目的 挖掘艾沙妥昔單抗引發(fā)的不良事件信號，為臨床安全用藥提供重要參考。方法 收集2020年第2季度至2025年第1季度上報至美國食品藥品管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫的不良事件報告，選擇以艾沙妥昔單抗為首要懷疑藥物的不良事件報告。采用報告比值比（ROR）法、綜合標準（MHRA）法以及貝葉斯置信區(qū)間遞進神經(jīng)網(wǎng)絡（BCPNN）法對不良事件信號進行深入挖掘。結(jié)果 收集到以艾沙妥昔單抗為首要懷疑藥物的不良事件報告共4 168份，涉及患者2 027名，男性患者的構(gòu)成比高于女性患者（48.50% vs 38.97%）。挖掘出不良事件信號158個，涉及20個SOC。信號強度前5位的不良事件信號為淋巴細胞減少癥、低蛋白血癥、輸液相關(guān)反應、COVID-19肺炎和中性粒細胞計數(shù)降低。低蛋白血癥、血栓性微血管病、低鈣血癥、肺栓塞和胃腸炎等說明書未記載的不良事件報告數(shù)較多，信號較強，臨床使用時值得警惕。結(jié)論 醫(yī)務人員應警惕艾沙妥昔單抗頻發(fā)的及說明書未記載的不良事件，保障患者安全用藥。

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

湘南學院校級科研項目醫(yī)院聯(lián)合項目（2024XJ141）；中國藥學會科普研究重點項目（CMEI2024KPYJ00180）