目的 挖掘美國(guó)不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫(kù)中與達(dá)沙替尼相關(guān)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(dá)沙替尼相關(guān)的報(bào)告，采用報(bào)告比值比法（ROR）、綜合標(biāo)準(zhǔn)法（MHRA）和貝葉斯置信傳播神經(jīng)網(wǎng)絡(luò)法（BCPNN）進(jìn)行比例失衡分析，以挖掘與達(dá)沙替尼相關(guān)的重要醫(yī)療事件信號(hào)。結(jié)果 從FAERS數(shù)據(jù)庫(kù)中提取到以達(dá)沙替尼為首要懷疑藥物的不良事件報(bào)告共28 740份。在排除達(dá)沙替尼藥物的可能適應(yīng)證后，共得到60個(gè)不良事件信號(hào)，將以上的信號(hào)與美國(guó)食品藥品管理局（FDA）官網(wǎng)最新的達(dá)沙替尼說(shuō)明書進(jìn)行對(duì)比，發(fā)現(xiàn)肝靜脈閉塞、主動(dòng)脈發(fā)育不良、胃竇血管擴(kuò)張、視神經(jīng)乳頭水腫等不良事件均未在說(shuō)明書提及，值得進(jìn)一步關(guān)注。結(jié)論 達(dá)沙替尼可能導(dǎo)致新的重要醫(yī)療事件。臨床醫(yī)生應(yīng)了解并監(jiān)測(cè)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(guó)家自然科學(xué)基金面上項(xiàng)目（7247041356）