目的 挖掘日本药品不良事件报告（JADER）数据库中防风通圣散相关的不良事件信号，以期为防风通圣颗粒/丸的临床安全合理应用提供参考。方法 提取JADER数据库中2004年4月—2024年7月的数据，应用MedDRA最新版本（27.0版本），对数据库中防风通圣散相关的不良事件的首选语（PT）和器官分类（SOC）进行中日文映射，采用比例失衡法中的报告比值比法（ROR）、综合标准法（MHRA）进行信号检测。结果 提取到以防风通圣散为怀疑药物的不良事件718个，涉及不良事件报告567例。经ROR法检测出25个有效的不良事件信号、MHRA法检测出21个有效的不良事件信号，共21个重叠的不良事件信号，其中20个为我国药品说明书未记载的新的不良事件信号，分别为间质性肺疾病、肝功能异常、肝脏疾病、药物诱导的肝损伤、肺部疾病、黄疸、肠系膜静脉硬化、假性醛固酮增多症等。结论 新发现的不良事件信号对我国防风通圣颗粒/丸的药品说明书中现有的安全性信息提供了有益补充，建议临床用药时考虑其可能引起的不良反应，加强用药监护，注意用药疗程以及药物间的相互作用。

Objective To explore adverse events signals associated with Fangfeng Tongsheng Powder in JADER database, which could provide reference for safe and rational clinical application of Fangfeng Tongsheng Granules/Pills in China. Methods The data from JADER database from July 2004 to April 2024 were extracted, and the latest version of MedDRA（version 27.0） was applied to map the preferred terms（PT） and organ classifications（SOC） of adverse drug events related to Fangfeng Tongsheng Powder in the database in Chinese-Japanese language, and the ratio of reported ratios（ROR） in the proportional imbalance method, and the combined criteria method（MHRA） was adopt for signal detection. Results 718 adverse events were extracted, involving 567 cases. 25 valid adverse drug event signals were detected by ROR method and 21 by MHRA method, including 21 overlapping adverse drug events signals, 20 of which were new adverse drug events signals and not recorded in Chinese drug instructions. They were interstitial lung disease, abnormal liver function, liver disease, drug-induced liver injury, lung disease, jaundice, mesenteric venous sclerosis, pseudoaldosteronism, etc. Conclusion The newly founded adverse drug events signals provided a useful supplement to the safety information recorded in the instruction of Fangfeng Tongsheng Granules/Pills in China, and it is recommended to consider the possible adverse reactions caused by them, strengthen the monitoring of the use of medication, and pay attention to the duration of the medication as well as the interactions between the drugs.

R286.4