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国际头痛学会丛集性头痛对照临床试验指南。

Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache.

机构信息

CHU de Liège, Neurology, Headache Research Unit, Citadelle Hospital, Liège, Belgium.

Rigshospitalet Glostrup, Danish Headache Center, Glostrup, Denmark.

出版信息

Cephalalgia. 2022 Dec;42(14):1450-1466. doi: 10.1177/03331024221120266. Epub 2022 Oct 21.

DOI:10.1177/03331024221120266
PMID:36268950
Abstract

In 1995, a committee of the International Headache Society developed and published the first edition of the These have not been revised. With the emergence of new medications, neuromodulation devices and trial designs, an updated version of the International Headache Society is warranted. Given the scarcity of evidence-based data for cluster headache therapies, the update is largely consensus-based, but takes into account lessons learned from recent trials and demands by patients. It is intended to apply to both drug and neuromodulation treatments, with specific proposals for the latter when needed. The primary objective is to propose a template for designing high quality, state-of-the-art, controlled clinical trials of acute and preventive treatments in episodic and chronic cluster headache. The recommendations should not be regarded as dogma and alternative solutions to particular methodological problems should be explored in the future and scientifically validated.

摘要

1995 年,国际头痛协会的一个委员会制定并发布了第一版的《国际头痛疾病分类》。这些分类并未修订。随着新药物、神经调节设备和试验设计的出现,有必要更新国际头痛协会的分类。鉴于丛集性头痛治疗的循证数据稀缺,此次更新主要基于共识,但考虑了从最近的试验中吸取的经验教训和患者的需求。该分类旨在适用于药物和神经调节治疗,必要时为后者提出具体建议。主要目标是提出一个模板,用于设计高质量、最先进的、针对发作性和慢性丛集性头痛急性和预防性治疗的对照临床试验。这些建议不应被视为教条,未来应探索针对特定方法学问题的替代解决方案,并进行科学验证。

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