目的 基于美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫挖掘麥角新堿的不良事件信號，為臨床安全用藥提供參考。方法 從FAERS數(shù)據(jù)庫中收集2004年第1季度—2024年第3季度與麥角新堿相關(guān)的不良事件。采用比例失衡法如報告比值比（ROR）、比例報告比值比（PRR）、貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)（BCPNN）和經(jīng)驗貝葉斯幾何平均值（EBGM）來檢測藥物不良事件的信號。結(jié)果 共確定了446例與麥角新堿相關(guān)的不良事件報告，涉及22個系統(tǒng)器官分類（SOCs）。相關(guān)性較強(qiáng)的SOCs主要為妊娠期、產(chǎn)褥期及圍產(chǎn)期狀況，血管疾病和心臟器官疾病。胎盤早剝、大腦血管收縮、陣攣性驚厥、心電圖ST段壓低、新生兒紫紺、血管收縮、冠狀動脈痙攣等為高信號。報告數(shù)較多的不良事件有冠狀動脈痙攣、子宮出血、麥角中毒、高碳酸血癥和心室運動功能減退等。結(jié)論 檢測到的麥角新堿相關(guān)不良事件與說明書基本一致，同時還發(fā)現(xiàn)了一些罕見不良事件如網(wǎng)狀青斑、故作姿態(tài)和桿狀核粒細(xì)胞增多癥等，值得臨床關(guān)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

國家自然科學(xué)基金資助項目(82305291)