肾康福液对大鼠慢性肾功能衰竭的预防、治疗作用和Ⅱ期临床试验

Effect of preventing and treating in rats with chronic renal failure and phase Ⅱ clinical trial of Shenkangfu liquid

目的 :探讨肾康福液预防和治疗慢性肾功能衰竭 (肾衰 )的疗效。方法 :2 4只慢性肾衰大鼠模型随机分为 4组 :(1)空白对照组不给任何药物仅灌同容积水 ;(2 )阳性对照组灌服包醛氧化淀粉水溶液 (0 .5 g·kg- 1) 2mL ,tid ;(3 )治疗组灌服肾康福液 2mL ,tid ;(4)预防组在肾切除前 7d灌服肾康福液 ,剂量同治疗组。疗程均为 18wk。 2 40例慢性肾衰病人随机分为治疗组 12 0例 ,口服肾康福液2 0mL ,tid× 18wk ;对照组 12 0例口服包醛氧化淀粉 5～ 10 g ,tid× 18wk。结果 :肾康福液组大鼠和病人的肌酐、尿素氮、尿蛋白定量均明显下降 (P <0 .0 5 )。 2组临床总有效率分别是 95 .8%及 68.3 %(P <0 .0 5 )。结论 :肾康福液对慢性肾衰大鼠和病人有明显预防和治疗作用。

AIM: To investigate the effect of Shenkangfu liquid(SKFL) in preventing and treating chronic renal failare. METHODS: Twenty four CRF rats were divided into four groups: (1) the empty control group was healed water for 18 wk; (2) the pair control group was treated with aldehyele coated oxystarch (ACO) 0.5 kg·kg -1 (2 mL), tid for 18 wk; (3) the treatment group was treated with SKFL 2 mL, tid for 18 wk;(4) preventing group rats fed SKFL 2 mL, tid for 7 d before 5/6 nephrectomized and 18 d in this study. Two handred and forey patients of CRF were randomly divided into two groups. One group of 120 patients was treated with SKFL 20 mL, tid ×18 wk. Another group of 120 patients was treated with ACO 5-10 g, tid ×18 wk. Scr, Bun, urine protein etc, in CRF rats model and patients were studied. RESULTS: Scr, Bun, and urine protein were obviously reduced in the treatment group patients and rats model of 5/6 nephrectomized with SKFL. The total effective rates of the two gronps were 95.8% and 68.3 % respectively. It was obvious that the therapeutic effect of SKFL group was better than that of the control group ( P < 0.05). CONCLUSION: It shows that there is an obvious treatment effect on SD rats model and patients of chronic renal failure with SKFL.