高剂量的维生素B会增加糖尿病肾病患者的肾功能衰竭
转自丁香园动态版 ，margeryscm编译
Patients with diabetic nephropathy (kidney disease caused by diabetes) who received high dose B-vitamin therapy experienced a more rapid decline in kidney function and had a higher rate of heart attack and stroke than patients who received placebo, according to a study in the April 28 issue of JAMA.
4月28日出版的JAMA杂志中发表的文献显示:在糖尿病肾病的患者中,与安慰剂相比,使用大剂量维生素B治疗的患者,肾功能下降的更快,更容易发生心血管事件,卒中等疾病.
Diabetic nephropathy typically affects the network of tiny blood vessels in the glomerulus, a key structure in the kidney composed of capillary blood vessels, which is necessary for the filtration of the blood. "In addition to the personal burden, the societal burden of diabetic nephropathy is enormous, exceeding U.S. $10 billion in annual medical expenditures. Despite effective therapies to slow disease progression, approximately 40 percent of the estimated 21 million patients with diabetes in the United States develop overt nephropathy. New treatment approaches to this problem are needed," the authors write.
糖尿病肾病主要影响肾小球的细小血管,肾小球是肾脏的主要结构,主要有毛细血管网所组成,这些毛细血管网是血液滤过所必需的.作者在文章中指出,除了带给个人沉重的负担,糖尿病肾病也给社会沉重的负担.在美国,每年约有超过10亿美金是用于糖尿病肾病的治疗.尽管为了延缓疾病的进展已经采取了有效的手段,但是在美国2100万糖尿病患者中的40%仍进展称为显著的糖尿病肾病.为此,必需有新的治疗手段.
According to background information in the article, several observational studies have shown a significant association between high concentrations of plasma total homocysteine and the risk of developing diabetic nephropathy, retinopathy, and vascular diseases, including myocardial infarction (MI; heart attack) and stroke. B-vitamin therapy (folic acid, vitamin B6, and vitamin B12) has been shown to lower the plasma concentration of homocysteine.
在文章的研究背景中指出,一些观察性的研究显示: 同型半胱氨酸浓度与糖尿病肾病,糖尿病视网膜病变,糖尿病血管病变(包括心肌缺血,心肌梗死,心脏病发作),脑卒中等显著相关.而B族维生素(叶酸,维生素B6,维生素B12等)显示能降低血中同型半胱氨酸的浓度.
Andrew A. House, M.D., of the University of Western Ontario, and J. David Spence, M.D., of the Robarts Research Institute, London, Ontario, and colleagues conducted a study to examine whether B-vitamin therapy would slow the progression of diabetic nephropathy and prevent vascular events in 238 patients with type 1 or 2 diabetes. The randomized, placebo-controlled trial was conducted at five university medical centers in Canada between May 2001 and July 2007. Patients received 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. The primary outcome was change in radionuclide glomerular filtration rate (GFR; a measure of kidney function) between baseline and 36 months. Other outcomes included dialysis and a composite of heart attack, stroke, revascularization and all-cause death. Plasma total homocysteine was measured. Participants were followed-up for an average of 31.9 months.
来自Western Ontario 大学的Andrew A. House博士,Robarts研究中心的David Spence博士,以及他们的同事,主持进行了一项关于B族维生素是否能延缓糖尿病肾病进展,预防血管事件的临床研究.这项研究在238名1型及2型糖尿病患者中进行.此项研究是随机的,安慰剂对照的研究,从2001年3月-2007年7月间,在加拿大五所大学的医学中心内进行.患者随机的服用单种B族维生素胶囊,包括2.5mg/日的叶酸,25mg/日的维生素B6.1mg/日的维生素B12,以及安慰剂.研究的主要终点事件是比较基线水平及36个月后的肾小球滤过率(GFR).次要终点事件包括比较透析比例,心血管事件发生率,脑卒中发生率,血管重建率,以及全因死亡率等.测定基线水平及36个月后的血同型半胱氨酸浓度.所有参加研究的患者平均的随访时间是31.9个月.
Among the results, the researchers found that participants assigned to the B-vitamin group had a greater decrease in radionuclide GFR (and subsequently poorer kidney function) compared with the placebo group. Also, participants randomized to receive B vitamins had a significantly greater number of cardiovascular and cerebrovascular events, with the 36-month risk of a composite outcome, including heart attack, stroke, revascularization, and all-cause mortality that was double in the B-vitamin group, compared to the placebo group. There was no difference in requirement of dialysis.
