Oldman A D, Smith L A, McQuay H J, Moore R A
62 Campbell Road, Oxford, UK, OX4 3PG. oldman
Cochrane Database Syst Rev. 2001(3):CD003221. doi: 10.1002/14651858.CD003221.
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.
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).
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.
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.
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.
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.
REVIEWER'S CONCLUSIONS: Rizatriptan 5 mg and 10 mg are effective in treating acute migraine, with a dose-related increase in efficacy.
治疗急性偏头痛有多种不同的药物疗法,目前有四种曲坦类药物,未来可能还会有更多。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。
使用半小时、一小时、两小时时的头痛缓解及无痛反应以及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。用需治疗人数(NNT)来表示疗效。
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。
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;国际头痛协会有或无先兆偏头痛的诊断标准;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。
考虑的主要结果为: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及无痛反应,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获益(RB)和需治疗人数(NNT)。
七项试验符合我们的纳入标准,2626例患者服用利扎曲普坦,902例患者服用安慰剂。对于所有五项主要疗效结果(从1小时到24小时),两种剂量(5毫克和10毫克)的利扎曲普坦均显示出优于安慰剂的显著获益。主要结果呈现剂量反应关系。无法以有意义的方式分析不良反应信息。
5毫克和10毫克的利扎曲普坦有效治疗急性偏头痛,疗效呈剂量相关增加。