoneal dialysis patients.

BACKGROUND: End-stage renal disease (ESRD) is associated with marked alterations in the pharmacokinetics of many drugs, not only from reduction in renal clearance but also from changes in metabolic activity, bioavailability, volume of distribution and plasma protein binding. OBJECTIVE: To study the pharmacokinetics of a single 8-mg oral dose of rosiglitazone in patients with ESRD and requiring long-term chronic ambulatory peritoneal dialysis (CAPD). METHOD: The medication was administered just before the first exchange of peritoneal dialysis fluid on the day that blood and peritoneal dialysate collection was performed. RESULTS: In our CAPD patients the mean (+/-SD) T(max) and T(1/2) of rosiglitazone were 1.20 +/- 0.26 and 21.38 +/- 21.96 h respectively. These values were different to those reported for healthy volunteers reported in previous studies. The mean area under the concentration-time curve (AUC((0-infinity))) and an average maximum observed plasma concentration (C(max)) of rosiglitazone in our CAPD patients were 4203.56 +/- 2916.97 ng h/mL and 409.67 +/- 148.89 ng/mL respectively. These appear no different from those reported in healthy volunteers . CONCLUSION: The apparently significant difference in T(1/2) of rosiglitazone in CAPD patients compared with healthy volunteers suggest that dose adjustment may be necessary in order to avoid toxicity.

Simple and sensitive high-performance liquid chromatographic.

A rapid, selective, sensitive, and reproducible reversed-phase HPLC procedure for the quantitative determination of mycophenolic acid (MPA)--an active plasma metabolite of the immunosuppressant mycophenolate mofetil (MMF) in plasma is described. The procedure involves one-step extraction of MPA and the internal standard, standard [RS-60461-000: (E)-6-[1,3-dihydro-4-(4-carboxy-butoxy)-6-methoxy-7-methyl-3-oxo-5-is obenzo-furanyl-4-methyl-4-hexenoic acid] with dichloromethane-dichloroethane (1:1, v/v) at acidic pH. Chromatographic separation consisted of the mobile phase [acetonitrile-0.05% phosphate buffer, pH 3.4 (45:55, v/v)] running through the column (Techopak-10 C18) at flow-rate of 0.8 ml/min. Detection was at UV wavelength of 254 nm. The mean recoveries of MPA and the internal standard at concentrations of 0.1 and 20 microg/ml were 89-98%, and 90-96%, respectively. The within-day coefficients of variation for MPA were 0.3-7.8% and the day-to-day coefficients of variation were 1.1-2.0%. The minimum detectable concentrations for both MPA and the internal standard in plasma were 0.005 microg/ml. The method was found to be suitable for use in clinical pharmacokinetic study.