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那拉曲普坦治疗急性偏头痛:随机对照试验的荟萃分析

Naratriptan for the treatment of acute migraine: meta-analysis of randomised controlled trials.

作者信息

Ashcroft Darren M, Millson David

机构信息

School of Pharmacy and Pharmaceutical Sciences, University of Manchester, UK.

出版信息

Pharmacoepidemiol Drug Saf. 2004 Feb;13(2):73-82. doi: 10.1002/pds.890.

Abstract

OBJECTIVE

To evaluate the comparative efficacy and tolerability of naratriptan in the treatment of acute attacks of migraine.

DESIGN

Meta-analysis of randomised controlled trials using a random effects model.

SUBJECTS

A total of 4499 patients suffering from moderate or severe attacks of acute migraine reported in ten trials.

MAIN OUTCOME MEASURES

Response rate ratios for headache relief, pain-free response and sustained relief (4-24 hours). Adverse events were estimated with the rate ratio (RR), risk difference and number needed to harm.

RESULTS

Pooled RRs relative to placebo for pain-free response at 2 and 4 hours for naratriptan 2.5 mg were 2.52 (95% CI: 1.78-3.57) and 2.58 (1.99-3.35). Naratriptan 2.5 mg was more effective than naratriptan 1 mg; the corresponding RRs for pain-free response at 2 and 4 hours were 1.54 (95% CI: 1.28-1.86) and 1.35 (1.20-1.51). In contrast, naratriptan 2.5 mg was less effective in pain-free response than either rizatriptan 10 mg at 4 hours (RR: 0.68; 95% CI: 0.55-0.85) or sumatriptan 100 mg at 4 hours (RR: 0.79; 95% CI: 0.67-0.93). However, significantly fewer patients experienced adverse effects with naratriptan 2.5 mg than with rizatriptan 10 mg (RR: 0.73; 95% CI: 0.56-0.97) or sumatriptan 100 mg (RR: 0.68; 95% CI: 0.55-0.86).

CONCLUSIONS

Naratriptan is an effective and well-tolerated treatment for acute attacks of migraine. Head-to-head comparisons suggest that naratriptan 2.5 mg is significantly more effective than the 1 mg dose. Rizatriptan 10 mg and sumatriptan 100 mg were superior to naratriptan in terms of headache relief, while zolmitriptan 2.5 mg seemed to have comparable efficacy. Randomised controlled trials have shown that at licensed doses (1 and 2.5 mg), naratriptan is associated with a lower incidence of adverse effects than rizatriptan, sumatriptan and zolmitriptan. The incidence rates of adverse effects were similar to placebo.

摘要

目的

评估那拉曲普坦治疗偏头痛急性发作的相对疗效和耐受性。

设计

采用随机效应模型对随机对照试验进行荟萃分析。

研究对象

10项试验中总共4499例患有中度或重度急性偏头痛发作的患者。

主要观察指标

头痛缓解、无痛反应和持续缓解(4 - 24小时)的反应率比值。用率比(RR)、风险差和伤害所需人数估计不良事件。

结果

那拉曲普坦2.5mg在2小时和4小时时相对于安慰剂的无痛反应合并RR分别为2.52(95%CI:1.78 - 3.57)和2.58(1.99 - 3.35)。那拉曲普坦2.5mg比那拉曲普坦1mg更有效;2小时和4小时时无痛反应的相应RR分别为1.54(95%CI:1.28 - 1.86)和1.35(1.20 - 1.51)。相比之下,那拉曲普坦2.5mg在4小时时的无痛反应效果不如利扎曲普坦10mg(RR:0.68;95%CI:0.55 - 0.85)或舒马曲普坦100mg(RR:0.79;95%CI:0.67 - 0.93)。然而,那拉曲普坦2.5mg发生不良反应的患者明显少于利扎曲普坦10mg(RR:0.73;95%CI:0.56 - 0.97)或舒马曲普坦100mg(RR:0.68;95%CI:0.55 - 0.86)。

结论

那拉曲普坦是治疗偏头痛急性发作的一种有效且耐受性良好的药物。直接比较表明,那拉曲普坦2.5mg比1mg剂量显著更有效。在头痛缓解方面,利扎曲普坦10mg和舒马曲普坦100mg优于那拉曲普坦,而佐米曲普坦2.5mg似乎具有相当的疗效。随机对照试验表明,在许可剂量(1mg和2.5mg)下,那拉曲普坦的不良反应发生率比利扎曲普坦、舒马曲普坦和佐米曲普坦低。不良反应发生率与安慰剂相似。

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