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氯沙坦对2型糖尿病肾病患者肾脏及心血管并发症的影响

[Effect of losartan on renal and cardiovascular complications of patients with type 2 diabetes and nephropathy].

作者信息

Parving H H, Brenner B M, Cooper M E, de Zeeuw D, Keane W F, Mitch W E, Remuzzi G, Snapinn S M, Zhang Z, Shahinfar S

机构信息

Steno Diabetes Center, Gentofte.

出版信息

Ugeskr Laeger. 2001 Oct 1;163(40):5514-9.

Abstract

INTRODUCTION

Diabetic nephropathy is the leading cause of end-stage renal disease. Interruption of the renin-angiotensin system slows the progression of renal disease in type 1 diabetic patients, but similar data are not available for type 2, the most common form of diabetes. We assessed the role of the angiotensin II receptor antagonist, losartan, in type 2 diabetic patients with nephropathy.

MATERIAL AND METHODS

One thousand five hundred and thirteen patients were enrolled in this randomised, placebo-controlled study of losartan (50 to 100 mg, once daily) or placebo, in addition to conventional antihypertensive treatment (calcium antagonists, diuretics, alpha- and beta-blockers, centrally acting agents) for a mean of 3.4 years. The primary outcome was the composite of doubling of baseline serum creatinine, end-stage renal disease, or death. Secondary end points included a composite of cardiovascular morbidity and mortality, proteinuria, and the progression rate of renal disease.

RESULTS

Baseline demographics in the two groups were similar. Three hundred and twenty-seven patients receiving losartan reached the primary end point, as compared with 359 on placebo (risk reduction = 16 per cent, p = 0.02). Losartan reduced the incidence of doubling of serum creatinine (risk reduction = 25 per cent, p = 0.006) and end-stage renal disease (risk reduction = 28 per cent, p = 0.002), but had no effect on death. Benefits exceeded that attributable to changes in blood pressure. The composite of cardiovascular morbidity and mortality was similar in the two groups, except hospitalisation for heart failure, which was reduced with losartan (risk reduction = 32 per cent, p = 0.005). Proteinuria declined by 35 per cent with losartan (p < 0.001).

DISCUSSION

Losartan conferred significant renal benefits in type 2 diabetic patients with nephropathy and was generally well tolerated.

摘要

引言

糖尿病肾病是终末期肾病的主要病因。肾素 - 血管紧张素系统的阻断可减缓1型糖尿病患者肾病的进展,但对于最常见的糖尿病类型2型糖尿病,尚无类似数据。我们评估了血管紧张素II受体拮抗剂氯沙坦在2型糖尿病肾病患者中的作用。

材料与方法

1513例患者参加了这项随机、安慰剂对照研究,除常规抗高血压治疗(钙拮抗剂、利尿剂、α和β受体阻滞剂、中枢作用药物)外,给予氯沙坦(50至100毫克,每日一次)或安慰剂,平均治疗3.4年。主要结局是基线血清肌酐翻倍、终末期肾病或死亡的复合情况。次要终点包括心血管发病率和死亡率的复合情况、蛋白尿以及肾病进展率。

结果

两组的基线人口统计学特征相似。接受氯沙坦治疗的327例患者达到主要终点,而接受安慰剂治疗的有359例(风险降低 = 16%,p = 0.02)。氯沙坦降低了血清肌酐翻倍的发生率(风险降低 = 25%,p = 0.006)和终末期肾病的发生率(风险降低 = 28%,p = 0.002),但对死亡无影响。益处超过了血压变化所带来的影响。两组心血管发病率和死亡率的复合情况相似,但氯沙坦降低了因心力衰竭住院的发生率(风险降低 = 32%,p = 0.005)。氯沙坦使蛋白尿下降了35%(p < 0.001)。

讨论

氯沙坦对2型糖尿病肾病患者具有显著的肾脏益处,且耐受性一般良好。

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