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阿苯达唑和甲苯达唑单独或联合伊维菌素治疗 Trichuris trichiura:一项随机对照试验。

Albendazole and mebendazole administered alone or in combination with ivermectin against Trichuris trichiura: a randomized controlled trial.

机构信息

Departments of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.

出版信息

Clin Infect Dis. 2010 Dec 15;51(12):1420-8. doi: 10.1086/657310. Epub 2010 Nov 9.

DOI:10.1086/657310
PMID:21062129
Abstract

BACKGROUND

Single-dose albendazole and mebendazole show limited efficacy in the treatment of trichuriasis. The combination of albendazole with ivermectin improves efficacy, but a mebendazole-ivermectin combination has not been previously investigated.

METHODS

We performed a randomized controlled trial in 2 schools in Zanzibar, Tanzania, to assess the efficacy and safety of albendazole (400 mg) plus placebo, albendazole plus ivermectin (200 μg/kg), mebendazole (500 mg) plus placebo, and mebendazole plus ivermectin in children with a parasitologically confirmed Trichuris trichiura infection. Cure rate (CR) and egg reduction rate were assessed by intent-to-treat analysis. Adverse events were monitored within 48 h after treatment.

RESULTS

Complete data records were available for 548 children. The highest CR against T. trichiura was achieved with a mebendazole-ivermectin combination (55%). Low CRs were observed with albendazole-ivermectin (38%), mebendazole (19%), and albendazole (10%). Compared with placebo, the use of ivermectin statistically significantly increased the CRs from 14% to 47% (odds ratio, 0.19; 95% confidence interval [CI], 0.12-0.28). The highest egg reduction rate (97%; 95% CI, 95%-98%) was observed using the mebendazole-ivermectin combination, followed by albendazole-ivermectin (91%; 95% CI, 87%-94%), mebendazole (67%; 95% CI, 52%-77%), and albendazole (40%; 95% CI, 22%-56%). The adverse events, reported by 136 children, were generally mild, with no significant difference between the treatment arms.

CONCLUSIONS

Addition of ivermectin improves the therapeutic outcomes of both albendazole and mebendazole against T. trichiura and may be considered for use in soil-transmitted helminth control programs and individual patient management.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN08336605.

摘要

背景

单次剂量的阿苯达唑和甲苯咪唑在治疗鞭虫病方面疗效有限。阿苯达唑联合伊维菌素可提高疗效,但尚未研究过甲苯咪唑-伊维菌素联合用药。

方法

我们在坦桑尼亚桑给巴尔的 2 所学校进行了一项随机对照试验,以评估阿苯达唑(400mg)加安慰剂、阿苯达唑加伊维菌素(200μg/kg)、甲苯咪唑(500mg)加安慰剂和甲苯咪唑加伊维菌素在寄生虫学确诊的鞭虫感染儿童中的疗效和安全性。通过意向治疗分析评估治愈率(CR)和虫卵减少率。在治疗后 48 小时内监测不良事件。

结果

548 名儿童的完整数据记录可用。甲苯咪唑-伊维菌素联合用药的鞭虫治愈率最高(55%)。阿苯达唑-伊维菌素(38%)、甲苯咪唑(19%)和阿苯达唑(10%)的 CR 较低。与安慰剂相比,伊维菌素的使用使 CR 从 14%显著增加至 47%(比值比,0.19;95%置信区间[CI],0.12-0.28)。甲苯咪唑-伊维菌素联合用药的虫卵减少率最高(97%;95%CI,95%-98%),其次是阿苯达唑-伊维菌素(91%;95%CI,87%-94%)、甲苯咪唑(67%;95%CI,52%-77%)和阿苯达唑(40%;95%CI,22%-56%)。136 名儿童报告了不良反应,一般为轻度,各治疗组之间无显著差异。

结论

伊维菌素的添加可提高阿苯达唑和甲苯咪唑治疗鞭虫病的疗效,可考虑将其用于土壤传播性蠕虫控制规划和个体患者管理。

试验注册

isrctn.org 标识符:ISRCTN08336605。

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