| Objective:To observe the clinical efficacy and safety of Zhuang medicine Compound Xiancao Granules in the treatment of early DN.To explore the effect of Zhuang medicine Compound Xiancao Granules on TCM syndrome score,urinary albumin excretion rate,renal function,microcirculation disturbance,endothelial function,hemorheology and immune function indexes of early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome.To reveal the possible mechanism of Zhuang medicine Compound Xiancao Granules.To provide objective basis for the treatment of early DN of spleen and kidney deficiency and damp-heat and blood stasis syndrome with Zhuang medicine Compound Xiancao Granules.Methods:60 patients with early DN of spleen and kidney deficiency and damp-heat and blood stasis syndrome were randomly divided into control group and treatment group,30 cases in each group.Two groups of patients were given conventional basic treatment.On the basis of conventional basic treatment,the control group was treated with alprostadil injection,while the treatment group was treated with Zhuang medicine Compound Xiancao Granules on the basis of the control group.Both groups were treated for 4weeks.Clinical response,TCM syndrome score,urinary albumin excretion rate(UAER),renal function parameters[serum creatinine(Scr)and serum cystatin C(Cys C)],microcirculation and endothelial function parameters[thromboxane-B2(TX B2),nitric oxide(NO),endothelin-1(ET-1),von Willebrand factor(v WF)and thrombomodulin(TM)],whole blood viscosity at high shear rates(ηb H),whole blood viscosity at medium shear rates(ηb M),whole blood viscosity at low shear rates(ηb L),plasma viscosity(ηp),fibrinogen(FIB),and erythrocyte aggregation index(AI)],and immune parameters[CD4~+helper T cells,CD8~+T suppressor cells,and CD4~+/CD8~+ratio]and safety index were compared between the two groups before and after treatment.Results:1.Clinical effects:After treatment,the total clinical effective rate of the treatment group was 90.00%,significantly better than 63.33%of the control group,the difference was statistically significant(P<0.05).2.Improvement of TCM syndrome score:There was no significant difference in total score of TCM syndromes between the two groups before treatment(P>0.05).After treatment,the total score of TCM syndromes in the two groups were lower than those before treatment(P<0.05).After treatment,the total score of TCM syndromes in the treatment group was significantly lower than those in the control group(P<0.05).3.Changes of urinary albumin excretion rate:There was no significant difference in UAER between the two groups before treatment(P>0.05).After treatment,the levels of UAER in the two groups were lower than those before treatment(P<0.05).After treatment,the level of UAER in the treatment group was significantly lower than those in the control group(P<0.05).4.Improvement of renal function indexes:There was no significant difference in Scr and Cys C between the two groups before treatment(P>0.05).After treatment,the levels of Scr and Cys C in the two groups were lower than those before treatment(P<0.05).After treatment,the levels of Scr and Cys C in the treatment group were significantly lower than those in the control group(P<0.05).5.Changes of microcirculation disturbance and endothelial function index:There was no significant difference in the levels of serum TX-B2,NO,ET-1,v WF and TM between the two groups before treatment(P>0.05).After treatment,the levels of serum TX-B2,ET-1,v WF and TM in the two groups were lower than those before treatment,and the levels of serum NO in the two groups were higher than those before treatment,the difference was statistically significant(P<0.05).After treatment,the levels of serum TX-B2,ET-1,v WF and TM in the treatment group were lower than those in the control group,and the level of serum NO in the treatment group was higher than that in the control group,the difference was statistically significant(P<0.05).6.Changes of hemorheology indexes:There was no significant difference in the levels ofηb H,ηb M,ηb L,ηp,FIB and AI between the two groups before treatment(P>0.05).After treatment,the levels ofηb H,ηb M,ηb L,ηp,FIB and AI in the two groups were lower than those before treatment,the difference was statistically significant(P<0.05).After treatment,the levels ofηb H,ηb M,ηb L,ηp,FIB and AI in the treatment group were lower than those in the control group,the difference was statistically significant(P<0.05).7.Changes of immune function indexes:There was no significant difference in the levels of CD4~+,CD8~+and CD4~+/CD8~+between the two groups before treatment(P>0.05).After treatment,the levels of CD4~+and CD4~+/CD8~+in the two groups were higher than those before treatment,and the levels of CD8~+in the two groups were lower than those before treatment,and the difference was statistically significant(P<0.05).After treatment,the levels of CD4~+and CD4~+/CD8~+in the treatment group were higher than those in the control group,and the levels of CD8~+in the treatment group were lower than those in the control group,and the difference was statistically significant(P<0.05).8.Safety of patients in two groups:During the treatment,there was no significant adverse reactions in both groups.Conclusion:1.The clinical effect of Zhuang medicine Compound Xiancao Granules on the early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome is significant and safe.2.Zhuang medicine Compound Xiancao Granules can improve the TCM clinical syndromes of early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome.3.Zhuang medicine Compound Xiancao Granules can reduce the levels of UAER,Scr and Cys C in early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome,so as to improve the renal function of the patients.4.Zhuang medicine Compound Xiancao Granules can improve the microcirculation disturbance of early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome,so as to improve the endothelial function and hemorheology of the patients.5.Zhuang medicine Compound Xiancao Granules can improve the immune function of early DN patients with spleen and kidney deficiency and damp-heat and blood stasis syndrome. |
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