达比加群酯治疗非瓣膜性心房颤动疗效及安全性的Meta分析

Dabigatran etexilate for non-valvular atrial fibrillation:a meta-analysis

目的系统评价新型口服抗凝药物达比加群酯治疗非瓣膜性心房颤动的疗效及安全性。方法计算机检索中国知网数据库（CNKI）、万方数据资源库、维普期刊资源整合服务平台、超星学术发现系统、PubMed／Medline、Proguest期刊全文数据库（PHMC）、医知网，筛选符合纳入、排除标准的达比加群酯应用于非瓣膜性心房颤动抗凝治疗的随机对照试验（RCT）研究文献，纳入文献7篇（中文4篇，英文3篇），共计病例19816例。双人独立判定后，采用Jadad量表进行质量评价，应用RevMan5．3软件对提取的数据资料进行Meta分析。结果疗效性分析显示，达比加群酯能显著降低非瓣膜性心房颤动患者脑卒中发病率[OR=0．79，95％CI（0．66～0．93），Z=2．74，P〈0．05]；安全性分析显示，达比加群酯治疗非瓣膜性心房颤动对比华法林，在降低主要出血事件[OR=0．84，95％CI（0．74～0．95），Z=2．68，P〈0．05]、轻微出血事件[OR=0．81，95％CI（0．76～0．87），Z=6．17，P〈0．05]、颅内出血[OR=0．37，95％CI（0．27～0．51），Z=6．12，P〈0．053、全因死亡[OR=0．88，95％CI（0．78～0．99），Z=2．22，P〈0．05]的风险上，均有明显优势。结论达比加群酯能显著降低非瓣膜性心房颤动患者脑卒中、出血事件等风险，疗效及安全性均优于华法林。但本次研究纳入文献研究质量存在一定程度的差异，证据强度有限，本结论需要更高质量的循证研究进一步支持。

Objective To evaluate the clinical efficacy and safety of dabigatran etexilate in anticoagulation therapy for nonvalvular atrial fibrillation. Methods A systematic search on randomized controlled trial data in CNKI, Wangfang Databases, Weipu journal resources databases, super star academic discovery system, PubMed/Medline, PHMC and medical knowledge network, was performed. Two reviewers extracted data independently, and used Reviewer Manager Software（RevMan5.3）for statistical analysis. Results 7 studies （4 Chinese,3 English papers）with 19816 patients were included in the systematic review. Clinical efficacy analysis showed that dabigatran etexilate can significantly reduce the incidence of stroke in patients with nonvalvular atrial fibrillation [OR= 0. 79,95 % CI（0.66-0.93） ,Z= 2.74,P〈0. 05]; Safety analysis showed that, compared with warfarin, dabigatran etexilate can significantly reduce the incidence of major bleeding events [OR= 0. 84,95% CI（0.74 - 0.95）, Z = 2.68, P〈0.05], minor bleeding events [OR = 0.81,95% CI （0. 76-0. 87）, Z= 6.17, P〈0.05 ], intracranial hemorrhage [OR = 0. 37,95 % CI （0.27 -0. 51 ）, Z= 6.12, P〈0.05], all-cause mortality [OR=0.88,95%CI（0.78-0.99） ,Z=2.22,P〈0.05]. Conclusion Based on the current evidence, dahigatran etexilate can significantly reduce the incidence of stroke and bleeding events in the patients with nonvalvular atrial fibrillation, showing better efficacy and safety than warfarin. Because of low-quality literatures, the strength of the evidence is limited. Higher quality evidence-based studies are needed.