Effect of Addition of Silymarin to Renin-Angiotensin System Inhibitors on Proteinuria in Type 2 Diabetic Patients With Overt Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial
Effect of Addition of Silymarin to Renin-Angiotensin System Inhibitors on Proteinuria in Type 2 Diabetic Patients With Overt Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial
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DOI：
10.1053/j.ajkd.2012.06.005
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发表时间：
2012-12-01
影响因子：
13.2
通讯作者：
Lankarani, Kamran B.
中科院分区：
文献类型：
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作者：
Fallahzadeh, Mohammad Kazem;Dormanesh, Banafshe;Lankarani, Kamran B.
背景：2型糖尿病患者中有很大一部分合并糖尿病肾病。尽管目前的治疗包括肾素-血管紧张素系统抑制剂，但在大多数患者中，糖尿病肾病进展为终末期肾病。因此，迫切需要为这些患者找到新的治疗方法。本研究的目的是评估水飞蓟素（一种具有抗氧化和抗炎特性的草药）在预防糖尿病肾病进展中的疗效。研究设计：随机、双盲、安慰剂对照、2组平行试验。60例伴有大量白蛋白尿的2型糖尿病患者（尿白蛋白排泄> 300 mg/24 h），尽管用最大剂量的肾素-血管紧张素系统抑制剂治疗超过6个月，估计肾小球滤过率> 30 mL/min/1.73 m（2）。干预：患者被随机分配到2个相等的组，每天接受3片140 mg的水飞蓟素或3片安慰剂，持续3个月。结果：主要结果是尿白蛋白-肌酐比值（UACR）从基线到治疗期结束的绝对变化。测量：UACR以及尿液和血清TNF-α水平（肿瘤坏死因子α;一种炎症标志物），丙二醛（MDA;氧化应激标志物）和TGF β（转化生长因子β;纤维化的标志物）。结果：尽管两组的UACR均下降，但水飞蓟素组的下降幅度显著高于安慰剂组;两组之间UACR变化的平均差异为-347（95%CI，-690至-4）mg/g。尿液中的TNF-α和尿液和血清中的MDA水平也显着下降，在水飞蓟素与安慰剂group.Limitations相比：小样本量和治疗phase.Conclusions持续时间短：水飞蓟素减少尿中白蛋白，TNF-α，和MDA的排泄在糖尿病肾病患者，可被认为是一种新的除了抗糖尿病肾病armamentarium。美国肾脏病杂志60（6）：896-903。(C)2012年，美国国家肾脏基金会（National Kidney Foundation，Inc.）
Background: A large proportion of patients with type 2 diabetes mellitus have diabetic nephropathy. Despite current therapies including renin-angiotensin system inhibitors, diabetic nephropathy progresses to end-stage renal disease in most of these patients. Therefore, there is an urgent need to find new treatments for such patients. The aim of this study was to evaluate the efficacy of silymarin, an herbal drug with antioxidant and anti-inflammatory properties, in preventing the progression of diabetic nephropathy.Study Design: Randomized, double-blind, placebo-controlled, 2-arm parallel trial.Setting & Participants: 60 patients with type 2 diabetes with macroalbuminuria (urinary albumin excretion > 300 mg/24 h) despite treatment with the maximum dose of a renin-angiotensin system inhibitor for more than 6 months and estimated glomerular filtration rate > 30 mL/min/1.73 m(2).Intervention: Patients were randomly assigned to 2 equal groups to receive three 140-mg tablets of silymarin or 3 tablets of placebo daily for 3 months.Outcomes: The primary outcome was absolute change in urinary albumin-creatinine ratio (UACR) from baseline to the end of the treatment phase.Measurements: UACR and urinary and serum levels of TNF-alpha (tumor necrosis factor alpha; an inflammatory marker), malondialdehyde (MDA; an oxidative stress marker), and TGF beta (transforming growth factor beta; a marker of fibrosis) at baseline and the end of the treatment phase.Results: Although UACR decreased in both groups, this decrement was significantly higher in the silymarin compared with the placebo group; mean difference in change in UACR between the 2 groups was -347 (95% CI, -690 to -4) mg/g. Urinary levels of TNF-alpha and urinary and serum levels of MDA also decreased significantly in the silymarin compared with the placebo group.Limitations: Small sample size and short duration of the treatment phase.Conclusions: Silymarin reduces urinary excretion of albumin, TNF-alpha, and MDA in patients with diabetic nephropathy and may be considered as a novel addition to the anti-diabetic nephropathy armamentarium. Am J Kidney Dis. 60(6): 896-903. (C) 2012 by the National Kidney Foundation, Inc.