基于openFDA对新型口服抗凝药依度沙班的不良反应分析

Analysis of the adverse reactions of the new oral anticoagulant edoxaban based on the openFDA adverse event report

目的:基于美国FDA公共数据开放项目(openFDA)中新型口服抗凝药依度沙班不良事件(adverse events, ADEs)数据,分析研究依度沙班的不良反应特性,为临床合理用药提供参考。方法:收集2015年1月1日至2021年9月30日美国FDA ADEs报告系统(FDA Adverse Event Reporting System, FAERS)中依度沙班ADEs报告,提取患者性别、年龄、ADEs发生区域、ADEs上报人群、ADEs严重性、ADEs类型等相关数据及首选术语报告数排名前30位ADEs报告,分析依度沙班不良反应。结果:在2015年1月1日至2021年9月30日期间FAERS共收到依度沙班的ADEs报告5 578例,其中严重ADEs 5 042例,死亡701例。对报告数排名前30位ADEs进行药物不良反应分析,ADEs报告数前5位依次为贫血、脑梗死、胃肠道出血、脑血管意外、呼吸困难。结论:利用依度沙班ADEs的真实世界数据分析不良反应的危险因素及使用的注意事项,为合理用药提供依据,提高临床用药安全性。

OBJECTIVE Analyzing and studying the adverse reactions of edoxaban based on the data of the new oral anticoagulant edoxaban adverse events(ADEs)in openFDA.The data were analyzed to provide references for rational drug use in clinic.METHODS Access the API sample panel of the openFDA to collect the adverse drug events of edoxaban from January 1 st, 2015 to September 30 th, 2021.Relevant data such as patient gender, age, ADEs occurrence area, ADEs reporting population, ADEs severity, ADEs type, etc.were extracted, as well as the top 30 ADEs reports ranked by the number of preferred term reports, and the adverse reactions of edoxaban were analyzed.RESULTS From January 1 st, 2015 to September 30 th, 2021,FAERS received a total of 5 578 ADEs reports of edoxaban, including 5 042 severe ADEs and 701 deaths.The adverse drug reactions of the top 30 ADEs reported were analyzed, and the top five reported ADEs were anemia, cerebral infarction, gastrointestinal bleeding, cerebrovascular accident, and dyspnea.CONCLUSION The real-world data of edoxaban ADEs was used to deeply analyze the risk factors of adverse reactions and precautions for use, to provide a basis for rational drug use, and to improve drug safety in clinical use.