Clinical Trial Research Of Yishenhuashi Granule In Treatment Of Diabetic Kidney Disease Based On The Theory Of “Gut Kidney Axis”

Objective:To explore the clinical effects and mechanism of improving diabetic kidney disease（DKD）by regulating intestinal flora through"gut kidney axis".Methods:One hundred patients of diabetic kidney disease with the syndrome of spleen deficiency and damp excess were randomly divided into the treatment group and the control group,50 cases in each one.The treatment group was treated with additional YSHS Granule combined with Western basic medicine,while the control group was treated only with Western basic medicine after8 weeks,The Changes of TCM syndrome score,total clinical efficacy and laboratory indexes were collected.Fecal samples from 60 patients（30 patients in each group）were recruited to gut microbiota 16S r DNA V3+V4 regions analysis.Results:1.After treatment,the total effectiveness rate was significantly higher in the treatment than in the control group（96%vs 72%,P<0.01）,and the treatment group had significantly lower TCM syndrome scores than the control group（P<0.01）.2.After treatment,significantly greater improvement was observed in UACR,UMALB,Hb A_1c,BUN and IL-6 in the two groups（P<0.05 or P<0.01）.The treatment group was better than the control group in improving UACR,Hb A_1c,ALB,SOD and IL-6（P<0.05 or P<0.01）;3.No significant difference in Scr and e GFR was observed between these two groups.4.Compared with the control group,the diversity and abundance of flora in the treatment group increased,the aggregate degree of flora increased,and the F/B ratio decreased.5.Lefse analysis showed that the dominant genera and species of the experimental group were Parabacteroides,Bifidobacterium longum and Lactobacillus mucosae.Further random forest model showed that Parabacteroides and Bifidobacterium longum were important target bacteria.Conclusions:YSHS in addition to Western basic treatments can effectively improve the clinical syndromes of DKD,spleen deficiency and damp heat syndrome,G1A1-G3a A3,reduce blood sugar,reduce proteins and stabilize renal function.One of the mechanisms may be to increase the content of probiotics,such as Parabacteroides,Bifidobacterium and Lactobacillus mucosae,can regulate glucose and the level of oxidative stress and inflammation as a whole.