目的 利用FAERS数据库对埃纳妥单抗上市后的不良事件信号进行挖掘，为临床安全用药提供参考。方法 提取FAERS数据库2023第3季度—2025年第4季度报告中以埃纳妥单抗为首要怀疑药物的不良事件报告，采用国际医学术语词典（MedDRA）28.1对不良事件进行标准化映射，利用报告比值比（ROR）、比例报告比（PRR）及贝叶斯置信传播神经网络（BCPNN）3种算法并行筛选。结果 共收集以埃纳妥单抗为首要怀疑不良事件报告1 292份，筛选出同时满足ROR、PRR、BCPNN的阳性信号87个，累及16个系统器官分类（SOC）。其中报告例数最多的SOC为感染及侵染类疾病，其次是免疫系统疾病。报告例数排前5位的不良事件是细胞因子释放综合征、发热、免疫效应细胞相关性神经毒性综合征、感染性肺炎、巨细胞病毒感染再激活。结论 基于FAERS数据库挖掘到的埃纳妥单抗相关不良事件与药品说明书基本一致，同时还挖掘出药品说明书中未明确收录、具有风险预警的新安全信号。临床用药中，应提高警惕，提升用药安全性。

Objective To mine the post-marketing adverse event signals of elranatamab based on the FAERS database, to provide reference for clinical drug safety. Methods The adverse event reports with elranatamab as the primary suspected drug in the FAERS database reports from the third quarter of 2023 to the fourth quarter of 2025 were extracted. The adverse events were standardized using the MedDRA version 28.1. Signal detection was performed by ROR, PRR, and BCPNN. Results A total of 1 292 reports listing elranatamab as the primary suspected drug were collected. 87 positive signals meeting the criteria of all three algorithms were identified, involving 16 SOC. Among them, the SOC with the largest number of reported cases was infections and infestations, followed by immune system disorders. The top 5 adverse events in terms of the number of reported cases were cytokine release syndrome, pyrexia, immune effector cell-associated neurotoxicity syndrome, pneumonia, and cytomegalovirus infection reactivation. Conclusion Based on the FAERS database, the adverse events related to elranatamab are basically consistent with the drug instructions. At the same time, new safety signals that are not clearly included in the drug instructions and have risk warning are also excavated. It is recommended to enhance vigilance regarding these signals in clinical practice to optimize patient monitoring and management, thereby improving medication safety.

R979.1

国家资助博士后研究人员计划B档资助（GZB20250499）