达比加群酯对非瓣膜性房颤患者抗凝治疗效果及安全性的Meta分析

目的评价达比加群酯对非瓣膜性房颤患者抗凝治疗的效果及安全性。方法检索有关达比加群酯对非瓣膜性房颤患者抗凝治疗的随机对照试验及多中心对照研究等文献,并进行质量评估,采用RevMan 5.2对符合条件的研究进行Meta分析,评价达比加群酯对非瓣膜性房颤患者的抗凝效果及安全性。结果符合纳入标准的文献共7篇(中文1篇,英文6篇),总样本量为33 502例。Meta分析显示,与华法林比较,达比加群酯明显降低房颤患者脑卒中发生率(OR=0.82,95%CI 0.73⁰.93,P=0.001)、全因出血率(OR=0.86,95%CI 0.790.93,P=0.001)、全因出血率(OR=0.86,95%CI 0.79⁰.95,P=0.003)及颅内出血发生率(OR=0.42,95%CI 0.290.95,P=0.003)及颅内出血发生率(OR=0.42,95%CI 0.29⁰.62,P=0.001);而动脉栓塞率(OR=0.75,95%CI 0.450.62,P=0.001);而动脉栓塞率(OR=0.75,95%CI 0.45¹.25,P=0.28)及全因死亡率(OR=0.91,95%CI 0.821.25,P=0.28)及全因死亡率(OR=0.91,95%CI 0.82¹.00,P=0.06)无明显差异。结论达比加群酯可有效降低房颤患者脑卒中、全因出血及颅内出血的风险,疗效优于传统药物华法林且安全性高。

Meta-analysis of effect and safety of Dabigatran etexilate in patients with non valvular atrial fibrillation anticoagulation

Objective To evaluate effect and safety of dabigatran etexilate for the treatment of non valvular atrial fi -brillation anticoagulation .Methods Retrieval review literature of randomized controlled trial and multi-center study of dabiga-tran etexilate for the anticoagulation treatment in patients with non valvular atrial fibrillation , and performed the quality assess-ment, the RevMan 5.2 were used to performed the Meta-analysis for these studies, to evaluate dabigatran etexilate anticoagu-lant effect and safety for patients with non valvular atrial fibrillation .Results 7 papers met the inclusion criteria were enrolled （1 English, 6 Chinese papers）, included 33 502 patients.Meta-analysis showed that, compared with warfarin, dabigatran significantly reduce the incidence of cerebral apoplexy in AF patients （OR=0.82, 95%CI, 0.73-0.93, P =0.001）, all-cause hemorrhage rate （OR=0.86, 95%CI 0.79-0.95, P =0.003） and intracranial hemorrhage （OR=0.42, 95%CI, 0.29-0.62, P =0.001） ;and arterial embolism rate （OR=0.75, 95%CI 0.45-1.25, P =0.28） and all-cause mortality （OR=0.91, 95%CI, 0.82-1.00, P =0.06） had no significant difference .Conclusion Dabigatran can effectively reduce the cerebral apoplexy , all-cause bleeding and the risk of intracranial hemorrhage in AF patients , the curative effect is better than traditional warfarin .