| Objective: 1.To observe the clinical efficacy and safety of Yishen Huashi granule in the treatment of diabetic kidney disease(Diabetic kidney disease,DKD)with spleen deficiency and dampness syndrome.2.The intervention effects of Yishen Huashi granule on the pathological morphology,ultrastructure and function of kidney in DKD rats were observed through animal experiments,so as to explore the possible mechanism of Yishen Huashi granule in the treatment of diabetic kidney disease.Methods: 1.Clinical observation: DKD patients with spleen deficiency and dampness syndrome were included in the outpatient clinic and ward of the first Department of Nephropathy of Shandong Hospital of traditional Chinese Medicine,and were randomly divided into control group and experimental group.Patients in the control group were treated with routine treatment + lifestyle intervention + valsartan capsule(Daiwen),while patients in the experimental group were treated with lifestyle intervention + routine treatment + Yishen Huashi granule for 12 weeks.24-hour urine and venous blood were collected before and after treatment,and 24-hour urinary protein(24h UP),urinary microalbuminuria / creatinine(UACR),blood glucose(PBG),serum creatinine(SCr),urea nitrogen(BUN),glomerular filtration rate(e GFR)and serum cystatin (Cys C)were measured.The efficacy and safety of Yishen Huashi granule in the treatment of DKD were evaluated and analyzed.2.In animal experiment,SD rats were fed with high-fat and high-sugar diet combined with intraperitoneal injection of STZ to establish DKD model.The rats were randomly divided into blank control group,model group,valsartan group and Yishen Huashi granule group(hereinafter referred to as "YSHS group").The general state of rats was observed,and the indexes of 24-hour urinary protein quantity(24h UP),blood glucose(PBG),serum creatinine(SCr),urea nitrogen(BUN)and low density lipoprotein(LDL-C)were detected.The pathological morphology of kidney tissue was observed by light microscope.The ultrastructure of kidney and the morphology of podocytes were observed by electron microscope.To explore the possible mechanism of Yishen Huashi granule in the treatment of DKD.Results: 1.Clinical observation: a total of 80 patients were included in this trial,77 cases completed the observation for 12 weeks,including 38 cases in the experimental group and 39 cases in the control group.There was no significant difference in laboratory indexes and TCM syndrome scores between the two groups before treatment(P > 0.05).After 12 weeks of treatment,24 h UP,UACR,e GFR,SCr,BUN,Csy C and PBG in the test group were improved as compared with those before treatment,and there was also statistical significance compared with the control group.The UA of the two groups decreased after treatment,but there was no significant difference between the two groups(P > 0.05).After treatment,the TCM syndrome score of the experimental group was significantly lower than that of the control group(P < 0.05).The total clinical effective rate of the experimental group was 92.1%,while that of the control group was 66.7%.The TCM curative effect of the experimental group was significantly better than that of the control group(P < 0.05).The incidence of adverse reactions in the test group and control group was 2.56% and 2.50% respectively,and no serious adverse reactions occurred.2.Animal experiments: the general condition of the blank control group was good,the general condition of the model group was poor,the general condition of rats in each treatment group was OK,and the diet,body weight,urine volume and mental condition were improved in varying degrees compared with the model group.After 8 weeks of treatment,compared with the blank control group,the PBG of each group was significantly increased,there was no significant difference between the valsartan group and the model group,and the PBG of the YSHS group was significantly improved compared with the model group and valsartan group.Compared with the blank control group,the SCr of each group increased significantly,and the SCr of YSHS group and valsartan group decreased compared with the model group,but there was no significant difference between YSHS group and valsartan group.Compared with the blank control group,the BUN of each group increased significantly,and compared with the model group,the BUN in YSHS group and valsartan group decreased,but there was no significant difference between YSHS group and valsartan group.Compared with the blank control group,the LDL-C of each group increased significantly,compared with the model group,YSHS group decreased significantly,valsartan group had no significant improvement,and YSHS group improved significantly compared with valsartan group.Compared with the blank control group,the 24 h UP of each group was significantly increased,compared with the model group,YSHS group and valsartan group were significantly improved(P < 0.0l),but there was no difference between YSHS group and valsartan group.Renal pathology: PAS staining showed no significant change in the blank control group.In the model group,mild to moderate proliferation of Mesangial area,increase of Mesangial matrix,thickening of basement membrane and infiltration of monocytes and lymphocytes in renal interstitium.Compared with the model group,the pathological changes of all treatment groups were alleviated,and the remission of YSHS group was more obvious.PASM staining showed no significant change in the blank control group.In the model group,there were mild to moderate Mesangial hyperplasia,slight increase of Mesangial matrix,glomerular pyknosis,capillary stiffness and fusion,thickening of basement membrane,focal atrophy of renal tubules,swelling of epithelial cells,granule and vacuolar degeneration.Compared with the model group,the pathological changes of all treatment groups were alleviated,and the remission of YSHS group was more obvious.Under electron microscope,the glomerular basement membrane thickened,the foot process of podocyte arranged disorderly,and the foot process fused and disappeared.The pathological changes of rats in YSHS group and valsartan group were less than those in model group,and the relief in YSHS group was more obvious.Conclusion: 1.The use of Yishen Huashi granule in the treatment of DKDG1-3b A2-3 patients with spleen deficiency and dampness syndrome can significantly improve the TCM clinical syndrome.Yishen Huashi granule plays a certain role in regulating glucose metabolism,reducing urinary protein and protecting renal function,and has high safety.2.Yishen Huashi granule was not inferior to valsartan in delaying the deterioration of renal function and reducing urinary protein in DKD rats,and could regulate lipid metabolism.After treatment,the pathological changes of glomeruli,Mesangial area and renal tubule in YSHS group and podocyte injury under electron microscope were less than those in model group and valsartan group,indicating that its protective effect on podocytes may be one of the mechanisms of treatment for DKD. |
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