| Background and Objective:Diabetic kidney disease(DKD)is caused by diabetic microangiopathy and glomerulosclerosis.Hypertension,proteinuria,edema of limbs and facial areas are common clinical manifestations.It is one of the most frequent and serious complications of diabetic patients,and it is also the main cause of endstage renal disease(ESRD).Microalbuminuria pathological changes of the glomeruli and tubules appeared pathologically are the early stage's clinical manifestations.Traditional chinese medicine doctors have different cognitions on the etiology and pathogenesis of diabetic nephropathy,but most of them think that it is based on the deficiency of qi and yin,and on the basis of this deficiency is mixed with real factors such as stasis,phlegm,dampness,heat,etc.A variety of viewpoints such as the theory of collateral disease and the theory of miniature disease have been developed in Shanghai.The tutor is rooted in Zhang Jingyue's "Zhenyin Jingqi Theory",and proposes that collateral damage is the fundamental cause of diabetic nephropathy.Qiditangshen Granule is ideal for clinical application,and has been shown to have a protein-lowering effect in early animal experiments and clinical observations.This study evaluated the clinical efficacy of Qiditangshen Granule by observing the changes of laboratory indicators and TCM syndromes of DKD patients with DKD stage ?-?(CKD1-2)of Qi and Yin deficiency with stasis and heat resistance.The changes in the expression levels of the nephrin and podocin proteins in the urine of patients with urinary podocytes shed in the urine of patients were explored for the possible mechanism of action of Qiditangshen Granule.Methods:A randomized double-blind control method was used to enroll 80 patients with DKD?-?(CKD1-2)with qi and yin deficiency with stasis and heat obstruction.After the introduction of the basic treatment,patients will be randomly divided into an observation group and a control group.During treatment,the observation group took Qiditangshen Granule on the basis of basic treatment,and the control group received placebo.The patients were followed up every month and observed continuously for 3 months.Clinical efficacy,TCM syndrome improvement,urine microalbumin/Creatininerate(ACR),fasting blood glucose(FBG),Glycosylated hemoglobin(HbA1c)and blood lipid levels Changes in indicators,urine neprhin,urine podocin and safety indicators were compared among the two groupsResults:1.A total of 80 patients with DKD stage ?-?(CKD1-2)with qi and yin deficiency and stasis,heat obstruction that met the inclusion criteria were included in this trial,4 patients in each of observation group and control group fell off,with a total of 72 patients finally completed the trial.2.The general conditions including gender,age,DM course,DKD course,ACR,eGFR and other laboratory indicators and the distribution of TCM syndrome scores before the start of treatment were not statistically different(P>0.05),and were comparable.3.After treatment,the clinical effectiveness of the two groups of patients was 72.22%and 33.33%,and the TCM syndrome scores decreased,the score reduction rates were 66.67%and 36.11%.The observation group clinical effectiveness and syndrome score reduction rate are better than the control group,the difference is statistically significant(P<0.05)4.After treatment,the ACR level of the observation group was lower than before,the difference was statistically significant(P<0.05),and the treatment group was better than the control group(P<0.05).The ACR level of the control group after treatment was higher than that of the previous group.The difference was not statistically significant(P>0,05).5.After treatment,the eGFR of the observation group and the control group increased compared with before,but there was no statistical significance between the groups and between groups(P>0.05).The FPG,HbAlc,TC,LDLC of the two groups of patients showed a tendency to decrease There was no decrease in TG and HDLC,and there was no statistically significant difference between the index group and between groups(P>0.05).6.After the course of treatment,the safety indicators of blood routine,liver and kidney function,ion,etc.of the two groups were not significantly changed compared with before treatment,and there was no statistical difference between the groups and between groups(P>0.05).7.After treatment,the excretion of nephrin and podocin in the observation group and the control group increased slightly,and there was no statistically significant difference between the groups(P>0.05).The difference of urine podocin excretion in the observation group was statistically significant(P<0.05).Conclusions:1.Qiditangshen Granule has obvious clinical curative effect,and can obviously relieve the symptoms of traditional Chinese medicine among patients,and can significantly reduce the proteinuria excretion level in patients with DKD,but the effect of reducing fasting blood glucose and lipid is not obvious.No obvious adverse reactions were seen during treatment,and the safety was good2.After treatment,the increase of urine podocin in the observation group was significantly lower.It is speculated that Qiditangshen Granule may have a certain protective effect on the glomerulus,and it can delay the progression of diabetic nephropathy by reducing the dropout of podocyte split pore membrane protein However,more clinical observations are needed for evidence. |
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