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评估伊维菌素在减少巴西亚马逊地区感染的 III 期临床试验。

Phase III Clinical Trial to Evaluate Ivermectin in the Reduction of infection in the Brazilian Amazon.

机构信息

Universidade Federal de São João Del Rei, Campus Centro Oeste, Divinópolis, Brazil.

Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil.

出版信息

Am J Trop Med Hyg. 2018 Mar;98(3):786-790. doi: 10.4269/ajtmh.17-0698. Epub 2018 Jan 4.

DOI:10.4269/ajtmh.17-0698
PMID:29313486
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5930903/
Abstract

The treatment of mansonelliasis is still a challenge because there are few clinical trials for the treatment of the disease. This double-blind, randomized, placebo-controlled study (phase III clinical trial) was conducted to evaluate the effectiveness of a single oral dose of ivermectin (0.15 mg/kg) in the reduction of the microfilaraemia and the occurrence of adverse effects in infected people compared with the control group treated with placebo. A total of 49 microfilaraemic patients were randomly selected from the municipality of Lábrea, State of Amazonas, in the Brazilian Amazon. Among them, 40 patients have concluded the study, 19 treated with ivermectin and 21 treated with placebo. In the first and third days after the treatment, all the patients were clinically evaluated, and the diagnostic and quantification of blood microfilariae through blood filtration in polycarbonate membranes was performed. A significant reduction of the microfilaraemia (99.9%) was observed in the patients who received ivermectin. Slight changes in laboratory test results, without clinical importance, were seen in treated and control groups. Our results suggest that ivermectin is effective and safe for the treatment of infections caused by .

摘要

曼森线虫病的治疗仍然是一个挑战,因为针对这种疾病的临床试验很少。本项双盲、随机、安慰剂对照研究(III 期临床试验)旨在评估单次口服伊维菌素(0.15mg/kg)治疗与安慰剂治疗相比,在减少感染人群的微丝蚴血症和不良反应发生率方面的有效性。从巴西亚马逊州拉布雷亚市的 49 名微丝蚴血症患者中随机选择了 49 名患者。其中,40 名患者完成了研究,19 名接受伊维菌素治疗,21 名接受安慰剂治疗。在治疗后的第 1 天和第 3 天,所有患者均进行了临床评估,并通过聚碳酸酯膜进行血液过滤来进行血液微丝蚴的诊断和定量。接受伊维菌素治疗的患者微丝蚴血症显著降低(99.9%)。治疗组和对照组的实验室检查结果均有轻微变化,但无临床意义。我们的结果表明,伊维菌素对 感染的治疗是有效且安全的。

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本文引用的文献

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Sustained clearance of Mansonella ozzardi infection after treatment with ivermectin in the Brazilian Amazon.在巴西亚马逊地区使用伊维菌素治疗后,曼氏线虫感染的持续清除。
Am J Trop Med Hyg. 2014 Jun;90(6):1170-5. doi: 10.4269/ajtmh.13-0410. Epub 2014 Apr 7.
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Mansonella ozzardi (Nematoda: Onchocercidae) in the riverine population of the Tefé River, State of Amazonia, Brazil.巴西亚马逊州特菲河河畔人群体中的曼森线虫(Nematoda: Onchocercidae)。
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Mansonella ozzardi corneal lesions in the Amazon: a cross-sectional study.亚马逊流域曼森线虫角膜病变:一项横断面研究。
BMJ Open. 2012 Nov 27;2(6). doi: 10.1136/bmjopen-2012-001266. Print 2012.
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Ivermectin-related adverse clinical events in patients treated for Mansonella ozzardi infections.接受奥氏曼森线虫感染治疗的患者中与伊维菌素相关的不良临床事件。
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