Study On The Effect Of Qidi Tangshen Granules On Treating Proteinuria And Intervening Renal Tubular Indexes In Patients With DK

Background and Purpose:Diabetic kidney disease(DKD)is one of the common and more serious complications of diabetes and a major cause of end-stage renal disease in China.The understanding of this disease in Chinese medicine has many developments based on the traditional etiology and pathogenesis.The mentor believes that the core pathogenesis of diabetic kidney disease is essence depletion and the collateral impediment,and has established the treatment method of tonifying the kidney and filling essence,taking into account the activation of blood and circulation of ligaments and the clearing of heat,and developed QidiTangshen Granules.This study aims to investigate the clinical efficacy of QidiTangshen Granules,mainly by observing the changes of TCM symptoms and laboratory indices in DKD patients(CKD1-3b stage,A2A3 stage)with deficiency of both qi and yin and stasis-heat blockage of ligaments,and to evaluate whether QidiTangshen Granules can improve The clinical efficacy of QidiTangshen Granules was evaluated,and the possible mechanism of its action on renal tubules was further explored by observing the effects of QidiTangshen Granules on TMBIM-6,KIM-1 and RBP-4.Methods:A randomized,double-blind,controlled approach was used to include 92 patients with DKD(CKD1-3b stage,A2-A3 stage)with deficiency of both qi and yin and stasis-heat obstruction.After the introduction period,they were randomly divided into the test group and the control group,and clinical observation was conducted.The test group was treated with QidiTangshen Granules after the basic treatment,while the control group was treated with placebo,and monthly follow-up and continuous observation was conducted for 3 months.The clinical efficacy,improvement of TCM symptoms,urinary microalbumin/urinary creatinine ratio(ACR),blood creatinine(SCr),estimated glomerular filtration rate(eGFR),fasting blood glucose(FPG),glycosylated hemoglobin(HbA1C),lipid-related indexes and changes in safety indexes were compared between the two groups.Three indicators,TMBIM-6,KIM-1 and RBP4 in urine,were selected and tested in all subjects before enrollment and 3 months after enrollment to study the mechanism of the action of QidiTangshen Granules on renal tubules.Results:1.A total of 92 patients with DKD(CKD1-3b stage)who met the inclusion criteria of qi and yin deficiency and stasis-heat blockage were enrolled in this trial,and were divided into two groups,46 cases in the test group and 46 cases in the control group.Among them,2 cases were shed in the test group,totaling 44 cases;2 cases were shed in the control group,totaling 44 cases,and a total of 88 cases were finally completed in the trial.2.Before treatment,the baseline characteristics of patients in both groups were similar,and there was no statistical difference between the two groups in terms of gender,age,diabetes course,DKD course,ACR,eGFR and other laboratory parameters(P>0.05),and TCM syndrome parameters were not statistically different(P>0.05),indicating comparability.3.After treatment,the clinically effective rates for both groups were 67.4%and 30.2%,respectively,while the TCM syndrome rates decreased to 72%and 30.2%.The clinically effective rate and the rate of decline in syndrome score were better in the test group than in the control group,and the difference was statistically significant(P<0.05).4.After treatment,the ACR rate of the experimental group was lower than before treatment,the difference was statistically significant(P<0.05),and the treatment group was better than the control group(P<0.05),the ACR rate of the control group was higher after treatment,but there was no statistically significant difference within the group(P>0.05).5.There was no statistically significant difference between the observation group and the control group in terms of FPG,HbA1C,TC,LDL-C,TG,HDL-C and other parameters after treatment(P>0.05).6.After the treatment course,there was no significant change in blood routine,liver and kidney function,ion and other safety parameters compared with pretreatment values,and there was no statistically significant difference between the two groups(P>0.05).7.After treatment,TMBIM6 tended to increase in the experimental group,while KIM-1 and RBP-4 decreased with statistically significant differences(P<0.05).Conclusion:QidiTangshen Granules have significant clinical effects,which can obviously alleviate the symptoms of TCM and reduce the albuminuria excretion rate of TCM patients at all stages,but the hypoglycemic and lipid-lowering effects are not obvious.No obvious side effects were observed during treatment,and the safety is good.It is hypothesized that QidiTangshen Granules can reduce KIM-1 and RBP-4 excretion in renal tubules and improve tubular structure and function by increasing TMBIM6 protein synthesis.