目的 基于FAERS數據庫挖掘索米妥昔單抗相關的不良事件，為臨床安全用藥提供參考。方法 收集FAERS庫中2022年第4季度—2024年第4季度索米妥昔單抗相關不良事件數據，采用報告比值比（ROR）和英國藥品和保健品管理局綜合標準法（MHRA）對索米妥昔單抗進行檢驗，根據國際醫(yī)學用語詞典系統(tǒng)器官分類（SOC）和首選術語（PT）進行分類統(tǒng)計和描述性分析。結果 共收集到以索米妥昔單抗為首要懷疑藥物的不良事件755份，女性患者占絕大多數，中位年齡65歲，主要適應癥為卵巢癌，嚴重不良反應占比43.18%，主要上報國家是美國。索米妥昔單抗的不良事件涉及25個SOC，采用ROR法和MHRA法分析，獲得48個PT信號。挖掘的該藥物的主要不良事件與說明書和臨床試驗基本一致，包括眼毒性、角膜炎、角膜病變、視物模糊、腹瀉和周圍神經病等。而結腸炎、肺纖維化、眼睛刮傷和眼刺激等說明書未記載的不良事件，其報告數較多，信號較強，臨床使用時值得警惕。結論 基于FAERS數據庫挖掘的索米妥昔單抗不良事件與藥品說明書基本相符，眼器官和胃腸道不良事件需要臨床重視并及時干預。同時還發(fā)現潛在的新的不良事件信號。

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

上海市黃浦區(qū)科研項目（HLQ202303）