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左乙拉西坦与丙戊酸钠用于慢性偏头痛预防性治疗的比较:一项随机双盲临床试验

Levetiracetam in Compare to Sodium Valproate for Prophylaxis in Chronic Migraine Headache: A Randomized Double-Blind Clinical Trial.

作者信息

Kashipazha Davood, Ghadikolaei Hooshan Shariati, Siavashi Mehrnoush

机构信息

Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Department of Neurosurgery, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

Curr Clin Pharmacol. 2017;12(1):55-59. doi: 10.2174/1574884712666170329094419.

Abstract

BACKGROUND

Migraine is not curable, but preventive treatments are usually used to decrease the intensity and frequency of headache attacks. Different therapeutic options are widely studied for chronic migraine (CM), but all of them have different inefficacies.

OBJECTIVE

The aim of this study was to compare the efficacy of levetiracetam versus sodium valproate in the treatment of CM.

METHODS

A randomized controlled clinical trial was conducted on 62 patients with chronic migraine (30 patients in intervention group-treated with levetiracetam and 32 patients in control group- treated with sodium valproate). The treatment regimen consisted of initial dose of levetiracetam or sodium valproate 500 mg daily which increased to 500 mg two times a day after two weeks. The treatment response was evaluated by measuring pain frequency, pain severity, and the MIDAS (migraine disability assessment) score over three months follow-up.

RESULTS

During a three-month follow-up, the mean of headache frequency, severity, and MIDAS score were changed significantly. The rate of decrease in headache frequency was higher in control group than intervention group ((6.7±2.7 and 14.4±5.3 day/month, respectively) (P<0.001). Also, headache severity and MIDAS score significantly decreased in the control group than intervention group (3.4±1.1 and 5.7±1.6, respectively P<0.001, 16.7 ± 6.1 and 30.2±9.8, respectively (P<0.001).

CONCLUSIONS

According to our findings, levetiracetam offered improvement in headache frequency, severity, and MIDAS score in patients with CM. However, levetiracetam was not effective enough for chronic migraine as valproate, despite some significant effect. Thus levetiracetam can be one of the choices for limited chronic migraine subjects who are in contraindication of Valproate.

摘要

背景

偏头痛无法治愈,但预防性治疗通常用于降低头痛发作的强度和频率。针对慢性偏头痛(CM),人们广泛研究了不同的治疗方案,但所有方案都存在不同程度的无效性。

目的

本研究旨在比较左乙拉西坦与丙戊酸钠治疗慢性偏头痛的疗效。

方法

对62例慢性偏头痛患者进行了一项随机对照临床试验(干预组30例,接受左乙拉西坦治疗;对照组32例,接受丙戊酸钠治疗)。治疗方案为左乙拉西坦或丙戊酸钠初始剂量每日500毫克,两周后增至每日两次,每次500毫克。在三个月的随访期间,通过测量疼痛频率、疼痛严重程度和偏头痛残疾评估(MIDAS)评分来评估治疗反应。

结果

在三个月的随访期间,头痛频率、严重程度和MIDAS评分的平均值有显著变化。对照组头痛频率的降低率高于干预组(分别为(6.7±2.7和14.4±5.3天/月)(P<0.001)。此外,对照组的头痛严重程度和MIDAS评分显著低于干预组(分别为3.4±1.1和5.7±1.6,P<0.001;分别为16.7±6.1和30.2±9.8,P<0.001)。

结论

根据我们的研究结果,左乙拉西坦可改善慢性偏头痛患者的头痛频率、严重程度和MIDAS评分。然而,尽管有一些显著效果,但左乙拉西坦对慢性偏头痛的疗效不如丙戊酸钠。因此,对于有丙戊酸钠禁忌证的有限慢性偏头痛患者,左乙拉西坦可以是一种选择。

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