| Objective: Objective to observe and analyze the clinical efficacy and safety of Bushen Huoxue Tongluo decoction combined with basic Western medicine in the treatment of diabetic nephropathy(DKD)stage III-IV(spleen kidney deficiency and blood stasis syndrome).Method: Firstly,68 patients with diabetic nephropathy who visited Nephrology Department of Affiliated Hospital of Chengdu University of traditional Chinese medicine from June 2019 to August 2020 were selected and randomly divided into experimental group(34 cases)and control group(34 cases).The control group was given basic Western medicine treatment,and the experimental group was given Bushen Huoxue Tongluo Decoction on the basis of the control group.The two groups were treated for 12 weeks,and they were followed up every 4 weeks.Before and after treatment,the changes of clinical comprehensive efficacy,TCM syndrome score,urinary protein,coagulation function,renal function,blood glucose,blood lipid,liver function,electrolyte and adverse events of the two groups were observed,and the clinical efficacy and safety were determined by statistical software.Results: Finally,32 cases in the experimental group and 33 cases in the control group were removed.Comparison after treatment:(1)clinical comprehensive efficacy: the effective rate of the experimental group was 87.5%,and that of the control group was75.76%,which was statistically significant(P<0.05),and the comprehensive efficacy of the experimental group was significantly better than that of the control group;(2)TCM syndrome score and efficacy: The comparison of TCM syndrome efficacy between the two groups was statistically significant(P<0.05),and the TCM syndrome score of the two groups decreased compared with that before treatment(P<0.05).The comparison between the two groups after treatment was statistically significant(P<0.05),and the effect of the experimental group was more significant than that of the control group;(3)after treatment,the total score of TCM syndrome of the two groups was decreased compared with that before treatment(P<0.05),and,Urinary protein index(UACR,24 h UTP)decreased,coagulation index(PT,APTT)prolonged,with statistical significance(P<0.05),the experimental group was better than the control group(P<0.05);(4)renal function index(Cys C,Scr,e GFR)improved,with statistical significance(P<0.05).After Cys C treatment,there was statistical difference between the groups(P<0.05),while Scr and e GFR treatment,there was no statistical significance(P>0.05);(5)after treatment,blood glucose index(FBG,2h PBG,Hb A1c),blood lipid index(TC,TG)were decreased,there was statistical significance(P<0.05),there was no statistical significance between the two groups after treatment(P>0.05);(6)during this study,the blood glucose index(FBG,2h PBG,Hb A1c),blood lipid index(TC,TG)were decreased,there was statistical significance(P<0.05),The safety indexes(blood routine,liver function,electrolyte)of the two groups before and after treatment were in the normal range,and there was no statistical significance(P>0.05).Conclusion:(1)Bushen Huoxue Tongluo recipe can significantly improve the TCM syndrome score and related clinical symptoms of patients with diabetic nephropathy(spleen kidney deficiency and blood stasis syndrome);(2)Bushen Huoxue Tongluo recipe combined with western medicine basic treatment can reduce urinary protein,improve coagulation function and early renal function and other laboratory indicators,and its curative effect is more significant than simple western medicine basic treatment;(3)There was no obvious adverse reaction during the study,and the safety was good. |