目的 對英克司蘭不良事件風險信號進行挖掘和分析，為該藥臨床安全使用提供參考。方法 采用比例失衡法中的報告比值比（ROR）法和比例報告比值比（PRR）法對美國食品藥品管理局（FDA）不良事件報告系統(tǒng)數(shù)據(jù)庫中2020年第4季度—2023年第4季度上報的英克司蘭上報的不良事件進行挖掘和分析。結果 共得到英克司蘭首選語（PT）陽性信號164個，相關報告數(shù)4 831份，涉及19個SOC分類，主要集中在各種肌肉骨骼及結締組織疾病、全身性疾病及給藥部位各種反應、呼吸系統(tǒng)、胸及縱隔疾病和胃腸系統(tǒng)疾病。硬斑病、硬結、國際標準化比率降低、膀胱不適、面部不適、肌痛既是新的不良事件信號，也是信號強度排前20位的不良事件信號。結論 英克司蘭常見不良事件（注射部位反應、關節(jié)痛、支氣管炎）的發(fā)生情況與其藥品說明書基本一致，在臨床應用中，要關注呼吸困難、硬斑病、硬結、肌痛、面部不適、腹瀉等說明書中未提及的不良事件，并密切監(jiān)測國際標準化比率等指標，及時做出干預。

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

杭州市醫(yī)藥衛(wèi)生科技項目（A20230089）