Clinical Efficacy And Safety Of Yi-shen-hua-shi Granule For Diabetic Kidney Disease: A Cohort Study

Background:Yi-Shen-Hua-Shi(YSHS)granule is derived from a traditional Chinese medicine formula named Sheng-Yang-Yi-Wei decoction,developing by Guangzhou Consun pharmaceutical Co.Ltd.The aim of the present formula is to tonify yang and spleen,replenish renal and resolve dampness,and increase urine excretion to relieve edema.Previous clinical studies have shown that YSHS granule can effectively reduce proteinuria and hematuria,improve microcirculation,stabilize renal function,and reduce the occurrence of related adverse reactions in the treatment of Ig A nephropathy and chronic glomerulonephritis.However,there is still a lack of clinical researches on large samples of diabetic kidney disease(DKD).Therefore,we conducted a retrospective cohort study to evaluate the relative efficacy and safety of YSHS granule in DKD patients.Methods:This study included a total of 260 DKD patients who were hospitalized and followed up in the Second Affiliated Hospital of Nanchang University in Jiangxi province from June 2012 to June 2019.The urinary albumin-to-creatinine ratio(UACR)of the selected patients is≥30 mg/g and the estimated glomerular filtration rate(e GFR)is>30 ml/min/1.73 m~2.Among them,130 subjects received conventional treatment[including stabilize their blood glucose,blood pressure,and serum triglyceride(TG)levels]on the basis of YSHS granule(YSHS group),and the130 counterpart patients receiving baseline treatment alone.The primary outcomes were included serum creatinine(Scr),24-hour urinary protein(24h UTP),UACR,and the overall response rate(ORR).The secondary outcomes included fasting blood glucose(FBG),hemoglobin A1c(Hb A1c),total cholesterol(TC),TG,and low-density lipoprotein cholesterol(LDL-C).Results:There was no statistically significant difference in baseline indicators between the two group.The median duration of diabetes in the YSHS group was 8.6 years and that in the control group was 7.8 years;the median UACR in the YSHS group was264.64 mg/g,and the control group was 236.34 mg/g.At the end of the 6th week of treatment,subjects in the YSHS group were able to significantly reduce Scr levels than the control group(P=0.004).There was no statistical difference in the levels of 24h UTP(P=0.176)and UACR(P=0.374),and ORR(P=0.726)between the two groups.At the end of the 12th week follow-up,compared with the controls,the YSHS group significantly reduced 24h UTP(P=0.007),UACR(P=0.001),FBG(P=0.024),Hb A1c(P=0.005),TC(P=0.018),TG(P=0.001),LDL-C(P=0.034),and the ORR in the YSHS group was higher(P=0.005).At week 12,the ORR achieved in the YSHS group was 47%(61 out of 130 subjects achieved overall remission),and the ORR in the control group was 30%(39 out of 130 subjects achieved overall remission).There was no statistical difference in Scr levels and the incidence of major adverse events between the two groups.Conclusion:The YSHS granule has significant curative effects on DKD,especially in reducing proteinuria,improving blood glucose and lipid metabolism,with no obvious adverse reactions.