益肾保真方治疗脾肾两虚型慢性肾脏病3~4期的多中心队列研究

Multi-center Cohort Study of Yishen Baozhen Recipe for Treatment of Chronic Kidney Disease with Deficiency of Both Spleen and Kidney in the Stage 3-4

【目的】观察益肾保真方治疗脾肾两虚型慢性肾脏病(CKD)3~4期的临床疗效。【方法】采用多中心队列研究,按是否暴露于益肾保真方治疗将198例CKD 3~4期患者分为2组,其中治疗组102例,对照组96例。2组均给予基础治疗,在此基础上,治疗组加用益肾保真方治疗,对照组加用药用碳片治疗,疗程为6个月。观察2组患者治疗前后中医证候积分和血清胱抑素C(Cys-C)、尿素氮(BUN)、肌酐(Scr)及肾小球滤过率(eGFR)等肾功能指标的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)疗程结束后,治疗组脱落17例,对照组脱落18例,最终治疗组纳入85例,对照组纳入78例。(2)治疗后,治疗组的总有效率为81.2%(69/85),对照组为69.2%(54/78),治疗组的疗效明显优于对照组,差异有统计学意义(P<0.01)。(3)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.01),且治疗组的降低作用明显优于对照组,差异有统计学意义(P<0.01)。(4)治疗后,血清Cys-C、Scr水平2组患者均较治疗前下降(P<0.05或P<0.01),而eGFR水平仅治疗组较治疗前升高(P<0.01),BUN水平2组患者治疗前后均无明显变化(P>0.05);组间比较,治疗组血清Cys-C水平低于对照组,e GFR水平高于对照组,差异均有统计学意义(P<0.05),而2组Scr和BUN比较,差异均无统计学意义(P>0.05)。(5)2组患者的各项安全性指标比较,差异均无统计学意义(P>0.05)。【结论】益肾保真方可以提高CKD 3~4期患者的临床疗效,改善患者临床症状,降低血清Cys-C、Scr水平,提高肾小球滤过率,具有一定的肾脏保护作用,同时无严重不良反应。

Objective To observe the clinical efficacy of Yishen Baozhen Recipe for the treatment of chronic kidney disease with deficiency of both spleen and kidney in the stage 3-4.Methods The multi-center cohort study was adopted.A total of 198 patients with chronic kidney disease in the stage 3-4 were divided into 2 groups according to the presence of exposure to Yishen Baozhen Recipe.A total of 102 cases were were in the treatment group and 96 cases were in the control group.The two groups were given conventional fundamental treatment,and additionally the treatment group was given Yishen Baozhen Recipe and the control group was given medicinal charcoal tablets.The treatment for the two groups lasted 6 months.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome,levels of serum cystatin C(Cys-C),blood urea nitrogen(BUN),serum creatinine(SCr),and estimated glomerular filtration rate(eGFR)in the two groups were observed.After treatment,the clinical efficacy and safety in the two groups were evaluated.Results(1)At the end of the treatment,17 patients in the treatment group and 18 patients in the control group dropped out,and 85 cases of the treatment group and78 cases of the control group finished the course of treatment.(2)After treatment,the total effective rate of the treatment group was 81.2%(69/85),higher than that of the control group(69.2%,54/78),and the difference was statistically significant(P<0.01),indicating that the treatment group had stronger clinical effect than the control group.(3)After treatment,the scores of TCM syndrome in the two groups were decreased in comparison with those before treatment(P<0.01),and the treatment group had stronger effect on decreasing the scores than the control group,the difference being statistically significant(P<0.01).(4)After treatment,the levels of CysC and SCr in the two groups were decreased(P<0.05 or P<0.01),eGFR was increased(P<0.01),while BUN showed no obvious changes(P>0.05)in comparison with those before treatment.The intergroup comparison after treatment showed that serum Cys-C level in the treatment group was lower and eGFR was higher than the control group,the difference being statistically significant(P<0.05),but the differences of SCr and BUN between the two groups were insignificant(P>0.05).(5)The differences of the safety indicators between the two groups were insignificant(P>0.05).Conclusion Yishen Baozhen Recipe can enhance the clinical efficacy of chronic kidney disease patients in the stage 3-4 by relieving the clinical symptoms,reducing serum Cys-C and SCr levels,and increasing eGFR.Yishen Baozhen Recipe exerts certain protective effect for the kidney,and has no obvious adverse reaction.