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一项关于伊维菌素在中国抗肠道线虫感染疗效的随机、双盲、多中心临床试验。

A randomized, double-blind, multicenter clinical trial on the efficacy of ivermectin against intestinal nematode infections in China.

作者信息

Wen Li-Yong, Yan Xiao-Lan, Sun Feng-Hua, Fang Yue-Yi, Yang Ming-Jin, Lou Lei-Jun

机构信息

Institute of Parasitic Diseases, Zhejiang Academy of Medical Sciences, WHO Collaborating Center for Research on Helminthiasis, Hangzhou, China.

出版信息

Acta Trop. 2008 Jun;106(3):190-4. doi: 10.1016/j.actatropica.2008.03.007. Epub 2008 Mar 27.

DOI:10.1016/j.actatropica.2008.03.007
PMID:18452885
Abstract

To assess the efficacy of ivermectin against intestinal nematode infections, a randomized, double-blind, multicenter clinical trial was carried out in a total of 816 human individuals infected with different nematodes from three counties in China. The subjects were randomly assigned into experimental and control groups and orally given a single dose of 0.1, 0.2, 0.2 and 0.2mg/kg ivermectin against Ascaris lumbricoides, hookworm, Trichuris trichiura and Enterobius vermicularis, respectively. Parallel control groups to each of the ivermectin groups were given a single oral dose of 6.7 mg/kg albendazole. The cure rates with ivermectin and albendazole were 100% (102/102) and 99.0% (101/102) for Ascaris, and 66.7% (68/102) and 67.7% (69/102) for Trichuris, respectively, with no significant difference (P>0.05) between the two treatments. The parasitological cure rates of albendazole were 69.6% (71/102) for hookworm and 94.1% (96/102) for Enterobius, which were significantly higher than ivermectin (33.3% and 52.9%, respectively, P<0.0001). The expulsion of worm in the feces reached its peak 1-2 days after ivermectin treatment. The study showed that ivermectin, with few side effects, could be used as an additional treatment tool for intestinal nematodes, especially for the treatment of Ascaris and Trichuris infections in China.

摘要

为评估伊维菌素治疗肠道线虫感染的疗效,在中国三个县对总共816名感染不同线虫的人群开展了一项随机、双盲、多中心临床试验。受试者被随机分为试验组和对照组,分别口服单剂量0.1、0.2、0.2和0.2mg/kg伊维菌素,以治疗蛔虫、钩虫、鞭虫和蛲虫感染。每个伊维菌素组均设有平行对照组,口服单剂量6.7mg/kg阿苯达唑。伊维菌素和阿苯达唑治疗蛔虫的治愈率分别为100%(102/102)和99.0%(101/102),治疗鞭虫的治愈率分别为66.7%(68/102)和67.7%(69/102),两种治疗方法之间无显著差异(P>0.05)。阿苯达唑治疗钩虫和蛲虫的寄生虫学治愈率分别为69.6%(71/102)和94.1%(96/102),显著高于伊维菌素(分别为33.3%和52.9%,P<0.0001)。伊维菌素治疗后1 - 2天粪便中排虫达到高峰。该研究表明,伊维菌素副作用少,可作为肠道线虫的辅助治疗手段,尤其在中国用于治疗蛔虫和鞭虫感染。

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