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氟桂利嗪治疗普通偏头痛的安慰剂对照、双盲、交叉试验

A placebo-controlled, double-blind, cross-over trial of flunarizine in common migraine.

作者信息

Sørensen P S, Hansen K, Olesen J

出版信息

Cephalalgia. 1986 Mar;6(1):7-14. doi: 10.1046/j.1468-2982.1986.0601007.x.

Abstract

After four weeks of medication-free baseline observation, 29 patients with common migraine randomly received flunarizine (10 mg daily) or placebo for a 16-week period. After four weeks wash-out they crossed treatments for another 16 weeks; 27 patients completed the trial. Compared with placebo, flunarizine significantly reduced the frequency of migraine attacks and the derived headache indices, but the duration and severity of single attacks remained unchanged (Mann-Whitney U-test). The effect of flunarizine increased during the 16-week treatment period and during the last four weeks the number of migraine attacks reduced to 50% compared to the wash-out period. The only side-effect of flunarizine was mild daytime sedation in three patients. It is concluded that flunarizine is a valuable new prophylactic agent for common migraine.

摘要

在进行了四周无药物的基线观察后,29名普通偏头痛患者被随机分配,在16周的时间里接受氟桂利嗪(每日10毫克)或安慰剂治疗。四周的洗脱期后,他们交叉接受另一种治疗,为期16周;27名患者完成了试验。与安慰剂相比,氟桂利嗪显著降低了偏头痛发作的频率和由此得出的头痛指数,但单次发作的持续时间和严重程度保持不变(曼-惠特尼U检验)。在16周的治疗期内,氟桂利嗪的效果增强,在最后四周,与洗脱期相比,偏头痛发作次数减少了50%。氟桂利嗪唯一的副作用是三名患者出现轻度日间嗜睡。结论是,氟桂利嗪是一种用于普通偏头痛的有价值的新型预防药物。

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