目的 挖掘真實(shí)世界中伊匹木單抗的不良事件（ADE）信號(hào)，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(bào)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(bào)告數(shù)據(jù)并進(jìn)行分析。采用報(bào)告比值比法（ROR）和貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)法（BCPNN）進(jìn)行信號(hào)挖掘。結(jié)果 共得到ADE信號(hào)285個(gè)，累及胃腸系統(tǒng)疾病、內(nèi)分泌系統(tǒng)疾病、全身性疾病及給藥部位各種反應(yīng)、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(gè)系統(tǒng)器官分類（SOC），挖掘到34個(gè)說明書未記錄的可疑ADE。結(jié)論 伊匹木單抗在真實(shí)世界中發(fā)生的常見ADE和嚴(yán)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(dǎo)致ADE風(fēng)險(xiǎn)增加，臨床用藥宜密切關(guān)注，做好患者用藥前風(fēng)險(xiǎn)評(píng)估，用藥后及時(shí)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