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枕神经阻滞用于偏头痛的短期预防性治疗:一项随机、双盲、安慰剂对照研究。

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study.

作者信息

Dilli Esma, Halker Rashmi, Vargas Bert, Hentz Joseph, Radam Teresa, Rogers Robert, Dodick David

机构信息

University of British Columbia, Department of Medicine, Canada

Mayo Clinic, Department of Neurology, USA.

出版信息

Cephalalgia. 2015 Oct;35(11):959-68. doi: 10.1177/0333102414561872. Epub 2014 Dec 12.

Abstract

BACKGROUND

Occipital nerve (ON) injections with corticosteroids and/or local anesthetics have been employed for the acute and preventive treatment of migraine for decades. However, to date there is no randomized, placebo-controlled evidence to support the use of occipital nerve block (ONB) for the prevention of migraine.

OBJECTIVE

The objective of this article is to determine the efficacy of ONB with local anesthetic and corticosteroid for the preventive treatment of migraine.

PARTICIPANTS AND METHODS

Patients between 18 and 75 years old with ICHD-II-defined episodic (> 1 attack per week) or chronic migraine (modified ICHD-II as patients with > 10 days with consumption of acute medications were permitted into the study) were randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml (20 mg) methylprednisolone over the ipsilateral (unilateral headache) or bilateral (bilateral headache) ON or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine (placebo). Patients completed a one-month headache diary prior to and after the double-blind injection. The primary outcome measure was defined as a 50% or greater reduction in the frequency of days with moderate or severe migraine headache in the four-week post-injection compared to the four-week pre-injection baseline period.

RESULTS

Thirty-four patients received active and 35 patients received placebo treatment. Because of missing data, the full analysis of 33 patients in the active and 30 patients in the placebo group was analyzed for efficacy. In the active and placebo groups respectively, the mean frequency of at least moderate (mean 9.8 versus 9.5) and severe (3.6 versus 4.3) migraine days and acute medication days (7.9 versus 10.0) were not substantially different at baseline. The percentage of patients with at least a 50% reduction in the frequency of moderate or severe headache days was 30% for both groups (10/30 vs nine of 30, Δ 0.00, 95% CI -0.22 to 0.23).

CONCLUSIONS

Greater ONB does not reduce the frequency of moderate to severe migraine days in patients with episodic or chronic migraine compared to placebo.The study was registered with ClinicalTrial.gov (NCT00915473).

摘要

背景

数十年来,使用皮质类固醇和/或局部麻醉剂进行枕神经(ON)注射已被用于偏头痛的急性和预防性治疗。然而,迄今为止,尚无随机、安慰剂对照的证据支持使用枕神经阻滞(ONB)预防偏头痛。

目的

本文旨在确定局部麻醉剂和皮质类固醇联合ONB预防偏头痛的疗效。

参与者和方法

年龄在18至75岁之间,符合国际头痛疾病分类第二版(ICHD-II)定义的发作性(每周发作超过1次)或慢性偏头痛患者(根据改良的ICHD-II,允许每周服用急性药物超过10天的患者纳入研究)被随机分为两组,一组在同侧(单侧头痛)或双侧(双侧头痛)枕神经处注射2.5毫升0.5%布比卡因加0.5毫升(20毫克)甲泼尼龙,另一组注射2.75毫升生理盐水加0.25毫升不含肾上腺素的1%利多卡因(安慰剂)。患者在双盲注射前后完成为期一个月的头痛日记。主要结局指标定义为与注射前四周基线期相比,注射后四周中度或重度偏头痛头痛天数减少50%或更多。

结果

34例患者接受了活性治疗,35例患者接受了安慰剂治疗。由于数据缺失,对活性组的33例患者和安慰剂组的30例患者进行了疗效的全面分析。在活性组和安慰剂组中,基线时至少中度(平均9.8天对9.5天)和重度(3.6天对4.3天)偏头痛天数以及急性药物服用天数(7.9天对10.0天)的平均频率没有显著差异。两组中中度或重度头痛天数频率至少降低50%的患者百分比均为30%(30例中的10例对30例中的9例,差异为0.00,95%置信区间为-0.22至0.23)。

结论

与安慰剂相比,强化ONB并未降低发作性或慢性偏头痛患者中度至重度偏头痛天数的频率。该研究已在ClinicalTrial.gov注册(NCT00915473)。

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