| Objective:To observe the clinical efficacy and safety of traditional Chinese medicine(TCM)Jianpi Gushen Heluo Decoction in treatment of early diabetic kidney disease(DKD)with deficiency of qi and Yin and blood stasis.Methods:Sixty cases of DKD patients were selected as the clinical study objects and randomly divided into western medicine control group and integrated traditional and western medicine treatment group,with 30 cases in each group.The control group received hypoglycemic,antihypertensive treatment and lipid-lowering treatments.The treatment group on the basis of control group therapy combined with Chinese medicine prescriptions.The drug was taken continuously for 12 weeks and followed up for 8 weeks.To observe the differences of TCM syndrome scores,glucose and lipid metabolism indexes,renal function,urinary protein and other indexes between two groups before and after treatment.Statistical analysis was conducted on the research data to comprehensively evaluate the efficacy of jianpi gushen heluo decoction.Results:1.Comparison of efficacy of TCM syndromes:All TCM syndromes in the treatment group were improved(P<0.01).In the control group,mental fatigue,thirst and drinking,skin nail fault and limb tingling were improved(P<0.05).However,cold limbs,pain in waist and knee,frequent urination and turbidities,and hypodermic ecchymosis were not relieved(P<0.05).There were significant differences between the two groups(P<0.01).2.Comparison of glucose metabolism indexes:After treatment,the levels of glycated hemoglobin,fasting blood glucose and postprandial blood glucose in 2 groups were significantly decreased(P<0.05).There was no significant difference between the two groups(P>0.05).3.Comparison of lipid metabolism indexes:After treatment,the levels of low density lipoprotein,high density lipoprotein,triglyceride and total cholesterol,in 2 groups were all improved(P<0.01 or P<0.05);The improvement of total cholesterol and triglyceride in treatment group was better than that in control group(P<0.05).There was no significant difference in the improvement of LDL and HDL compared with the control group(P>0.05).4.Comparison of urinary protein excretion rate and renal function:the improvement of 24-hour urinary protein quantity,urinary microalbumin/creatinine ratio,serum cystatin C,serum creatinine and glomerular filtration rate in the treatment group was better than that in the control group(P<0.01 or P<0.05);There was significant difference between groups(P<0.05).5.Comparison of blood pressure:After treatment,blood pressure were decreased in both groups(P<0.05);However,there was no statistical significance in the improvement of blood pressure between the treatment group and the control group(P>0.05)6.Comparison of comprehensive efficacy:In the treatment group,the total effective rate of 76.67%.In the control group,the total effective rate was 50.00%.The comprehensive efficacy of the treatment group was better than that of the observation group(P<0.05).7.Long term effect comparison:Follow up showed that the recurrence rate of the control group was 26.67%,and that of the treatment group was 6.67%,which was lower than that of the control group(P<0.05).8.Safety comparison:No obvious adverse reactions occurred in the two groups during the treatment process.Conclusion:The effect of Jianpi Gushen Heluo Decoction on the treatment of early diabetic renal disease with qi deficiency and blood stasis syndrome is better,and it can effectively improve the symptoms and signs of TCM.It has obvious therapeutic effect and good safety on improving glucose and lipid metabolism,reducing urinary protein excretion,improving renal function and delaying the clinical progress of diabetic kidney disease. |