目的 利用美国食品药品管理局（FDA）不良事件报告系统（FAERS）挖掘维贝格隆的药品不良反应信号，为维贝格隆安全风险控制和临床合理用药提供参考。方法 收集美国FAERS数据库中2018年9月21日—2025年2月26日与维贝格隆相关的不良事件数据，采用比例失衡法中的报告比值比法（POR）、比例报告比值比法（PRR）和贝叶斯置信区间神经网络传播法（BCPNN）进行信号挖掘，对报告频数、信号强度排名前20位及各系统器官分类的不良事件进行统计分析。结果 获得69个维贝格隆不良反应信号，以头痛、尿潴留、腹泻、尿路感染、尿频、尿失禁、夜尿症等较为常见，共涉及15个系统器官，主要集中在肾脏及泌尿系统疾病、胃肠系统疾病、感染及侵染类疾病、各类神经系统疾病等。结论 在临床使用维贝格隆时，除了关注药品说明书中记载的维贝格隆不良反应外，还需密切关注药品说明书未提及的不良反应，尤其在女性及老年患者人群中及早评估，以降低用药风险，保障患者用药安全。

Objective To mine the adverse drug event signals of vibegron using the FAERS, and provide references for the safety risk control and clinical rational use of vibegron. Methods Adverse drug events data related to vibegron from the FAERS database between September 21, 2018 to February 26, 2025, were collected. Signal mining was performed using the ROR, PRR, and BCPNN method. The top 20 adverse drug events ranked by reporting frequency and signal strength, as well as adverse drug events categorized by organ systems, were statistically analyzed. Results A total of 69 adverse drug event signals for vibegron were identified, with common adverse drug events including headache, urinary retention, diarrhea, urinary tract infection, frequency of urination, urinary incontinence, nocturia, involved 15 organ systems, primarily focusing on renal and urinary system diseases, gastrointestinal disorders, infectious diseases, and various neurological diseases. Conclusion When using vibegron clinically, attention should not only be paid to the adverse reactions listed in the drug label but also to those not mentioned in the label. Early evaluation of unlisted adverse reactions, especially in female and elderly patient populations, should be conducted to minimize medication risks and ensure patient safety.

R983

重庆市卫生健康委医学科研项目（2025WSJK075）