Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections.
Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections.
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DOI：
10.1155/2012/590463
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发表时间：
2012
影响因子：
2.2
通讯作者：
Albonico M
中科院分区：
文献类型：
--
作者：
Friedman AJ;Ali SM;Albonico M
主要目的是评价新的甲苯咪唑咀嚼片制剂治疗≤10岁儿童土源性蠕虫（STH）感染的安全性和耐受性，目的是在预防性化疗项目中使用该制剂，并将治疗扩展到无法吞咽固体片剂的幼儿。在坦桑尼亚桑给巴尔的奔巴岛进行的这项开放标签、单组、III期研究中，2至10岁（中位年龄：4岁）的儿童接受了甲苯咪唑500 mg咀嚼片单次给药。在给药后30分钟和3天后评估安全性。在完成研究的390名（98%）儿童中，195名（55%）在基线时有≥1例STH感染，157名（45%）无感染。最常见的STH感染是鞭虫（51%）、钩虫（16%）和蛔虫（7%）。11%的儿童发生了治疗后出现的不良事件（TEAE）。2-5岁和6-10岁年龄层之间发生TEAE的儿童百分比无差异。仅2-5岁儿童报告腹泻。未观察到AE的类型或百分比与感染的存在或严重程度之间存在相关性。甲苯咪唑500 mg咀嚼片单次给药在2 ~ 10岁儿童中安全性和耐受性良好。
The primary objective was to evaluate the safety and tolerability of the new chewable formulation of mebendazole to treat soil-transmitted helminth (STH) infections in children ≤10 years old with the goal of using this formulation in preventive chemotherapy programs and expand treatment to young children who are unable to swallow solid tablets. In this open-label, single-arm, phase 3 study conducted at Pemba Island, Zanzibar, Tanzania, children aged 2 to 10 years (median age: 4 years) were administered a single dose of the mebendazole 500 mg chewable tablet. Safety was assessed 30 minutes after dose and 3 days later. Of the 390 (98%) children who completed the study, 195 (55%) had ≥1 STH infection and 157 (45%) had no infection at baseline. The most common STH infections were Trichuris trichiura (51%), hookworm (16%), and Ascaris lumbricoides (7%). Treatment-emergent adverse events (TEAEs) were experienced by 11% of children. There was no difference in the percentage of children experiencing TEAEs between the age strata of 2–5 years and 6–10 years. Diarrhea was reported only in children aged 2–5 years. No correlation was observed between the type or percentage of AEs and presence or severity of infection. A single dose of mebendazole 500 mg chewable tablet was safe and well tolerated in children aged 2 to 10 years.