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Oral vitamin K did not reduce bleeding in patients with excessive anticoagulation after receiving warfarin

机译:口服华法林后,口服维生素K并不能减少抗凝药过多的患者的出血

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QuestionnnIn patients with warfarin-associated coagulopathy, does low-dose oral vitamin K reduce risk for bleeding?nnMethodsnnDesign: Randomized placebo-controlled trial. ClinicalTrials.gov NCT00143715.nnAllocation: Concealed.*nnBlinding: Blinded (patients, clinicians, research coordinators, and outcome adjudicators).*nnFollow-up period: 90 days.nnSetting: 14 anticoagulant centers in the USA, Canada, and Italy.nnPatients: 724 outpatients 18 years of age (mean age 69 y, 53% men) who attended clinic for routine international normalized ratio (INR) assessment, were receiving warfarin with a target INR of 2.0 to 3.5, were not bleeding, and had an INR between 4.5 and 10.0 in the past 24 hours. Exclusion criteria included life expectancy < 10 days, indication for acute normalization of INR, scheduled discontinuation of warfarin, known bleeding disorder, recent major bleeding, inability to take oral medication or undergo follow-up, contraindication to vitamin K, severe liver disease, thrombolytic therapy within 48 hours, and platelet count < 50 x 109 cells/L.nnIntervention: Single-dose oral vitamin K, 1.25 mg (n = 355), or placebo (n = 369).nnOutcomes: Any bleeding events at 90 days. Secondary outcomes included major bleeding (fatal bleeding, bleeding requiring transfusion of 2 units of packed red blood cells or therapeutic intervention, or objectively confirmed bleeding into an enclosed space), objectively confirmed venous or arterial thromboembolism, and death.nnPatient follow-up: 98% (100% in intention-to-treat analysis).
机译:在华法林相关性凝血病患者中,低剂量口服维生素K是否可降低出血风险?nn方法设计:随机安慰剂对照试验。 ClinicalTrials.gov NCT00143715.nn分配:隐藏。* nn盲:盲人(患者,临床医生,研究协调员和结果判断者)。* nn随访时间:90天。nn设置:美国,加拿大和意大利的14个抗凝中心。 :724名18岁(平均年龄69岁,男性占53%)的门诊病人就诊,接受常规国际标准化比率(INR)评估,接受华法林的目标INR为2.0至3.5,不出血,并且具有INR在过去24小时内处于4.5和10.0之间。排除标准包括预期寿命<10天,INR急性恢复正常,华法林计划停药,已知出血性疾病,近期大出血,不能口服药物或无法随访,维生素K禁忌症,严重肝病,溶栓48小时内接受治疗,血小板计数<50 x 109个细胞/升.nn干预:单剂量口服维生素K,1.25毫克(n = 355)或安慰剂(n = 369).nn结果:90天时发生任何出血事件。次要结果包括严重出血(致命性出血,需要输注2个单位堆积红细胞或治疗性干预的出血,或客观确诊的出血进入密闭空间),客观确诊的静脉或动脉血栓栓塞和死亡.nn患者的随访情况:98 %(意向性分析中为100%)。

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  • 来源
    《ACP Journal Club》 |2009年第6期|p.9-9|共1页
  • 作者

    Matthew Rondina MD;

  • 作者单位

    University of UtahSalt Lake City, Utah, USA;

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  • 正文语种 eng
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