Albendazole and Mebendazole Administered Alone or in Combination with Ivermectin against Trichuris trichiura: A Randomized Controlled Trial

Albendazole and Mebendazole Administered Alone or in Combination with Ivermectin against Trichuris trichiura: A Randomized Controlled Trial
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DOI:
10.1086/657310
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发表时间:
2010-12-15
影响因子:
11.8
通讯作者:
Utzinger, Juerg
Utzinger, Juerg
中科院分区:
医学1区
文献类型:
--
作者:
Knopp, Stefanie;Mohammed, Khalfan A.;Utzinger, Juerg

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背景资料。单剂阿苯达唑和甲苯咪唑治疗鞭毛虫病的疗效有限。阿苯达唑与伊维菌素联合应用可提高疗效,但甲苯咪唑与伊维菌素联合应用的研究尚未见报道。我们在坦桑尼亚桑给巴尔的两所学校进行了一项随机对照试验,以评估阿苯达唑(400 Mg)加安慰剂、阿苯达唑加伊维菌素(200 mg/kg)、甲苯达唑(500 Mg)加安慰剂、甲苯达唑加伊维菌素治疗寄生虫学确诊的旋毛虫感染儿童的疗效和安全性。采用意向处理分析评价治愈率(CR)和减卵率。在治疗后48小时内监测不良事件。有548名儿童的完整数据记录。甲苯咪唑和伊维菌素联合用药对毛滴虫的CR最高(55%)。阿苯达唑-伊维菌素(38%)、甲苯咪唑(19%)和阿苯达唑(10%)的CRS较低。与安慰剂相比,伊维菌素的使用使CRS从14%显著增加到47%(优势比为0.19;95%可信区间为0.12-0.28)。甲苯咪唑和伊维菌素联合用药的减卵率最高(97%;95%CI,95%~98%),其次是阿苯达唑和伊维菌素(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名儿童报告的不良事件总体上是轻微的,治疗组之间没有显著差异。加入伊维菌素可改善阿苯达唑和甲苯咪唑对毛滴虫的治疗效果,并可考虑用于土传蠕虫控制项目和个体患者管理。
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 mg/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.