2-5岁儿童功能性便秘的林纳克洛提德的安全性和有效性:第二阶段,随机研究
Carlo Di Lorenzo1, Jon Robert2, Gerardo Rodriguez-Araujo3
1Division of Pediatric Gastroenterology, Hepatology and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
利纳克洛提德在幼儿的功能性便秘中显示出有效性的趋势. 72mcg的剂量是最有希望的,有轻微的副作用,如腹,这表明在这个儿科群体中耐受性很好.
科学领域:
- 儿科胃肠病学 儿科胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床试验研究 临床试验研究
背景情况:
- 功能性便秘 (FC) 是儿童常见的胃肠道疾病.
- 利纳克洛提德是一种 guanylate cyclase-C 激动剂,已被批准用于患有FC的老年儿童 (6-17岁).
- 利纳克洛在患有FC的幼儿 (2-5岁) 的疗效和安全性需要进一步研究.
研究的目的:
- 为了评估林纳克洛提德的剂量反应,安全性和有效性,在2-5岁的功能性便秘儿童中.
- 为了在4周的时间内比较林纳克洛提德治疗与安慰剂.
- 评估关键的终点,包括自发排便频率,便一致性,紧张和便失禁.
主要方法:
- 一个2期,随机,双盲,安慰剂控制,多剂量研究.
- 35名患有FC的儿童 (罗马III标准) 被随机分配给接受利纳克洛提德 (9-72微克) 或安慰剂.
- 疗效终点包括SBM频率的变化,便一致性,压力和便失禁;记录了不良事件.
主要成果:
- 在35名患者中,有34名患者完成了这项研究.
- 与安慰剂相比,72微克林克洛提德组在四个关键疗效终点中的三个方面表现出更大的改善.
- 观察到便一致性的剂量反应趋势;治疗出现的不良事件是轻度或中度的,其中有一例轻度腹.
结论:
- 在2-5岁的功能性便秘的儿童中,林卡洛的耐受性很好.
- 与安慰剂相比,与72μg的林纳克洛提德观察到一种疗效趋势.
- 进一步的研究可能会探索这个儿科年龄组的最佳剂量和长期影响.
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