| Object:To objectively evaluate the clinical efficacy and safety of Suyedihuang Decoction in improving micro-inflammatory state in patients with chronic kidney disease stage 3-4(spleen and kidney qi deficiency,dampness and turbid stasis type),and to provide basis for clinical application.Methods:70 cases meeting the inclusion criteria were randomly divided into control group and experimental group,35 cases in each group.The control group was given conventional treatment,and the experimental group was additionally given Suyedihuang decoction on the basis of the treatment in the control group.Both groups were treated for 8 consecutive weeks.The changes of microinflammatory indexes(CRP,TNF-α,ALB),blood lipid(TG,TC,LDL-C),renal function(SCR,BUN,EGFR),TCM syndrome scores and their safety indexes were detected at the beginning and end of treatment,and statistical analysis was conducted accordingly to objectively evaluate efficacy and safety.Results:(1)Microinflammatory markers:Compared with before treatment,the levels of CRP,TNF-α and ALB in both experimental group and control group were significantly decreased(P<0.01),and the experimental group was better than the control group(P<0.05);(2)Blood lipid:the levels of TG,TC and LDL-C in both groups were significantly decreased after treatment(P<0.01),and the decrease rates of TG,TC and LDL-C in experimental group were better than those in control group(P<0.05);(3)Renal function:Scr and GFR levels in both experimental and control groups were significantly decreased(P<0.01),BUN in the two groups was lower than that before treatment(P<0.05),the experimental group was better than the control group in decreasing the levels of Scr and BUN and increasing GFR(P<0.05);(4)Therapeutic effect of TCM syndromes: the total effective rate of the experimental group and the control group was 73.53%and 93.94%,respectively,and the experimental group was better than the control group(P<0.05);(5)Clinical comprehensive efficacy:the total effective rate of the experimental group and the control group was 76.47% and93.94%,respectively,and the experimental group was better than the control group(P<0.05);(6)Safety:There were no obvious abnormalities in blood,urine,stool routine,ECG and liver function in both groups before and after treatment.Conclusion:Suyedihuang decoction can effectively reduce serum CRP and TNF-α levels,increase the content of ALB,improve micro-inflammatory state,reduce blood lipid level,protect renal function and improve clinical treatment efficiency in patients with CKD stage 3-4(spleen and kidney qi deficiency,dampness and turbidity stasis type),and it is safe and reliable. |