新型口服抗凝药对我国非瓣膜性心房颤动患者治疗效果与安全性的Meta分析

摘要

背景 非瓣膜性心房颤动(NVAF)是临床常见的心律失常,常引起栓塞事件发生,故抗凝治疗在NVAF治疗中尤为重要.华法林已被证实为有效的传统口服抗凝药,但出血风险高等缺点限制了其临床应用.近年来出现的新型口服抗凝药(NOACs)弥补了华法林的缺陷而备受临床关注.目的 评价NOACs对国内NVAF患者治疗的效果与安全性.方法 2015年9月-2016年8月,计算机检索Cochrane Library、PubMed、Web of Science、EMBase、中国知网、中国生物医学文献数据库、维普网和万方数据知识服务平台,筛选关于NOACs与华法林对NVAF患者治疗比较的随机对照试验(RCT).提取纳入文献相关信息,并评价纳入文献质量.结果 纳入15篇文献,共2 246例患者,文献质量评分为4～5分.Meta分析显示,与华法林比较,NOACs可降低NVAF患者脑卒中发生率[OR=0.65,95％CI (0.43,0.97),P=0.04]、非严重性出血发生率[OR=0.44,95％CI (0.31,0.61),P＜0.001]及严重性出血发生率[OR=0.45,95％CI (0.22,0.91),P=0.03];而非神经系统性血栓栓塞发生率比较,差异无统计学意义[OR=0.72,95％CI (0.46,1.14),P=0.16].结论 采用NOACs治疗NVAF患者脑卒中、非严重性出血及严重性出血发生率低于华法林,非神经系统性血栓栓塞发生率与华法林无差异,NOACs用于治疗国内NVAF患者具有良好的效果和安全性.%Background Non-valvular atrial fibrillation (NVAF) is a common clinical arrhythmia,which often causes embolic events,so the anticoagulant therapy is particularly important in the treatment of atrial fibrillation.Warfarin has been proved to be effective traditional oral anticoagulants,but has been limited in clinical because of the shortcomings as high risk of bleeding.Recently,the emergence of new oral anticoagulants (NOACs) overcomes the drawback of warfarin and gets much clinical attention.Objective To evaluate the efficacy and safety of NOACs in the treatment of domestic patients with NVAF.Methods From September 2015 to August 2016,the related randomized controlled trials (RCT) of NOACs and warfarin in the treatment of NVAF were selected from Cochrane Library,PubMed,Web of Science,EMBase,CNKI,CBM,VIP and Wanfang Data Knowledge Service Platform through computer retrieval.Extract the relevant information from the literature,and evaluate the quality of the literature.Results 15 literatures and a total of 2 246 patients were included,the quality score of the literatures were from 4 to 5.Meta analysis showed that compared with warfarin,NOACs can reduce the incidence of stroke [OR =0.65,95％CI (0.43,0.97),P=0.04],non-major bleeding [OR=0.44,95％CI (0.31,0.61),P＜0.001],and major bleeding [OR =0.45,95％ CI (0.22,0.91),P =0.03] of patients with NVAF.However,no significant differences were found in the incidence of non central nervous system thromboembolism [OR =0.72,95％ CI (0.46,1.14),P =0.16].Conclusion The incidence of stroke,non-major bleeding and major bleeding of patients using NOACs is lower than that of patients using warfarin,and no difference in the incidence of non central nervous system of patients using NOACs or warfarin.The efficacy and safety of NOACs is good in the treatment of domestic patients with NVAF.