目的 通过系统评价和药品说明书形成药物治疗房颤不良事件/反应清单，为房颤不良事件/反应评价标准的构建奠定基础。方法 检索中国知网、万方、SinoMed、EMBASE、PubMed、Cochrane等数据库中明确诊断为房颤的临床研究，检索时限为2015年1月—2022年6月，提取临床研究中报告的不良事件/反应；从《国家医疗保险目录》《国家基本药物目录》和《世界卫生组织基本药物清单》中选取治疗房颤的中成药、化学药，从药品说明书提取中药、化学药治疗房颤报告的不良事件/反应。经过规范及合并，形成药物治疗房颤的不良事件/反应清单。结果 共纳入411项临床研究，提取47种药物药品说明书，经过规范及合并，形成了包含106个不良事件/反应的清单。其中神经系统和胃肠道疾病不良事件/反应报告频次最高，缺血性脑卒中、死亡、恶心、颅内出血、血栓栓塞事件是药物治疗房颤最常见的不良事件/反应。结论 药物治疗房颤的不良事件/反应涉及多个系统，在相关临床研究报告中应重点关注神经系统及胃肠道疾病不良事件/反应；应进一步构建心血管病不良事件/反应报告标准，为临床研究者选择和报告危害指标提供依据。

Objective To lay a foundation for the construction of evaluation criteria for adverse events/reactions of atrial fibrillation, to form a list of adverse events/reactions of drug treatment of atrial fibrillation through systematic review and package insert. Methods Clinical studies with a diagnosis of atrial fibrillation were searched from CNKI, Wanfang, SinoMed, EMBASE, PubMed and Cochrane, and the search time was from January 2015 to June 2022. Adverse events/reaction reported in clinical studies were extracted. Chinese patent medicines and western medicines for the treatment of atrial fibrillation were selected from the National Medical Insurance Catalogue, the National Essential Medicines Catalogue and the World Health Organization Essential Medicines List, and the adverse events/reactions reported were extracted through the package insert. After specification and merger, a list of adverse events/reactions were formed. Results A total of 411 clinical studies were included, 47 kinds of package insert of Chinese patent medicines and western medicines were extracted, and 106 adverse events/reactions were included in the final list of adverse events/reactions after standardization and consolidation. The top two most frequently reported systems were nervous system and gastrointestinal disease, and the top five most frequently reported indicators were ischemic stroke, death, nausea, intracranial hemorrhage, and thromboembolic events. Conclusion Adverse events/reactions to drug therapy for atrial fibrillation involves multiple systems, the adverse events/reactions of nervous system and gastrointestinal disease should be paid attention to report in atrial fibrillation clinical study. Reporting standards for adverse events/reactions of cardiovascular diseases should be further established to provide a basis for clinical investigators to select and report hazard indicators.

R973

北京中医药大学东直门医院2024年度科技创新专项（DZMKJCX-2024-004）;岐黄学者（RS086）