目的 基于FAERS數(shù)據(jù)庫挖掘索米妥昔單抗相關(guān)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(guān)不良事件數(shù)據(jù)，采用報(bào)告比值比（ROR）和英國藥品和保健品管理局綜合標(biāo)準(zhǔn)法（MHRA）對索米妥昔單抗進(jìn)行檢驗(yàn)，根據(jù)國際醫(yī)學(xué)用語詞典系統(tǒng)器官分類（SOC）和首選術(shù)語（PT）進(jìn)行分類統(tǒng)計(jì)和描述性分析。結(jié)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(shù)，中位年齡65歲，主要適應(yīng)癥為卵巢癌，嚴(yán)重不良反應(yīng)占比43.18%，主要上報(bào)國家是美國。索米妥昔單抗的不良事件涉及25個(gè)SOC，采用ROR法和MHRA法分析，獲得48個(gè)PT信號(hào)。挖掘的該藥物的主要不良事件與說明書和臨床試驗(yàn)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(jīng)病等。而結(jié)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(bào)告數(shù)較多，信號(hào)較強(qiáng)，臨床使用時(shí)值得警惕。結(jié)論 基于FAERS數(shù)據(jù)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(shí)干預(yù)。同時(shí)還發(fā)現(xiàn)潛在的新的不良事件信號(hào)。

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(xiàng)目（HLQ202303）