目的 挖掘和分析格菲妥单抗的药品不良事件信号，为临床安全用药提供参考。方法 收集美国食品药品管理局不良事件报告系统（FAERS）数据库2004年第1季度—2025年第3季度格菲妥单抗不良事件数据，采用报告比值比（ROR）法和比例报告比（PRR）法进行目标信号挖掘。结果 最终筛选以格菲妥单抗为主要怀疑药物的不良事件案例1 876份，涉及目标人群为977例，共获得487个不良事件信号，符合2种检测方法的不良事件信号75个。其中男性多于女性。具有严重结局的不良事件（导致住院或住院延长、死亡、危及生命、残疾）报告占比为64.48%。发生频次较高的阳性不良事件包括细胞因子释放综合征、发热、中性粒细胞减少症、COVID-19等。信号较强的阳性不良事件包括燃瘤反应、细胞因子释放综合征、高热、播散型结核、免疫效应细胞相关性神经毒性综合征等。其中感染性休克、播散型结核和小肠结肠炎等说明书未收录。结论 挖掘的格菲妥单抗相关不良事件信号与说明书基本一致，除了细胞因子释放综合征、燃瘤反应和神经系统相关的常见不良反应之外，应警惕其导致的各类感染情况，密切监测患者感染进展。

Objective To explore and analyze adverse drug event signals of glofitamab, and provide reference for safe clinical use. Methods Adverse drug events data for glofitamab was collected from the first quarter of 2004 to the third quarter of 2025 in the FAERS database. Signal mining was conducted using ROR and PRR methods. Results A total of 1 876 adverse drug event cases with glofitamab as the main suspected drug were finally screened out, involving 977 target individuals. A total of 487 adverse drug event signals were obtained, among which 75 adverse drug event signals met the criteria of both detection methods. Males outnumbered females. Reports of adverse drug events with serious outcomes (including hospitalization or prolonged hospitalization, death, life-threatening events, and disability) accounted for 64.48% of the total. Frequently reported positive adverse drug events included cytokine release syndrome, fever, neutropenia, and COVID-19, etc. Strong adverse drug events signals included tumor flare reaction, cytokine release syndrome, hyperpyrexia, disseminated tuberculosis, and immune effector cell-associated neurotoxicity syndrome, etc. Notably, septic shock, disseminated tuberculosis, and enterocolitis, etc were not listed in the drug prescribing information. Conclusion Overall, the identified adverse drug event signals of glofitamab are largely consistent with the drug label. In addition to common adverse reactions such as cytokine release syndrome, tumor flare and neurological events, special vigilance should be maintained against various types of infections induced by the treatment as well as the progression of infections in patients.

R979.1