Clinical And Targeted Metabonomic Study Of Qizhu Capsule On Diabetic Nephropathy

Objective: This study is based on the previous clinical study of Qizhu Capsules for the treatment of diabetic nephropathy(DN)stage ?~?,and further observe the clinical symptoms and laboratory of each group after DN stage III and IV patients apply Qizhu Capsules.Indicators and differences in serum amino acid metabolites before and after treatment and between groups.While exploring the early and mid-term effects of Qizhu Capsules on DN,further improve the efficacy evaluation system of Qizhu Capsules for DN,and better guide clinical medication.The large sample clinical research and clinical promotion of Qizhu Capsules will pave the way.Methods:(1)48 cases of DN III and 48 cases of DN IV patients who met the diagnosis and inclusion criteria were divided into control group and treatment group according to the random number table method;(2)According to the specific needs of patients,the control groups were given diabetic diet,exercise,basic and symptomatic treatment;the treatment groups were added with the Qi Zhu capsules orally,0.25 g,4capsules,2 times per day;(3)Detailed records of all subjects' general information,symptom scores,laboratory test results,and differences in serum amino acid metabolites;(4)SPSS 22.0 statistical software was used for data analysis.1H-NMR technique and multivariate analysis system were used for metabonomics test and analysis.Results: Results of clinical studies:(1)There were no significant differences in general conditions,syndrome scores,and physical and chemical indicators between the treatment group and the control group at the same time before treament(P >0.05).(2)After treatment,the clinical syndrome scores of the four groups were significantly reduced(P<0.05),and the syndrome scores of the treatment group were significantly lower than that of the control group at the same time(P<0.05),indicating that the four groups can improve the clinical symptoms of DN,and the curative effect of Qizhu capsule in improving the clinical syndrome of DN stage III and stage IV was better than that of the basic treatment.(3)After treatment,the levels of 24 hPro and MAU in the four groups were significantly reduced compared with that before treatment(P<0.05),and the levels of24 hPro and MAU in the treatment group was significantly lower than that in the control group at the same time(P<0.05),which shows that all of the four groups can effectively reduce the 24 hPro and MAU levels in the DN patients with,and the treatment groups arebetter.(4)After treatment,the values of SCR and BUN in the four groups were lower than those before treatment(P<0.05),and at the same time,the values of SCR and BUN in the treatment group were lower than those in the control group(P<0.05),indicating that the four groups can improve the renal function of DN patients,and the effect of Qizhu Capsule on improving the renal function of DN patients in stages III and IV was better than that in the control group.(5)There was no significant change in FBG and HbA1 c in the four groups before and after treatment(P>0.05),indicating that Qizhu capsule did not affect the normal blood glucose level of patients with DN ? and ?.(6)There was no significant difference in TC,TG,LDL and HDL levels between the four groups before and after treatment(P>0.05),indicating that Qizhu capsule did not affect the normal blood lipid level of patients with DN ? and ?.(7)Before and after treatment,there were no significant differences in liver function and blood routine between the four groups(P>0.05).Results of metabolomics research :(1)31 compounds were identified in serum NMR,including glycolysis products,TCA cycle intermediates,choline,ethanolamine,and organic bases,etc.;(2)There were differences in metabolites such as 3-hydroxybutyric acid,formic acid,lactic acid,?-glucose,glutamic acid,and taurine in the serum of patients in the DN ? treatment group,but only 3-hydroxybutyric acid was significant(P < 0.05);(3)Serum levels of valine,taurine,glycine,betaine,and creatine in patients in the DN?treatment group were significantly reduced(P<0.05),while lipid and glutamic acid levels were increased(P<0.05).Conclusion:(1)Qizhu capsule can significantly improve the clinical syndrome of DN? and ? patients,reduce the level of urine protein,and protect the renal function;and Qizhu capsule has the same effect on improving the clinical syndrome of DN ? and ?patients;(2)Qizhu capsule has no effect on the normal glucose and lipid level of DN ?and ? patients;(3)Qizhu Capsules can recall some serum amino acid metabolites of patients with DN.The mechanism of Qizhu capsule intervention on DN may be related to the improvement of TCA.