摘要
偏头痛是一种常见的慢性神经血管性疾病,常反复发作、缠绵难愈,给患者带来巨大的生活和经济负担,因此,找寻具有优势的长期治疗方案极其必要。中医药治疗偏头痛积累了丰富的临床经验,已成为优势特色病种之一,然而获得证据的相关临床试验尚处于起步阶段。国际头痛学会(IHS)临床试验常设委员会于1991年出版了第一版偏头痛药物对照试验指南,此后,在其持续推动下,偏头痛的药物治疗临床试验方法不断更新和完善,并于2020年6月颁布了《成人发作性偏头痛预防治疗的对照试验指南》更新版。本文结合临床试验关键要素及研究实例对该指南进行解读,旨在为我国成人发作性偏头痛预防性治疗临床研究,尤其是中医药领域临床研究设计提供参考与借鉴,推动该领域中医药临床试验的高质量发展。
Migraine is a prevalent chronic neurovascular disorder characterized by recurrent episodes that can be debilitating,imposing significant lifestyle and economic burdens on patients.Consequently,identifying effective long-term treatment strategies is essential.Traditional Chinese medicine has accumulated significant clinical experience in migraine treatment,establishing itself as a distinctive and beneficial therapeutic approach.However,relevant clinical trials to provide supporting evidence remain in the early stages.The International Headache Society(IHS)Clinical Trials Subcommittee published the first edition of guidelines for controlled trials of migraine drugs in 1991.Since then,ongoing efforts have refined and enhanced clinical trial methodologies for migraine pharmacotherapy,culminating in the release of an updated version of the Guideline for Controlled Trials of Preventive Treatment of Adult Episodic Migraine in June 2020.This article interprets the guidelines in conjunction with key elements of clinical trials and relevant research examples,aiming to provide references for clinical research on the preventive treatment of adult episodic migraine in China,particularly within the field of traditional Chinese medicine.The objective is to promote the high-quality development of clinical trials in this area.
作者
李牧之
王思村
党海霞
刘骏
王忠
于亚南
LI Muzhi;WANG Sicun;DANG Haixia;LIU Jun;WANG Zhong;YU Yanan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Traditional Chinese Medicine Development Research Center,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国中医基础医学杂志》
2025年第8期1403-1408,共6页
JOURNAL OF BASIC CHINESE MEDICINE
基金
中国中医科学院科技创新工程项目(CI2021A04707)
国家自然科学基金项目(82105052)
中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-076)
中央级公益性科研院所基本科研业务费专项(Z0599)。
关键词
成人发作性偏头痛
预防治疗
临床试验设计
指南解读
中医药
Adult episodic migraine
Preventive treatment
Design of clinical trial
Guide interpretation
Traditional Chinese medicine
