目的 挖掘美國不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫中與達沙替尼相關的重要醫(yī)療事件，為臨床安全用藥提供參考。方法 提取2006年第3季度—2024年第3季度與達沙替尼相關的報告，采用報告比值比法（ROR）、綜合標準法（MHRA）和貝葉斯置信傳播神經(jīng)網(wǎng)絡法（BCPNN）進行比例失衡分析，以挖掘與達沙替尼相關的重要醫(yī)療事件信號。結(jié)果 從FAERS數(shù)據(jù)庫中提取到以達沙替尼為首要懷疑藥物的不良事件報告共28 740份。在排除達沙替尼藥物的可能適應證后，共得到60個不良事件信號，將以上的信號與美國食品藥品管理局（FDA）官網(wǎng)最新的達沙替尼說明書進行對比，發(fā)現(xiàn)肝靜脈閉塞、主動脈發(fā)育不良、胃竇血管擴張、視神經(jīng)乳頭水腫等不良事件均未在說明書提及，值得進一步關注。結(jié)論 達沙替尼可能導致新的重要醫(yī)療事件。臨床醫(yī)生應了解并監(jiān)測這些新的重要醫(yī)療事件。

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

國家自然科學基金面上項目（7247041356）