| Objective:To observe the clinical efficacy and security of Qi Zhi JiangTang Capsules in treating patients with diabetic kidney disease(G3aA2 stage)of Qi and Yin Deficiency and Blood Stasis Syndrome that based on the short-term application of Qi Zhi JiangTang Capsules in the treatment of diabetic kidney disease in stages 3b and III.Methods:Select patients who were diagnosed with diabetic kidney disease(G3aA2 stage)with both Qi and Yin deficiency and blood stasis and obstruction were randomly assigned to the experimental group and the control group after a 2-week washout period.Two groups of patients were given basic Western medicine treatment.The experimental group was given Qi Zhi Jiang Tang Capsules(25g,tid).The control group was supplemented with Valsartan capsules(80-160mg,qd).The duration of treatment is 6 months.At the time of enrollment and at 1,3,and 6 months after treatment,observe two groups of patients urine protein/creatinine(UACR),serum creatinine(SCr),serum cystatin(Cys-C),and fasting blood glucose(FBG),changes in glycated hemoglobin(HbA1c)and TCM symptoms,and calculated the glomerular filtration rate(eGFR);observe renal insufficiency,renal function progress,the number of endpoint events and the incidence of adverse reactions.Results:A total of 118 patients completed the 6-month observation in this trial,including 60 in the experimental group and 58 in the control group.(1)There were no statistical differences in laboratory indexes and TCM symptom scores between the two groups of patients before treatment(P>0.05).(2)Laboratory indicators:In the experimental group,the UACR and SCr were lower than the baseline value 1 month after treatment,and eGFR increased from before,the difference was statistically significant(P<0.01 or P<0.05);3 months after treatment,the experimental group,SCr,eGFR improved significantly from baseline values(P<0.01),Cys-C decreased from baseline values,the difference was statistically significant(P<0.05);in the experimental group 6 months after treatment,UACR,SCr,eGFR,Cys-C were significantly improved compared with the baseline value(P<0.01),FBG,HbA1c decreased from the baseline value,the difference was statistically significant(P<0.05).Compared between the two groups,the difference between the two groups was not statistically significant 1 month after treatment(P>0.05);the UACR level of the experimental group was lower than that of the control group 3 months after treatment(P<0.05),and there was no significant difference in other indicators(P>0.05);6 months after treatment,the levels of SCr,Cys-C and FBG in the experimental group were lower than the control group of the same period,the difference was statistically significant(P<0.05),and the levels of UACR and eGFR were significantly improved compared with the control group of the same period<0.01).HbA1c was not significantly different between the two groups(P>0.05).(3)TCM symptom score:After 6 months of treatment,the TCM symptoms of the experimental group were significantly improved,with an effective rate of 90%,and there was a significant statistical difference between the groups after treatment(P<0.01).(4)Total clinical efficacy:The total clinical effective rate of the experimental group after treatment was 81.67%,and that of the control group was 58.62%.The total effective rate of the experimental group in treating this disease was better than that of the control group(P<0.05).(5)There was no significant difference in Renal Insufficiency,Renal Function Progression,Incidence of Endpoint Events,and Incidence of Adverse Reactions at each follow-up point between the two groups(P>0.05).Conclusion:Medium and long term application of Qi Zhi Jiang Tang Capsules can reduce urine protein excretion in patients with DKD(G3aA2)deficiency of Qi and Yin,and blood stasis and obstruction and maintain early renal function Stable levels,regulate blood sugar levels,and delay DKD progression. |