目的 利用美国食品药品管理局（FDA）不良事件报告系统（FAERS）分析阿伐可泮在真实世界中发生的药物不良事件，为临床安全使用提供重要依据。方法 检索FAERS中2021年第4季度—2025年第1季度的相关不良事件报告数据，采用报告比值比（ROR）法和比例报告比（PRR）法挖掘不良事件信号，采用国际医学术语词典（MedDRA术语）27.1中的首选语（PT）、系统器官分类（SOC）对相关不良事件名称进行规范性表达。结果 共检索得到阿伐可泮相关不良事件报告3 510例，报告年龄主要集中在50岁以上，美国报告例数最多（74.16%）。共挖掘到106个不良事件信号，累及至16个SOC。主要包括胃肠系统疾病（14个）、感染及侵染类疾病（19个）、肝胆系统疾病（13个）等。不良事件报告数排名前3位的PT分别为腹泻（187例）、恶心（182例）、感染性肺炎（96例）。不良事件信号强度排名前3位的PT（按ROR值）分别为胆管消失综合征、疑似药物性肝损伤、黄疸。结论 在阿伐可泮用药期间，除关注药品说明书中提及的不良事件外，还应密切关注胆管消失综合征、类固醇糖尿病、黄疸等潜在新的风险信号，保障患者的用药安全。

Objective To analyze the adverse drug events of avacopan in the real world using the FAERS database, and provide a reference for the safe clinical use of the drug. Methods The adverse event report data of the drug from the fourth quarter of 2021 to the first quarter of 2025 in FAERS were retrieved, and the ROR and PRR methods were used to mine adverse drug events signals. The PT and SOC in the International Medical Terminology Dictionary (MedDRA terminology) 27.1 were used to standardize the expression of related adverse drug events names. Results A total of 3 510 adverse drug events reports related to avcaopan were retrieved, and the reporting age was mainly concentrated in those over 50 years old, with the largest number of reports from the United States (74.16%). A total of 106 adverse drug events signals were mined, involving 16 SOC. Mainly including gastrointestinal system diseases (14), infections and infective diseases (19), hepatobiliary system diseases (13), etc. The top three PT in terms of adverse drug events reports were diarrhea (187 cases), nausea (182 cases), and infectious pneumonia (96 cases). The top three PT (by ROR value) adverse event signal intensities were biliary disappearance syndrome, suspected drug-induced liver injury, and jaundice. Conclusion During the administration of avacopan, in addition to monitoring the adverse event mentioned in the drug package insert, close attention should also be paid to potential new adverse reactions such as biliary disappearance syndrome, steroid diabetes, and jaundice to ensure patient safety.

R972

国家自然科学基金资助项目（72304007）；北京市自然科学基金资助项目（7244474）