Department of Gynecology and Obstetrics, Women's Headache Center, University of Turin, Via Ventimiglia 3, 10126 Turin, Italy.
Neurol Sci. 2012 May;33 Suppl 1(Suppl 1):S65-9. doi: 10.1007/s10072-012-1044-7.
The objective of this study was to review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), in women with menstrually related migraine (IHS criteria) through a pooled analysis of three individual studies. Subjects with a history of migraine with or without aura were randomized to F 2.5 mg or R 10 mg (study 1), F or Z 2.5 mg (study 2), and F or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double-blind, crossover design. After treating three episodes of migraine in no more than 3 months with the first treatment, patients had to switch to the next treatment for other 3 months. 346 subjects formed intention-to-treat population of the main study; 280 of them were of a female gender, 256 had regular menses and 187 were included in the menstrual migraine subgroup analysis. Rate of pain free at 2, 4 and 24 h was 23, 52 and 67 % with F and 30, 61 and 66 % with comparators (P = NS). Pain relief episodes at 2, 4 and 24 h were 37, 60 and 66 % for F and 43, 55 and 61 % for comparators (P = NS). Rate of recurrence was significantly (P < 0.05) lower under F either at 24 h (11 vs. 24 % comparators) or at 48 h (15 vs. 26 % comparators). Number of menstrual migraine attacks associated with drug-related adverse events was equally low (P = NS) between F (5 %) and comparators (4 %).
本研究旨在通过对三项独立研究的汇总分析，评估曲普坦类药物（佐米曲普坦、那拉曲普坦和阿莫曲普坦）中，与女性经期偏头痛（IHS 标准）相关的有效性和安全性。研究对象为伴有或不伴先兆的偏头痛病史患者，随机分为三组：曲普坦 2.5mg 组或利扎曲普坦 10mg 组（研究 1）、曲普坦或佐米曲普坦 2.5mg 组（研究 2）、曲普坦或阿莫曲普坦 12.5mg 组（研究 3）。这三项研究均采用了相同的多中心、随机、双盲、交叉设计。在最初的治疗中，患者需要在 3 个月内最多治疗 3 次偏头痛发作，然后再切换至下一种治疗药物，持续 3 个月。346 名受试者构成了主要研究的意向治疗人群；其中 280 名女性，256 名患者经期规律，187 名患者被纳入经期偏头痛亚组分析。治疗 2、4 和 24 小时后，无痛率分别为 23%、52%和 67%（曲普坦组）和 30%、61%和 66%（对照药物组）（P = NS）。治疗 2、4 和 24 小时后，疼痛缓解率分别为 37%、60%和 66%（曲普坦组）和 43%、55%和 61%（对照药物组）（P = NS）。24 小时时（曲普坦组 11%，对照药物组 24%）或 48 小时时（曲普坦组 15%，对照药物组 26%），曲普坦组的复发率显著更低（P < 0.05）。与药物相关不良反应相关的经期偏头痛发作次数同样较低（P = NS），曲普坦组为 5%，对照药物组为 4%。
