摘要
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 to warfarin for the treatment of venous thromboembolism.METHODS The 200 patients were randomly divided into dabigatran and warfarin groups.we compared oral dabigatran,administered at a dose of 150 mg twice daily,with warfarin that was dose-adjusted to achieve an international normalized ratio of 2.0to 3.0.The treatment period was 6 months.RESULTS As compared with warfarin,dabigatran was noninferior with regard to the prevention of recurrent or fatal venous thromboembolism,the difference in risk was 0.4 percentage points.Major bleeding episodes occurred in dabigatran（1.6%）and in warfarin（1.9%）and episodes of any bleeding were observed in dabigatran（16.3%）and in warfarin（22.1%）.The numbers of acute coronary syndromes,and abnormal liver-function tests were similar in the two groups.Adverse events leading to discontinuation of the study drug occurred in 9.1% of patients assigned to dabigatran and in7.9% of patients assigned to warfarin.CONCLUSION For the treatment of acute venous thromboembolism,a fixed dose of dabigatran is as effective as warfarin,has a safety profile that is similar to that of warfarin,and does not require laboratory monitoring.
出处
《中国医院药学杂志》
CAS
北大核心
2017年第5期466-468,共3页
Chinese Journal of Hospital Pharmacy
关键词
达比加群
华法林
静脉血栓
临床疗效
dabigatran
warfarin
venous thromboembolism
clinical efficacy
