目的 分析喹硫平上市后藥物不良事件信號，為臨床合理用藥提供參考。方法 對美國食品藥品管理局（FDA）藥物不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫進行信號挖掘，收集喹硫平2004年1月－2024年3月的不良事件報告，采用比例失衡法中的報告比值比（ROR）法、比例報告比值比法（PRR）和貝葉斯可信傳播神經(jīng)網(wǎng)絡(luò)（BCPNN）法對喹硫平的不良事件信號進行分析。結(jié)果 共挖掘出以喹硫平為首要懷疑藥物的不良事件報告75 213份，女性比男性占比高，涉及27個系統(tǒng)器官分類，信號頻數(shù)排名前30位的不良事件信號中血清素綜合征和睡眠呼吸暫停綜合征為新的不良反應(yīng)。信號強度排名前30位的不良事件信號中新的不良事件有第四顱神經(jīng)疾病、腮腺炎、惡性嗜鉻細胞瘤、良性蛛網(wǎng)膜下腔擴張和昏迷性水皰癥。結(jié)論 使用喹硫平前應(yīng)做好患者的用藥評估，一些新的潛在不良反應(yīng)信號應(yīng)重點關(guān)注。

Objective To analyze adverse drug event signals of quetiapine after marketing, and to provide references for rational drug use. Mehtods The adverse drug event reports of quetiapine from January 2004 to March 2024 were collected by signal mining from FDA Adverse Drug Event Reporting System (FAERS) database. The adverse drug event signals of quetiapine were analyzed by ROR, PRR and BCPNN methods. Results A total of 75 213 adverse drug event reports were screened out as the primary suspect drug. The proportion of females was higher than that of males, involving 27 system organ classes. The adverse drug event signals ranked in the top 30 signal frequencies included serotonin syndrome, and sleep apnoea syndrome. Among the top 30 adverse drug event signals, the fourth nerve disorder, parotitis, malignant pheochromocytoma and coma blisterwere were the new adverse drug events. Conclusion Quetiapine should be used before the evaluation of drug use and some new potential adverse events should be focused on.

R971

山西省大健康產(chǎn)業(yè)高質(zhì)量發(fā)展科研專項課題(DJKZXKT2023264)