目的 通过FAERS真实世界数据分析对伊达比星的不良事件信号进行挖掘分析，为临床蒽环类药物安全应用提供依据。方法 提取以伊达比星为首要怀疑药物的不良事件报告。进行基线分析；并明确统计了伊达比星不良事件报告在系统器官分类（SOC）层面的信号分布及数量特征；采用ROR、PRR、MGPS及BCPNN 4种算法进行信号检测，并对核心SOC对应的首选术语（PT）进行深入分析。结果 共纳入1 154份报告，其中5个SOC在4种算法中均呈阳性信号。报告数位列前5位的SOC依次为感染及侵染类疾病、血液及淋巴系统疾病、全身性疾病及给药部位各种反应、胃肠系统疾病、各类检查。风险信号主要集中于感染类疾病与血液系统疾病。结论 伊达比星的风险主要集中于感染及血液系统，为其临床风险监测提供了多算法验证的关键证据。

Objective To mine and analyze the adverse event signals of idarubicin through the real-world data analysis of the FAERS, so as to provide evidence for the safe clinical application of anthracycline drugs. Methods Adverse event reports with idarubicin as the primary suspect drug were extracted. Baseline analysis was performed; the signal distribution and quantitative characteristics of idarubicin adverse event reports at the SOC level were statistically identified. Four algorithms including ROR, PRR, MGPS, and BCPNN were adopted for signal detection, and an in-depth analysis was conducted on the PT corresponding to the core SOCs. Results A total of 1 154 reports were included, among which 5 SOCs showed positive signals across all four algorithms. The top 5 SOCs in terms of the number of reports were in the following order: infections and infestations, blood and lymphatic system disorders, general disorders and administration site conditions, gastrointestinal disorders, and investigations. Risk signals were mainly concentrated in infectious diseases and blood system disorders. Conclusion The risks of idarubicin are mainly focused on the infectious and blood systems. This study provides key evidence verified by multiple algorithms for its clinical risk monitoring.

R979.1

安徽省医疗卫生重点专科建设项目[皖卫函(2021)273号]; 安徽医科大学第三附属医院基础与临床合作研究提升计划培育专项资助项目(2023sfy001)