目的 利用美国食品药品管理局不良事件报告系统（FAERS）数据库，分析艾伏尼布药物不良事件和超说明书用药情况，为临床安全用药提供参考。方法 下载FAERS数据库2018年第3季度—2024年第2季度的数据，使用报告比值比法（ROR）和比例报告比值比法（PRR）对艾伏尼布相关不良事件信号强度进行计算，并分析超说明书使用情况。结果 共提取到1 535例以艾伏尼布为主要怀疑药物的报告，去除与药物无关和受原发病影响的不良事件后，识别前30位的阳性不良事件信号，信号强度最高的不良事件为分化综合征。还发现血小板减少、代谢减退、Janus激酶2突变等未记录在药品说明书中的新信号。此外发现663例（43.19%）报告存在超说明书用药现象，主要集中在胆管癌和恶性脑肿瘤。结论 临床使用艾伏尼布过程中，应监测分化综合征等强信号，警惕血小板减少等新信号，及时采取预防和干预措施，以减少患者用药风险。同时需注意超说明用药情况，尤其是在胆管癌和恶性脑肿瘤领域的应用。本研究为临床安全使用艾伏尼布及拓宽其适应症提供参考，促进临床工作者在真实医疗环境中合理安全使用该药。

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

中国药学会医院药学专业委员会科研专项资助项目(CPA-Z05-ZC-2023002);南京鼓楼医院临床研究专项资金资助项目(2022-LCYJ-PY-48)