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儿童偏头痛预防性药物治疗的新进展:2017年有哪些新变化,我们又将何去何从?

New Developments in the Prophylactic Drug Treatment of Pediatric Migraine: What Is New in 2017 and Where Does It Leave Us?

作者信息

Kacperski Joanne, Bazarsky Allyson

机构信息

Division of Neurology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave-MLC 2015, Cincinnati, OH, 45229-3039, USA.

Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.

出版信息

Curr Pain Headache Rep. 2017 Aug;21(8):38. doi: 10.1007/s11916-017-0638-4.

Abstract

PURPOSE OF REVIEW

Headaches in children are quite common; however, the study and characterization of headache disorders in the pediatric age group has historically been limited. Because of the lack of controlled studies on prophylactic treatment of headache disorders in this age group, the diagnosis of migraine rests on criteria similar those in adults. Likewise, data from adult studies is often inferred and applied to children. Although it appears that many preventives are safe in children, currently none are FDA or EMA approved for this age group. Consequently, many children who present to their primary care physicians with migraines do not receive any preventive therapy despite experiencing significant disability.

RECENT FINDINGS

Controlled clinical trials investigating the use of preventive medications in children have suffered from high placebo response rates. The shorter duration of headaches and other characteristic features seen in children are such that designing randomized controlled trials in this age group is more problematic and limiting. Treatment practices vary widely, even among specialists, due to the absence of evidence-based guidelines from clinical trials. The Childhood and Adolescent Migraine Prevention Study (CHAMP) was developed to examine the effectiveness of two of the most widely prescribed preventive medications for pediatric migraine and help narrow this gap. To date, it has been the largest enrolling study of its kind within the pediatric migraine world; its results and implications will be discussed and considered here. The CHAMP trial was discontinued early on account of futility and exhibited that neither of two preventive medications for pediatric migraine was more effective than placebo in reducing the number of headache days over a period of 24 weeks. Subjects in the amitriptyline and topiramate groups had higher rates of adverse events than those who had received placebo.

摘要

综述目的

儿童头痛十分常见;然而,儿科年龄组头痛障碍的研究与特征描述在历史上一直有限。由于该年龄组头痛障碍预防性治疗缺乏对照研究,偏头痛的诊断基于与成人相似的标准。同样,来自成人研究的数据常被推断并应用于儿童。尽管许多预防药物似乎对儿童是安全的,但目前尚无一种获得美国食品药品监督管理局(FDA)或欧洲药品管理局(EMA)批准用于该年龄组。因此,许多因偏头痛就诊于初级保健医生的儿童尽管有明显的功能障碍,却未接受任何预防性治疗。

最新发现

研究儿童预防性药物使用的对照临床试验存在较高的安慰剂反应率。儿童头痛持续时间较短及其他特征使得在该年龄组设计随机对照试验更具问题且受限。由于缺乏来自临床试验的循证指南,治疗方法差异很大,即使在专家之间也是如此。儿童和青少年偏头痛预防研究(CHAMP)旨在研究两种最常用的儿科偏头痛预防性药物的有效性,并帮助缩小这一差距。迄今为止,它是儿科偏头痛领域同类研究中纳入人数最多的;其结果及影响将在此讨论和考量。CHAMP试验因无效而提前终止,结果显示两种儿科偏头痛预防性药物在24周内减少头痛天数方面均不比安慰剂更有效。阿米替林组和托吡酯组的不良事件发生率高于接受安慰剂的组。

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