Abstract | OBJECTIVES: 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: 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:
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Authors | T K Jha, P Olliaro, C P Thakur, T P Kanyok, B L Singhania, I J Singh, N K Singh, S Akhoury, S Jha |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 316
Issue 7139
Pg. 1200-5
(Apr 18 1998)
ISSN: 0959-8138 [Print] England |
PMID | 9583927
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Schistosomicides
- Paromomycin
- Antimony Sodium Gluconate
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Topics |
- Adolescent
- Adult
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Antimony Sodium Gluconate
(adverse effects, therapeutic use)
- Child
- Dose-Response Relationship, Drug
- Humans
- Injections, Intramuscular
- Leishmaniasis, Visceral
(drug therapy)
- Middle Aged
- Paromomycin
(adverse effects, therapeutic use)
- Risk Assessment
- Schistosomicides
(adverse effects, therapeutic use)
- Treatment Outcome
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