近日，西班牙纳瓦拉大学Carlos Chaccour团队研究了伊维菌素控制疟疾的疗效与安全性。相关论文于2025年7月24日发表在《新英格兰医学杂志》上。

疟疾的控制和消除受到杀虫剂耐药性蔓延和媒介行为适应的威胁。伊维菌素是一种广谱抗寄生虫药物，也能杀死以接受治疗的人为食的蚊子。大规模使用伊维菌素是否能减少疟疾传播尚不清楚。

研究组在肯尼亚沿海的夸莱县开展了一项集群随机试验。夸莱县疟疾高度流行，驱虫蚊帐的覆盖率和使用率很高。在“短雨”季节开始时，按1:1的比例随机分配成组的家庭区域，每月一次，连续3个月接受伊维菌素（每公斤体重400 μg）或阿苯达唑（400 mg，主动对照）的大规模给药。在第一轮治疗后的6个月内，对5至15岁儿童每月进行疟疾感染检测。两个主要结局是疟疾感染的累积发生率（在5至15岁的儿童中评估）和不良事件的累积发生率（在所有符合条件的参与者中评估）。根据意向处理原则，用广义估计方程进行分析。

共有84个分组，包括28932名符合条件的参与者进行了随机化。试验组参与者的基线特征相似。在第一轮治疗后6个月，伊维菌素组的疟疾感染发生率为2.20 /儿童年，阿苯达唑组为2.66 /儿童年；调整后的发病率比（伊维菌素vs阿苯达唑）为0.74（95%可信区间，0.58 ~ 0.95，P=0.02）。每100次治疗的严重不良事件发生率在试验组之间无显著差异（发生率比，0.63；95% CI, 0.21 ~ 1.91）。

研究结果表明，对于生活在高覆盖率和蚊帐使用率地区的5至15岁儿童，每月使用一次伊维菌素，连续3个月，使疟疾感染发生率比阿苯达唑低26%。没有发现安全隐患。

附：英文原文

Title: Ivermectin to Control Malaria — A Cluster-Randomized Trial

Author: Carlos Chaccour, Marta Maia, Mercy Kariuki, Paula Ruiz-Castillo, Caroline Wanjiku, Lydia Kasiwa, Aurelia Brazeal, Aina Casellas, Mwanajuma Ngama, Truphena Onyango, Eldo Elobolobo, Karisa Kazungu, Mary Mael, Winnie Wangari, Khadija Nuru, Rachel Otuko, Almudena Sanz, Isaac Ringera, Allan Matano, Starford Mitora, Marta Ribes, Joe Brew, Nika Gorski, Patricia Nicolas, Sara Stanulovic, Isaiah Omondi, Joanna Furnival-Adams, Laura Túnez, Jamal Mbarak, Vegovito Vegove, Esther Yaa, Shadrack Mramba, Yegon Kibet, Naomi Nyambura, Charles Rotich, Scholastica Wanjiru, Musa Vura, Faith Wanjiku, Leslie Sam, Lisa Collins, Kang Xia, Felix Hammann, Francisco Saúte, Matthew Rudd, Cassidy Rist, Caroline Jones, Joseph Mwangangi, N. Regina Rabinovich

Issue&Volume: 2025-07-24

Abstract:

Background

Malaria control and elimination is threatened by the spread of insecticide resistance and behavioral adaptation of vectors. Whether mass administration of ivermectin, a broad-spectrum antiparasitic drug that also kills mosquitoes feeding on treated persons, can reduce malaria transmission is unclear.

Methods

We conducted a cluster-randomized trial in Kwale, a county in coastal Kenya in which malaria is highly endemic and coverage and use of insecticide-treated nets are high. Clusters of household areas were randomly assigned in a 1:1 ratio to receive mass administration of ivermectin (400 μg per kilogram of body weight) or albendazole (400 mg, active control) once a month for 3 consecutive months at the beginning of the “short rains” season. Children 5 to 15 years of age were tested for malaria infection monthly for 6 months after the first round of treatment. The two primary outcomes were the cumulative incidence of malaria infection (assessed among children 5 to 15 years of age) and of adverse events (assessed among all eligible participants). Analyses were performed with generalized estimating equations in accordance with the intention-to-treat principle.

Results

A total of 84 clusters comprising 28,932 eligible participants underwent randomization. The baseline characteristics of the participants were similar in the trial groups. Six months after the first round of treatment, the incidence of malaria infection was 2.20 per child-year at risk in the ivermectin group and 2.66 per child-year at risk in the albendazole group; the adjusted incidence rate ratio (ivermectin vs. albendazole) was 0.74 (95% confidence interval [CI], 0.58 to 0.95, P=0.02). The incidence of serious adverse events per 100 treatments did not differ significantly between the trial groups (incidence rate ratio, 0.63; 95% CI, 0.21 to 1.91).

Conclusions

Among children 5 to 15 years of age who were living in an area with high coverage and use of bed nets, ivermectin, administered once a month for 3 consecutive months, resulted in a 26% lower incidence of malaria infection than albendazole. No safety concerns were identified.

DOI: NJ202507243930409

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2411262