目的 挖掘與分析異檸檬酸脫氫酶（IDH）2抑制劑恩西地平上市后的不良事件信號，為臨床安全用藥提供參考。方法 基于美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫提取恩西地平2017年8月—2024年12月的不良事件。采用報告比值比法（ROR）、比例報告比值法（PRR）、貝葉斯可信區(qū)間遞進神經(jīng)網(wǎng)絡(luò)（BCPNN）法和多項經(jīng)驗貝斯葉伽馬泊松分布縮減法（MGPS）算法進行信號挖掘，并分析其不良事件發(fā)生情況。結(jié)果 共篩選出恩西地平為PS的報告3 280份，上報國家以美國為主，不良事件陽性信號共65個，累及14個系統(tǒng)器官分類（SOC），累及的SOC主要集中在各類檢查。報告數(shù)較多的不良事件信號有死亡、疲勞、惡心、超說明書用藥，信號強度最強的不良事件為分化綜合征。結(jié)論 恩西地平對除急性髓系白血病以外的其他疾病也有潛在治療價值，在臨床應(yīng)用過程中，需要對說明書中未提及的不良事件提高警惕以減少用藥風(fēng)險。

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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