肾安康冲剂治疗慢性肾功能衰竭的临床研究

Clinical Observation on Shen'ankang Granules for Chronic Renal Failure

【目的】探讨肾安康冲剂治疗慢性肾功能衰竭(CRF)的临床疗效及作用机理。【方法】将72例CRF患者随机分为治疗组(36例)和对照组(36例),两组均服用爱西特片及常规西药支持对症治疗,治疗组加服肾安康冲剂(基本方:黄芪10 g、制大黄6 g、淫羊藿6 g、三七6 g、莪术6 g),疗程均为8周。观察两组临床疗效及治疗前后血尿素氮(BUN)、血肌酐(SCr)、内生肌酐清除率(Ccr),尿β2-微球蛋白(β2-M)、N-乙酰-βD氨基葡萄糖苷酶(NAG)及血清纤维化标志蛋白[Ⅳ型胶原(C-Ⅳ)、Ⅲ型前胶原(PC-Ⅲ)和层黏蛋白(LN)]的含量变化。【结果】治疗组总有效率为86.11%,对照组为61.11%,经Ridit检验,治疗组疗效优于对照组(P<0.05);治疗后治疗组血BUN、SCr、Ccr及尿β2-M和NAG含量均较治疗前有所改善(P<0.01),而对照组仅血SCr、BUN含量有所下降(P<0.05),治疗组上述指标的改善作用均优于对照组(P<0.05或P<0.01);两组患者血清C-Ⅳ、PC-Ⅲ、LN含量均高于正常人(P<0.01),治疗后治疗组上述血清纤维化标志蛋白均有改善(P<0.01),而对照组则无显著性改善(P>0.05),两组比较差异有统计学意义(P<0.05或P<0.01)。【结论】肾安康冲剂治疗CRF,能提高临床疗效,改善患者肾功能,其机理可能与其降低血清纤维化标志蛋白从而抗肾间质纤维化作用有关。

[ Objective] To observe the therapeutic effect of Shen＇ankang Granules （SG） for chronic renal failure （CRF） and to explore its therapeutic mechanism. [ Methods] Seventy-two CRF patients were equally randomized into groups A and B. The two groups were given oral use of Medicinal Charcoal Tablets and routine supportive and symptomatic treatment, and group A was given SG （mainly composed of Radix Astragali, Radix et Rhizoma Rhei, Herba Epimedii, Radix Notoginseng and Rhizoma Cureumae ） additionally. The treatment lasted 8 weeks. The therapeutic effect in the two groups was compared after treatment. Meanwhile, the changes of blood urea nitrogen （BUN）,serum creatine （SCr）, endogenous creatine clearance rate （Ccr）, urinary β2 microglobulin （β2-M） and β-Nacetyglucosamidase （NAG）, as well as changes of serum fibrosis-associated proteins of type Ⅳ collagen （C-Ⅳ）, type Ⅲ precollagen （PC-Ⅲ） and laminin （LN） levels were detected. [ Results ] The total therapeutic effect was 86.11% in group A, higher than 61.11% in group B （P 〈 0.05）. Serum levels of BUN, SCr, Ccr, urinary β2-M and NAG decreased after treatment in group A （ P 〈 0.01 as compared with those before treatment）, and serum SCr and BUN decreased in group B （ P 〈 0.05 as compared with those before treatment）, the effect on the above indexes in group A being superior to that in group B （P 〈0.05 or P 〈0.01）. Serum levels of C-Ⅳ, PC-Ⅲ and LN in groups A and B were higher that those in the healthy （ P 〈0.01）, and decreased in group A after treatment （ P 〈0.01 as compared with those before treatment）, while remained unchanged in group B （ P 〉 0.05）. The differences of serum C-Ⅳ, PC-Ⅲ and LN levels were significant between groups A and B （ P 〈 0.05 or P 〈 0.01）. [Conclusion] SG has a synergistic action with routine western medicine for CRF, and can improve renal function. Its therapeutic mechanism may be related to the decrease of serum fibrosis-associated proteins, and thus counteract renal interstitial fibrosis.