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

作　　者：夏洪颖[1] 尹文洁 李燕华[1] 游丽娜 耿兴星 谭飞龙 XIA Hongying;YIN Wenjie;LI Yanhua;YOU Lina;Geng Xingxing;TAN Feilong(Department of Pharmacy,Yan’an Hospital Affiliated to Kunming Medical University,Kunming Yunnan 650051;Department of Pharmacy,The Second People’s Hospital of Qujing,Qujing Yunnan 655400,China)

机构地区：[1]昆明医科大学附属延安医院药学部,云南昆明650051 [2]曲靖市第二人民医院药学部,云南曲靖655400

出　　处：《昆明医科大学学报》2025年第2期118-125,共8页Journal of Kunming Medical University

基　　金：云南省教育厅科学研究基金(2024J0371);云南省医疗机构药师协会科研专项基金(2024YSXH06);昆明市卫生科技人才培养“千工程”项目(2023-SW(后备)-84);昆明市卫生健康委员会卫生科研课题项目(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)。

摘　　要：目的挖掘尼拉帕利的风险信号,为临床安全合理用药提供参考。方法提取美国FDA不良事件报告系统(FAERS)数据库中2017年第1季度至2023年第2季度的尼拉帕利相关不良事件(ADE)报告。采用报告比值比法(ROR)、比例报告比值法(PRR)、贝叶斯可信区间递进神经网络法(BCPNN)和多项式伽马泊松分布缩减法(MGPS)对风险信号进行挖掘,利用监管活动医学词典(MedDRA)26.1中的首选系统器官分类(SOC)和首选术语(PT)对风险信号进行描述和分类,并对尼拉帕利ADE的发生时间进行分析。结果提取以尼拉帕利为首要怀疑药物的ADE报告16961例。通过筛选分析,共得到32个PTs,涉及11个SOCs,与药品说明书记载基本一致。说明书未提及的周围神经病、红细胞计数下降、红细胞压积降低、脱水、潮热等可疑信号需给予关注。中位发生时间为22 d(IQR 2~98 d),韦伯分布检验提示早期失败型曲线。结论在使用尼拉帕利时,尤其是在治疗初期,除关注血小板计数下降、恶心、疲劳等药品说明书提及的ADE外,还应密切关注周围神经病、红细胞计数下降等说明书中未收录但信号值较强的ADE,以保障患者的用药安全。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 Q12017 to Q22023 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 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]