在所有的研究结果中,研究者们发现,与安慰剂组相比,使用B族维生素的患者肾小球滤过率(GFR)显著下降,肾功能明显下降.同时,使用B族维生素治疗的患者发生更多的心血管及脑血管事件.在次要终点事件的研究中发现,36个月后,使用B组维生素治疗的患者心脏病发生率,脑卒中发生率,血管重建率及全因死亡率是安慰剂组的2倍.需要透析的比例两组没有统计学差异.
Regarding plasma total homocysteine levels, at 36 months, participants in the B-vitamin group had an average decrease while participants in the placebo group had an average increase.
而同型半胱氨酸浓度,使用安慰剂组是上升的,而使用B组维生素治疗组是下降的.
"Given the recent large-scale clinical trials showing no treatment benefit, and our trial demonstrating harm, it would be prudent to discourage the use of high-dose B vitamins as a homocysteine-lowering strategy outside the framework of properly conducted clinical research," the authors conclude.
著者认为.尽管许多的大型临床研究显示,B族维生素的治疗是无益的,但是我们的研究显示,大剂量使用B族维生素是有害的,因为以降低同型半胱氨酸为目的使用B族维生素需谨慎.
编译
高剂量的维生素B会增加糖尿病肾病患者的肾功能衰竭
4月28日出版的JAMA杂志中发表的文献显示:与安慰剂相比,在糖尿病肾病中使用大剂量维生素B治疗,肾功能衰退的更快,更易发生心血管事件,卒中等疾病.
糖尿病肾病主要影响肾小球的细小血管,肾小球是肾脏的主要结构,主要由毛细血管网所组成,这些毛细血管网是血液滤过所必需的.作者指出,除了带给个人沉重的负担,糖尿病肾病也给社会沉重的负担.在美国,每年超过10亿美金需用于糖尿病肾病的治疗.尽管为了延缓疾病的进展已经采取了一些有效的手段,但是美国2100万糖尿病患者中的40%仍进展为显著的糖尿病肾病.为此,必需发现新的治疗手段.
文章的研究背景指出,一些观察性的研究显示: 同型半胱氨酸浓度与糖尿病肾病,糖尿病视网膜病变,糖尿病血管病变(包括心肌缺血,心肌梗死,心脏病发作),脑卒中等显著相关.而B族维生素(叶酸,维生素B6,维生素B12等)显示能降低血中同型半胱氨酸的浓度.
来自Western Ontario 大学的Andrew A. House博士,Robarts研究中心的David Spence博士,以及他们的同事,主持进行了一项关于B族维生素是否能延缓糖尿病肾病进展,预防血管事件的临床研究.这项研究在238名1型及2型糖尿病患者中进行.此项研究是随机的,安慰剂对照的研究,从2001年3月-2007年7月间,在加拿大五所大学的医学中心内进行.患者随机的服用单种B族维生素胶囊,分为2.5mg/日的叶酸组,25mg/日的维生素B6组,1mg/日的维生素B12组,以及安慰剂组.研究的主要终点事件是比较基线水平及36个月后的肾小球滤过率(GFR).次要终点事件包括比较透析比例,心血管事件发生率,脑卒中发生率,血管重建率,以及全因死亡率等.测定基线水平及36个月后的血同型半胱氨酸浓度.所有参加研究的患者平均的随访时间是31.9个月.
在所有的研究结果中,研究者们发现,与安慰剂组相比,使用B族维生素的患者肾小球滤过率(GFR)显著下降,肾功能明显下降.同时,使用B族维生素治疗的患者发生更多的心血管及脑血管事件.在次要终点事件的研究中发现,36个月后,使用B组维生素治疗的患者心脏病发生率,脑卒中发生率,血管重建率及全因死亡率是安慰剂组的2倍.需要透析的比例两组没有统计学差异.
同型半胱氨酸浓度,在安慰剂组是上升的,B组维生素治疗组是下降的.
著者认为.尽管许多的大型临床研究显示,B族维生素的治疗是无益的,但是我们的研究显示,大剂量使用B族维生素是有害的,因此以降低同型半胱氨酸为目的使用B族维生素需谨慎.
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