目的 利用美國(guó)食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）挖掘維貝格隆的藥品不良反應(yīng)信號(hào)，為維貝格隆安全風(fēng)險(xiǎn)控制和臨床合理用藥提供參考。方法 收集美國(guó)FAERS數(shù)據(jù)庫(kù)中2018年9月21日—2025年2月26日與維貝格隆相關(guān)的不良事件數(shù)據(jù)，采用比例失衡法中的報(bào)告比值比法（POR）、比例報(bào)告比值比法（PRR）和貝葉斯置信區(qū)間神經(jīng)網(wǎng)絡(luò)傳播法（BCPNN）進(jìn)行信號(hào)挖掘，對(duì)報(bào)告頻數(shù)、信號(hào)強(qiáng)度排名前20位及各系統(tǒng)器官分類(lèi)的不良事件進(jìn)行統(tǒng)計(jì)分析。結(jié)果 獲得69個(gè)維貝格隆不良反應(yīng)信號(hào)，以頭痛、尿潴留、腹瀉、尿路感染、尿頻、尿失禁、夜尿癥等較為常見(jiàn)，共涉及15個(gè)系統(tǒng)器官，主要集中在腎臟及泌尿系統(tǒng)疾病、胃腸系統(tǒng)疾病、感染及侵染類(lèi)疾病、各類(lèi)神經(jīng)系統(tǒng)疾病等。結(jié)論 在臨床使用維貝格隆時(shí)，除了關(guān)注藥品說(shuō)明書(shū)中記載的維貝格隆不良反應(yīng)外，還需密切關(guān)注藥品說(shuō)明書(shū)未提及的不良反應(yīng)，尤其在女性及老年患者人群中及早評(píng)估，以降低用藥風(fēng)險(xiǎn)，保障患者用藥安全。

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

重慶市衛(wèi)生健康委醫(yī)學(xué)科研項(xiàng)目（2025WSJK075）