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撤回:利扎曲普坦用于急性偏头痛。

WITHDRAWN: Rizatriptan for acute migraine.

作者信息

Oldman A D, Smith L A, McQuay H J, Moore R A

机构信息

Churchill Hospital, c/o Pain Research Unit, Old Road, Headington, Oxford, UK, OX3 7LJ.

出版信息

Cochrane Database Syst Rev. 2007 Jul 18;2001(1):CD003221. doi: 10.1002/14651858.CD003221.pub2.

DOI:10.1002/14651858.CD003221.pub2
PMID:17636717
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6564089/
Abstract

BACKGROUND

There are a number of different drug treatments for acute migraine, including currently four triptans, with several more likely to become available in the future. There is a need for evidence-based information to help determine the balance of benefit and harm for acute migraine treatment.

OBJECTIVES

To quantitatively assess the efficacy of a single dose of rizatriptan (Maxalt) for treating a single migraine attack using the outcomes of headache response and pain-free response at half-an-hour, one hour, two hours, and sustained relief over 24 hours. To express efficacy in terms of numbers-needed-to-treat (NNTs).

SEARCH STRATEGY

Trials were identified by searching MEDLINE (1966-July 2000), EMBASE (1980-June 2000), the Cochrane Library (Issue 3, 2000) and the Oxford Pain Relief Database (1950-1994). Date of last search: July 2000.

SELECTION CRITERIA

The inclusion criteria were randomised, placebo-controlled trials of rizatriptan for acute migraine; double-blind design; International Headache Society diagnostic criteria for migraine with or without aura; single migraine attack; single-dose treatment at standard doses; adult population; baseline pain of moderate or severe intensity using a four-point standardised rating scale; dichotomous or percentage data for at least one of the main efficacy outcomes; and full journal publication.

DATA COLLECTION AND ANALYSIS

Main outcomes considered were i) headache response at two hours, ii) headache response at one hour, iii) pain-free response at two hours, iv) sustained relief over 24 hours, v) pain-free response at 24 hours and vi) adverse effects. Minor outcomes were headache response and pain-free response at half-an-hour and four hours, and pain-free response at one hour. Dichotomous or percentage data were extracted and used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for each outcome.

MAIN RESULTS

Seven trials met our inclusion criteria, with 2626 patients given rizatriptan and 902 given placebo. Significant benefit of rizatriptan over placebo was shown for both doses of rizatriptan (5 mg and 10 mg) for all five main efficacy outcomes (ranging from one to 24 hours). A dose response was seen for the main outcomes. It was not possible to analyse adverse effects information in a meaningful way.

AUTHORS' CONCLUSIONS: Rizatriptan 5 mg and 10 mg are effective in treating acute migraine, with a dose-related increase in efficacy.

摘要

背景

急性偏头痛有多种不同的药物治疗方法,目前包括四种曲坦类药物,未来可能会有更多药物上市。需要基于证据的信息来帮助确定急性偏头痛治疗的利弊平衡。

目的

使用半小时、一小时、两小时时的头痛缓解和无痛反应以及24小时持续缓解的结果,定量评估单剂量利扎曲普坦(麦克斯林)治疗单次偏头痛发作的疗效。以治疗所需人数(NNT)来表示疗效。

检索策略

通过检索MEDLINE(1966年 - 2000年7月)、EMBASE(1980年 - 2000年6月)、Cochrane图书馆(2000年第3期)和牛津疼痛缓解数据库(1950年 - 1994年)来识别试验。最后检索日期:2000年7月。

选择标准

纳入标准为利扎曲普坦治疗急性偏头痛的随机、安慰剂对照试验;双盲设计;国际头痛协会偏头痛伴或不伴先兆的诊断标准;单次偏头痛发作;标准剂量单剂量治疗;成年人群;使用四点标准化评分量表的中度或重度基线疼痛;至少一项主要疗效结果的二分法或百分比数据;以及完整的期刊发表。

数据收集与分析

主要考虑的结果为:i)两小时时的头痛缓解,ii)一小时时的头痛缓解,iii)两小时时的无痛反应,iv)24小时持续缓解,v)24小时时的无痛反应,以及vi)不良反应。次要结果为半小时和四小时时的头痛缓解和无痛反应,以及一小时时的无痛反应。提取二分法或百分比数据并用于计算每个结果的相对益处(RB)和治疗所需人数(NNT)。

主要结果

七项试验符合我们的纳入标准,2626例患者给予利扎曲普坦,902例给予安慰剂。两种剂量的利扎曲普坦(5毫克和10毫克)在所有五项主要疗效结果(从1小时到24小时)上均显示出比利扎曲普坦更显著的益处。主要结果呈现剂量反应。无法以有意义的方式分析不良反应信息。

作者结论

利扎曲普坦5毫克和10毫克有效治疗急性偏头痛,疗效呈剂量相关增加。

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引用本文的文献

1
Rizatriptan for acute migraine headaches in adults.利扎曲普坦用于成人急性偏头痛。
Cochrane Database Syst Rev. 2010(4). doi: 10.1002/14651858.CD008491.