【摘要】 目的 检索并收集美国FDA不良事件报告系统（FAERS）中奥拉帕利和尼拉帕利的不良事件，对两种药物的不良事件信号进行对比和评价，为临床用药提供参考。方法 提取2种药物自上市以来至2022年第3季度在FAERS数据库的不良事件报告数据，采用《监管活动医学词典》（MedDRA）术语集对ADE系统归类。采用报告比值比法（ROR）和比例报告比值法（PRR）进行数据挖掘，筛选ADE信号，并按照报告频次和信号强度对ADE排序。结果 尼拉帕利的不良事件报告数多于奥拉帕利，但低质量报告较多。筛选得到奥拉帕利ADE报告6 935份，尼拉帕利2 568份。共检测到124个奥拉帕利ADE信号，累及14个系统器官分类（SOC）;144个尼拉帕利ADE信号，累及18个SOC。信号强度前10位的ADE中分别有7个和9个新的高风险信号。结论 2种药物发生频次前20位的ADE大多被药品说明书收载，尼拉帕利ADE涉及的SOC多于奥拉帕利，而奥拉帕利血液毒性更强，且可能会出现感染及侵染类疾病等特殊不良反应。医生应当合理选择2种药物，识别可能发生的不良事件，保障安全用药。更多还原

【Abstract】 Objectivent Repo To retrieve and collect the adverse drug events(ADE)of olaparib and niraparib from the FDA Adverse Everting System(FAERS)database,and to compare and evaluate the adverse drug event(ADE)signals of the two drugs,so as to provide references for clinical drug use. Methods Adverse reaction reports on the two drugs were extracted from the FAERS database from the day of launch to the third quarter of2022,and ADE was systematically classified using the term set of Medical Dictionary for Regulatory Activities(MedDRA). Data mining was carried out by reporting odds ratio method(ROR)and proportional reporting ratio method(PRR),and ADE signals were screened and ranked according to reporting frequency and signal strength. Results In real world data,the number of ADE reports on niraparib was more than that of olaparib,and the low-quality reports was also more than that of olaparib. Totally6 935ADE reports on olaparib and2 568ADE reports on niraparib were obtained. A total of124olaparib ADE signals were detected by ROR and PRR,involving14SOCs;144niraparib ADE signals were detected,involving18SOCs. There were respectively7and9new high-risk signals in the top10ADE of signal strength. Conclusion Most of the top20ADE occurring frequently of the two drugs are included in the drug instructions. The ADE of niraparib involves more SOCs than olaparib;olaparib has higher blood toxicity,and might cause special adverse reactions,such as infection and infectious diseases. Doctors should choose the two drugs reasonably,identify possible adverse events,and ensure the safe medication.更多还原