Le Kai, Yu Dafan, Wang Jiamin, Ali Abdoulaye Idriss, Guo Yijing
Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, 210009, People's Republic of China.
J Headache Pain. 2017 Dec;18(1):69. doi: 10.1186/s10194-017-0776-4. Epub 2017 Jul 18.
Mainly based on evidence of success in adults, various medications are commonly used to prevent pediatric migraines. Topiramate has been approved for migraine prevention in children as young as 12 years of age. In this meta-analysis, we aimed to assess the currently published data pertaining to the efficacy of topiramate for migraine prevention in patients less than 18 years of age.
We searched PubMed/Medline, Embase and the Cochrane Library (from inception to April 2017) for randomized controlled trials (RCTs) published in English. Two independent investigators performed data extraction and quality evaluation using the Cochrane Collaboration's tool. The data extracted were analyzed by Review Manager 5.3 software.
A total of four RCTs matching the inclusion criteria were included, with an aggregate of 465 patients. Of these patients, 329 were included in the topiramate group, and 136 were included in the placebo group. This meta-analysis revealed that compared with placebo, topiramate failed to decrease the number of patients experiencing a ≥ 50% relative reduction in headache frequency (n = 465, RR = 1.26, 95% CI = [0.94,1.67], Z = 1.55, P = 0.12) or the number of headache days (n = 465, MD = -0.77, 95% CI = [-2.31,0.76], Z = 0.99, P = 0.32) but did reduce PedMIDAS scores (n = 205, MD = -9.02, 95% CI = [-17.34, -0.70], Z = 2.13, P = 0.03). Higher rates of side effects and adverse events in the topiramate group than in the placebo group were observed in the included trials.
Topiramate may not achieve a more effective clinical trial endpoint than placebo in the prevention of migraines in patients less than 18 years of age, and topiramate may lead to more side effects or adverse events in the included patients.
主要基于成人的成功证据，多种药物常用于预防儿童偏头痛。托吡酯已被批准用于预防12岁及以上儿童的偏头痛。在这项荟萃分析中，我们旨在评估目前已发表的有关托吡酯在18岁以下患者中预防偏头痛疗效的数据。
我们检索了PubMed/Medline、Embase和Cochrane图书馆（从创刊至2017年4月），以查找英文发表的随机对照试验（RCT）。两名独立研究人员使用Cochrane协作网的工具进行数据提取和质量评估。提取的数据用Review Manager 5.3软件进行分析。
共纳入4项符合纳入标准的随机对照试验，总计465例患者。其中，托吡酯组纳入329例患者，安慰剂组纳入136例患者。这项荟萃分析显示，与安慰剂相比，托吡酯未能减少头痛频率相对降低≥50%的患者数量（n = 465，RR = 1.26，95%CI = [0.94, 1.67]，Z = 1.55，P = 0.12）或头痛天数（n = 465，MD = -0.77，95%CI = [-2.31, 0.76]，Z = 0.99，P = 0.32），但确实降低了儿童偏头痛残疾评估量表（PedMIDAS）评分（n = 205，MD = -9.02，95%CI = [-17.34, -0.70]，Z = 2.13，P = 0.03）。在纳入的试验中，观察到托吡酯组的副作用和不良事件发生率高于安慰剂组。
在预防18岁以下患者偏头痛方面，托吡酯可能无法达到比安慰剂更有效的临床试验终点，且托吡酯可能会导致纳入患者出现更多的副作用或不良事件。
