达比加群酯用于非瓣膜性房颤抗凝治疗的不良反应分析

Analysis of adverse drug reactions induced by dabigatran etexilate in patients with non-valvular atrial fibrillation

目的:了解我院达比加群酯致药品不良反应发生的规律和特点,为临床安全合理使用达比加群酯提供参考依据。方法:采用回顾性分析方法,对我院2015年2月-2019年12月上报国家ADR监测中心的19例达比加群酯ADR报告进行统计分析。结果:19例达比加群酯ADR报告中,男女比例为1∶1.7;61~70岁患者最多(42.11%);发生ADR的时间主要集中在用药后1个月(89.48%);主要累及系统/器官为消化系统(37.50%)、泌尿系统(12.50%)及全身系统(12.50%);临床表现以出血最为常见(50.00%);一般的ADR占89.50%,新的ADR占10.50%,未出现严重的ADR。结论:达比加群酯具有良好的安全性,但针对肾功能不全、高龄及合并用药的患者治疗过程中需加强用药监测,减少ADR发生,确保安全用药。

Objective:To explore the regularity and characteristics of adverse drug reactions(ADR)induced by dabigatran etexilate,and provide references for rational drug use.Methods:19 case reports of ADR induced by dabigatran etexilate reported to the national ADR monitoring network from February 2015 to December 2019 in our hospital were retrospectively analyzed.Results:In 19 cases,the ratio of male to female was 1∶1.7.Most patients were from 61 to 70 years old(42.11%).The occurrence time of ADR was mainly 1 month(89.48%)after administration.The main systems/organs involved in ADR were the digestive system(37.50%),the urinary system(12.50%)and the systemic system(12.50%).Bleeding was the most common clinical manifestation(50.00%).General ADR was accounted for 89.50%,new ADR was accounted for 10.50%,and there was no severe ADR.Conclusion:Dabigatran etexilate was safe in clinic.But it should be closely monitored during the course of treatment in patients with renal insufficiency,old age and combined medication in order to avoid ADR and ensure the safety of drug use.