目的 挖掘艾沙妥昔单抗引发的不良事件信号，为临床安全用药提供重要参考。方法 收集2020年第2季度至2025年第1季度上报至美国食品药品管理局不良事件报告系统（FAERS）数据库的不良事件报告，选择以艾沙妥昔单抗为首要怀疑药物的不良事件报告。采用报告比值比（ROR）法、综合标准（MHRA）法以及贝叶斯置信区间递进神经网络（BCPNN）法对不良事件信号进行深入挖掘。结果 收集到以艾沙妥昔单抗为首要怀疑药物的不良事件报告共4 168份，涉及患者2 027名，男性患者的构成比高于女性患者（48.50% vs 38.97%）。挖掘出不良事件信号158个，涉及20个SOC。信号强度前5位的不良事件信号为淋巴细胞减少症、低蛋白血症、输液相关反应、COVID-19肺炎和中性粒细胞计数降低。低蛋白血症、血栓性微血管病、低钙血症、肺栓塞和胃肠炎等说明书未记载的不良事件报告数较多，信号较强，临床使用时值得警惕。结论 医务人员应警惕艾沙妥昔单抗频发的及说明书未记载的不良事件，保障患者安全用药。

Objective To explore the adverse event signals caused by isatuximab, to provide an important reference for safe clinical use. Methods Adverse event reports reported to the FAERS database from the second quarter of 2020 to the first quarter of 2025 were collected, adverse event reports with isatuximab as the primary suspect. The ROR, MHRA, and BCPNN were used to deeply explore adverse event signals. Results A total of 4 168 adverse drug event reports, primarily suspecting isatuximab were collected, involving 2 027 patients. The proportion of male patients was higher than that of female patients (48.50% vs 38.97%). 158 adverse event signals were detected, spanning 20 SOC. The top 5 adverse event signals by signal strength were lymphopenia, hypoproteinaemia, infusion related reaction, COVID-19 pneumonia, neutrophil count decreased. The number of reports of adverse events not recorded in the instructions, such as hypoproteinemia, thrombotic microangiopathy, hypocalcemia, pulmonary embolism and gastroenteritis was large and the signal was strong, so it is worth vigilance in clinical use. Conclusion Healthcare professionals should exercise vigilance regarding frequent and undocumented adverse drug events associated with isatuximab to ensure patient medication safety.

R979.1

湘南学院校级科研项目医院联合项目（2024XJ141）；中国药学会科普研究重点项目（CMEI2024KPYJ00180）