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OBJECTIVES:To assess the efficacy and tolerability of aminosidine compared with sodium stibogluconate for treating visceral leishmaniasis. DESIGN:Randomised, unblinded, controlled trial with 180 day follow up. SETTING:Kala-Azar Research Centre, Brahmpura, Muzaffarpur, Bihar, India. SUBJECTS:People of either sex aged 6-50 years with symptoms and signs suggestive of visceral leishmaniasis (fever, loss of appetite, enlarged spleen) with leishmania amastigotes detected in Giemsa stained aspirates of spleen or bone marrow. INTERVENTIONS:Aminosidine at three daily doses (12, 16, and 20 mg/kg) for 21 days and sodium stibogluconate 20 mg/kg/day for 30 days. MAIN OUTCOME MEASURES:Laboratory measures of efficacy: parasite count, haemoglobin concentration, white cell count, platelet count, serum albumin concentration. Clinical measures of efficacy: spleen size, fever, body weight, and liver size. Measures of safety: liver and renal function tests, reports of adverse events. RESULTS:Of the 120 patients enrolled (30 per treatment arm), 119 completed treatment and follow up. Cure at end of follow up was achieved in 23 (77%), 28 (93%), and 29 (97%) patients treated with 12, 16, and 20 mg aminosidine/kg/day respectively, and in 19 (63%) patients given sodium stibogluconate. At 16 and 20 mg/kg/day, aminosidine was significantly more active than sodium stibogluconate in both clinical and laboratory measures of efficacy. No significant clinical or laboratory toxicity occurred in any treatment group. CONCLUSIONS:A 21 day course of aminosidine 16 or 20 mg/kg/day should be considered as first line treatment for visceral leishmaniasis in Bihar.

Original publication

DOI

10.1136/bmj.316.7139.1200

Type

Journal article

Journal

BMJ (Clinical research ed.)

Publication Date

04/1998

Volume

316

Pages

1200 - 1205

Addresses

Kala-Azar Research Centre Muzaffarpur, Brahmpura, Muzaffarpur, Bihar, India.

Keywords

Humans, Leishmaniasis, Visceral, Antimony Sodium Gluconate, Paromomycin, Anti-Bacterial Agents, Schistosomicides, Treatment Outcome, Injections, Intramuscular, Risk Assessment, Dose-Response Relationship, Drug, Adolescent, Adult, Middle Aged, Child