Comparative Study The Effect Of The Granule And Traditional Decoction Of Tangshenjiangdan Formula On The DKD

Objectives:By studying the granule and traditional decoction of Tangshenjiangdan Formula(TSJDF)on the type 2 diabetic kidney disease(DKD),compared it's efficacy and safety,provided new evidence for Traditional Chinese Medicine(TCM)treating DKD and laid the foundation for further study that it treat DKD.Methods:According to inclusion and exclusion criteria,60 patients who visited Li Mingquan were enrolled form the nephrology department of the Sichuan province hospital of TCM.Among them,30 cases assigned to received the granule of TSJDF with conventional treatment in the trial group and 30 cases received the traditional decoction of TSJDF with conventional treatment in the control group.Observation time were 8 weeks.Primary outcome was 24-hour urinary protein(24h UP).Secondary outcomes included renal function(Bun,Cr,e GFR),serum lipids,the scores of symptom,safety indicators(liver function,blood routine electrocardiogram,and electrolytes)and adverse events.Results:1.Primary outcomes:3 cases were cured,19 cases were effective,8 cases were invalid,and the total effective rate was 73.3% in the trial group;4 cases were cured,18 cases were effective,8 cases were invalid,and the total effective rate was 73.3% in the control group.There were not significant differences(P>0.05)between two groups in the 24 h UP before and after the treatment.2.The renal function:(1)There were not significant differences in the serum creatinine(Scr)in the trial group(P>0.05)and in the control group(P>0.05)before and after the treatment.There were not significant differences(P>0.05)between two groups in the difference of Scr before and after the treatment;(2)There were not significant differences in the blood urea nitrogen(Bun)in the trial group(P>0.05)and in the control group(P>0.05)before and after the treatment.There were not significant differences(P>0.05)between two groups in the difference of Bun before and after the treatment;(3)There were significant differences in estimated glomerular filtration rate(e GFR)in the trial group(P<0.05)and in the control group(P<0.05)before and after the treatment.There were not significant differences(P>0.05)between two groups in the difference of e GFR before and after the treatment.3.The serum lipids:(1)There were significant differences between two groups in low density lipoproten-cholesterol(LDL-C)in the trial group(P<0.05)and in the control group(P < 0.05)before and after the treatment.There were not significant differences(P>0.05)between two groups in the difference of LDL-C before and after the treatment;(2)There were not significant differences in the high density lipoprotencholesterol(HDL-C,P>0.05),triglycerides(TG,P>0.05)and cholesterol(CHOL,P>0.05)in the trial group and in the control group before and after the treatment.There were not significant differences between two groups in the difference of HDL-C(P>0.05),TG(P>0.05)and CHOL(P>0.05)before and after the treatment.4.The scores of TCM:9 cases were cured,15 cases were effective,6 cases were invalid,and the total effective rate was 80% in the trial group;11 cases were cured,14 cases were effective,5 cases were invalid,and the total effective rate was 87% in the control group.There were not significant differences(P>0.05)between two groups in the difference of scores of TCM before and after the treatment.5.Adverse events:There were not adverse events occur during the trial in the trial group and the control group.Conclusions: There were not differences that the granule and traditional decoction of TSJDF remedied the 24h-UP,the renal function,the serum lipid and the scores of TCM of the patient with DKD,and both them are safety to these patients.