目的 分析喹硫平上市后药物不良事件信号，为临床合理用药提供参考。方法 对美国食品药品管理局（FDA）药物不良事件报告系统（FAERS）数据库进行信号挖掘，收集喹硫平2004年1月－2024年3月的不良事件报告，采用比例失衡法中的报告比值比（ROR）法、比例报告比值比法（PRR）和贝叶斯可信传播神经网络（BCPNN）法对喹硫平的不良事件信号进行分析。结果 共挖掘出以喹硫平为首要怀疑药物的不良事件报告75 213份，女性比男性占比高，涉及27个系统器官分类，信号频数排名前30位的不良事件信号中血清素综合征和睡眠呼吸暂停综合征为新的不良反应。信号强度排名前30位的不良事件信号中新的不良事件有第四颅神经疾病、腮腺炎、恶性嗜铬细胞瘤、良性蛛网膜下腔扩张和昏迷性水疱症。结论 使用喹硫平前应做好患者的用药评估，一些新的潜在不良反应信号应重点关注。

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

山西省大健康产业高质量发展科研专项课题(DJKZXKT2023264)