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达比加群酯与华法林预防老年房颤患者卒中的有效性和安全性随机对照试验 被引量:16

Efficacy and safety of dabigatran versus warfarin for preventing stroke in elderly patients with atrial fibrillation: a randomized controlled trial
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摘要 目的比较老年房颤患者长期服用达比加群酯和华法林预防卒中的有效性和安全性。方法研究设计为前瞻性随机对照试验。研究对象选自常州市第二人民医院门诊及病房诊断为非瓣膜性房颤且需要实施抗凝治疗的患者,研究起始时间为2015年3月20日,入选患者随机分为达比加群酯组(达比加群酯110mg口服,2次/d)和华法林组(口服华法林,定期门诊随诊调整剂量,使国际标准化比值保持在2~3之间),随访2年,比较2组患者预防血栓栓塞事件的有效性和出血事件的发生情况;并按患者年龄分层(<60岁组,60~<80岁组,≥80岁组),比较颅外出血事件的发生情况。结果截至2015年11月,共纳入患者180例,男性114例(63.3%),女性66例(36.7%);<60岁者65例(36.1%),60~<80岁者108例(60.0%),≥80岁者7例(3.9%)。达比加群酯组患者90例,华法林组90例。随访2年期间,2组患者中发生卒中/非中枢神经系统栓塞事件者各6例,颅内出血事件各5例;发生颅外出血事件者华法林组为12例,达比加群酯组为16例,2组患者血栓栓塞事件和出血事件发生率比较,差异均无统计学意义(各P >0.05)。比较2组不同年龄患者颅外出血发生情况,达比加群酯<60岁组患者颅外出血发生率低于华法林组(11.4%比13.3%),60~<80岁和≥80岁组患者颅外出血发生率高于华法林组(分别为19.6%比12.2%、50.0%比33.3%),但差异均无统计学意义(均P >0.05)。结论老年房颤患者长期服用达比加群酯和华法林预防卒中的有效性和颅内出血事件的发生率相似,高龄老年患者的颅外出血风险尚需扩大样本做进一步研究。 ObjectiveTo compare the efficacy and safety of long-term use of dabigatran and warfarin for prevention of stroke in elderly patients with atrial fibrillation.MethodsThe study was designed as a prospective randomized controlled trial.The subjects were outpatients or inpatients who were diagnosed as non-valvular atrial fibrillation and needed anticoagulant therapy in Changzhou No.2 People's Hospital.The study started on March 20,2015.Patients in accordance with the inclusion criteria were randomly divided into the dabigatran group(dabigatran 110 mg,twice daily)and warfarin group(warfarin dose was adjusted by regular follow-up results to maintain INR in the range of 2.0-3.0).After two years of follow-up,effectiveness of preventing thromboembolism events and occurrence of hemorrhagic events were compared between the two groups;occurrence of extracranial hemorrhage was also compared in patients with different ages(<60 years old group,60-<80 years old group,≥80 years old group)between the two groups.ResultsUp to October 2015,a total of 180 patients were enrolled,including 114 males(63.3%)and 66 females(36.7%);65 patients(36.1%)were <60 years old,108 patients(60.0%)were 60-<80 years old,and 7(3.9%)were≥80 years old.There were 90 patients in the dabigatran group and in the warfarin group,respectively.During the period of 2-year follow-up,stroke and non-central nervous system embolism occurred in 6 patients and intracranial hemorrhage in 5 patients in each group,extracranial hemorrhage occurred respectively in 12 and 16 patients in the warfarin and dabigatran groups,without statistically significant differences(P >0.05 for all comparisons).Comparisons of the extracranial hemorrhage incidences in patients with different ages between the 2 groups showed that the incidence of extracranial hemorrhage in patients <60 years old in the dabigatran group was lower than that in the warfarin group(11.4% vs.13.3%);the incidences of extracranial hemorrhage in patients aged 60-<80 and≥80 years in the dabigatran group were higher than those in the warfarin group(19.6% vs.12.2%,50.0% vs.33.3%,respectively),without statistically significant differences(P >0.05 for all comparisons).ConclusionsThe effectivenessfor preventing stroke and the incidences of hemorrhagic events were respectively similar in elderly atrial fibrillation patients with long-term use of dabigatran and warfarin.The risk of extracranial hemorrhage in very elderly patients needs to be further studied by expanding the sample size.
作者 陈井成 纪元 朱萌 周学军 朱傲霜 Chen Jingcheng;Ji Yuan;Zhu Meng;Zhou Xuejun;Zhu Aoshuang(Department of Cardiovascular, Yanghu District of Changzhou No.2 People′s Hospital, the Affiliated Hospital of Nanjing Medical University, Chang zhou 213164, China)
出处 《药物不良反应杂志》 CSCD 2018年第6期426-430,共5页 Adverse Drug Reactions Journal
关键词 心房颤动 达比加群酯 华法林 抗凝药 卒中 出血 Atrial fibrillation Dabigatran Warfarin Anticoagulants Stroke Hemorrhage
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