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托吡酯与丙戊酸钠预防偏头痛效果的比较:一项随机双盲交叉研究。

Comparison of the effect of topiramate and sodium valporate in migraine prevention: a randomized blinded crossover study.

作者信息

Shaygannejad Vahid, Janghorbani Mohsen, Ghorbani Abbas, Ashtary Fereshteh, Zakizade Naser, Nasr Vida

机构信息

Department of Neurology, Isfahan University of Medical Sciences and Health Services, Isfahan, Iran.

出版信息

Headache. 2006 Apr;46(4):642-8. doi: 10.1111/j.1526-4610.2006.00413.x.

DOI:10.1111/j.1526-4610.2006.00413.x
PMID:16643559
Abstract

BACKGROUND

Topiramate and sodium valporate are anticonvulsants, demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials.

OBJECTIVES

To compare the relative efficacy of topiramate and sodium valporate in the prevention of migraine.

PATIENTS AND METHODS

A 24-week, randomized, double-blind, crossover, clinical trial was conducted from October 2003 to September 2004. A total of 64 patients with migraine headache, aged 14 to 57 years, were randomly allocated to the 2 treatment groups. The first group received topiramate (25 mg daily increment over 1 week to 50 mg) for a total of 2 months. The second group received sodium valporate (200 mg daily increment over 1 week to 400 mg) for 2 months. Response to treatment was assessed at 0, 1, 8, 16, and 24 weeks after start of therapy.

RESULTS

Topiramate appeared to be equivalent in efficacy and safety to sodium valporate. A significant decrease in duration, monthly frequency, and intensity of headache occurred in both groups. Of the 32 patients treated with sodium valporate, the mean standard deviation (SD) of monthly migraine frequency decreased from 5.4 (2.5) to 4.0 (2.8) episode per month, headache intensity from 7.7 (1.2) to 5.8 (1.7) by visual analog scale (VAS), and headache duration from 21.3 (14.6) to 12.3 (10.7) hours (P < .001). Correspondingly, in the 32 patients treated with topiramate, the mean SD of monthly headache frequency decreased from 5.4 (2.0) to 3.2 (1.9) per month, headache intensity from 6.9 (1.2) to 3.7 (1.3), and headache duration from 17.3 (8.4) to 3.9 (2.7) hours (P < .001).

CONCLUSION

This study demonstrates that treatment with topiramate and sodium valporate both significantly reduce migraine headache. This effect of topiramate and sodium valporate has previously been shown to reduce migraine headache, and we postulate that treatment with topiramate and sodium valporate may have a similar benefit.

摘要

背景

托吡酯和丙戊酸钠是抗惊厥药,在安慰剂对照试验中已证明作为偏头痛预防的单一疗法有效。

目的

比较托吡酯和丙戊酸钠预防偏头痛的相对疗效。

患者和方法

2003年10月至2004年9月进行了一项为期24周的随机、双盲、交叉临床试验。共有64例年龄在14至57岁的偏头痛患者被随机分配到两个治疗组。第一组接受托吡酯(在1周内每日递增25mg至50mg),共2个月。第二组接受丙戊酸钠(在1周内每日递增200mg至400mg),共2个月。在治疗开始后的0、1、8、16和24周评估治疗反应。

结果

托吡酯在疗效和安全性方面似乎与丙戊酸钠相当。两组患者的头痛持续时间、每月发作频率和强度均显著降低。在接受丙戊酸钠治疗的32例患者中,每月偏头痛发作频率的平均标准差从5.4(2.5)降至4.0(2.8)次/月,通过视觉模拟量表(VAS)评估的头痛强度从7.7(1.2)降至5.8(1.7),头痛持续时间从21.3(14.6)小时降至12.3(10.7)小时(P <.001)。相应地,在接受托吡酯治疗的32例患者中,每月头痛发作频率的平均标准差从5.4(2.0)降至3.2(1.9)次/月,头痛强度从6.9(1.2)降至3.7(1.3),头痛持续时间从17.3(8.4)小时降至3.9(2.7)小时(P <.001)。

结论

本研究表明,托吡酯和丙戊酸钠治疗均能显著减轻偏头痛。托吡酯和丙戊酸钠的这种作用此前已被证明可减轻偏头痛,我们推测托吡酯和丙戊酸钠治疗可能具有相似的益处。

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