目的 分析与银杏叶提取物有关的过敏反应不良事件信号特征，以期为临床安全应用提供参考。方法 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行数据挖掘，采用比例失衡法与贝叶斯置信传播神经网络结合进行信号监测，提取满足信号阈值的不良事件进行进一步的分析。结果 筛选出使用银杏叶提取物且上报过敏反应的病例133例，不良事件报告376例。满足信号阈值的不良事件有咳嗽、胸部不适、异物感、哮鸣、瘙痒，严重的不良事件信号有心脏呼吸骤停。结论 FAERS数据库中所收录的与银杏叶提取物使用相关的过敏反应主要是呼吸系统反应，同时患者的基础疾病与合并用药也可能会增加不良事件的发生风险，所以在应用该类药物时应针对患者的个体特点进行用药监护，保证患者用药安全。

Objective To analyze the characteristics of adverse event signals related to Ginkgo biloba extract allergies to provide references for its safety of clinical use. Methods Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for data mining, the proportional imbalance method was used in conjunction with Bayesian confidence propagation neural network for signal monitoring, and the adverse events that met the signal threshold were extracted for further analysis. Results A total of 133 cases were screened who had used G. biloba extract and reported allergic reactions, and 376 adverse events were reported. Adverse events that met the signal threshold included cough, chest discomfort, sensation of foreign body, wheezing, and pruritus with important signals being cardio-respiratory arrest. Conclusion Respiratory disorders are predominant in allergic reactions to G. biloba extract reported in the FAERS database. The risk of adverse events may be increased by patients' underlying conditions and concurrent medications, necessitating tailored medication monitoring based on individual patient characteristics to prevent adverse reactions.

R285.6

国家自然科学基金资助项目（81703738）