目的 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库挖掘麦角新碱的不良事件信号，为临床安全用药提供参考。方法 从FAERS数据库中收集2004年第1季度—2024年第3季度与麦角新碱相关的不良事件。采用比例失衡法如报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯可信区间递进神经网络（BCPNN）和经验贝叶斯几何平均值（EBGM）来检测药物不良事件的信号。结果 共确定了446例与麦角新碱相关的不良事件报告，涉及22个系统器官分类（SOCs）。相关性较强的SOCs主要为妊娠期、产褥期及围产期状况，血管疾病和心脏器官疾病。胎盘早剥、大脑血管收缩、阵挛性惊厥、心电图ST段压低、新生儿紫绀、血管收缩、冠状动脉痉挛等为高信号。报告数较多的不良事件有冠状动脉痉挛、子宫出血、麦角中毒、高碳酸血症和心室运动功能减退等。结论 检测到的麦角新碱相关不良事件与说明书基本一致，同时还发现了一些罕见不良事件如网状青斑、故作姿态和杆状核粒细胞增多症等，值得临床关注。

Objective Mining adverse event signals of ergometrine based on the FAERS database to provide reference for clinical safe medication. Methods Adverse events related to ergometrine from the FAERS database from the first quarter of 2004 to the third quarter of 2024 were collected. Using proportional imbalance methods such as reporting odds ratio（ROR）, proportional reporting ratio（PRR）, Bayesian confidence propagation neural network（BCPNN）, and empirical Bayes geometric mean（EBGM） to detect signals of adverse drug events. Results A total of 446 adverse event reports related to ergometrine were identified, involving 22 system organ classes（SOCs）. The SOCs with strong correlation mainly included pregnancy, puerperium and perinatal conditions, vascular disorders and cardiac disorders. Premature separation of placenta, cerebral vasoconstriction, clonic convulsion, electrocardiogram st segment depression, cyanosis neonatal, vasoconstriction, arteriospasm coronary, etc. were high signals. Adverse events with a high number of reports included arteriospasm coronary, uterine haemorrhage, ergot poisoning, hypercapnia, and ventricular hypokinesia. Conclusion The detected adverse events related to ergometrine are basically consistent with the instructions, and some rare adverse events such as livedo reticularis, posturing, and bandaemia have also been found, which are worthy of clinical attention.

R984

国家自然科学基金资助项目(82305291)