A randomized, double-blind, placebo-controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis.

BACKGROUND: Several modalities have been used for the treatment of cutaneous leishmaniasis (CL) with various results. In vitro and in vivo studies have shown inhibitory effects of azole drugs on Leishmania parasites. OBJECTIVES: To evaluate the efficacy and tolerability of oral itraconazole in the treatment of CL caused by L. major. METHODS: A total of 200 patients with parasitologically confirmed CL with a duration of less than 45 days from a well known L. major endemic area were included in a randomized, double-blind, placebo-controlled clinical trial. The patients received either itraconazole 200 mg daily (100 patients) or placebo (100 patients) for 8 weeks. The primary outcome measures were clinical cure (complete re-epithelization of all lesions) and parasitological cure at the end of the treatment. RESULTS: Eighty-three patients in the itraconazole and 75 patients in the placebo group completed the treatment course. After 8 weeks of treatment, clinical cure was observed in 59% and 53% and parasitological cure was observed in 83% and 76% of patients in the itraconazole and placebo groups, respectively, which were not significantly different. There was no difference in the rate of adverse events. CONCLUSIONS: An 8-week course of oral itraconazole was not more effective than placebo in the treatment of CL.

The bone density of thalassemic patients of Boo Ali Sina Hospital, Sari, Iran in 2002 does hydroxyurea help?

Osteopenia and osteoporosis are well known complications in beta thalassemia major (TM) patients. Their main cause is bone marrow hyperfunctioning. Hydroxyurea (HU) has recently been used successfully in TM to control ineffective erythropoiesis. This study was designed to measure the bone density of TM patients and evaluate whether the use of HU in these patients affects the development of osteoporosis. Sixty three patients with TM, 67% female, aged 25 -/+ 7.2, were included in the study. Forty four percent were on HU and 56% had regular blood transfusions. Z-scores of the BD of femur and lumbar spine were -1.85 -/+ .78 and -1.61 -/+ 1.03 respectively and were the same in both sexes. Twenty two percent had normal BD, 45% were osteopenic, 17% had osteoporosis, and 16% had severe osteoporosis. There was no statistically significant correlation between BD and age. In a case-control analysis, BDs of 16 patients taking HU for at least 2 years were compared to 16 patients matched by sex and age who did not use HU. The bone densities in each group were not statistically different. Osteopenia is common in our patients. As a more severe osteopenia was expected in patients who were not on blood transfusions, HU may have some beneficial effect.