Wu Xinwei, Zhang Yan, Lu Mei, Yu Xiaolin, Ye Xiang, Wang Xingbang, Shan Peiyan
Department of Geriatrics, Qilu Hospital of Shandong University, Jinan, China.
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China.
Front Pediatr. 2020 Feb 27;8:28. doi: 10.3389/fped.2020.00028. eCollection 2020.
Migraine is the most common acute primary headache in children and adolescents. In 2014, topiramate became the first preventive drug for migraine, approved by the Food and Drug Administration (FDA) for adolescents. This meta-analysis was aimed to evaluate the efficacy and safety of topiramate in the prevention of pediatric migraine. We searched the PubMed, EMBASE, Cochrane Library, and Chinese National Knowledge Infrastructure (CNKI) databases up to June 2019 for eligible randomized controlled trials (RCTs). The primary outcomes were mean migraine days per month, ≥50% reduction rate, and Pediatric Migraine Disability Assessment Scale (PedMIDAS) scores. RevMan5.3 software was performed for statistical analysis. Overall, 5 RCTs recruiting 531 patients (6-17 years of age) were included in the meta-analysis. The target dose of topiramate was 2 mg/kg (the maintenance phase was 12 weeks), 2-3 mg/kg, 50 mg/day, and 100 mg/day (maintaining for 16 weeks), respectively, in the included studies. Our results demonstrate that participants receiving topiramate had a significant advantage in remitting the monthly migraine days than those receiving placebo, with a mean difference (MD) of -0.78 ( = 531; 95% CI, -1.23 to -0.32; = 3.37; = 0.0008). Topiramate could also reduce the mean PedMIDAS scores ( = 238; 95% CI, -16.53 to -0.49; = 2.43; = 0.04). However, there was no significant difference in the percentage of patients experiencing a ≥50% reduction in monthly headache days between topiramate and placebo groups ( = 531; 95% CI, 0.94-1.77; = 1.58; = 0.11). Topiramate was associated with higher rates of side effects such as weight decrease ( = 395; 95% CI, 2.73-22.98; = 3.81; < 0.01) and paresthesia ( = 531; 95% CI, 3.05-13.18; = 4.94; < 0.01). Topiramate can significantly decrease monthly headache days and migraine-related burden in migraine patients <18 years old. However, it failed to increase 50% response rate. Adverse events seem to be more frequent in topiramate-treated children.
偏头痛是儿童和青少年中最常见的急性原发性头痛。2014年，托吡酯成为首个获批用于青少年偏头痛的预防性药物，由美国食品药品监督管理局（FDA）批准。本荟萃分析旨在评估托吡酯预防儿童偏头痛的有效性和安全性。我们检索了截至2019年6月的PubMed、EMBASE、Cochrane图书馆和中国知网（CNKI）数据库，以查找符合条件的随机对照试验（RCT）。主要结局指标为每月平均偏头痛天数、≥50%的缓解率以及儿童偏头痛残疾评估量表（PedMIDAS）评分。采用RevMan5.3软件进行统计分析。总体而言，5项纳入531例患者（6至17岁）的RCT被纳入荟萃分析。在纳入的研究中，托吡酯的目标剂量分别为2mg/kg（维持期为12周）、2 - 3mg/kg、50mg/天和100mg/天（维持16周）。我们的结果表明，接受托吡酯治疗的参与者在缓解每月偏头痛天数方面比接受安慰剂的参与者具有显著优势，平均差值（MD）为 -0.78（n = 531；95%CI， -1.23至 -0.32；Z = 3.37；P = 0.0008）。托吡酯还可降低平均PedMIDAS评分（n = 238；95%CI， -16.53至 -0.49；Z = 2.43；P = 0.04）。然而，托吡酯组和安慰剂组在每月头痛天数减少≥50%的患者百分比方面无显著差异（n = 531；95%CI，0.94 - 1.77；Z = 1.58；P = 0.11）。托吡酯与较高的副作用发生率相关，如体重减轻（n = 395；95%CI，2.73 - 22.98；Z = 3.81；P < 0.01）和感觉异常（n = 531；95%CI，3.05 - 13.1
