TREATMENT OF CUTANEOUS LEISHMANIASIS WITH ORAL ITRACONAZOLE

Materials and Methods We conducted an open pilot study with the following inclusion criteria: (1) parasites detected on direct smear or in anatomopathological preparations, or strongly suggestive histology together with positive serology; (2) absence or failure of previous other specific antileishmanial treatnnent; (3) absence of spontaneous healing tendency; and (4) informed consent obtained. Pregnancy was an exclusion criterion. Direct smears were taken from the edge of lesions, fixed with methanol and stained with Giemsa stain. Skin biopsies (edge of lesions) were defined as positive when amastigotes were identified. If amastigotes could not be Identified, leishmaniasis was considered the most likely diagnosis when focal accumulations of histiocytes were observed in a dense dermal mononuclear infiltrate, associated with hyperplastic epidermis or necrosis and ulceration. Serological screening was performed with a precipitation-in-gel assay. Positive and suspect sera were analyzed with a direct agglutination test (DAT) as described previously^ and with immunoelectrophoresis.^ Itraconazole, 100 mg per capsule, was used. Adults were given 200 mg of itraconazole per os per day. Children received 5 mg/kg/day (maximum 200 mg/day). Treatment lasted for 4 or 8 weeks (depending upon the degree of healing after 4 weeks). Patients were seen at 0, 4, and 8 weeks. Blood for full blood count, urinalysis, and biochemistry tests (urea, creatinine, uric acid, liver enzymes, lactic dehydrogenase) was taken during every visit to detect toxicity. Final assessment was confirmed whenever possible at 6 months.

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