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鼻用舒马曲坦:新剂型。对青少年偏头痛患者而言:益处甚微。

Nasal sumatriptan: new dosage. For adolescents with migraine: too little benefit.

出版信息

Prescrire Int. 2005 Apr;14(76):45-7.

PMID:15875337
Abstract

(1) The reference first-line drug therapy for migraine attacks in adolescents is a non specific analgesic such as paracetamol or a nonsteroidal antiinflammatory drug like ibuprofen. Two specific analgesics are authorised for use in this setting in France, namely ergotamine and dihydroergotamine. (2) Nasal sumatriptan is the first triptan to be licensed for this age group in France. (3) Evaluation data includes three flawed placebo-controlled trials. (4) Effects were modest at best. Only one of the three trials showed that sumatriptan was more likely than placebo to give complete pain relief within two hours. The three trials fail to show that sumatriptan is effective against symptoms such as nausea and vomiting, photophobia and phonophobia. (5) The principal known adverse effects of sumatriptan are chest tightness, flushing, and increased blood pressure. (6) In the only trial report containing relevant information, unpleasant taste was the only adverse effect more commonly associated with sumatriptan than with placebo. (7) Postmarketing follow-up revealed a number of serious adverse effects, including stroke, myocardial infarction and loss of vision. (8) The packs containing 6 or 12 spray vials carry a risk of overuse and self-induced headache. (9) In practice, sumatriptan must not be used to treat migraine attacks in adolescents.

摘要

(1) 青少年偏头痛发作的一线参考药物治疗是使用对乙酰氨基酚等非特异性镇痛药或布洛芬等非甾体抗炎药。在法国,有两种特异性镇痛药被批准用于这种情况,即麦角胺和双氢麦角胺。(2) 鼻腔用舒马曲坦是法国首个获许可用于该年龄组的曲坦类药物。(3) 评估数据包括三项存在缺陷的安慰剂对照试验。(4) 效果充其量只能说是一般。三项试验中只有一项表明,舒马曲坦在两小时内实现完全疼痛缓解的可能性比安慰剂更大。这三项试验未能表明舒马曲坦对恶心、呕吐、畏光和畏声等症状有效。(5) 舒马曲坦已知的主要不良反应是胸部发紧、脸红和血压升高。(6) 在唯一一份包含相关信息的试验报告中,与安慰剂相比,不愉快的味道是唯一更常与舒马曲坦相关的不良反应。(7) 上市后随访发现了一些严重不良反应,包括中风、心肌梗死和视力丧失。(8) 装有6支或12支喷雾瓶的包装存在过度使用和自我诱发头痛的风险。(9) 在实际应用中,舒马曲坦不得用于治疗青少年的偏头痛发作。

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