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目的:比较达比加群和华法林治疗静脉血栓的安全性和有效性。方法:将200位患者随机分为达比加群组和华法林组,每组100人。达比加群组每天口服两次达比加群药物150 mg。华法林组利用华法林进行治疗,并将INR值调节至2.0~3.0之间。治疗时间为6个月。结果:与华法林相比较,达比加群组预防复发和死亡率并不逊色(P<0.01),而两者之间的风险区别仅为0.4%。达比加群组的大出血事件为1.6%,而华法林组为1.9%。对于任何出血事件而言,达比加群组为16.3%,华法林组为22.1%。急性冠脉综合征和异常肝功能测试结果在2组中是类似的。不良反应导致的停药事件在达比加群组为7.9%,华法林组为9.1%。结论:达比加群的固定剂量治疗静脉血栓栓塞与华法林同样有效,在安全性方面,它类似于华法林,但不需要实验室监测。
Objective: To compare the safety and efficacy of dabigatran and warfarin in the treatment of venous thrombosis. METHODS: Two hundred patients were randomly assigned to dabigatran and warfarin groups of 100 in each group. The dabigatran group received oral dabigatran 150 mg twice daily. Warfarin group warfarin treatment, and the INR value adjusted to between 2.0 to 3.0. Treatment time is 6 months. RESULTS: The dabigatran group was comparable to warfarin in preventing relapse and mortality (P <0.01), with a difference of only 0.4% between the two. The major bleeding in the dabigatran group was 1.6%, compared with 1.9% in the warfarin group. For any bleeding event, 16.3% were in the dabigatran group and 22.1% in the warfarin group. Acute coronary syndromes and abnormal liver function test results were similar in both groups. Adverse events led to withdrawal events in the dabigatran group was 7.9%, warfarin group was 9.1%. Conclusion: Dabigatran’s fixed-dose treatment of venous thromboembolism is as effective as warfarin, which is similar in safety to warfarin but does not require laboratory monitoring.