保肾片治疗慢性肾功能衰竭气阴两虚兼湿浊证临床观察

Multi-center Randomized Double-blind Controlled Clinical Trial on Baoshen Tablets in Treatment of Chronic Renal Failure with Qi and Yin Deficiency and Dampness Syndrome

目的:观察保肾片对慢性肾功能衰竭(CRF)气阴两虚兼湿浊证的疗效。方法:采用多中心、随机、双盲双模拟、阳性药物平行对照方法,试验组345例患者服用保肾片加空白模拟片,对照组118例服用肾康宁片加空白模拟片。观察两组患者治疗前后中医证候积分值、尿素氮(BUN)、血肌酐(SCr)、内生肌酐清除率(CCr)、血红蛋白(Hb)、24 h尿蛋白定量变化情况。结果:试验组总有效率为88.12%,对照组总有效率为74.58%。试验组患者中医证候积分值、BUN,SCr,24 h尿蛋白定量均明显下降(P<0.05或P<0.01),CCr,Hb明显升高(P<0.01),对照组对BUN,SCr,Hb,24 h尿蛋白定量指标无明显改善。结论:保肾片可明显改善CRF气阴两虚兼湿浊证患者的临床表现,降低BUN,SCr水平,减少尿蛋白丢失,提高CCr,在一定程度上纠正患者的贫血状态。

Objective：Observation the curative efficacy of Baoshen Tablets curing/therapy Chronic Renal Failure（CRF）with Qi and Yin Deficiency and dampness syndrome.Method： Using the methods of a multicenter,randomized,double-blind double-dummy,parallel control for positive drug,the experimental group 345 cases of patients taking Baoshen Tablets and imitated tablet,the control group of 118 patients taking Shenkangning Tablets and imitated tablet.Observing the changes before and after treatment by the value of TCM syndromes,blood urea nitrogen（BUN）,serum creatinine（SCr）,creatinine clearance rate of endogenous（CCr）,hemoglobin（Hb）,24h urinary protein.Result： The total effective rate of experimental group was 88.12%,and the total effective rate of the control group was 74.58%.The patients of experimental group the value of TCM syndromes,BUN,SCr,24h urine protein were significantly decreased（P 0.05 or P 0.01）,CCr,Hb significantly increased（P0.01）,the control group on BUN,SCr,Hb,24h urinary protein showed no significant improvement（P0.01）.The Control group of BUN,SCr,Hb,24h urinary protein showed no significant improvement.Conclusion： The Baoshen Tablets can significantly improve the CRF with Qi and Yin Deficiency and dampness syndrome of the clinical manifestations,lower BUN,SCr levels,reduce urinary protein loss,increased CCr,corrected to some extent in patients with anemia.