目的 基于美国食品药品管理局(FDA)不良事件报告系统(FAERS)挖掘贝林妥欧单抗的药品不良事件信号,为临床用药提供依据。方法 收集FAERS中贝林妥欧单抗2014年9月-2023年12月的数据,采用报告比值比(ROR)法和贝叶斯可信区间递进神经网络(BCPNN)法进行信号挖掘,分析其不良事件发生情况。结果 共得到不良事件信号250个,累及19个系统器官分类(SOC),合计报告5 013例。累及的SOC主要包括全身性疾病及给药部位各种反应、免疫系统疾病、各类神经系统疾病、血液及淋巴系统疾病及各类检查等;报告数较多的不良事件信号包括发热、细胞因子释放综合征、神经毒性、治疗无反应者、发热性中性粒细胞减少和中性粒细胞减少等。挖掘到18个说明书未记录的新发现可疑不良反应。结论 贝林妥欧单抗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,临床用药应重点关注此类不良反应。

Objective To mine the adverse drug event signals of blinatumomab based on the FAERS, to provide a basis for clinical drug use. Methods Data of blinatumomab in FAERS from September 2014 to December 2023 were collected, and the signal mining was performed by using the ROR method and BCPNN method to analyze the occurrence of adverse drug event. Results A total of 250 adverse drug event signals were obtained, involving 19 system organ classifications (SOC), with a total of 5 013 cases reported. Accumulated SOC mainly included systemic diseases and various reactions at the site of administration, immune system diseases, various neurological diseases, blood and lymphatic system diseases, and various reactions. Adverse drug event signals with a high number of reports included fever, cytokine release syndrome, neurotoxicity, treatment non-responders, febrile neutropenia, and neutropenia. A total of 18 new findings of suspected adverse were found. Conclusion The common adverse reactions occurring in the real world with blinatumomab were consistent with the specification, but there were some newly found suspicious adverse reactions, which should be paid attention to in clinical diseases.

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