厄贝沙坦对2型糖尿病患者的肾脏保护作用

Effect of Irbesartan on Systemic Blood Pressure of the Patients with Type 2 Diabetes

目的:旨在探讨厄贝沙坦或氨氯地平是否能独立于其降低体循环血压的作用而减慢2型糖尿病患者的肾病进展。方法:连续入选2009年1月-2011年5月在吴川市人民医院就诊的525例2型糖尿病所致肾病的高血压患者。随机分为接受厄贝沙坦(300mg/d)、氨氯地平(10mg/d)或安慰剂治疗组。所有各组目标血压均为≤130/85mmHg。比较各组达到主要复合终点的时间及到达次要心血管复合终点的时间。结果:随访时间为平均1.6年。厄贝沙坦治疗与主要复合终点危险下降相关,厄贝沙坦组的危险比安慰剂组低20%(P=0.02),比氨氯地平组低20%(P=0.006)。对于血清肌酐浓度倍增危险,厄贝沙坦组比安慰剂组低33%(P=0.003),比氨氯地平组低37%(P<0.001)。厄贝沙坦治疗使发生终末期肾病的相对危险比其他两组都低20%(两组比较均P=0.07)。这些差异不能用治疗获得的血压差异来解释。厄贝沙坦组血清肌酐浓度增加的速度比安慰剂组慢24%(P=0.008),比氨氯地平组慢21%(P=0.02)。所有原因死亡及心血管复合终点的发生率差异无统计学意义。结论:厄贝沙坦在保护2型糖尿病引起的肾病方面有效,这种保护作用与其引起的血压下降无关。

Objective：To evaluate whether the angiotensin-Ⅱ-receptor blocker irbesartan slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure. Method：We randomly assigned 525 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan（300 mg daily）,amlodipine（10 mg daily）,or placebo. The target blood pressure was 130/85 mm Hg or less in all groups. We compared them with regard to the time to a secondary,cardiovascular composite end point. Result：The mean duration of follow-up was 1.6 years. Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group（ P =0.02）and 23 percent lower than that in the amlodipine group（ P =0.006）. The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group（ P =0.003）and 37 percent lower in the irbesartan group than in the amlodipine group（ P 0.001）. Treatment with irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups（ P =0.07 for both comparisons）. These differences were not explained by differences in the blood pressures that were achieved. The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group（ P =0.008）and 21 percent more slowly than in the amlodipine group（ P =0.02）. There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point. Conclusion：The angiotensin- Ⅱ -receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes. This protection is independent of the reduction in blood pressure it causes.