吸附法无肝素透析对凝血酶原时间的影响抑平舒延缓慢性肾功能衰竭进展的开放和随机对照的多中心临床研究

Effect of the angiotensin converting enzyme inhibitor Inhibace on the progression of chronic renal insufficiency

目的 观察抑平舒降低血压、蛋白尿，延缓轻至中度慢性肾功能衰竭（ Ｃ Ｒ Ｆ） 进展的有效性和安全性。方法 轻、中度 Ｃ Ｒ Ｆ（ Ｓｃｒ １３４ ～３５４ μｍｏｌ／ Ｌ 或 Ｃｃｒ ３０ ～６０ ｍｌ／ｍｉｎ） 病人１１８ 例，其中慢性肾小球肾炎７１ 例，Ⅱ型糖尿病肾病５ 例，高血压肾小动脉硬化症３０ 例，多囊肾病３ 例，其他肾脏病９ 例。先依次选用倍他乐克、双氢克尿噻、心痛定控制病人血压，待血压及肾功能稳定后，根据 Ｃｃｒ将病人分为轻度 Ｃ Ｒ Ｆ组（ Ｃｃｒ４６ ～６０ｍｌ／ｍｉｎ） 和中度 Ｃ Ｒ Ｆ 组（ Ｃｃｒ ３０ ～４５ｍｌ／ｍｉｎ） ，每组病人再随机分为治疗组（ 抑平舒２ ．５ ～５ ．０ ｍｇ／ｑｄ ｎ ＝ ８０） 和对照组（ ｎ ＝ ３８） ，所有高血压病人继用上述降压药维持正常血压，随访期６ 个月。结果 治疗组治疗后收缩压平均下降１３ ｍｍ Ｈｇ（１ ｋ Ｐａ ＝ ７５ ｍ ｍ Ｈｇ） 、舒张压平均下降９５ ｍｍ Ｈｇ 和尿蛋白平均下降４０ ％ ，均较治疗前明显下降， Ｃｃｒ 明显增加；对照组治疗后收缩压、 Ｃｃｒ 明显下降， Ｓｃｒ、尿素明显增加，但舒张压和尿蛋白无明显差异，两组相比，治疗组降低血压、蛋白尿和延缓 Ｃ Ｒ Ｆ进展的作用明显优于对照组。?

Objective To determine the effect of the angiotensin converting enzyme inhibitor Inhibace on the progression of renal insufficiency in patients with various underlying renal diseases.Methods In six month trial involving 118 patients with renal insufficiency caused by various disorders,80 patients received inhibace and 38 received placebo.The underlying diseases included chronic glomerulonephritis(in 71 patients),nephrosclerosis(in 30),diabetic nephropathy(in 5),polycystic kidney disease(in 3),and miscellaneous or unknown disorders(in 9).The severity of renal insufficiency was classified under two groups according to the base line creatinine clearance(Ccr):32 patients had mild insufficiency (Ccr 46～60 ml/min),and 86 had moderate insufficiency (Ccr 30～45 ml/min).Each group was randomly divided into two subgroups:inhibace and control.Results At six months,patients in the inhibace group had lower systolic and diastolic blood pressure,fewer urinary protein excretion and slower progression rate of renal insufficiency than those in the placebo group.Inhibace slowed the progression of renal insufficiency in patients with mild or moderate renal insufficiency,hypertension or non hypertension,base line urinary protein excretion above 2 g/24 h or below 2 g/24 h.Its protection of renal function was greatest among the patients with glomerulonephritis and those with base line urinary protein excretion below 2g/24h.Inhibace was not effective in patients with nephrosclerosis.Conclusion Inhibace can significantly reduce blood pressure and urinary protein excretion.It provides protection against the progression of renal insufficiency in patients with various renal diseases.