目的 挖掘日本藥品不良事件報告（JADER）數據庫中防風通圣散相關的不良事件信號，以期為防風通圣顆粒/丸的臨床安全合理應用提供參考。方法 提取JADER數據庫中2004年4月—2024年7月的數據，應用MedDRA最新版本（27.0版本），對數據庫中防風通圣散相關的不良事件的首選語（PT）和器官分類（SOC）進行中日文映射，采用比例失衡法中的報告比值比法（ROR）、綜合標準法（MHRA）進行信號檢測。結果 提取到以防風通圣散為懷疑藥物的不良事件718個，涉及不良事件報告567例。經ROR法檢測出25個有效的不良事件信號、MHRA法檢測出21個有效的不良事件信號，共21個重疊的不良事件信號，其中20個為我國藥品說明書未記載的新的不良事件信號，分別為間質性肺疾病、肝功能異常、肝臟疾病、藥物誘導的肝損傷、肺部疾病、黃疸、腸系膜靜脈硬化、假性醛固酮增多癥等。結論 新發(fā)現(xiàn)的不良事件信號對我國防風通圣顆粒/丸的藥品說明書中現(xiàn)有的安全性信息提供了有益補充，建議臨床用藥時考慮其可能引起的不良反應，加強用藥監(jiān)護，注意用藥療程以及藥物間的相互作用。

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