近日，美国约翰霍普金斯大学Judd L Walson团队在贝宁、印度和马拉维开展了DeWorm3社区整群随机对照试验，以验证阻断土壤寄生虫传播的可行性。相关论文于2025年8月2日发表在《柳叶刀》杂志上。

作为一个公共卫生问题，土壤传播的寄生虫是消除的目标。研究组评估了在高覆盖率的情况下，社区范围内的大规模给药（MDA）是否会导致传播中断。

DeWorm3是一项在贝宁、印度和马拉维开展的开放标签、社区整群随机对照试验。在每个国家，将一个具有土壤传播蠕虫流行性且至少参与过五轮社区范围淋巴丝虫病MDA（药物驱虫活动）的政府行政单位（人口≥80000人）划分为40个整群（人口≥1650人），这些整群按1:1的比例随机分配至社区范围MDA组或学校基础驱虫组。在揭盲之前，实验室人员对暴露状态保持盲态，所有研究者对基线后的结局数据保持盲态。在所有整群中，学龄前儿童和学龄儿童均按照国家指南接受为期3年的学校基础驱虫。在干预整群中，社区药品分发人员每半年为所有符合条件的个体提供一次社区范围MDA（单次口服400 mg阿苯达唑），为期3年。在印度和贝宁，所有12个月及以上年龄的个体以及在马拉维所有24个月及以上年龄的个体均有资格接受治疗，但妊娠早期妇女、对苯并咪唑类药物有不良反应者、急性疾病或中毒患者以及报告在过去2周内接受过治疗者除外。共同主要结局是个体层面的患病率和整群层面的传播阻断率（即主要土壤传播蠕虫物种的加权患病率≤2%），通过定量聚合酶链反应（qPCR）在最后一轮MDA后24个月进行评估。分析集包含每个整群随机选择的一部分参与者，这些参与者参加了基线评估，提供了粪便样本，并获得了qPCR结果。所有接受治疗的个体均有资格纳入安全性人群。该试验已在ClinicalTrials.gov注册（NCT03014167），目前处于活跃状态但未招募受试者。

在2017年10月10日至2023年2月17日期间，研究组随机分配了120个集群（每个国家40个集群，共357716人），其中60个分配至社区范围药物管理（MDA）组，60个分配至学校基础驱虫组。基线时，集群中有184030人（51.4%）为女性，173663人（48.5%）为男性，23人（<0.1%）为其他性别。分析集包括对照组的58827人和干预组在停止所有驱虫24个月后的58554人。在贝宁（调整后的患病率比[aPR] 0.44 [95% CI 0.34–0.58]）、印度（0.41 [0.32–0.52]）和马拉维（0.40 [0.34–0.46]），社区范围MDA组的美洲钩虫（所有地点的主要虫种）患病率低于学校基础驱虫组。在贝宁，20个干预集群中有11个（55%）实现了美洲钩虫传播阻断，而20个对照集群中仅有6个（30%）实现传播阻断（p=0.20）；在印度，1个干预集群（5%）实现了传播阻断，而对照集群中无一实现（p=1.00）；在马拉维，两组中均无集群实现传播阻断（p=1.00）。研究期间，487名参与者中报告了984例不良事件，其中13名参与者中有32例导致住院，被归类为严重不良事件（其中3例与研究程序相关）。

研究结果表明，在重点地区，土壤传播的蠕虫传播中断是可能的，但在评估的时间范围内，似乎在规划上不可行。应考虑将社区范围内的大规模驱虫计划作为以学校为基础的驱虫规划的替代战略，以改善蠕虫流行地区的公平性和成果。

