目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）挖掘福他替尼的药品不良事件信号，为临床用药提供依据。方法 收集FAERS中福他替尼2018年第2季度—2024年第4季度的数据，采用报告比值比（ROR）法、比例报告比值法（PRR）、贝叶斯可信区间递进神经网络（BCPNN）法和多项经验贝叶斯伽马泊松分布缩减法（MGPS）进行信号挖掘，分析其不良事件发生情况。结果 共得到报告5 083份，上报年份以2024年为主，上报国家以美国为主。不良事件信号64个，累及15个系统器官分类（SOC）。累及的SOC主要包括各类检查，其次为各类损伤、中毒及操作并发症，胃肠系统疾病，各种手术及操作等；报告数较多的不良事件信号包括腹泻、血小板计数异常、血压升高等。结论 福他替尼在用药过程中发生的常见不良反应与说明书有较高一致性，临床用药时需警惕不良反应发生。

Objective To mine the adverse drug event signals of fostamatinib based on the FAERS, to provide a basis for clinical drug use. Methods The data of blinatumomab in FAERS from the second quarter of 2018 to the fourth quarter of 2024 were collected, and the signal mining was performed by using the reported odds ratio (ROR) method, proportional reporting ratio (PRR) method, bayesian confidence interval progressive neural network (BCPNN) method, and multi-item gamma poisson shrinker (MGPS) method to analyze the occurrence of adverse drug event. Results A total of 5 083 reports were obtained, with 2024 as the main reporting year and the United States as the main reporting country. There were 64 adverse drug event signals, involving 15 system organ classifications (SOC). The SOC involved mainly included various examinations, followed by various injuries, poisoning, and operational complications, gastrointestinal diseases, various surgeries and operations, etc. Adverse drug event signals with a high number of reports included diarrhea, abnormal platelet count and elevated blood pressure. Conclusion The common adverse reactions that occur during the use of fostamatinib are highly consistent with the instructions, and caution should be exercised when using it clinically.

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