目的 基于FAERS数据库，采用多种方法挖掘中药相关心脏不良事件信号，识别其心脏安全性风险，旨在为临床用药提供参考，探讨构建中药心脏风险警戒系统。方法 筛选FAERS数据库中心脏相关不良事件中“主要怀疑”和“次要怀疑”报告，通过查阅资料、专家咨询、名称规约等确定中药信息。对患者结局和不良事件信息进行分级筛选和归纳统计，运用报告比值比法（ROR）、比例报告比法（PRR）、综合标准法（MHRA）、贝叶斯置信传播神经网络法（BCPNN）4种方法检测风险信号。结果 共纳入582份中药致心脏不良事件报告，涉及659条记录。分析发现，银杏叶、番泻叶、人参、莨菪碱等与心脏不良事件关联显著，临床表现以心率及心律紊乱（58.45%）为主，严重结局包括死亡、住院治疗等。共发现9种具有心脏风险信号的中药、提取物及其制剂，包括银杏叶、人参、蒽醌类等，其中海藻制品、丹参和蒽醌类成分的心脏风险信号最强。结论 研究结果为临床安全用药提供了重要依据，建议进一步构建“识毒-用毒-防毒-解毒”中药心脏安全性警戒体系，加强监测与机制研究。

Objective The FAERS database was used to mine signals of cardiac adverse events associated with Chinese herbal medicine（CHM） through multiple analytical methods, aiming to identify potential cardiac safety risks and provide clinical reference. Additionally, it explores the construction of a CHM cardiac risk vigilance system. Methods Screen the cardiac-related adverse events in the FAERS database, focusing on reports classified as primary suspect and secondary suspect. Identify CHM information through literature review, expert consultation, and name standardization. Perform hierarchical screening and statistical summarization of patient outcomes and adverse event data. Detect risk signals using four disproportionality analysis methods: Reporting Odds Ratio（ROR）, Proportional Reporting Ratio（PRR）, Medicines and Healthcare products Regulatory Agency（MHRA） method, and Bayesian Confidence Propagation Neural Network（BCPNN）. Results A total of 582 reports of CHM-induced cardiac adverse events were included, involving 659 records. Analysis revealed that Ginkgo biloba, senna leaves, ginseng, and hyoscyamine were significantly associated with cardiac adverse events, with clinical manifestations predominantly involving heart rate and rhythm disorders（58.45%）. Severe outcomes included death and hospitalization. Nine CHMs, extracts, and their preparations with potential cardiac risk signals were identified, including G. biloba, ginseng, and anthraquinones, among which seaweed products, Salvia miltiorrhiza（Danshen）, and anthraquinone derivatives exhibited the strongest cardiac risk signals. Conclusion The research findings provide crucial evidence for clinical medication safety. It is recommended to further establish a "toxicity identification-application-prevention-detoxification" CHM cardiac safety vigilance system, with enhanced monitoring and mechanistic research.

R972

国家自然科学基金资助项目(82274117); 国家中医药管理局高水平重点学科建设项目-临床中药学(zyyzdxk-2023257)