随机双盲多中心临床试验观察伊维菌素治疗肠道线虫感染的效果

A Randomized, Double-blind and Multicenter Clinical Trials on the Efficacy of Ivermectin Against Intestinal Nematode Infections in China

目的评价伊维菌素治疗肠道线虫感染的效果。方法对3个县816名感染肠道线虫者进行随机双盲多中心现场试验。受试者被随机分成实验组和对照组，分别采用0．1，0．2，0．2和0．2mg/kg伊维菌素口服治疗蛔虫、钩虫、鞭虫和蛲虫感染者。同时用6．7mg／kg阿苯哒唑作为对照组。结果伊维菌素和阿苯哒唑对蛔虫感染者的治愈率分别为100％（102／102）和99．0％（101／102），对鞭虫感染者的治愈率分别为66．7％（68／102）和67．7％（69／102），差异均没有显著性意义（P〉0．05）。阿苯哒唑对钩虫和蛲虫的治愈率分别为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）。服药后1～2日排虫达高峰，不良反应小。结论伊维菌素可作为肠道线虫，特别是蛔虫和鞭虫感染的治疗药物。

Objective To assess the efficacy of Ivermectin against intestinal nematode infections.Methods A randomized, double-blind and multicenter clinical trials were carried out in a total of 816 human individuals infected with different nematodes from three provinces 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 6.7mg/kg Albendazole.Results 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 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 with few side effects.Conclusion The study showed that Ivermectin, could be used as an additional treatment tool for intestinal nematodes,especially for the treatment of Ascaris and Trichuris infections in China.