目的 基于FAERS数据库挖掘索米妥昔单抗相关的不良事件，为临床安全用药提供参考。方法 收集FAERS库中2022年第4季度—2024年第4季度索米妥昔单抗相关不良事件数据，采用报告比值比（ROR）和英国药品和保健品管理局综合标准法（MHRA）对索米妥昔单抗进行检验，根据国际医学用语词典系统器官分类（SOC）和首选术语（PT）进行分类统计和描述性分析。结果 共收集到以索米妥昔单抗为首要怀疑药物的不良事件755份，女性患者占绝大多数，中位年龄65岁，主要适应症为卵巢癌，严重不良反应占比43.18%，主要上报国家是美国。索米妥昔单抗的不良事件涉及25个SOC，采用ROR法和MHRA法分析，获得48个PT信号。挖掘的该药物的主要不良事件与说明书和临床试验基本一致，包括眼毒性、角膜炎、角膜病变、视物模糊、腹泻和周围神经病等。而结肠炎、肺纤维化、眼睛刮伤和眼刺激等说明书未记载的不良事件，其报告数较多，信号较强，临床使用时值得警惕。结论 基于FAERS数据库挖掘的索米妥昔单抗不良事件与药品说明书基本相符，眼器官和胃肠道不良事件需要临床重视并及时干预。同时还发现潜在的新的不良事件信号。

Objective To mine the adverse events signals of mirvetuximab soravtansine by FAERS database, so as to provide references for its safe use in clinical practice. Methods To collect mirvetuximab soravtansine related adverse events from the fourth quarter of 2022 to the fourth quarter of 2024 in the FAERS database, and test by using ROR and MHRA. To perform classification statistics and descriptive analysis according to SOC and PT. Results A total of 755 adverse drug events reports of mirvetuximab soravtansine were retrieved. The main drug use population were female, the median age of patients was 65 years, main indication was ovarian cancer, the severe adverse drug events accounted for 43.18%, and main reporting country was American. Adverse events of mirvetuximab soravtansine involved 25 SOC. 48 PT signals were obtained by means of ROR and MHRA. Ocular toxicity, keratitis, keratopathy, vision blurred, diarrhea and neuropathy peripheral which were the same as the adverse drug events in the instructions and clinical trials. However, colitis, pulmonary fibrosis, eye abrasion and eye irritation were not mentioned in the labels and showed strong signals. These adverse drug events need to be paid more attention to when clinical use. Conclusion Adverse events of mirvetuximab soravtansine based on FAERS database are generally consistent with drug labels. Ocular and gastrointestinal adverse events require clinical attention and timely intervention. Potential and new adverse event signals have been found.

R979.1

上海市黄浦区科研项目（HLQ202303）