Derry Christopher J, Derry Sheena, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford,UK.
Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008615. doi: 10.1002/14651858.CD008615.pub2.
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.
To determine the efficacy and tolerability of oral sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
We included randomised, double-blind, placebo- and/or active-controlled studies using oral sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
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.
Sixty-one studies (37,250 participants) compared oral sumatriptan with placebo or an active comparator. Most of the data were for the 50 mg and 100 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 50 mg versus placebo the NNTs were 6.1, 7.5, and 4.0 for pain-free at two hours and headache relief at one and two hours, respectively. NNTs for sustained pain-free and sustained headache relief during the 24 hours postdose were 9.5 and 6.0, respectively. For sumatriptan 100 mg versus placebo the NNTs were 4.7, 6.8, 3.5, 6.5, and 5.2, respectively, for the same outcomes. Results for the 25 mg dose were similar to the 50 mg dose, while sumatriptan 100 mg was significantly better than 50 mg for pain-free and headache relief at two hours, and for sustained pain-free during 24 hours. Treating early, during the mild pain phase, gave significantly better NNTs for pain-free at two hours and sustained pain-free during 24 hours than did treating established attacks with moderate or severe pain intensity.Relief of associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than with placebo. For the most part, adverse events were transient and mild and were more common with the sumatriptan than with placebo, with a clear dose response relationship (25 mg to 100 mg).Sumatriptan was compared directly with a number of active treatments, including other triptans, paracetamol (acetaminophen), acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and ergotamine combinations.
AUTHORS' CONCLUSIONS: Oral sumatriptan is effective as an abortive treatment for migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
偏头痛对个体而言是一种严重致残的疾病,对社会、医疗服务和经济也具有广泛影响。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。
确定与安慰剂及其他活性干预措施相比,口服舒马曲坦治疗成人急性偏头痛发作的疗效和耐受性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、在线数据库,并检索截至2011年10月13日的研究的参考文献列表。
我们纳入了使用口服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。
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)。
61项研究(37250名参与者)比较了口服舒马曲坦与安慰剂或活性对照。大多数数据针对50毫克和100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50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的NNT分别为6.1、7.5和4.0。给药后24小时持续无痛和持续头痛缓解的NNT分别为9.5和6.0。对于100毫克舒马曲坦与安慰剂相比,相同结局的NNT分别为4.7、6.8、3.5、6.5和5.2。25毫克剂量的结果与50毫克剂量相似,而100毫克舒马曲坦在两小时无痛和头痛缓解以及24小时持续无痛方面明显优于50毫克。在轻度疼痛阶段早期治疗,两小时无痛和24小时持续无痛的NNT明显优于治疗中度或重度疼痛强度的已确诊发作。与安慰剂相比,舒马曲坦对包括恶心、畏光和畏声在内的相关症状的缓解作用更大,舒马曲坦使用急救药物的情况低于安慰剂。在大多数情况下,不良事件是短暂且轻微的,舒马曲坦组比安慰剂组更常见,且有明确的剂量反应关系(25毫克至100毫克)。舒马曲坦与多种活性治疗进行了直接比较,包括其他曲坦类药物、对乙酰氨基酚、乙酰水杨酸、非甾体抗炎药(NSAIDs)和麦角胺组合。
口服舒马曲坦作为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,但与不良事件增加有关。