| Background and Objective:Diabetic kidney disease(DKD)is one of common microvascular complications of diabetes mellitus(DM).The degree of urinary protein reflects the severity of DKD renal injury.The early clinical manifestations are mainly microalbuminuria.The theory of TCM holds that the early pathogenesis of DKD is mainly deficiency of both Qi and Yin.Based on the theory of"True Yin Essence and Qi"of Zhang Jingyue,a physician in the Ming Dynasty,and combined with years of clinical experience,my tutor tried to find out the Qidi TangShen prescription for treating DKD,which mainly replenishing Qi and Yin of the kidney,clearing away heat and removing blood stasis.It is effective in treating DKD patients with deficiency of both Qi and Yin and stagnant heat.Some clinical and animal experiments have proved that the formula has the effect of reducing urinary protein.In this study,the clinical efficacy of QiDiTangShen granule in the treatment of DKD was evaluated by observing the changes of objective indexes and traditional Chinese medicine symptoms of the patients in the microalbuminuria of DKD.It’s to observe the effect of QiDi TangShen granule on the expression of urine podocalyxin(PCX)and leucine aminopeptidase(LAP)in patients,and to provide reference for further study on its mechanism.Methods:This study used a randomized,double-blind,placebo-controlled trial design.The 60DKD patients with deficiency of both Qi and Yin and stagnant heat were randomly divided into treatment group and control group according to the central block method.All patients received basic treatment,including diet instruction,hypoglycemic,hypotensive and lipid-lowering therapy.The treatment group was treated with QiDiTangShen granule on the basis of treatment for 3 months,while the control group was treated with placebo.The clinical curative effect,traditional Chinese medicine symptoms curative effect and the change of urinary albumin/creatinine ratio(ACR),fasting blood glucose(FBG),glycosylated hemoglobin(HbA1c),blood fat,urine PCX and urine LAP were observed.Results:1.In this study,60 DKD patients with deficiency of both Qi and Yin and stagnant heat were included.During the trial,2 cases fell off due to failure to recheck,1 case in the treatment group and 1 case in the control group,which were not included in the statistics.Finally,58cases completed the test,while the each group was 29 cases.2.There were 16 males and 13 females in the treatment group.Their average age was64.50±12.00 years,DM course was 13.44±7.69 years,DKD course was 0.5-18 years,BMI was 24.49±2.67 kg/m~2.There were 15 males and 14 females in the control group.Their average age was 63.50±11.00 years,DM course was 10.65±6.13 years,DKD course was 0.5-14 years,BMI was 26.12±3.83 kg/m~2.3.The total effective rate of the treatment group was 68.97%,including 13 cases with obvious effect,7 cases with effect and 9 cases with no effect.The total effective rate of the control group was 37.93%,including 7 cases with obvious effect,4 cases with effect,18cases with no effect.The total effective rate of the treatment group was higher than that of the control group(P<0.05).4.The total effective rate of traditional Chinese medicine symptoms integral in the treatment group was 62.07%,including 2 cases with obvious effect,16 cases with effect and 11 cases with no effect.In the control group,the total effective rate was 34.48%,including 0 cases with obvious effect,10 cases with effect and 19 cases with no effect.The total effective rate of traditional Chinese medicine symptoms integral in the treatment group was higher than that in the control group(P<0.05).5.After treatment,the level of ACR in the treatment group was significantly lower than that before treatment,and the difference was statistically significant compared with the control group(P<0.05).The FBG,TG,and TC in the treatment group decreased,while HbA1c,HDL-C and LDL-C did not decrease.There was no significant difference between the two groups(P>0.05).There were no significant changes in liver function,renal function,ion and blood routine between the two groups(P>0.05).6.After treatment,the level of PCX in urine of the two groups had a tendency to decrease.But there was no significant difference(P>0.05).Urine LAP in the treatment group decreased significantly compared with that in the control group(P<0.05).Conclusions:1.QiDiTangShen granule has effect on treating DKD patients with deficiency of both Qi and Yin and stagnant heat,which can effectively improve the traditional Chinese medicine symptoms and reduce albuminuria.But its effect of reducing blood sugar and blood fat is not obvious.There is no obvious side effect in the course of treatment,so it has certain safety and is worthy of further promotion and research.2.After treatment,the urine LAP of the patients decreased obviously,and the urine PCX showed a decreasing trend.It is speculated that QiDiTangShen granule may delay the progress of DKD by decreasing the urine LAP of the patients,and it has some protective effect on the kidney tubules.It provides a direction for clinical research and animal experiments on the mechanism of QiDiTangShen granule. |
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