Palmeirim Marta S, Ame Shaali M, Ali Said M, Hattendorf Jan, Keiser Jennifer
Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute and University of Basel, Basel, Switzerland.
Public Health Laboratory Ivo de Carneri, Chake Chake, Tanzania.
EClinicalMedicine. 2018 Jul 11;1:7-13. doi: 10.1016/j.eclinm.2018.06.004. eCollection 2018 Jul.
Single-dose mebendazole is widely used in preventive chemotherapy against the soil-transmitted helminths (STHs) , hookworm and , yet it shows limited efficacy against hookworm and infections. The use of adapted treatment regimens might provide a strategy to control and eliminate STH infections in STH-persistent settings. We evaluated the safety and efficacy of the multiple dose mebendazole regimen (3 days 100 mg bid) a single dose of 500 mg mebendazole in a setting with high STH prevalence and high drug pressure.
This randomised, double-blind clinical trial took place in a primary school on Pemba Island, Tanzania, in school-aged children (6-12 years). Using a computer random number generator (block size 10), hookworm-positive children were randomly assigned (1:1) to either a single or multiple dose regimen of mebendazole by an independent statistician. Two stool samples were collected at baseline and follow-up (18 to 22 days after treatment) for Kato-Katz analysis. The primary outcome was cure rate (CR) against hookworm. Secondary outcomes were egg reduction rate (ERR) against hookworm, CRs and ERRs against and , and tolerability assessed 3, 24 and 48 h post-treatment. Participants, investigators, caregivers, outcome assessors and the trial statistician were blinded. This trial is registered with ClinicalTrials.gov, number NCT03245398.
93 children were assigned to each treatment arm. 185 children completed treatment and provided follow-up stool samples. CR against hookworm was significantly higher in the multiple dose (98%) than in the single dose arm (13%, OR 389.1, 95% CI 95.2 to 2885.7%, p < 0.001). 34 and 42 children reported mild adverse events in the single and multiple dose arms, respectively. The most common events were abdominal pain, headache and diarrhoea.
The poor performance of single dose mebendazole against hookworm infections was confirmed, but the multiple dose treatment regimen of mebendazole showed high efficacy. Hence, multiple dose mebendazole might provide a treatment strategy in given epidemiological situations to boost control and elimination of STH infections.
PATH.
单剂量甲苯达唑广泛用于预防化疗以对抗土源性蠕虫（STH）、钩虫和蛔虫感染，但其对钩虫和蛔虫感染的疗效有限。采用适应性治疗方案可能为在STH持续流行地区控制和消除STH感染提供一种策略。我们在STH高流行率和高药物压力的环境中评估了多剂量甲苯达唑方案（3天，每日2次，每次100mg）与单剂量500mg甲苯达唑的安全性和疗效。
这项随机、双盲临床试验在坦桑尼亚奔巴岛的一所小学对学龄儿童（6至12岁）进行。使用计算机随机数生成器（区组大小为10），由一名独立统计学家将钩虫阳性儿童随机分配（1:1）至单剂量或多剂量甲苯达唑方案。在基线和随访时（治疗后18至22天）收集两份粪便样本用于加藤-卡茨分析。主要结局是针对钩虫的治愈率（CR）。次要结局是针对钩虫的虫卵减少率（ERR）、针对蛔虫和鞭虫的CR和ERR，以及治疗后3、24和48小时评估的耐受性。参与者、研究者、照料者、结局评估者和试验统计学家均处于盲态。本试验已在ClinicalTrials.gov注册，编号为NCT03245398。
每个治疗组分配了93名儿童。185名儿童完成治疗并提供了随访粪便样本。多剂量组针对钩虫的CR（98%）显著高于单剂量组（13%，OR 389.1，95%CI 95.2至2885.7%，p<0.001）。单剂量组和多剂量组分别有34名和42名儿童报告了轻度不良事件。最常见的事件是腹痛、头痛和腹泻。
证实了单剂量甲苯达唑对钩虫感染的疗效不佳，但多剂量甲苯达唑治疗方案显示出高效。因此，在特定的流行病学情况下，多剂量甲苯达唑可能为加强控制和消除STH感染提供一种治疗策略。
PATH。
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