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B族维生素疗法对糖尿病肾病进展的作用:一项随机对照临床试验



    背景:
经常有报导糖尿病肾病患者同时伴有高同型半胱氨酸血症。而B族维生素疗法(叶酸,VB6,VB12)被证实可降低血浆同型半胱氨酸的浓度。

    目标: 确定B族维生素疗法是否能延缓糖尿病肾病的进展和延缓血管并发症。

    试验设计、步骤、受试对象:多中心,随机,双盲包含安慰剂效应(维生素疗法干预糖尿病以改善肾脏病进展)从2001年五月到2007年7月,在加拿大的五个大学医学中心进行,238名1型或2型糖尿病合并临床糖尿病肾病的患者参与。

    干预方案:用于干预的B族维生素每片含叶酸(2.5 mg/d), VB 6 (25 mg/d), VB12,(1 mg/d), 或者给予安慰剂。

    测定指标:主要分析对比了比较初始水平,36个月内,同位素法测得的肾小球滤过率改变。另外还对比了透析,心梗,卒中,血管再生等所有其他的致死原因。还测量了血浆总同型半胱氨酸的含量。

    结果: 随访的平均值(SD)是31.9(14.4)。通过B族维生素的干预后36个月后,同位素法测得的GFR平均(S.E.)减少了 16.5 (1.7) mL/min/1.73 m2 ,与之对比的是安慰剂组的数据是10.7 (1.7) mL/min/1.73 m2 (平均值差为5.8,95%的可信区间为-10.6至-1.1,p=0.02),在需要透析的患者中两组无明显区别(危险几率 [HR] 1.1; 95% CI, 0.4-2.6, P =0.88),复杂的结果在使用B族维生素的组中更常出现。HR:2.0; 95% CI, 1.0-4.0; P = 0.04). 血浆同型半胱氨酸治疗36个月减少的平均值(SE)是 2.2 (0.4) µmol/L 而安慰剂组的平均值(SE)是2.6 (0.4) µmol/L(平均值差 –4.8; 95% CI, –6.1 to –3.7; P < 0.001, 使用B族维生素的患者组)。 

    结论:
对于糖尿病肾病的患者,大剂量的使用B族维生素比之安慰剂,可以明显的减少肾小球滤过率,增加血管意外事件。



附JAMA原文摘要:

Effect of B-Vitamin Therapy on Progression of Diabetic Nephropathy: A Randomized Controlled Trial
 
 
Andrew A. House, MD; Misha Eliasziw, PhD; Daniel C. Cattran, MD; David N. Churchill, MD; Matthew J. Oliver, MD; Adrian Fine, MD; George K. Dresser, MD; J. David Spence, MD 
 
JAMA. 2010;303(16):1603-1609. 
 
ABSTRACT 
 
Context Hyperhomocysteinemia is frequently observed in patients with diabetic nephropathy. B-vitamin therapy (folic acid, vitamin B6, and vitamin B12) has been shown to lower the plasma concentration of homocysteine. 
 
Objective To determine whether B-vitamin therapy can slow progression of diabetic nephropathy and prevent vascular complications. 
 
Design, Setting, and Participants A multicenter, randomized, double-blind, placebo-controlled trial (Diabetic Intervention with Vitamins to Improve Nephropathy [DIVINe]) at 5 university medical centers in Canada conducted between May 2001 and July 2007 of 238 participants who had type 1 or 2 diabetes and a clinical diagnosis of diabetic nephropathy. 
 
Intervention Single tablet of B vitamins containing folic acid (2.5 mg/d), vitamin B6 (25 mg/d), and vitamin B12 (1 mg/d), or matching placebo. 
 
Main Outcome Measures Change in radionuclide glomerular filtration rate (GFR) between baseline and 36 months. Secondary outcomes were dialysis and a composite of myocardial infarction, stroke, revascularization, and all-cause mortality. Plasma total homocysteine was also measured. 
 
Results The mean (SD) follow-up during the trial was 31.9 (14.4) months. At 36 months, radionuclide GFR decreased by a mean (SE) of 16.5 (1.7) mL/min/1.73 m2 in the B-vitamin group compared with 10.7 (1.7) mL/min/1.73 m2 in the placebo group (mean difference, –5.8; 95% confidence interval [CI], –10.6 to –1.1; P = 0.02). There was no difference in requirement of dialysis (hazard ratio [HR], 1.1; 95% CI, 0.4-2.6; P = 0.88). The composite outcome occurred more often in the B-vitamin group (HR, 2.0; 95% CI, 1.0-4.0; P =0.04). Plasma total homocysteine decreased by a mean (SE) of 2.2 (0.4) µmol/L at 36 months in the B-vitamin group compared with a mean (SE) increase of 2.6 (0.4) µmol/L in the placebo group (mean difference, –4.8; 95% CI, –6.1 to –3.7; P < 0.001, in favor of B vitamins). 
 
Conclusion Among patients with diabetic nephropathy, high doses of B vitamins compared with placebo resulted in a greater decrease in GFR and an increase in vascular events.

PMID:20424250
 

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