Accession Number : ADA269848
Title : Efficacy and Safety of Pentostam in Peruvian Mucosal Leishmaniasis.
Descriptive Note : Final rept. 15 Jul 88-31 Aug 92,
Corporate Author : NAVAL MEDICAL RESEARCH AND DEVELOPMENT COMMAND BETHESDA MD
Personal Author(s) : Franke, Eileen
Report Date : 01 OCT 1992
Pagination or Media Count : 25
Abstract : In the first part of this study we showed that the World Health Organization recommended regimen for the treatment of mucosal leishmaniasis, which is 20 mg antimony (Sb)/kilogram body weight/day for a minimum period of 28 days, although safe, is ineffective in the treatment of disease involving both the nasal and oral mucosa. Although 75% of patients with nasal lesions only were cured, the cure rate in patients with both nasal and oral lesions was only 10%. In an effort to improve upon this low cure rate, in the second part of the study we compared the efficacy and toxicity of two regimens of Sb, 28 and 40 days of 20 mg Sb/kg/day, in the treatment of culture-positive mucosal leishmaniasis involving more than one anatomic site. Forty consecutive eligible Peruvians with infiltrative or ulcerative mucosal disease of the lips, nose, palate-uvula-pharynx, or larynx-epiglottis were randomized to receive either 28 days (P28) or 40 days (P40) of sodium stibogluconate (Pentostam). Treatment was prematurely terminated due to thrombocytopenia in 3 patients and 2 patients did not complete 6 months of follow up. The cure rate after 12 months of follow up was 63% for both groups (10/16 in the P28 group and 12/19 in the P40 group). Since the cure rates did not differ between the two treatment regimens, there is no therapeutic advantage to increasing the length of treatment with Pentostam to 40-days in patients with disease involving more than one anatomic site.
Descriptors : *LEISHMANIASIS, *RESISTANCE(BIOLOGY), *ANTIPARASITIC DRUGS, ANTIMONY, BODIES, BODY WEIGHT, CULTURES(BIOLOGY), DISEASES, HEALTH, LARYNX, LENGTH, LESIONS, NOSES, ORGANIZATIONS, PATIENTS, RATES, SITES, SODIUM, THROAT, THROMBOCYTOPENIA, TOXICITY, WEIGHT, ADVERSE CONDITIONS, CLINICAL MEDICINE, SKIN DISEASES, PARASITIC DISEASES, VEINS, INFECTIOUS DISEASES.
Subject Categories : Medicine and Medical Research
Distribution Statement : APPROVED FOR PUBLIC RELEASE