目的 挖掘并分析非格司亭相关不良事件的信号，为该药的临床安全使用提供参考依据。方法 收集FAERS中的2013年1月1日—2023年12月31日关于非格司亭的不良事件数据，采用比例失衡法中的ROR、PRR和BCPNN法进行信号挖掘，对报告频数和信号强度排名前20位以及各系统器官分类的不良事件进行统计分析。结果 共收集非格司亭相关的不良事件报告数4 434份，挖掘到相关信号328个，以发热、骨痛、白细胞计数降低等较为常见；共涉及22个系统器官，主要集中在血液及淋巴系统疾病、感染及侵染类疾病、各类检查等。挖掘到78个说明书未记录的新发现可疑不良反应，以脓毒症、恶性肿瘤、骨整合不充分为主。结论 非格司亭在真实世界中发生的常见不良反应与说明书有一致性，但存在部分新发现可疑的不良反应，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 To excavate and analyze the safety signals of filgrastim related adverse events, and to provide reference for the safe clinical use of filgrastim. Methods To collected adverse events of filgrastim from FAERS from January 1, 2013 to December 31, 2023. Subsequently signals mining were carried out by using the ROR, PRR and BCPNN methods. Statistical analysis was carried out to reveal the top 20 frequent reports and intensive signals, and adverse events classified by various systems and organs. Results A total of 4 434 adverse event reports related to filgrastim were collected, and 328 related signals were found. Fever, bone pain and decreased white blood cell count were common. A total of 22 systemic organs are involved, mainly focusing on diseases of the blood and lymphatic system, infections and infectious diseases, and various examinations. 78 new suspected adverse reactions not recorded in the instructions were found, mainly sepsis, malignant tumor and inadequate bone integration. Conclusion The common adverse reactions of fegelstim in the real world are consistent with the instructions, but there are some newly found suspicious adverse reactions. It is recommended to pay close attention to clinical drug use, do a good job of risk assessment before drug use, and timely monitoring after drug use to ensure the safety of drug use for patients.

R973

山东省医学会临床科研资金–齐鲁专项项目（YXH2022ZX02199）；白求恩·肿瘤放疗转化医学研究基金资助项目（YXZL-2023-B-001）