目的 系统评价新型口服抗凝药(达比加群酯、利伐沙班、阿哌沙班及依度沙班)治疗房颤的有效性和安全性。方法 计算机检索截止2015年5月,在Pubmed, Embase, Medline, Cochrane, ClinicalTrials.gov, 中国知网、万方及维普数据库中检索关于新型口服抗凝药与华法林对比治疗房颤的随机对照研究,根据纳入标准对文献进行筛选和质量评价,使用Rev Man 5.3和Stata 13.1软件对数据进行Meta分析。结果 共纳入11篇随机对照研究,总计75 621例患者。Meta分析结果 显示,与华法林相比,新型口服抗凝药可显著降低全因死亡率[RR=0.90,95% CI(0.85,0.94),P<0.000 1]、卒中和体循环栓塞率[RR=0.86,95% CI(0.79,0.93),P=0.000 1]、严重出血率[RR=0.79,95% CI(0.74,0.84),P<0.000 01]及颅内出血率[RR=0.43,95% CI(0.37,0.51),P<0.000 01],而缺血性卒中率[RR=1.02,95% CI(0.93,1.12),P=0.71]和心肌梗死率[RR=1.02,95% CI(0.91,1.16),P=0.70]无显著差异。亚组分析降低了异质性,漏斗检测多数结局无发表偏倚存在,敏感性分析提示结果 稳健。结论 新型口服抗凝药的有效性及安全性均优于华法林,前景广阔。
Abstract
OBJECTIVE To evaluate the efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) in the treatment of atrial fibrillation. METHODS The randomized controlled trials of new oral anticoagulants versus warfarin in the treatment of atrial fibrillation, which had been published from the time of library foundation to May, 2015, were collected from Pubmed, Embase, Medline, Cochrane, ClinicalTrials.gov, CNKI, Wanfang database, and VIP database according to the inclusion criterias. At the same time the quality of the trials was evaluated and the RESULTS of studies were analyzed using RevMan 5.3 software and Stata 13.1 software. RESULTS Eleven randomized controlled trials were included, involving 75 621 patients. Meta-analysis showed that compared with warfarin, the new oral anticoagulants significantly reduced the incidences of all-cause mortality [RR=0.90, 95% CI (0.85, 0.94), P<0.000 1], stroke and systemic embolism [RR=0.86, 95% CI(0.79, 0.93), P=0.000 1], major bleeding [RR=0.79, 95% CI(0.74, 0.84), P<0.000 01], and intracranial bleeding[RR=0.43, 95% CI(0.37, 0.51), P<0.000 01]. No differences were found in the incidence of ischemic stroke [RR=1.02, 95% CI (0.93, 1.12), P=0.71] and myocardial infarction [RR=1.02, 95% CI (0.91, 1.16), P=0.70]. Heterogeneity was lower through subgroup analysis, no publication bias was found in funnel plots of most outcomes, and sensitivity analysis indicated the RESULTS were reliable. CONCLUSION The efficacy and safety of new oral anticoagulants are better than warfarin, which may have broad prospects.
关键词
新型口服抗凝药 /
华法林 /
房颤 /
有效性 /
安全性 /
Meta分析
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Key words
new oral anticoagulant /
warfarin /
atrial fibrillation /
efficacy /
safety /
Meta-analysis
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中图分类号：
R969.3
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参考文献
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