Departments of Neurology Emergency Rehabilitation, the First Affiliated Hospital Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou, China The Carolinas Center for Medical Excellence, Cary, North Carolina, USA.
Pain Med. 2012 Jan;13(1):80-6. doi: 10.1111/j.1526-4637.2011.01295.x.
The objective of this study was to observe the efficacy, safety, and side effects of a combination of flunarizine plus topiramate compared with either flunarizine and or toparamate alone for migraine prophylaxis.
Out of 150 patients with migraine recruited into the study and randomly assigned to one of three conditions, 126 completed the trial in their group: flunarizine (39), topiramate (44), and flunarizine plus topiramate (43). Patient information was assessed at enrollment and at follow-up visits at the end of months 1-3, 6, 9, and 12. The primary measure of efficacy reduction in mean monthly migraine frequency of at least 50% as compared with baseline. Secondary efficacy parameters included reduction in mean monthly migraine days and severity of headache. Side effects were compared in the three groups by recording adverse reactions and weight changes.
The proportion whose monthly headache frequency decreased more than 50% was 66.7% (26/39) in the flunarizine group, 72.7% (32/44) in the topiramate group and 76.7% (33/43) in the combination group, respectively (P=0.593). The mean monthly days and severity of headache in the three groups also declined and was more significant in the flunarizine plus topiramate group than in the flunarizine group and the topiramate group (P<0.05). In the flunarizine group, the average weight change was 0.6kg. Topiramate was associated with a mean weight loss was of -0.9kg in the topiramate group and -0.2kg in the flunarizine plus topiramate group.
Flunarizine, topiramate, and the combination of flunarizine with topiramate are all effective and have good tolerability in migraine prophylaxis. Adding topiramate to flunarizine may reduce the latter's impact on body weight.
本研究旨在观察氟桂利嗪联合托吡酯与氟桂利嗪或托吡酯单药治疗偏头痛预防的疗效、安全性和副作用。
在纳入研究并随机分为三组的 150 名偏头痛患者中，有 126 名完成了他们所在组的试验：氟桂利嗪（39 名）、托吡酯（44 名）和氟桂利嗪加托吡酯（43 名）。在入组时和第 1、3、6、9 和 12 个月结束时的随访就诊时评估患者信息。主要疗效评估指标为与基线相比，每月偏头痛发作频率至少降低 50%。次要疗效参数包括每月偏头痛天数和头痛严重程度的减少。通过记录不良反应和体重变化，比较三组的副作用。
氟桂利嗪组每月头痛频率降低 50%以上的比例为 66.7%（26/39），托吡酯组为 72.7%（32/44），联合组为 76.7%（33/43）（P=0.593）。三组每月头痛天数和严重程度均下降，氟桂利嗪联合托吡酯组较氟桂利嗪组和托吡酯组下降更显著（P<0.05）。氟桂利嗪组平均体重变化为 0.6kg。托吡酯组的平均体重减轻为-0.9kg，而氟桂利嗪联合托吡酯组为-0.2kg。
氟桂利嗪、托吡酯和氟桂利嗪联合托吡酯在偏头痛预防中均有效且耐受性良好。在氟桂利嗪中添加托吡酯可能会降低后者对体重的影响。
