目的 挖掘美国不良事件报告系统（FAERS）数据库中与达沙替尼相关的重要医疗事件，为临床安全用药提供参考。方法 提取2006年第3季度—2024年第3季度与达沙替尼相关的报告，采用报告比值比法（ROR）、综合标准法（MHRA）和贝叶斯置信传播神经网络法（BCPNN）进行比例失衡分析，以挖掘与达沙替尼相关的重要医疗事件信号。结果 从FAERS数据库中提取到以达沙替尼为首要怀疑药物的不良事件报告共28 740份。在排除达沙替尼药物的可能适应证后，共得到60个不良事件信号，将以上的信号与美国食品药品管理局（FDA）官网最新的达沙替尼说明书进行对比，发现肝静脉闭塞、主动脉发育不良、胃窦血管扩张、视神经乳头水肿等不良事件均未在说明书提及，值得进一步关注。结论 达沙替尼可能导致新的重要医疗事件。临床医生应了解并监测这些新的重要医疗事件。

Objective To mine the FAERS database for important medical events related to dasatinib for safe clinical use. Methods Reports related to dasatinib from the third quarter of 2006 to the third quarter of 2024 were extracted, and proportional imbalance analyses were performed using ROR, MHRA, and BCPNN method, in order to mine the signals of important medical events related to dasatinib. Results A total of 28 740 adverse event reports with dasatinib as the first suspected drug were extracted from the FAERS database. After excluding possible indications for dasatinib drug, a total of 60 adverse event signals were obtained. Comparing the above signals with the latest dasatinib specification in the FDA official website, it was found that the adverse events of hepatic vein occlusion, aorta hypoplasia, gastric antral vascular ectasia, and papilloedema were not mentioned in the specification, which warranted further attention. Conclusion Dasatinib was found to potentially cause new important medical events. Clinicians should be aware of and monitor these new important medical events.

R973

国家自然科学基金面上项目（7247041356）