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目的 分析RE-LY试验中中国非瓣膜病心房颤动患者服用达比加群与华法林的有效性和安全性,及其对卒中预防的作用.方法 RE-LY试验是1项前瞻性、国际多中心、随机、平行组设计的临床试验.全国13个医学中心从2006年3月至2009年3月共入选541例伴有卒中风险的非瓣膜病心房颤动患者,对服用110 mg、2次/d(180例)和150 mg、2次/d(181例)2种固定剂量达比加群(每种均以盲化方式给药)与开放标签的华法林患者(180例,目标国际标准化比值2.0～3.0)进行比较.主要疗效终点是卒中和(或)体循环栓塞的年化发生率,主要安全性终点是大出血的年化发生率.结果 达比加群110 mg组、达比加群150 mg组和华法林组卒中或体循环栓塞的发生率分别为7例(1.94％/年)、4例(1.10％/年)和10例(2.87％/年);其中3组的缺血性卒中分别为4例(1.11％/年)、3例(0.82％/年)和7例(2.01％/年),出血性卒中分别为1例(0.28％/年)、1例(0.27％/年)和2例(0.57％/年);全因死亡率分别为12例(3.33％/年)、8例(2.19％/年)和9例(2.58％/年).达比加群2个剂量组均有2例(0.56％/年)大出血,而华法林组为5例(1.43％/年).达比加群2个剂量组和华法林组的消化系统不良事件(特别是腹部不适和上腹痛)发生率分别为12.8％(23/179)、12.8％(23/180)和5.6％(10/180).结论 与华法林一样,达比加群在中国人群中有较好的疗效及安全性,达比加群可安全有效地用于中国非瓣膜病心房颤动患者卒中的预防.临床试验注册美国国立卫生研究院(http://www.clinicaltrials.gov),注册号CT00262600.

Objective This analysis was performed to evaluate the efficacy in stroke prevention and safety of dabigatran in Chinese nonvalvular atrial fibrillation (NVAF) patients enrolled in RE-LY trial.Methods RE-LY was an prospective,open-label,randomized,multicenter study.From March 2006 to March 2009,541 atrial fibrillation patients at risk of stroke were recruited from 13 medical centers in China.Patients randomly received,in a blinded fashion,fixed doses of dabigatran-110 mg or 150 mg twice daily or,in an unblinded fashion,adjusted-dose warfarin.The primary efficacy endpoint was stroke or systemic embolism.The primary safety endpoint was major bleeding.Results The incidence of stroke in the Chinese subpopulation was 1.94％ per year(7 cases) in the group that received 110 mg of dabigatran (dabigatran 110) and 1.10％ per year (4 cases) in the group that received 150 mg of dabigatran (dabigatran 150),as compared with 2.87％ per year (10 cases) in warfarin group.Incidence of ischemic stroke was 1.11％ per year(4 patients) in dabigatran 110 group,0.82％ per year(3 cases) in dabigatran 150 group and 2.01％ per year(7 patients) in warfarin group.Incidence of hemorrhagic stroke was 0.28％per year(1 case) in dabigatran 110 group,0.27％ per year(1 case) in dabigatran 150 group and 0.57％per year(2 cases) in warfarin group.All-cause mortality was similar among the three treatment groups:3.33％ per year (12 cases) in dabigatran 110,2.19％ per year(8 cases) in dabigatran 150 and 2.58％per year(9 cases) in warfarin group.Incidence of major bleeding event was 0.56％ per year(2 cases) in both dabigatran groups,as compared with 1.43％ per year(5 cases) in warfarin group.Gastrointestinal disorders such as dyspepsia occurred in 12.8％ patients of both dabigatran groups,and in 5.6％ patients of warfarin group.Conclusions Despite the descriptive statistical analysis in nature of present study due to the limited number of subjects,our subgroup analysis implies that like warfarin,dabigatran is efficacious and safe for thromboembolism prevention in Chinese patients with atrial fibrillation at risk of stroke.Clinical Trail Registry National Institutes of Health (http://www.clinicaltrials.gov),CT00262600.