Ravid M, Savin H, Jutrin I, Bental T, Katz B, Lishner M
Sackler Faculty of Medicine, Tel Aviv University, Israel.
Ann Intern Med. 1993 Apr 15;118(8):577-81. doi: 10.7326/0003-4819-118-8-199304150-00001.
To evaluate the long-term effect of angiotensin-converting enzyme inhibition on proteinuria and on the rate of decline in kidney function in patients with type II diabetes mellitus and microalbuminuria.
Randomized, double-blind, placebo-controlled trial. Each patient was followed for 5 years.
Six clinics for diabetes mellitus coordinated by a department of medicine in a university hospital in Israel.
Ninety-four normotensive, type II diabetic patients with microalbuminuria and normal renal function.
The patients were randomly assigned to receive enalapril, 10 mg per day, or placebo. Any increase in blood pressure was treated with long-acting nifedipine.
Albuminuria, blood pressure, serum creatinine, fasting blood glucose, and glycosylated hemoglobin levels, every 3 to 4 months.
In the patients treated with enalapril, albuminuria decreased from 143 +/- 64 (mean +/- SD) mg/24 h to 122 +/- 67 mg/24 h during the first year. Thereafter, we observed a slow increase to 140 +/- 134 mg/24 h after 5 years. In the placebo group, albuminuria increased from 123 +/- 58 mg/24 h to 310 +/- 167 mg/24 h after 5 years. (Difference in rate of change in proteinuria [P < 0.05]). Kidney function (expressed as mean reciprocal creatinine) declined by 13% in the placebo group and remained stable (-1%) in the enalapril group (P < 0.05). Control of blood glucose levels remained stable, in both groups, throughout the study. The mean blood pressure was stable in the enalapril group (initial group mean, 99 +/- 2.1 mm Hg; fifth-year mean, 100 +/- 3.2 mm Hg) and increased in the placebo group from an initial mean value of 97 +/- 3.2 mm Hg to 102 +/- 3.4 mm Hg at the end of the study period (P = 0.082).
In normotensive patients with diabetes mellitus type II, the institution of angiotensin-converting enzyme inhibition during early stages of diabetic nephropathy results in long-term stabilization of plasma creatinine levels and of the degree of urinary loss of albumin. These effects are probably independent of the antihypertensive action of these agents.
评估血管紧张素转换酶抑制剂对II型糖尿病合并微量白蛋白尿患者蛋白尿及肾功能下降速率的长期影响。
随机、双盲、安慰剂对照试验。每位患者随访5年。
以色列一所大学医院内科协调的6家糖尿病诊所。
94例血压正常、II型糖尿病合并微量白蛋白尿且肾功能正常的患者。
患者被随机分配接受每天10毫克依那普利或安慰剂治疗。血压升高时用长效硝苯地平治疗。
每3至4个月测量蛋白尿、血压、血清肌酐、空腹血糖及糖化血红蛋白水平。
接受依那普利治疗的患者，第一年蛋白尿从143±64（均值±标准差）毫克/24小时降至122±67毫克/24小时。此后，5年后缓慢升至140±134毫克/24小时。安慰剂组5年后蛋白尿从123±58毫克/24小时升至310±167毫克/24小时。（蛋白尿变化速率差异[P<0.05]）。安慰剂组肾功能（以肌酐均值倒数表示）下降13%，依那普利组保持稳定（-1%）（P<0.05）。整个研究期间两组血糖水平控制均保持稳定。依那普利组平均血压稳定（初始组均值，99±2.1毫米汞柱；第5年均值，100±3.2毫米汞柱），安慰剂组从初始均值97±3.2毫米汞柱升至研究期末的102±3.4毫米汞柱（P = 0.082）。
在II型糖尿病血压正常患者中，糖尿病肾病早期应用血管紧张素转换酶抑制剂可使血浆肌酐水平及尿白蛋白丢失程度长期稳定。这些作用可能与这些药物的降压作用无关。
