Tong P C Y, Ko G T C, Chan W-B, Ma R C W, So W-Y, Lo M K W, Lee K-F, Ozaki R, Chow C-C, Cockram C S, Chan J C N
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, NT, Hong Kong.
Diabetes Obes Metab. 2006 May;8(3):342-7. doi: 10.1111/j.1463-1326.2005.00514.x.
The renoprotective effect of angiotensin II antagonists has been demonstrated in type 2 diabetic patients with nephropathy but similar data on angiotensin-converting enzyme (ACE) inhibitors are limited. We examined the efficacy and tolerability of fosinopril, an ACE inhibitor with dual hepatic and renal clearance, in 38 type 2 diabetic patients with moderate renal impairment (plasma creatinine 130-300 micromol/l) over a 2-year period.
This was a single-centre, randomized, double-blinded, placebo-controlled trial comparing fosinopril 20 mg daily vs. placebo in addition to conventional antihypertensive treatment over a 2-year period. The primary endpoints were the rate of change and the percentage change in both 24-h urinary albumin excretion (UAE) and creatinine clearance (CrCl).
The mean age of the patients was 65 +/- 6 years (range 47-76 years, median 66 years) and plasma creatinine 190 +/- 49 micromol/l. For similar blood pressure control, the percentage change of UAE in patients with microalbuminuria was greater in the fosinopril than the placebo group (-24.2 +/- 28.8 vs. 11.6 +/- 42.1%, p = 0.003 after adjustment for baseline covariates). In the fosinopril group, the rate of change of endogenous CrCl was slower than the placebo group (-0.07 +/- 0.19 vs. -0.24 +/- 0.35 ml/min/week, p = 0.026). The incidence of adverse events was similar between the two groups.
Fosinopril treatment reduced albuminuria and rate of decline in renal function in type 2 diabetic patients with moderate renal insufficiency and did not increase the incidence of adverse events.
血管紧张素II拮抗剂对2型糖尿病肾病患者的肾脏保护作用已得到证实，但关于血管紧张素转换酶（ACE）抑制剂的类似数据有限。我们在38例中度肾功能损害（血肌酐130 - 300微摩尔/升）的2型糖尿病患者中，对具有肝肾双通道清除功能的ACE抑制剂福辛普利进行了为期2年的疗效和耐受性研究。
这是一项单中心、随机、双盲、安慰剂对照试验，在2年期间，除常规降压治疗外，比较每日20毫克福辛普利与安慰剂的疗效。主要终点是24小时尿白蛋白排泄量（UAE）和肌酐清除率（CrCl）的变化率及变化百分比。
患者的平均年龄为65±6岁（范围47 - 76岁，中位数66岁），血肌酐为190±49微摩尔/升。在血压控制相似的情况下，微量白蛋白尿患者中，福辛普利组UAE的变化百分比大于安慰剂组（-24.2±28.8 vs. 11.6±42.1%，经基线协变量调整后p = 0.003）。福辛普利组内源性CrCl的变化率比安慰剂组慢（-0.07±0.19 vs. -0.24±0.35毫升/分钟/周，p = 0.026）。两组不良事件的发生率相似。
福辛普利治疗可降低中度肾功能不全的2型糖尿病患者的蛋白尿及肾功能下降速率，且不增加不良事件的发生率。
