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舒马曲坦(鼻内给药途径)用于成人急性偏头痛发作。

Sumatriptan (intranasal route of administration) for acute migraine attacks in adults.

作者信息

Derry Christopher J, Derry Sheena, Moore R Andrew

机构信息

Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford,UK.

出版信息

Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD009663. doi: 10.1002/14651858.CD009663.

Abstract

BACKGROUND

Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Intranasal administration may be preferable to oral for individuals experiencing nausea and/or vomiting, although it is primarily absorbed in the gut, not the nasal mucosa.

OBJECTIVES

To determine the efficacy and tolerability of intranasal sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.

SEARCH METHODS

We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.

SELECTION CRITERIA

We included randomised, double-blind, placebo- and/or active-controlled studies using intranasal sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.

MAIN RESULTS

Twelve studies (4755 participants) compared intranasal sumatriptan with placebo or an active comparator. Most of the data were for the 10 mg and 20 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 10 mg versus placebo the NNTs were 7.3, 7.4, and 5.5 for pain-free at two hours, and headache relief at one and two hours, respectively. For sumatriptan 20 mg versus placebo the NNTs were 4.7, 4.9, and 3.5, respectively, for the same outcomes. The 20 mg dose was significantly better than the 10 mg dose for each of these three primary efficacy outcomes.Relief of headache-associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo.Direct comparison of sumatriptan with active treatments was limited to two studies, one comparing sumatriptan 20 mg and dihydroergotamine (DHE) 1 mg, and one comparing sumatriptan 20 mg with rizatriptan 10 mg.

AUTHORS' CONCLUSIONS: Intranasal sumatriptan is effective as an abortive treatment for acute migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events compared with placebo.

摘要

背景

偏头痛对个体而言是一种严重致残的疾病,对社会、医疗服务和经济也有广泛影响。舒马曲坦是一种用于偏头痛发作的终止性药物,属于曲坦类药物。对于出现恶心和/或呕吐的个体,鼻内给药可能比口服给药更可取,尽管它主要在肠道而非鼻黏膜吸收。

目的

确定与安慰剂及其他活性干预措施相比,鼻内使用舒马曲坦治疗成人急性偏头痛发作的疗效和耐受性。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、在线数据库,并查阅了截至2011年10月13日的研究参考文献列表。

选择标准

我们纳入了使用鼻内舒马曲坦治疗偏头痛发作的随机、双盲、安慰剂和/或活性对照研究,每个治疗组至少有10名参与者。

数据收集与分析

两名综述作者独立评估试验质量并提取数据。我们使用达到各结局的参与者数量来计算相对风险(或“风险比”),以及与安慰剂或不同活性治疗相比的获益所需治疗人数(NNT)或伤害所需治疗人数(NNH)。

主要结果

12项研究(4755名参与者)比较了鼻内舒马曲坦与安慰剂或活性对照。大多数数据针对10毫克和20毫克剂量。在所有疗效结局方面,舒马曲坦均优于安慰剂。对于10毫克舒马曲坦与安慰剂相比,两小时无痛、一小时和两小时头痛缓解情况下的NNT分别为7.3、7.4和5.5。对于20毫克舒马曲坦与安慰剂相比,相同结局下的NNT分别为4.7、4.9和3.5。在这三个主要疗效结局中,20毫克剂量均显著优于10毫克剂量。与安慰剂相比,舒马曲坦对包括恶心、畏光和畏声在内的头痛相关症状的缓解作用更强,且舒马曲坦使用急救药物的情况比安慰剂更少。在大多数情况下,不良事件短暂且轻微,舒马曲坦组比安慰剂组更常见。舒马曲坦与活性治疗的直接比较仅限于两项研究,一项比较20毫克舒马曲坦与1毫克双氢麦角胺(DHE),另一项比较20毫克舒马曲坦与10毫克利扎曲坦。

作者结论

鼻内舒马曲坦作为急性偏头痛发作的终止性治疗有效,可缓解疼痛、恶心、畏光、畏声和功能障碍,但与安慰剂相比不良事件有所增加。

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