目的 对英克司兰不良事件风险信号进行挖掘和分析，为该药临床安全使用提供参考。方法 采用比例失衡法中的报告比值比（ROR）法和比例报告比值比（PRR）法对美国食品药品管理局（FDA）不良事件报告系统数据库中2020年第4季度—2023年第4季度上报的英克司兰上报的不良事件进行挖掘和分析。结果 共得到英克司兰首选语（PT）阳性信号164个，相关报告数4 831份，涉及19个SOC分类，主要集中在各种肌肉骨骼及结缔组织疾病、全身性疾病及给药部位各种反应、呼吸系统、胸及纵隔疾病和胃肠系统疾病。硬斑病、硬结、国际标准化比率降低、膀胱不适、面部不适、肌痛既是新的不良事件信号，也是信号强度排前20位的不良事件信号。结论 英克司兰常见不良事件（注射部位反应、关节痛、支气管炎）的发生情况与其药品说明书基本一致，在临床应用中，要关注呼吸困难、硬斑病、硬结、肌痛、面部不适、腹泻等说明书中未提及的不良事件，并密切监测国际标准化比率等指标，及时做出干预。

Objective To explore the risk signals of the adverse events of inclisiran to provide reference for the safe clinical use of this drug. Methods To mine and analyze inclisiran’s reported adverse events in the FAERS database from the fourth quarter of 2020 through the fourth quarter of 2023 by ROR and PRR methods. Results A total of 164 positive PT signals were obtained, and 4 831 related reports were reported, involving 19 SOC categories, mainly focusing on various musculoskeletal and connective tissue diseases, systemic diseases and reactions at the administration site, respiratory, thoracic and mediastinal diseases and gastrointestinal diseases. Maculopathy, induration, decreased international standardized ratio, bladder discomfort, facial discomfort, and myalgia were the new adverse event signals and also the top 20 adverse event signals with signal intensity. Conclusion The occurrence of common adverse events (injection site reaction, arthralgia, bronchitis) of inclisiran is basically consistent with the instructions of the drug. In clinical application, attention should be paid to adverse events not mentioned in the instructions, such as dyspnea, hard spot, induration, myalgia, facial discomfort, diarrhea, etc., and indicators such as the international standardized ratio should be closely monitored to make timely intervention.

R972

杭州市医药卫生科技项目（A20230089）