肿瘤药学2025，Vol.15Issue(4)：544-550,7.DOI:10.3969/j.issn.2095-1264.2025.04.15
基于FAERS数据库的泽布替尼不良事件信号挖掘与分析
Signal mining and analysis of zanubrutinib-related adverse events based on FAERS database
摘要
Abstract
Objective To explore the risk signals of zanubrutinib to provide reference for its clinical rational and safe use.Methods Data on adverse drug events(ADE)related to zanubrutinib from October 1,2019 to September 30,2023 were collected from the United States Food and Drug Administration Adverse Event Reporting System(FAERS)database.Dispro-portionality measurement was used for data mining.The mined risk signals were classified and described by the preferred system organ class(SOC)and preferred term(PT)of the adverse drug reaction terminology set in the Medical Dictionary for Regulatory Activities(version 26.0).Results A total of 2 356 ADEs with the zanubrutinib as the primary suspected drug were extracted.The majority of reports came from the United States.The outcomes primarily involved hospitalization and death,and the number of reports showed an increasing annual trend.The disproportionality measurement of detection yield-ed 49 ADEs involving 15 SOCs.These signals mainly focused on injury,poisoning and procedural complications,skin and subcutaneous tissue disorders,and investigations.Additionally,20 new ADEs were identified that were not included in the label,along with 12 important medical events(IMEs)that are included in the EU list of IMEs.Conclusion When clinically applying zanubrutinib,it is important to closely monitor patients for any adverse events and take appropriate measures to in-tervene in a timely manner.关键词
泽布替尼/美国FDA不良事件报告系统/比例失衡法/风险信号Key words
Zanubrutinib/FDA adverse event reporting system/Disproportionality measurement/Risk signal分类
医药卫生引用本文复制引用
谭飞龙,尹文洁,周丽,游丽娜,王丽,王洋,李翠红,夏洪颖..基于FAERS数据库的泽布替尼不良事件信号挖掘与分析[J].肿瘤药学,2025,15(4):544-550,7.基金项目
云南省医疗机构药师协会科研专项基金项目(2024YSXH06) （2024YSXH06）
云南省教育厅科学研究基金项目(2024J0371) （2024J0371）
昆明市卫生科技人才培养"千工程"项目(2023-SW(后备)-84) （2023-SW(后备）
昆明市卫生健康委员会卫生科研课题项目(2023-13-01-017). （2023-13-01-017）
