目的 挖掘与分析异柠檬酸脱氢酶（IDH）2抑制剂恩西地平上市后的不良事件信号，为临床安全用药提供参考。方法 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库提取恩西地平2017年8月—2024年12月的不良事件。采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯可信区间递进神经网络（BCPNN）法和多项经验贝斯叶伽马泊松分布缩减法（MGPS）算法进行信号挖掘，并分析其不良事件发生情况。结果 共筛选出恩西地平为PS的报告3 280份，上报国家以美国为主，不良事件阳性信号共65个，累及14个系统器官分类（SOC），累及的SOC主要集中在各类检查。报告数较多的不良事件信号有死亡、疲劳、恶心、超说明书用药，信号强度最强的不良事件为分化综合征。结论 恩西地平对除急性髓系白血病以外的其他疾病也有潜在治疗价值，在临床应用过程中，需要对说明书中未提及的不良事件提高警惕以减少用药风险。

Objective To explore and analyze the adverse event signals of the IDH2 inhibitor enasidenib, providing reference for safe clinical medication.Methods The adverse events of enasidenib from August 2017 to December 2024 were extracted based on the FAERS database. Signal mining was carried out by using the ROR, PRR, BCPNN, and MGPS, and the occurrence of adverse events was analyzed.Result A total of 3 280 reports with enasidenib as PS were screened out. The reporting countries were mainly the United States. There were a total of 65 positive signals of adverse events, involving 14 system organ classifications (SOCs), and the involved SOCs were mainly concentrated in various examinations. The adverse event signals with a relatively large number of reports include death, fatigue, nausea, off-label drug use, etc. The adverse event with the strongest signal intensity was differentiated syndrome. The adverse reactions related to enasidenib mostly occured within 30 to 180 days after medication. During this process, in addition to paying attention to the adverse reactions mentioned in the drug instructions, potential new adverse reactions such as thrombocytopenia and decreased physical ability should also be vigilant.Conclusion Enasidenib also has potential therapeutic value for diseases other than acute myeloid leukemia. During the clinical application process, it is necessary to be vigilant about adverse events not mentioned in the instructions to reduce the risk of medication.

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