目的 挖掘維替索妥尤單抗的不良事件信號，為臨床安全用藥提供依據(jù)。方法 從美國食品藥品管理局不良事件報告系統(tǒng)數(shù)據(jù)庫（FAERS）收集2021年第3季度—2025年第1季度的報告數(shù)據(jù)，篩選以維替索妥尤單抗為首要懷疑藥物的報告。采用報告比值比（ROR）法和貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)（BCPNN）法進(jìn)行不良事件信號挖掘。用國際醫(yī)學(xué)用語詞典（MedDRA）首選系統(tǒng)器官分類（SOC）和首選術(shù)語（PT）對ADE進(jìn)行分類統(tǒng)計。結(jié)果 共納入以維替索妥尤單抗為首要懷疑藥物的不良事件報告556份，患者以女性為主（74.46%），適應(yīng)證為宮頸癌最多（28.42%），嚴(yán)重報告占51.08%，主要上報國家為美國（89.39%）。采用ROR法和BCPNN共檢出48個信號，涉及18個SOC。信號強(qiáng)度前5位的不良事件信號為眼球黏連、眼毒性、點狀角膜炎、外周運(yùn)動神經(jīng)病變和被截獲的用藥錯誤。說明書未記載的不良事件包括貧血、發(fā)熱性中性粒細(xì)胞減少、白內(nèi)障和低鉀血癥。結(jié)論 維替索妥尤單抗的不良事件與說明書基本相符，眼器官不良事件信號強(qiáng)且發(fā)生率高，值得臨床關(guān)注和警惕。

Objective To mine adverse drug event signals of tisotumab vedotin to provide a basis for safe use in clinical practice. Methods To collect reported data from the third quarter of 2021 to the first quarter of 2025 by FAERS database, screen reports with tisotumab vedotin as the primary suspect drug. The adverse drug event signals were detected by ROR and BCPNN methods. The SOC and PT in the MedDRA were used for classification statistics and descriptive analysis. Results A total of 556 adverse drug event reports with tisotumab vedotin as the primary suspected drug were included, with female patients being the majority (74.46%), the main indication was cervical cancer (28.42%), the severe adverse drug event account 51.08%, and the main reporting country was the United States (89.39%). A total of 48 positive PT signals were detected simultaneously by ROR and BCPNN methods, involving 18 SOCs. The top five adverse drug event signals in terms of signals strength were symblepharon, ocular toxicity, punctate keratitis, peripheral motor neuropathy and intercepted medication error. The adverse drug event not recorded in the drug included anemia, febrile neutropenia, cataract and hypokalemia. Conclusion The adverse drug event induced by tisotumab vedotin were generally consistent with those in the drug instruction, the intensity and frequency of ocular signals are high which require clinical attention and timely intervention.

R979.1

上海市黃浦區(qū)科研項目（HLQ202303）；上海市長寧區(qū)婦幼保健院科研啟動基金項目（2023Y-10）