基于美国食品药品管理局对艾多沙班及利伐沙班药品不良反应的比较

Comparison of adverse drug reactions between Edoxaban and rivaroxaban based on the U.S.food and drug administration data

目的利用美国食品药品管理局开放数据网站(openFDA)检索口服抗凝药物艾多沙班和利伐沙班,挖掘艾多沙班和利伐沙班的药品不良反应(ADR)信号,对比分析两药的ADR相关情况,为其临床安全合理使用提供参考。方法基于美国FDA不良事件报告系统,采用报告比值比法和比例报告比法对FDA公共数据开放项目中于2015-01-01-2022-03-31上报的利伐沙班、艾多沙班ADR报告进行数据挖掘,分析相关ADR报告并映射得到对应的系统器官分类(SOC);同时,统计报告病例的性别、年龄、严重不良反应等基本信息。结果以艾多沙班为伴随和怀疑药物的ADR报告有1417例;以利伐沙班为伴随和怀疑药物的ADR报告有104695例。年龄主要在60~80岁(分别占41.07%和31.64%)。两者ADR信号的SOC主要集中在各类神经系统疾病、胃肠系统疾病、各类检查中;从数据中还挖掘出一些说明书中未提及的首选术语(PT),如脑血管意外、大脑梗死、黑便、腹泻、便秘以及体质量的变化等。结论在实际临床应用中应结合openFDA数据库对利伐沙班与艾多沙班既往ADR相关信息进行综合分析,结合患者实际情况用药,为临床合理、安全用药提供参考。

Objective To use the Open U.S.Food and Drug Administration(OpenFDA)website to search for oral anticoagulant drugs such as Edoxaban and rivaroxaban,and to explore the adverse drug reactions(ADR)signals of Edoxaban and rivaroxaban.The ADR related information of the two drugs was compared and analyzed to provide references for their safe and reasonable clinical use.Methods Based on the U.S.FDA Adverse Event Reporting System,data mining was performed on the ADR reports of rivaroxaban and Edoxaban reported from January 1,2015 to March 31,2022 in the FDA's public data open project.Relevant ADR reports were analyzed and mapped to their corresponding System Organ Classes(SOC).Meanwhile,basic information such as gender,age,and severe adverse reactions of the reported cases was statistically compiled.Results There were 1417 ADR reports with Edoxaban as a concomitant and suspected drug,and104695 ADR reports with rivaroxaban as a concomitant and suspected drug.The age range is mainly between 60 and 80years old(41.07%and 31.64%,respectively).The SOC of both ADR signals were mainly concentrated in various neurological diseases,gastrointestinal diseases,and various examinations;Some perferred terms(PTs)not mentioned in the manual were also extracted from the data,such as cerebrovascular accidents,cerebral infarction,black stools,diarrhea,constipation,and changes in weight.Conclusion In practical clinical applications,a comprehensive analysis of past ADR related information of rivaroxaban and Edoxaban should be conducted in conjunction with the OpenFDA database,and medication should be used in combination with the actual situation of patients,providing references for rational and safe clinical medication.