| ObjectiveThe purpose of this study is to observe and study the clinical efficacy of Jianpi Bushen Huoxue decoction on early gouty nephropathy patients with spleen kidney deficiency and blood stasis syndrome,mainly through the observation of serum uric acid,creatinine,Cystatin-C;24-hour urine protein quantitative,urine α1-microglobulin,urine β2-microglobulin;syndrome score and safety indicators,and try to explore the possible mechanism of Jianpi Bushen Huoxue decoction.MethodsAccording to the established inclusion and exclusion criteria,74 patients with gouty nephropathy from May 2020 to December 2020 were randomly divided into two groups.Both groups were given routine treatment,the control group was given oral febuxostat tablets,and the treatment group was given Jianpi Bushen Huoxue decoction on the basis of the control group,the two groups were treated for 8 weeks.The indexes were measured and recorded before and after treatment,and the efficacy and safety were evaluated after treatment.Results1.There were 74 patients in this study(37 cases in the control group and 37 cases in the treatment group).There were no significant differences in gender ratio,age and course of disease between the two groups(P>0.05).No case fell out during the study.2.In the aspect of the influence on the indexes of renal function:before treatment,there was no significant difference in serum uric acid(UA),creatinine(SCr)and Cystatin-C(Cys-C)between the two groups(P>0.05);after treatment,there was a significant difference between the two groups(P<0.05),and the treatment group was better than the control group(P<0.05).2.In the aspect of the influence on the urinary protein index:before treatment,there was no significant difference in 24-hour urinary protein,urinary α1-microglobulin and urinary β 2-microglobulin between the two groups(P>0.05);after treatment,the two groups were decreased,with significant difference(P<0.05).Compared with the control group,the 24-hour urinary protein quantity and the decline of urinary α1-microglobulin in the treatment group were more advantageous,with significant difference(P<0.05);there was no significant difference in urinary β 2-microglobulin between the two groups after treatment(P>0.05).4.In terms of TCM symptom score and curative effect:before treatment,there was no significant difference between the two groups(P>0.05);after treatment,the total score of the two groups decreased,and the treatment group was better than the control group,with significant difference(P<0.05).In terms of efficacy evaluation,the total effective rate of the treatment group was 97.29%,and that of the control group was 54.05%.5.Safety evaluation:two groups of patients did not appear vital signs instability,gout acute attack,drug intolerance and other clinical symptoms.No liver damage,renal function acute exacerbation.The safety is good.ConclusionJianpi Bushen Huoxue decoction combined with febuxostat tablets in the treatment of gouty nephropathy(spleen and kidney deficiency with blood stasis type)can effectively improve the clinical symptoms of patients,the effective rate is high.At the same time,it is clear that Jianpi Bushen Huoxue decoction can reduce the level of uric acid,reduce renal proteinuria and improve renal function,and the mechanism may be related to the control of uric acid and the repair of renal tubular function.It is safe and effective in clinical application. |