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BMJ. 1998 Apr 18;316(7139):1200-5.

Randomised controlled trial of aminosidine (paromomycin) v sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India.

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  • 1Kala-Azar Research Centre Muzaffarpur, Brahmpura, Muzaffarpur, Bihar, India.

Abstract

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.

Comment in

PMID:
9583927
[PubMed - indexed for MEDLINE]
PMCID:
PMC28521
Free PMC Article
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