Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: a randomized, placebo-controlled, double-blind trial
Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: a randomized, placebo-controlled, double-blind trial
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DOI：
10.1182/blood-2006-04-014654
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发表时间：
2007-01-01
期刊：
影响因子：
20.3
通讯作者：
Bos, Gerard M. J.
中科院分区：
文献类型：
--
作者：
den Heijer, Martin;Willems, Huub P. J.;Bos, Gerard M. J.
维生素D和血栓形成（VITRO）研究调查了每日补充B族维生素降低同型半胱氨酸对降低深静脉血栓形成（DVT）和肺栓塞（PE）风险的影响。要求年龄在20 - 80岁之间的患者参与研究（高同型半胱氨酸血症组），这些患者在没有主要风险因素的情况下首次客观证实近端DVT或PE，并且同型半胱氨酸浓度高于参考组的第75百分位数。在同型半胱氨酸水平低于参考组第75百分位数的患者（同型半胱氨酸正常组）的随机样本中进行了类似的研究。获得知情同意后，患者被随机分配每日补充多种维生素（5毫克叶酸、50毫克维生素B6和0.4毫克维生素B12）或安慰剂，并随访2.5年。终点为客观诊断为复发性DVT或PE。共入组701例患者（高同型半胱氨酸血症组360例，正常同型半胱氨酸血症组341例）。维生素组353例中静脉血栓形成复发事件为43例（54/1000 py），安慰剂组348例中为50例（64/1000 py）。与维生素治疗相关的风险比在高同型半胱氨酸血症组为0.84（95%CI，0.56-1.26）：1.14（95%CI，0.65-1.98），在正常同型半胱氨酸血症组为0.58（95%CI，0.31-1.07）。我们的研究结果并没有表明通过补充B族维生素降低同型半胱氨酸可以预防静脉血栓的复发。该试验在www.clinicaltrials.gov上注册为#NCT00314990。
The Vitamins and Thrombosis (VITRO) study investigated the effect of homocysteine lowering by daily supplementation of B vitamins on the risk reduction of deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients between 20 to 80 years old with a first objectively confirmed proximal DVT or PE in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent was obtained, patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine, and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End points were objectively diagnosed recurrent DVT or PE. A total of 701 patients were enrolled (360 in the hyperhomocysteinemic and 341 in the normohomocysteinemic group). The number of recurrent events of venous thrombosis was 43 of 353 in the vitamin group (54/1000 py) and 50 of 348 in the placebo group (64/1000 py). The hazard ratio associated with vitamin treatment was 0.84 (95% CI, 0.56-1.26): 1.14 (95% CI, 0.65-1.98) in the hyperhomocysteinemic group and 0.58 (95% CI, 0.31-1.07) in the normohomocysteinemic group. The results of our study do not show that homocysteine lowering by B vitamin supplementation prevents recurrent venous thrombosis. This trial was registered at www.clinicaltrials.gov as #NCT00314990.