Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism

Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism
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DOI:
10.1056/nejmoa035029
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发表时间:
2003-04-10
影响因子:
158.5
通讯作者:
Boross-Harmer, S
Boross-Harmer, S
中科院分区:
医学1区
文献类型:
--
作者:
Ridker, PM;Goldhaber, SZ;Boross-Harmer, S

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背景:预防复发性静脉血栓栓塞的标准治疗包括3 - 12个月的全剂量华法林治疗,目标国际标准化比值(INR)在2.0 - 3.0之间。然而,对于长期管理,没有治疗剂显示出可接受的效益风险比。方法:特发性静脉血栓栓塞患者接受全剂量抗凝治疗的中位数为6.5个月,随机分配到安慰剂或低强度华法林(目标国际标准化比值,1.5至2.0)。参与者随后复发静脉血栓栓塞,大出血,death.RESULTS:试验提前终止后,508例患者进行了随机分组,并已随访长达4.3年(平均2.1)。在253名接受安慰剂治疗的患者中,37名患者复发静脉血栓栓塞(7.2/100人-年),相比之下,255名接受低强度华法林治疗的患者中有14名患者复发静脉血栓栓塞(2.6/100人-年),风险降低64%(风险比,0.36 [95%置信区间,0.19至0.67]; P
BACKGROUND:Standard therapy to prevent recurrent venous thromboembolism includes 3 to 12 months of treatment with full-dose warfarin with a target international normalized ratio (INR) between 2.0 and 3.0. However, for long-term management, no therapeutic agent has shown an acceptable benefit-to-risk ratio.METHODS:Patients with idiopathic venous thromboembolism who had received full-dose anticoagulation therapy for a median of 6.5 months were randomly assigned to placebo or low-intensity warfarin (target INR, 1.5 to 2.0). Participants were followed for recurrent venous thromboembolism, major hemorrhage, and death.RESULTS:The trial was terminated early after 508 patients had undergone randomization and had been followed for up to 4.3 years (mean, 2.1). Of 253 patients assigned to placebo, 37 had recurrent venous thromboembolism (7.2 per 100 person-years), as compared with 14 of 255 patients assigned to low-intensity warfarin (2.6 per 100 person-years), a risk reduction of 64 percent (hazard ratio, 0.36 [95 percent confidence interval, 0.19 to 0.67]; P