目的 挖掘妊娠期万古霉素用药不良事件信号，为妊娠期临床合理用药提供循证参考。方法 采用报告比值比法与贝叶斯置信区间递进神经网络法，针对2004年1月1日—2025年12月31日美国食品药品监督管理局不良事件报告系统（FAERS）数据库中收集的妊娠期万古霉素暴露相关的不良事件报告数据进行信号挖掘分析。结果 最终纳入万古霉素相关不良事件报告921份（330例）。万古霉素共检出不良反应阳性信号24个。其中万古霉素所致急性肾损伤为高强度风险信号，输注反应、白细胞减少症为中等强度信号。万古霉素先天性异常阳性信号包括支气管肺发育异常、急性卟啉病。结论 妊娠期应用万古霉素，应警惕母儿用药风险，关注子代不良事件。

Objective To explore the adverse event signals of vancomycin in pregnancy, so as to provide evidence-based references for rational clinical medication during pregnancy. Methods To employ the reporting odds ratio method and bayesian confidence propagation neural network method to perform signal detection and analysis on adverse event report data associated with gestational exposure to vancomycin, which were collected from FAERS database between January 2004 and December 2025. Results A total of 921 vancomycin-related adverse event reports (330 cases). 24 Positive signals were identified for vancomycin. Vancomycin-induced acute kidney injury was identified as a high-intensity risk signal, while infusion reactions and leukopenia were moderate-intensity signals. Positive signals of congenital anomalies associated with vancomycin included bronchopulmonary dysplasia and acute porphyria. Conclusion The use of vancomycin during pregnancy warrants vigilance over medication-related risks in mothers and fetuses. Close attention should be paid to adverse events in offspring.

R978.1

福建省药品监督管理局科技项目（2024014）