老挝和坦桑尼亚联合共和国两地伊维菌素-阿苯达唑对比阿苯达唑单独治疗土壤传播性蠕虫的长期疗效：随机对照试验结果。
Long-term outcomes of ivermectin-albendazole versus albendazole alone against soil-transmitted helminths: Results from randomized controlled trials in Lao PDR and Pemba Island, Tanzania.
机构信息
Medical Parasitology and Infection Biology, Helminth Drug Development Unit, Swiss Tropical and Public Health Institute, Basel, Switzerland.
University of Basel, Basel, Switzerland.
出版信息
PLoS Negl Trop Dis. 2021 Jun 30;15(6):e0009561. doi: 10.1371/journal.pntd.0009561. eCollection 2021 Jun.
BACKGROUND
Preventive chemotherapy is the cornerstone of soil-transmitted helminth (STH) control. Long-term outcomes and adequate treatment frequency of the recently recommended albendazole-ivermectin have not been studied to date.
METHODOLOGY/PRINCIPAL FINDINGS: Double-blind randomized controlled trials were conducted in Lao PDR, Pemba Island, Tanzania and Côte d'Ivoire between 2018 and 2020 to evaluate the efficacy and safety of ivermectin-albendazole versus albendazole-placebo in Trichuris trichiura-infected individuals aged 6 to 60. In the framework of this study, in Lao PDR 466 and 413 participants and on Pemba Island, 558 and 515 participants were followed-up six and 12 months post-treatment, respectively. From each participant at least one stool sample was processed for Kato-Katz diagnosis and cure rates (CRs), egg reduction rates (ERRs) and apparent reinfection rates were calculated. If found helminth-positive at six months, participants were re-treated according to their allocated treatment. Long-term outcomes against T. trichiura based on CRs and ERRs of ivermectin-albendazole compared to albendazole were significantly higher at six months in Lao PDR (CR, 65.8 vs 13.4%, difference; 52.4; 95% CI 45.0-60.0; ERRs, 99.0 vs 79.6, difference 19.4; 95% CI 14.4-24.4) and Pemba Island (CR, 17.8 vs 1.4%, difference; 16.4; 95% CI 11.6-21.0; ERRs, 84.9 vs 21.2, difference 63.8; 95% CI 50.6-76.9) and also at 12 months in Lao PDR (CR, 74.0 vs 23.4%, difference; 50.6; 95% CI 42.6-61.0; ERRs, 99.6 vs 91.3, difference 8.3; 95% CI 5.7-10.8) and Pemba Island (CR, 19.5 vs 3.4%, difference; 16.1; 95% CI 10.7-21.5; ERRs, 92.9 vs 53.6, difference 39.3; 95% CI 31.2-47.4) respectively. Apparent reinfection rates with T. trichiura were considerably higher on Pemba Island (100.0%, 95% CI, 29.2-100.0) than in Lao PDR (10.0%, 95% CI, 0.2-44.5) at 12 months post-treatment for participants treated with albendazole alone.
CONCLUSIONS/SIGNIFICANCE: The long-term outcomes against T. trichiura of ivermectin-albendazole are superior to albendazole in terms of CRs and ERRs and in reducing infection intensities. Our results will help to guide decisions on how to best use ivermectin-albendazole in the context of large-scale PC programs tailored to the local context to sustainably control STH infections.
TRIAL REGISTRATION
ClinicalTrials.gov registered with clinicaltrials.gov, reference: NCT03527732, date assigned: 17 May 2018.
背景
预防性化疗是控制土壤传播性蠕虫（STH）的基石。最近推荐的阿苯达唑-伊维菌素的长期结果和足够的治疗频率尚未得到研究。
方法/主要发现：2018 年至 2020 年期间，在老挝人民民主共和国、坦桑尼亚奔巴岛和科特迪瓦进行了双盲随机对照试验，以评估伊维菌素-阿苯达唑与阿苯达唑-安慰剂治疗感染有鞭虫的 6 至 60 岁个体的疗效和安全性。在这项研究的框架内，在老挝人民民主共和国，466 名和 413 名参与者，以及在奔巴岛，558 名和 515 名参与者分别在治疗后 6 个月和 12 个月进行了随访。从每个参与者中至少采集了一份粪便样本进行加藤氏粪便检查，并计算了治愈率（CR）、虫卵减少率（ERR）和明显再感染率。如果在六个月时发现寄生虫阳性，则根据其分配的治疗方案对参与者进行重新治疗。与阿苯达唑相比，伊维菌素-阿苯达唑在老挝人民民主共和国（CR，65.8%对 13.4%，差异；52.4%；95%置信区间 45.0-60.0；ERRs，99.0%对 79.6%，差异 19.4%；95%置信区间 14.4-24.4）和奔巴岛（CR，17.8%对 1.4%，差异；16.4%；95%置信区间 11.6-21.0；ERRs，84.9%对 21.2%，差异 63.8%；95%置信区间 50.6-76.9），以及在老挝人民民主共和国 12 个月时（CR，74.0%对 23.4%，差异；50.6%；95%置信区间 42.6-61.0；ERRs，99.6%对 91.3%，差异 8.3%；95%置信区间 5.7-10.8）和奔巴岛（CR，19.5%对 3.4%，差异；16.1%；95%置信区间 10.7-21.5；ERRs，92.9%对 53.6%，差异 39.3%；95%置信区间 31.2-47.4），伊维菌素-阿苯达唑治疗的鞭虫再感染率明显高于阿苯达唑单独治疗的参与者，分别为 12 个月和 100.0%（95%置信区间，29.2-100.0）和 10.0%（95%置信区间，0.2-44.5）。
结论/意义：伊维菌素-阿苯达唑治疗鞭虫的长期结果在 CR 和 ERR 方面优于阿苯达唑，并且降低了感染强度。我们的研究结果将有助于指导如何在适合当地情况的大规模 PC 计划背景下，如何最好地使用伊维菌素-阿苯达唑来可持续地控制 STH 感染。
试验注册
ClinicalTrials.gov 在 ClinicalTrials.gov 注册，注册号：NCT03527732，注册日期：2018 年 5 月 17 日。
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