Sakai Fumihiko
Saitama International Headache Center, Saitama Neuropsychiatric Institute, 6-11-1 Honmachi-Higashi, Chuo-ku, Saitama-City, Saitama, 338-8577, Japan,
Curr Pain Headache Rep. 2015 Mar;19(3):8. doi: 10.1007/s11916-015-0478-z.
This review evaluates the recent progress in clinical trials on oral triptans for acute migraine in children and adolescents. Randomized controlled trials (RCT) on the treatment of migraine in pediatric patients were rare and difficult to design. In particular, high placebo response in many of the trials made it difficult to prove efficacy of triptans. Using a "novel study design" for RCT, a study successfully proved the efficacy of an oral rizatriptan. This trial enrolled patients with unsatisfactory response to nonsteroidal anti-inflammatory or acetaminophen and with migraine lasting longer than 3 h. Rizatriptan was approved by Food and Drug Administration (FDA) (USA) for children and adolescents of 6-17 years. The triptan-NSAID combination drug for pediatric patients also showed efficacy.
本综述评估了口服曲坦类药物用于儿童和青少年急性偏头痛临床试验的最新进展。关于儿科患者偏头痛治疗的随机对照试验（RCT）很少且难以设计。特别是，许多试验中的高安慰剂反应使得难以证明曲坦类药物的疗效。通过对RCT采用“新颖的研究设计”，一项研究成功证明了口服利扎曲普坦的疗效。该试验纳入了对非甾体抗炎药或对乙酰氨基酚反应不佳且偏头痛持续超过3小时的患者。利扎曲普坦已获美国食品药品监督管理局（FDA）批准用于6至17岁的儿童和青少年。用于儿科患者的曲坦类-非甾体抗炎药联合药物也显示出疗效。
