基于美国FAERS数据库的达比加群酯不良反应信号挖掘研究  

Data-mining of Adverse Drug Reaction Signals of Dabigatran Etexilate Based on US FAERS

作　　者：曾露[1] 王璐 魏安华 ZENG Lu;WANG Lu;WEI Anhua(Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan Hubei 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院,湖北武汉430030

出　　处：《药品评价》2023年第5期607-611,共5页Drug Evaluation

摘　　要：目的挖掘达比加群酯的药品不良反应(ADR)信号,为其临床使用安全性提供参考依据。方法基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS),联合报告比值比法(ROR)、比例报告比值法(PRR)、综合标准法(MHRA)和贝叶斯置信度递进神经网络法(BCPNN)对FAERS中2010年10月至2022年12月上报的达比加群酯ADR报告进行数据挖掘,分析相关ADR信号分布及信号强度,并深入分析不同部位出血相关ADR情况。结果共筛选出达比加群酯不良反应例次155881例,ADR信号783个,映射到27个系统器官,最多的系统器官为胃肠系统,排名前三的强信号分别为胃肠出血、脑血管意外和出血。药品说明书未收载的ADR包括有脑血管意外、跌倒、缺血性脑卒中、急性肾损伤、房颤等。同时得到出血相关ADR数31669例,以胃肠系统,神经系统、血管和淋巴系统等出血为主。结论达比加群酯在临床使用过程中应重点关注出血相关ADR,尤其是胃肠出血,同时应警惕说明书中未记录的ADR,并做好相关事件的应对措施。Objective To explore the adverse drug reaction(ADR)signal of dabigatran etexilate,and to provide reference of the clinical safety information.Methods Based on the FDA Adverse Event Reporting System(FAERS),the ADRs of dabigatran etexilate reported from Octorber 2010 to December 2022 were mined with the ratio of reports to odds(ROR),proportional report ratio(PRR),healthcare products regulatory agency(MHRA),and bayesian confidence propagation neural network(BCPNN)method,and the signal distribution and signal strength were analyzed.Results A total of 155881 ADR cases of dabigatran were screened,and 783 ADR signals were mapped to 27 corresponding system organ classification(SOC).The SOC of dabigatran ADR singals mainly focused on the gastrointestinal system,and the main strong ADR signals were gastrointestinal bleeding,cerebrovascular accident,hemorrhage,etc.The cerebrovascular accident,fall,ischemic stroke,acute kidney injury,atrial fibrillation were not recorded in the medicine specification.At the same time,31669 cases of hemorrhagic events were obtained,mainly in gastrointestinal(GI),nervous systems and vascular and lymphatic system.Conclusion In the clinical use of dabigatran etexilate,attention should be paid to hemorrhagic events,especially gastrointestinal bleeding,the ADRs not recorded in the medicine specification should be vigilant,and countermeasures should be prepared for the events.

关 键 词：达比加群酯 药物相关性副作用和不良反应 药物不良反应报告系统 比例失衡法 综合标准法 贝叶斯置信度递进神经网络法 

分 类 号：R95[医药卫生—药学]