目的 挖掘真实世界中伊匹木单抗的不良事件（ADE）信号，为临床合理安全用药提供参考。方法 检索美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中伊匹木单抗2011年第1季度至2023年第1季度ADE报告数据并进行分析。采用报告比值比法（ROR）和贝叶斯可信区间递进神经网络法（BCPNN）进行信号挖掘。结果 共得到ADE信号285个，累及胃肠系统疾病、内分泌系统疾病、全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、免疫系统疾病、肝胆系统疾病等21个系统器官分类（SOC），挖掘到34个说明书未记录的可疑ADE。结论 伊匹木单抗在真实世界中发生的常见ADE和严重ADE与说明书基本一致，并发现部分新的可疑ADE，与纳武利尤单抗联用有可能导致ADE风险增加，临床用药宜密切关注，做好患者用药前风险评估，用药后及时监测，以保证患者用药安全。

Objective Explore the adverse event (ADE) signals of ipilimumab in the real world to provide reference for reasonable and safe clinical use. Method The adverse event reports of ipilimumab from the first quarter of 2011 to the first quarter of 2023 in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) were retrieved and analyzed. The Reporting Odds Ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) were used for signal mining. Results A total of 285 ADE signals were obtained, involving 21 system organ classes (SOCs) such as gastrointestinal system diseases, endocrine system diseases, systemic diseases and various reactions at the site of administration, skin and subcutaneous tissue diseases, immune system diseases, and hepatobiliary system diseases; and 34 unrecorded suspicious adverse reactions were mined. Conclusions The common ADE and serious ADE of ipilimumab in the real world are generally consistent with the instructions, and some new suspected ADE are found. The combination of ipilimumab and nivolumab may increase the risk of ADE. It is necessary to pay close attention to the risk assessment of patients before medication and timely monitoring after medication to ensure the safety of patients.

R979.1