昆明医科大学学报2025，Vol.46Issue(2)：118-125,8.DOI:10.12259/j.issn.2095-610X.S20250217
基于美国FAERS数据库的尼拉帕利不良事件分析
Signal Analysis of Niraparib-Related Adverse Events Based on US FAERS Database
摘要
Abstract
Objective To explore the risk signals of niraparib and provide references for rational and safe clinical medication.Methods Niraparib-related adverse drug events(ADEs)reports from Q1 2017 to Q2 2023 were extracted from the US FDA Adverse Event Reporting System(FAERS)database.Risk signals were identified using the reporting odds ratio(ROR),proportional reporting ratio(PRR),Bayesian confidence propagation neural network(BCPNN),and multi-item gamma Poisson shrinker(MGPS)methods.The Risk signals were described and classified by preferred system organ classes(SOCs)and preferred terms(PTs)from the Medical Dictionary for Regulatory Activities(MedDRA)version 26.1,and the occurrence of niraparib-related ADEs was also analyzed.Results A total of 16,961 ADE reports with niraparib as the primary suspected drug were extracted.Through screening and analysis,32 PTs were identified involving 11 SOCs,which were largely consistent with the information in the drug label.However,suspicious signals not mentioned in the label,including neuropathy peripheral,decreased red blood cell count,reduced hematocrit,dehydration,and hot flashes,require further attention.The median occurrence time was 22 days(IQR 2-98 days),and the Weibull distribution test indicated an early failure-type curve.Conclusion When using niraparib,particularly in early stages of treatment,it is essential to monitor not only the ADEs mentioned in the drug instructions,such as decreased platelet count,nausea and fatigue,but also to pay close attention to the ADEs not included in the instructions,such as peripheral neuropathy and decreased red blood cell count,which exhibit strong signal values,to ensure patient medication safety.关键词
尼拉帕利/FAERS/比例失衡法/风险信号Key words
Niraparib/FDA adverse event reporting system/Disproportionality measurement/Risk signal分类
医药卫生引用本文复制引用
夏洪颖,尹文洁,李燕华,游丽娜,耿兴星,谭飞龙..基于美国FAERS数据库的尼拉帕利不良事件分析[J].昆明医科大学学报,2025,46(2):118-125,8.基金项目
云南省教育厅科学研究基金(2024J0371) （2024J0371）
云南省医疗机构药师协会科研专项基金(2024YSXH06) （2024YSXH06）
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）
昆明市卫生健康委员会卫生科研课题项目(2023-13-01-001) （2023-13-01-001）
