Fogari R, Zoppi A, Corradi L, Mugellini A, Lazzari P, Preti P, Lusardi P
Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
J Hum Hypertens. 1999 Jan;13(1):47-53. doi: 10.1038/sj.jhh.1000732.
The aim of this study was to compare the effects of ramipril and nitrendipine chronic treatment on urinary albumin excretion (UAE) in hypertensive patients with type II non-insulin-dependent diabetes mellitus (NIDDM) and impaired renal function. A 2-year, prospective, randomised study was conducted on 51 men with a diastolic blood pressure (DBP) > or =95 and < or =105 mm Hg, stable NIDDM, serum creatinine between 1.6 and 3.0 mg/dl and persistent UAE >300 and <2000 mg/24 h. After a 3-month preliminary observation period, during which patients began a low-protein, low-sodium diet, and a subsequent 4-week run-in period on placebo, patients were randomly treated with ramipril 5 mg or nitrendipine 20 mg for 2 years. Both drugs similarly reduced BP without affecting glucose homeostasis. In the ramipril group UAE significantly decreased after only 3 months of treatment, whereas in the nitrendipine group a significant although lesser reduction in UAE was observed only after 1 year. During the second year the UAE% change was not statistically different between the two treatments. Serum creatinine and creatinine clearance showed no significant change with both drugs. The progression of renal insufficiency as assessed by the rate of reduction of creatinine clearance over the 2 years of the study was similar in the ramipril and the nitrendipine groups. In conclusion both ramipril and nitrendipine were associated with a decrease in UAE although such a reduction was earlier and more marked with ramipril. The decline of renal function did not differ significantly between the two treatments.
本研究旨在比较雷米普利和尼群地平长期治疗对伴有II型非胰岛素依赖型糖尿病(NIDDM)及肾功能受损的高血压患者尿白蛋白排泄(UAE)的影响。对51名男性患者进行了一项为期2年的前瞻性随机研究,这些患者舒张压(DBP)≥95且≤105 mmHg,NIDDM病情稳定,血清肌酐在1.6至3.0 mg/dl之间,持续性UAE>300且<2000 mg/24 h。在为期3个月的初步观察期内,患者开始低蛋白、低钠饮食,随后在安慰剂上进行为期4周的导入期,之后患者被随机给予5 mg雷米普利或20 mg尼群地平治疗2年。两种药物均能相似地降低血压,且不影响葡萄糖稳态。在雷米普利组,治疗仅3个月后UAE就显著下降,而在尼群地平组,仅在1年后才观察到UAE有显著但较小程度的下降。在第二年,两种治疗之间UAE的变化百分比无统计学差异。血清肌酐和肌酐清除率在两种药物治疗下均无显著变化。在研究的2年期间,根据肌酐清除率降低速率评估的肾功能不全进展在雷米普利组和尼群地平组相似。总之,雷米普利和尼群地平均与UAE降低有关,尽管雷米普利的这种降低更早且更明显。两种治疗之间肾功能的下降无显著差异。