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静脉注射地塞米松与安慰剂作为辅助疗法降低急性偏头痛复发率的多中心、双盲、安慰剂对照随机临床试验

Intravenous dexamethasone vs placebo as adjunctive therapy to reduce the recurrence rate of acute migraine headaches: a multicenter, double-blinded, placebo-controlled randomized clinical trial.

作者信息

Donaldson David, Sundermann Ryan, Jackson Raymond, Bastani Aveh

机构信息

William Beaumont Hospital.

出版信息

Am J Emerg Med. 2008 Feb;26(2):124-30. doi: 10.1016/j.ajem.2007.03.029.

DOI:10.1016/j.ajem.2007.03.029
PMID:18272089
Abstract

OBJECTIVES

Some physicians prescribe corticosteroids as adjunctive therapy for patients with migraine headaches to decrease the rate of rebound headache. The efficacy of this practice has not been tested. Our objective is to determine the efficacy of single-dose dexamethasone as adjunctive therapy for emergency medicine patients with migraine headache in preventing headache recurrence at 3 and 30 days posttreatment.

METHODS

From November 2004 to November 2005, we conducted a multicenter, double-blinded, placebo-controlled randomized clinical trial of adult patients who met the International Headache Society definition of migraine headache. After informed consent, patients were randomly assigned to one of two groups: receiving either placebo or 24 mg dexamethasone intravenously. To ensure generalizability, all other aspects of patient care were left to the discretion of the emergency physician. Clinical and demographic information was obtained; and patients were subsequently contacted at both 3 and 30 days to determine headache recurrence, current functional disability, and need for return to the ED. Our primary outcome measures were the recurrence of migraine headache at 3 and 30 days. We used Fisher exact to test for statistical significance.

RESULTS

A total of 115 patients were enrolled, with 16 patients lost to follow-up at 3 days and 3 additional patients lost at 30 days. Baseline characteristics as well as adverse event profiles were equivalent in both study groups. At 3-day follow-up, 45% (95% confidence interval [CI] 31%-60%) of the placebo group had recurrence of their migraine compared with 35% (95% CI 24%-48%) in the dexamethasone group (P = .68). At 30-day follow-up, this relative reduction in migraine recurrence decreased to a 4% difference between the 2 groups (P = .68). Limitations include small sample size and significant proportion lost to follow-up.

CONCLUSION

A single dose of dexamethasone as adjunctive therapy for migraine headache does not decrease the recurrence of migraines at 3 or 30 days.

摘要

目的

一些医生为偏头痛患者开具皮质类固醇作为辅助治疗,以降低反弹性头痛的发生率。这种做法的疗效尚未得到验证。我们的目的是确定单剂量地塞米松作为辅助治疗对急诊医学中偏头痛患者在治疗后3天和30天预防头痛复发的疗效。

方法

2004年11月至2005年11月,我们对符合国际头痛协会偏头痛定义的成年患者进行了一项多中心、双盲、安慰剂对照的随机临床试验。在获得知情同意后,患者被随机分为两组之一:接受安慰剂或静脉注射24mg地塞米松。为确保普遍性,患者护理的所有其他方面由急诊医生自行决定。获取了临床和人口统计学信息;随后在3天和30天时联系患者,以确定头痛复发情况、当前功能残疾情况以及返回急诊科的需求。我们的主要结局指标是3天和30天时偏头痛头痛的复发情况。我们使用Fisher精确检验来检验统计学显著性。

结果

共纳入115例患者,16例患者在3天时失访,另外3例患者在30天时失访。两个研究组的基线特征以及不良事件情况相当。在3天随访时,安慰剂组45%(95%置信区间[CI]31%-60%)的患者偏头痛复发,而地塞米松组为35%(95%CI 24%-48%)(P = 0.68)。在30天随访时,偏头痛复发的这种相对降低在两组之间降至4%的差异(P = 0.68)。局限性包括样本量小和失访比例显著。

结论

单剂量地塞米松作为偏头痛头痛的辅助治疗在3天或30天时不会降低偏头痛的复发率。

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