北京地区2011-2021年三种新型口服抗凝药不良反应数据分析

Analysis of adverse reactions induced by three novel oral anticoagulants in Beijing between 2011 and 2021

目的分析3种新型口服抗凝药的药品不良反应(ADR)报告数据,了解该类药ADR的特点,为临床安全合理用药提供参考。方法检索并整理2011年至2021年期间北京市药品不良反应监测中心收集的利伐沙班、达比加群酯、艾多沙班的ADR报告,对ADR报告的年度分布、性别、年龄、累及器官系统及临床表现、转归及严重ADR等信息进行统计分析,并分析临床使用过程中可能存在的风险点。结果利伐沙班、达比加群酯、艾多沙班ADR报告例数分别为142例、73例、3例;男女比例分别为1.06∶1、0.66∶1、2∶1;以60岁以上老年人居多;严重ADR报告例数分别为12例、6例、1例。利伐沙班ADR主要累及胃肠系统、皮肤及皮下组织、肾脏及泌尿系统等,其中出血相关ADR例次占总例次的56.71%;达比加群酯ADR主要累及胃肠系统、各类检查、皮肤及皮下组织等,其中出血相关ADR例次占总例次的42.86%;艾多沙班3例ADR均与出血相关。结论3种药物的ADR报告中,以60岁以上老年人居多,累及器官系统主要为胃肠系统、皮肤及皮下组织等,临床表现以出血相关ADR所占比例较高。

Objective Adverse drug reactions(ADRs)induced by three novel oral anticoagulants was conducted to un?derstand the characteristics of their ADRs,thereby providing references for clinically safe use of these drugs.Methods ADR re?ports on novel oral anticoagulants collected by the Beijing Center for ADR Monitoring between 2011 and 2021 were retrieved and sorted out.Statistical analysis was performed on the annual distribution,gender,age,the organ systems affected,clinical manifestation,outcome and serious cases of the ADRs.Key points of possible risks in clinical use were concurrently analyzed.Results The number of reported ADRs of rivaroxaban,dabigatran etexilate and edoxaban was 142,73 and 3.The male to fe?male ratio was 1.06∶1,0.66∶1 and 2∶1 respectively.In terms of age,elderly people aged over 60 were found to predominate in the ADRs.Serious cases accounted for 12,6 and 1 respectively.Rivaroxaban induced ADRs were attributable primarily to the gastrointestinal system,skin and subcutaneous tissue,renal and urinary system,with bleeding related cases accounting for 56.71%of the total.The ADRs resulting from dabigatran etexilate mainly involved gastrointestinal system,investigations,skin and subcutaneous tissue,where bleeding related cases accounted for 42.86%of the total.All the 3 ADRs of edoxaban related to bleeding.Conclusion People above 60 years old made up a considerable proportion of the ADRs of three drugs,affecting chiefly the gastrointestinal system,skin and subcutaneous tissue,with a noticeably higher frequency of bleeding related ADRs.