基于FAERS的比伐芦定不良反应信号挖掘与分析

Signal Mining and Analysis of Bivalirudin - Induced Adverse Drug Reaction Based on FAERS

目的 挖掘并分析比伐芦定不良反应(ADR)信号,为临床合理用药提供参考。方法 收集2004年1月至2021年12月美国食品和药物管理局(FDA)药品不良事件报告系统(FAERS)中的比伐芦定药品不良事件(ADE)报告,采用报告比值比法(ROR)和比例报告比法(PRR)进行数据挖掘,采用Spearman秩相关进行相关性分析。结果 共收集首要怀疑药物为比伐芦定的ADE报告1 549份,涉及患者1 549例,其中男641例,女482例,性别不详426例;平均年龄(63.71±15.42)岁;报告数居首的国家为美国(81.79%)。经ROR法和PRR法筛选得到143个ADR信号,累及15个系统器官分类(SOC)。相关性分析显示,年龄与比伐芦定出血、栓塞的发生和结局严重程度均呈显著正相关(P <0.05)。结论 临床使用比伐芦定时应密切关注出血和栓塞,尤其应加强高龄人群的临床用药监测。

Objective To mine and analyze the signals of bivalirudin-induced adverse drug reaction(ADR),and to provide a reference for the rational drug use in the clinic.Methods The adverse drug event(ADE)reports of bivalirudin in the Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)from January 2004 to December 2021 were collected.The reporting odds ratio(ROR)and the proportional reporting ratio(PRR)were adopted for the data mining,and the Spearman rank correlation was adopted for the correlation analysis.Results A total of 1549 ADE reports mainly induced by bivalirudin were collected,involving 1549 patients,including 641 males,482 females and 426 patients with unknown sex.The average age of the above patients was(63.71±15.42)years,and the top one country with the most reports was the United States of America(81.79%).A total of 143 ADR signals were screened by the ROR and PRR methods,involving 15 system organ classification(SOC).The correlation analysis showed that the age was positively correlated with the incidence and severe degree of outcome of bivalirudin-induced bleeding and embolism(P<0.05).Conclusion During the use of bivalirudin in the clinic,bleeding and embolism should be monitored,especially for the elderly.