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不同类型房颤患者使用新型口服抗凝药物和华法林预防卒中的疗效比较:Meta分析

Comparison of efficacy of new oral anticoagulants and warfarin in patients with various atrial fibrillation patterns: a meta-analysis
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摘要 目的比较新型口服抗凝药物(NOACs)与华法林预防不同类型心房颤动(房颤)患者卒中的有效性和安全性。方法应用计算机从PubMed、 Cochrane图书馆、 Elsevier、 Web of Science、中国知网、万方等电子数据库中检索自建库至2018年7月关于口服抗凝治疗预防房颤患者卒中的随机对照临床试验(RCTs)。获取数据资料后用RevMan 5.3和STATA软件进行荟萃及偏倚统计分析,比较口服抗凝治疗在阵发性房颤与持续性或永久性房颤患者卒中预防的有效性和安全性。结果通过筛选最终纳入了4项大型Ⅲ期RCTs,对其荟萃分析表明在阵发性房颤患者中,无论使用NOACs还是华法林,患者卒中和全身性栓塞发生率[NOACs组(2.58%, 197/7 642) vs.华法林组(3.25%, 193/5 929), RR=0.83, 95%CI:0.61~1.13, P=0.24, I^2=57%]和大出血发生率[NOACs组(6.4%, 489/7 642) vs.华法林组(7.12%, 422/5 929),RR=0.88, 95%CI:0.78~1.00, P=0.06, I^2=0%]无显著差异。在持续性或永久性房颤患者中,NOACs组卒中和全身性栓塞发生率显著低于华法林组[NOACs组(3.22%, 813/25 197) vs.华法林组(7.12%, 846/20 956), RR=0.82, 95%CI:0.75~0.90, P <0.000 1, I^2=0%],同时大出血事件也显著降低[NOACs组(5.5%, 1 386/25 197) vs.华法林组(6.45%, 1 351/20 956), RR=0.85, 95%CI:0.73~0.99, P=0.03, I^2=77%]。结论阵发性房颤患者使用NOACs预防卒中的有效性和安全性与华法林相当,持续性或永久性房颤患者使用NOACs预防卒中的有效性和安全性较华法林好。 AIM To evaluate the efficacy and safety of new oral anticoagulants (NOACs) in patients with various atrial fibrillation( AF) patterns compared with warfarin. METHODS Comprehensive literatures searches were conducted using the PubMed, Cochrane Library, Elsevier, Web of Science, CNKI and Wanfang from inception to July 2018. Randomized controlled trials (RCTs) focusing on efficacy and safety of oral anticoagulant therapy for prevention of stroke in patients with AF were adopted. Statistical analyses were performed using RevMan 5.3 and STATA software. RESULTS Four phase Ⅲ RCTs were finally appraised and included. In patients with paroxysmal AF, NOACs was comparable to warfarin for stroke and systemic embolism (NOACs group (2.58%, 197/7 642) vs. warfarin group (3.25%, 193/5 929), RR = 0.83, 95%CI: 0.61-1.13, P = 0.24, I^2= 57%) as well as major bleeding (NOACs group (6.4%, 489/7 642) vs. warfarin group (7.12%, 422/5 929), RR = 0.88, 95%CI: 0.78-1.00, P = 0.06, I^2= 0%). In patients with persistent or permanent AF, NOACs had a favorable point estimate in stroke and systemic embolism(NOACs group (3.22%,813/25 197) vs. warfarin group (7.12%, 846/20 956), RR = 0.82, 95%CI: 0.75-0.90, P < 0.000 1, I^2=0%) as well as major bleeding(NOACs group (5.5%, 1 386/25 197) vs. warfarin group (6.45%, 1 351/20 956), RR = 0.85, 95% CI: 0.73-0.99, P = 0.03, I^2= 77%) compared with warfarin. CONCLUSION NOACs were similarly effective and safe for the prevention of stroke in patients with paroxysmal AF but more effective and safer in those with persistent or permanent AF compared with warfarin.
作者 张卫芳 鲍慧慧 熊友文 熊爱珍 谢珊珊 程晓曙 ZHANG Wei-fang;BAO Hui-hui;XIONG You-wen;XIONG Ai-zhen;XIE Shan-shan;CHENG Xiao-shu(Department of Pharmacy,the Second Affiliated Hospital of Nanchang University,Nanchang JIANGXI 330006,China;Department of Cardiology,the Second Affiliated Hospital of Nanchang University,Nanchang JIANGXI 330006,China;Jiangxi Supervision and Inspection Center for Medical Devices,Nanchang JIANGXI 330029,China)
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2019年第1期50-56,共7页 Chinese Journal of New Drugs and Clinical Remedies
基金 国家自然科学基金(81460010,81460045) “十二五”计划国家科技重大专项课题(2014ZX09303305) 江西省科技厅青年科学基金(20171BAB215002) 中国博士后科学基金(2017M622107) 江西省博士后科学基金(2016KY51) 中国健康促基金会科研课题公益项目(会字(2016)第99号).
关键词 心房颤动 抗凝药 卒中 META分析 atrial fibrillation anticoagulants stroke meta-analysis
作者简介 张卫芳,女,主管药师,博士,主要从事心血管药物及机制的研究,E—mail:z_weifang@163.com;责任作者:程晓曙,男,主任医师,博士,主要从事心血管疾病及机制的研究,E-mail:xiaoshumenfan@126.com.
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