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氟桂利嗪与安慰剂治疗儿童偏头痛的对照研究。一项双盲研究。

Flunarizine v. placebo in childhood migraine. A double-blind study.

作者信息

Sorge F, Marano E

出版信息

Cephalalgia. 1985 May;5 Suppl 2:145-8. doi: 10.1177/03331024850050S227.

Abstract

Successful migraine prophylaxis with flunarizine has been reported in adults by several authors. We used flunarizine in a double-blind, placebo controlled, randomized trial in childhood migraine. Twenty-four children with classical or common migraine were followed by a 12-week flunarizine treatment period. Each patient took 5 mg/day of the drug before going to sleep. Twenty-four children with similar clinical characteristics were assigned to placebo treatment. Efficacy of flunarizine versus placebo was assessed on the basis of the reduction of headache frequency and duration. A statistical comparison was performed between values reported in the treatment period and those in the three months before. Children treated with flunarizine experienced a statistically significant reduction in headache (66%) and duration (51%). These results were statistically superior to those observed in the placebo group. Sixteen patients on flunarizine therapy experienced an improvement of more than 50% of both parameters. We found flunarizine is an effective agent in children's migraine prophylaxis. Moreover it is suitable for the low incidence of mild side effects.

摘要

几位作者报告了氟桂利嗪在成人偏头痛预防方面取得成功。我们在一项针对儿童偏头痛的双盲、安慰剂对照、随机试验中使用了氟桂利嗪。24名患有典型或普通偏头痛的儿童接受了为期12周的氟桂利嗪治疗。每位患者在睡前服用5毫克/天的该药物。另外24名具有相似临床特征的儿童被分配接受安慰剂治疗。根据头痛频率和持续时间的减少情况评估氟桂利嗪与安慰剂的疗效。对治疗期间报告的值与前三个月的值进行了统计学比较。接受氟桂利嗪治疗的儿童头痛次数(66%)和持续时间(51%)在统计学上有显著减少。这些结果在统计学上优于安慰剂组观察到的结果。16名接受氟桂利嗪治疗的患者两个参数的改善均超过50%。我们发现氟桂利嗪是预防儿童偏头痛的有效药物。此外,它因轻度副作用发生率低而适用。

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