Randomised controlled trial of aminosidine (paromomycin) υ sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India
Randomised controlled trial of aminosidine (paromomycin) υ sodium stibogluconate for treating visceral leishmaniasis in North Bihar, India
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DOI：
10.1136/bmj.316.7139.1200
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发表时间：
1998-04-18
影响因子：
--
通讯作者：
Jha, S
中科院分区：
文献类型：
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作者：
Jha, TK;Olliaro, P;Jha, S
目的：目的：评估氨基苷与葡萄糖酸锑钠相比治疗内脏利什曼病的疗效和耐受性。设计：随机、非盲、对照试验，随访180天。设置：卡拉-阿扎尔研究中心，Brahmpura，Muzaffarpur，比哈尔邦，印度。受试者：6-50岁的任何性别的人，症状和体征提示内脏利什曼病（发热，食欲不振，脾脏肿大）。与利什曼原虫无鞭毛体检测Giemsa染色吸出物的脾或骨髓。干预：氨基苷在三个每日剂量（12，16，和20毫克/公斤）为21天和葡萄糖酸锑钠20毫克/公斤/天为30 day.Main结局measures：实验室措施的效力：寄生虫计数，血红蛋白浓度，白色细胞计数血小板计数，血清白蛋白浓度。疗效的临床指标：脾脏大小、发热、体重和肝脏大小。安全措施：结果：在120名患者中（每个治疗组30名），119名完成了治疗和随访。随访结束时，分别有23例（77%）、28例（93%）和29例（97%）患者接受12、16和20 mg氨基糖苷/kg/天治疗，19例（63%）患者接受葡萄糖酸锑钠治疗。在16和20 mg/kg/天剂量下，氨基糖苷在临床和实验室有效性指标方面的活性均显著高于葡萄糖酸锑钠。没有显着的临床或实验室毒性发生在任何treatment group.Conclusions：21天的疗程aminosidine 16或20 mg/kg/day应被视为一线治疗内脏利什曼病在比哈尔邦。
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.