目的 挖掘真實世界中伊匹木單抗的不良事件（ADE）信號，為臨床合理安全用藥提供參考。方法 檢索美國食品藥品監(jiān)督管理局（FDA）不良事件報告系統(tǒng)（FAERS）中伊匹木單抗2011年第1季度至2023年第1季度ADE報告數(shù)據(jù)并進行分析。采用報告比值比法（ROR）和貝葉斯可信區(qū)間遞進神經網絡法（BCPNN）進行信號挖掘。結果 共得到ADE信號285個，累及胃腸系統(tǒng)疾病、內分泌系統(tǒng)疾病、全身性疾病及給藥部位各種反應、皮膚及皮下組織類疾病、免疫系統(tǒng)疾病、肝膽系統(tǒng)疾病等21個系統(tǒng)器官分類（SOC），挖掘到34個說明書未記錄的可疑ADE。結論 伊匹木單抗在真實世界中發(fā)生的常見ADE和嚴重ADE與說明書基本一致，并發(fā)現(xiàn)部分新的可疑ADE，與納武利尤單抗聯(lián)用有可能導致ADE風險增加，臨床用藥宜密切關注，做好患者用藥前風險評估，用藥后及時監(jiān)測，以保證患者用藥安全。

Objective Explore the adverse event (ADE) signals of ipilimumab in the real world to provide reference for reasonable and safe clinical use. Method The adverse event reports of ipilimumab from the first quarter of 2011 to the first quarter of 2023 in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) were retrieved and analyzed. The Reporting Odds Ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) were used for signal mining. Results A total of 285 ADE signals were obtained, involving 21 system organ classes (SOCs) such as gastrointestinal system diseases, endocrine system diseases, systemic diseases and various reactions at the site of administration, skin and subcutaneous tissue diseases, immune system diseases, and hepatobiliary system diseases; and 34 unrecorded suspicious adverse reactions were mined. Conclusions The common ADE and serious ADE of ipilimumab in the real world are generally consistent with the instructions, and some new suspected ADE are found. The combination of ipilimumab and nivolumab may increase the risk of ADE. It is necessary to pay close attention to the risk assessment of patients before medication and timely monitoring after medication to ensure the safety of patients.

R979.1