目的 利用美國食品藥品管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫，分析艾伏尼布藥物不良事件和超說明書用藥情況，為臨床安全用藥提供參考。方法 下載FAERS數(shù)據(jù)庫2018年第3季度—2024年第2季度的數(shù)據(jù)，使用報告比值比法（ROR）和比例報告比值比法（PRR）對艾伏尼布相關(guān)不良事件信號強(qiáng)度進(jìn)行計算，并分析超說明書使用情況。結(jié)果 共提取到1 535例以艾伏尼布為主要懷疑藥物的報告，去除與藥物無關(guān)和受原發(fā)病影響的不良事件后，識別前30位的陽性不良事件信號，信號強(qiáng)度最高的不良事件為分化綜合征。還發(fā)現(xiàn)血小板減少、代謝減退、Janus激酶2突變等未記錄在藥品說明書中的新信號。此外發(fā)現(xiàn)663例（43.19%）報告存在超說明書用藥現(xiàn)象，主要集中在膽管癌和惡性腦腫瘤。結(jié)論 臨床使用艾伏尼布過程中，應(yīng)監(jiān)測分化綜合征等強(qiáng)信號，警惕血小板減少等新信號，及時采取預(yù)防和干預(yù)措施，以減少患者用藥風(fēng)險。同時需注意超說明用藥情況，尤其是在膽管癌和惡性腦腫瘤領(lǐng)域的應(yīng)用。本研究為臨床安全使用艾伏尼布及拓寬其適應(yīng)癥提供參考，促進(jìn)臨床工作者在真實醫(yī)療環(huán)境中合理安全使用該藥。

Objective To analyze the adverse events and off-label drug use of ivosidenib by FAERS database, to provide reference for clinical safe drug use. Methods Download data from the FAERS database from Q3 2018 to Q2 2024 to calculate signal strength for ivosidenib-related adverse events using the reporting odds ratio (ROR) and proportional reporting odds ratio (PRR) method, and analyze off-label usage. Results A total of 1 535 reports of ivosidenib as the main suspected drug were extracted, and the first 30 positive adverse events signals were identified after removing the adverse events that were not related to the drug and affected by the primary disease, and the adverse events with the highest signal intensity was differentiation syndrome. New signals such as thrombocytopenia, metabolic hypometabolism, and Janus kinase 2 mutations that were not recorded in the drug label were also found. In addition, 663 cases (43.19%) were found to report off-label drug use, mainly concentrated in cholangiocarcinoma and malignant brain tumors. Conclusion During the clinical use of ivosidenib, strong signals such as differentiation syndrome should be monitored, new signals such as thrombocytopenia should be alerted, and preventive and intervention measures should be taken in time to reduce the risk of drug use in patients. At the same time, it is necessary to pay attention to the use of off-label drugs, especially in the field of cholangiocarcinoma and malignant brain tumors. This study provides a reference for the safe use of ivosidenib in clinical practice and broadens its indications, and promotes the rational and safe use of ivosidenib in a real medical environment.

R973

中國藥學(xué)會醫(yī)院藥學(xué)專業(yè)委員會科研專項資助項目(CPA-Z05-ZC-2023002);南京鼓樓醫(yī)院臨床研究專項資金資助項目(2022-LCYJ-PY-48)