目的 挖掘并分析非格司亭相關不良事件的信號，為該藥的臨床安全使用提供參考依據(jù)。方法 收集FAERS中的2013年1月1日—2023年12月31日關于非格司亭的不良事件數(shù)據(jù)，采用比例失衡法中的ROR、PRR和BCPNN法進行信號挖掘，對報告頻數(shù)和信號強度排名前20位以及各系統(tǒng)器官分類的不良事件進行統(tǒng)計分析。結果 共收集非格司亭相關的不良事件報告數(shù)4 434份，挖掘到相關信號328個，以發(fā)熱、骨痛、白細胞計數(shù)降低等較為常見；共涉及22個系統(tǒng)器官，主要集中在血液及淋巴系統(tǒng)疾病、感染及侵染類疾病、各類檢查等。挖掘到78個說明書未記錄的新發(fā)現(xiàn)可疑不良反應，以膿毒癥、惡性腫瘤、骨整合不充分為主。結論 非格司亭在真實世界中發(fā)生的常見不良反應與說明書有一致性，但存在部分新發(fā)現(xiàn)可疑的不良反應，臨床用藥宜密切關注，做好患者用藥前風險評估，用藥后及時監(jiān)測，以保證患者用藥安全。

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

山東省醫(yī)學會臨床科研資金–齊魯專項項目（YXH2022ZX02199）；白求恩·腫瘤放療轉化醫(yī)學研究基金資助項目（YXZL-2023-B-001）