新型口服抗凝药治疗非瓣膜性房颤安全性Meta分析

Safety of New Oral Anticoagulants in the Treatment of Patients with Non-Valvular Atrial Fibrillation: a Meta-Analysis

目的系统评价新型口服抗凝药治疗非瓣膜性房颤的安全性。方法计算机检索PubMed、中国知网、维普和万方等数据库,纳入新型口服抗凝药治疗非瓣膜性房颤的随机对照试验,检索时限为自建库至2018年5月。对检索到的文献进行筛选和质量评价,使用RevMan 5. 3软件进行Meta分析。结果纳入32项研究,共78 475例患者,文献质量评分4～7分。Meta分析结果显示,达比加群酯、利伐沙班、阿哌沙班治疗非瓣膜性房颤卒中或体循环栓塞发生率低于华法林(P <0. 05),依度沙班与华法林比较无显著差异(P> 0. 05);达比加群酯、阿哌沙班、依度沙班严重出血发生率低于华法林(P <0. 05),利伐沙班与华法林比较无显著差异(P> 0. 05);达比加群酯、依度沙班非严重出血发生率低于华法林(P <0. 05),利伐沙班与华法林比较无显著差异(P> 0. 05),阿哌沙班、华法林非严重出血发生率分别为11. 49%和13. 51%。结论达比加群酯及阿哌沙班降低卒中或体循环栓塞和严重及非严重出血发生率效果优于华法林。

Objective To systematically evaluate the safety of new oral anticoagulants in the treatment of patients with non-valvular atrial fibrillation.Methods The randomized controlled trials about new oral anticoagulants in the treatment of patients with non-valvular atrial fibrillation were collected from PubMed,CNKI,VIP and Wanfang database from inception to May 2018.The retrieved literature was screened and evaluated.Meta-analysis was carried out by RevMan 5.3 software.Results Totally 32 literature involving 78475 patients were included,the quality scores of the literature were from 4 to 7 points.Meta-analysis showed that the incidence rates of stroke or systemic circulation embolism in patients with non-valvular atrial fibrillation treated with dabigatran etexilate,rivaroxaban and apixaban were lower than those of warfarin(P<0.05),and there was no significant difference between edoxaban and warfarin(P>0.05).The incidence rates of severe hemorrhage in patients with non-valvular atrial fibrillation treated with dabigatran etexilate,apixaban and edoxaban were lower than those of warfarin(P<0.05),but there was no significant difference between rivaroxaban and warfarin(P>0.05),the incidence rates of non-severe hemorrhage in patients with non-valvular atrial fibrillation treated with dabigatran etexilate and edoxaban were lower than those of warfarin(P<0.05),but there was no significant difference between rivaroxaban and warfarin(P>0.05).The incidence rates of non-severe hemorrhage in patients with non-valvular atrial fibrillation treated with apixaban and warfarin were 11.49% and 13.51%,respectively.Conclusion Apixaban had better effects in stroke or systemic embolism,major and non-major bleeding than that of warfarin.Among the new oral anticoagulants,dabigatran etexilate and apixaban are better than warfarin in reducing the incidence of stroke or systemic circulation embolism,severe and non-severe hemorrhage.