对于患有病感染的幼儿的艾弗梅克丁治疗:多中心的第二阶段非随机试验
Amanda Gwee1,2,3, Andrew Steer1,3, Khampheng Phongluxa4
1The Royal Children's Hospital Melbourne, 50 Flemington Rd, Parkville, Victoria, Australia.
The Lancet regional health. Western Pacific
|August 7, 2024
概括
一剂3毫克的艾弗梅克丁是安全有效的治疗幼儿 (2-4岁,10-14公斤) 的. 这种剂量可以实现与老年儿童相比较的药物暴露,支持对这种被忽视的疾病的更广泛的治疗机会.
科学领域:
- 药理学 药理学是指药理学的学科.
- 热带医学 热带医学
- 儿科 儿科 儿科
背景情况:
- 伊弗梅克丁是一种有效的治疗方法,但未经授权用于15公斤以下的儿童.
- 药物动力学建模表明,在幼儿 (2-4岁,10-14公斤) 中,3毫克的剂量提供了与老年儿童标准剂量相似的药物暴露.
- 这项研究旨在评估3毫克的艾弗梅克丁剂量在这个较年轻的儿科组中的安全性和有效性.
研究的目的:
- 评估3毫克艾弗梅克丁剂量在患的幼儿 (2-4岁,10-14公斤) 中的药理动力学概况.
- 为了评估这种ivermectin剂量的临床疗效和安全性.
- 为了将药物暴露与接受200μg/kg剂量的老年儿童的历史数据进行比较.
主要方法:
- 在老人民民主共和国进行了一项多中心二期试验,涉及100名2至4岁,体重为10至14公斤的患有的儿童.
- 参与者接受了单次3毫克剂量的ivermectin,并测量了血度.
- 临床结果和不良反应在第14天被评估,第二剂药物被给予以完成治疗.
主要成果:
- 观察到的平均ivermectin AUC0-∞ (815 μg·h/L) 与历史对照组 (953 μg·h/L,p=0.256) 的平均值可比.
- 到第14天,90/99名儿童的病完全消失.
- 副作用是轻微的,仅在7/99名儿童中报告.
结论:
- 在药理学上,3毫克的伊弗梅克丁剂量与老年儿童的标准剂量相比,可用于治疗幼儿 (2-4岁,10-14公斤) .
- 这种剂量在研究人群中显示出高疗效和良好的安全性.
- 这些研究结果支持将伊弗梅克治疗扩展到年幼的儿童身上,帮助全球打击的努力.
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