Lamsudin R, Sadjimin T
Clinical Epidemiology and Biostatistics Unit, Faculty of Medicine Gadjah Mada University, Dr. Sardjito's General Hospital, Yogyakarta, Indonesia.
Headache. 1993 Jun;33(6):335-8. doi: 10.1111/j.1526-4610.1993.hed3306335.x.
Several calcium channel blockers have been evaluated in controlled clinical studies and some hold considerable promise for future. Efficacy in migraine prophylaxis has been claimed for drugs belonging to all three classes of calcium channel blockers (nifedipine-like, verapamil-like, and flunarizine-like), but the extent and quality of the evidence varies, and a comparison of efficacy between different calcium channel blockers has not been reported.
The objective of the study is to assess the comparison of efficacy and safety of flunarizine and nifedipine in migraine prophylaxis.
The study was conducted in a prospective, double-blind, randomized controlled trial, parallel group design. 78 patients were studied for a 1-month period during which all patients received placebo followed by a 3-month experimental period. Headache response to medication was measured monthly by compilation of migraine-scores derived from quantitative data recorded by patients in a daily diary. Student's t-test was used to compare results from the flunarizine (10 mg) and nifedipine (20 mg) group for each month.
Both groups showed a significant reduction in the migraine-scores after 3-months. No significant differences were detected between groups, but there was a clinical significantly different reduction of migraine-scores between the groups in the first month after the run-in period (58% vs 38%). It shows that the beneficial effect of flunarizine was more rapidly manifest than that of flunarizine. Tachycardia more frequently occurred in the nifedipine group than in the flunarizine treatment group.
It concluded that flunarizine is a potentially more useful agent in the prophylaxis of migraine headache.
几种钙通道阻滞剂已在对照临床研究中进行了评估，其中一些对未来具有很大的前景。所有三类钙通道阻滞剂（硝苯地平类、维拉帕米类和氟桂利嗪类）的药物都声称对偏头痛预防有效，但证据的程度和质量各不相同，且尚未有不同钙通道阻滞剂之间疗效比较的报道。
本研究的目的是评估氟桂利嗪和硝苯地平在偏头痛预防中的疗效和安全性比较。
本研究采用前瞻性、双盲、随机对照试验、平行组设计。对78例患者进行了为期1个月的研究，在此期间所有患者均接受安慰剂治疗，随后进入为期3个月的试验期。通过汇总患者每日日记中记录的定量数据得出偏头痛评分，每月测量药物对头痛的反应。使用学生t检验比较氟桂利嗪（10毫克）组和硝苯地平（20毫克）组每月的结果。
3个月后两组偏头痛评分均显著降低。两组之间未检测到显著差异，但在导入期后的第一个月，两组之间偏头痛评分的临床降低有显著差异（58%对38%）。这表明氟桂利嗪的有益作用比硝苯地平更迅速显现。硝苯地平组心动过速的发生率高于氟桂利嗪治疗组。
得出结论，氟桂利嗪在预防偏头痛方面可能是一种更有用的药物。