附：英文原文

Title: Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi

Author: Sitara Swarna Rao Ajjampur, Kumudha Aruldas, Kristjana H ásbjrnsdóttir, Euripide Avokpaho, Robin Bailey, Gilles Cottrell, Sean R Galagan, Katherine E Halliday, Parfait Houngbégnon, Moudachirou Ibikounlé, Gideon John Israel, Saravanakumar Puthupalayam Kaliappan, Khumbo Kalua, Hugo Legge, D Timothy J Littlewood, Adrian J F Luty, Malathi Manuel, Achille Massougbodji, Arianna Rubin Means, William E Oswald, Nils Pilotte, Rachel Pullan, Rohan Michael Ramesh, Lyson Samikwa, James Simwanza, Katherine K Thomas, Steven A Williams, Stefan Witek-McManus, Judd L Walson, Manfred Mario Kokou Accrombessi, Justine Ahlonsou, Roy Anderson, Eloc Atindegla, Simon Brooker, Donald A.P. Bundy, Félicien Chabi, David Chaima, Alvin Chisambi, Georgia Damien, Mira Emmanuel-Fabula, Jasmine Farzana Sheik Abdullah, Jeanne L Goodman, Venkateshprabhu Janagaraj, David Kennedy, Edith Aloukoutou Layo, Hastings Mangawa, Zayina Zondervenni Manoharan, Rejoice Msiska, Gokila Palanisamy, Emily Pearman, Doug Rains, Elliott Rogers, Rajiv Sarkar, Naveen Kumar Sekar, Alexandra Schaefer, Mariyam Sheikh, Katherine Sharrock, Alyson Shumays, Edoux Jol Eric Siko, Fadel Tanimomon, Joseph Timothy, Comlanvi Innocent Togbevi, Firmine Viwami

Issue&Volume: 2025/08/02

Abstract:

Background

Soil-transmitted helminths are targeted for elimination as a public health problem. This study assessed whether, with high coverage, community-wide mass drug administration (MDA) could lead to transmission interruption.

Methods

DeWorm3 is an open-label, community cluster-randomised controlled trial in Benin, India, and Malawi. In each country, a single governmental administrative unit (population ≥80000 individuals) with soil-transmitted helminth endemicity and participation in at least five rounds of community-wide MDA for lymphatic filariasis, was divided into 40 clusters (population ≥1650 individuals), which were randomly assigned (1:1) to community-wide MDA versus school-based deworming. Laboratory personnel were masked to exposure status and all investigators were masked to post-baseline outcome data until unmasking. In all clusters, preschool-aged and school-aged children received school-based deworming as per national guidelines for 3 years. In intervention clusters, door-to-door community-wide MDA (a single oral dose of 400 mg albendazole) was delivered to all eligible individuals biannually by community drug distributors for 3 years. All individuals aged 12 months and older in India and Benin and aged 24 months and older in Malawi were eligible for treatment, except women in the first trimester of pregnancy, those with adverse reactions to benzimidazoles, those who were acutely ill or intoxicated, or those reporting treatment within the previous 2 weeks. The co-primary outcomes were individual-level prevalence and cluster-level transmission interruption (ie, weighted prevalence of predominant species of ≤2%) of the predominant soil-transmitted helminth species, assessed by quantitative PCR (qPCR) 24 months after the last round of MDA. The analysis set contained a subset of randomly selected participants per cluster who enrolled in the endline assessment, provided a stool sample, and had a qPCR result. All individuals who received treatment were eligible for inclusion in the safety population. This trial is registered with ClinicalTrials.gov (NCT03014167), and is active but not recruiting.

Findings

Between Oct 10, 2017, and Feb 17, 2023, 120 clusters (40 clusters per country, comprising 357716 individuals) were randomly assigned, 60 to community-wide MDA and 60 to school-based deworming. 184030 (51·4%) individuals in the clusters at baseline were female, 173663 (48·5%) were male, and 23 (<0·1%) were other. The analysis set consisted of 58827 individuals in the control group and 58554 in the intervention group 24 months after the cessation of all deworming, Necator americanus prevalence (the predominant species at all sites) in the community-wide MDA group was lower than the school-based deworming group in Benin (adjusted prevalence ratio [aPR] 0·44 [95% CI 0·34–0·58]), India (0·41 [0·32–0·52]), and Malawi (0·40 [0·34–0·46]). Transmission interruption was achieved for N americanus in 11 (55%) of 20 intervention clusters versus six (30%) of 20 control clusters in Benin (p=0·20), in one (5%) intervention cluster versus no control clusters in India (p=1·00), and in no clusters in either group in Malawi (p=1·00). 984 adverse events were reported among 487 participants over the study, of which 32 among 13 participants resulted in hospitalisation and were classified as serious adverse events (three of which were related to study procedures).

Interpretation

Soil-transmitted helminth transmission interruption might be possible in focal geographies but does not appear to be programmatically feasible within the evaluated timeframe. Community-wide MDA should be considered as an alternative strategy to school-based deworming programmes to improve equity and outcomes in helminth-endemic areas.

DOI: 10.1016/S0140-6736(25)00766-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00766-4/abstract