| BackgroundDiabetic kidney disease(DKD),as a common complication of diabetes mellitus(DM),has been the leading cause of chronic kidney disease(CKD)in China.Therefore,the study of DKD has become the research focus in the nephrology field worldwide.With the presence of dominant proteinuria,renal function of DKD patients will gradually decline and then rapidly develop to end stage kidney disease(ESRD).It is common knowledge that urine protein level is strongly linked to renal damage and disease progression of DKD.Thus the surveillance and treatment of proteinuria is important for DKD patients..Podocytes play the key role in maintaining glomerular filtration function.The epithelial mesenchymal transition(EMT)can induce the change of the structure and function of podocyte.Herein,the therapy for podocytes EMT can effectively reduce proteinuria and alleviate the progression of DKD.The treatment of DKD which mainly focused on controlling blood glucose and blood pressure,has certain limitations for reducing albuminuria.Baoshen Tongluo Prescription can reduce proteinuria,improve renal function,protect podocytes and alleviate the deterioration of disease in DKD patients.The purpose of this study is to observe the clinical effect of Baoshen Tongluo Prescribe on DKD,and further explore its mechanism for podocyte protection effect.ObjectiveTo observe the clinical efficacy and safety of Baoshentongluo prescription in the treatment of type 2 diabetic nephropathy patients at G1-3 stage with deficiency of both Qi and Yin combined with blood stasis syndrome.Moreover our study want to explore the mechanism of Baoshentongluo prescription on podocytes EMT in DKD.MethodsOur study is a randomized,controlled,and double-blind trial.All participants meeting the inclusion criteria were recruited from Beijing Traditional Chinese Medicine Hospital.A total of 60 DKD Participants will be randomized into two groups at a ratio of 1:1.The two groups are "control group" and "therapeutic group" respectively.Participants of therapeutic group were received basic treatment+Baoshen Tongluo prescription,while the control group was treated with basic treatment+placebo granules.(2)Urinary protein of 24-h of DKD patients was detected at 0,4,8,12weeks respectively.Other laboratory tests was detected at 0 and 12weeks respectively.Clinical therapeutic effect is evaluated according to the change of 24 h urinary protein level,serum creatinine,serum urea nitrogen,serum uric acid,serum glucose,serum transforming growth factor-?1,excretion of Podocalyxin in urine and the changes of TCM syndrome scores.Results(1)A total of 59 participants were included in this study,including 29 in the therapeutic group and 30 in the control group.(2)Analysis of therapeutic indexes:?The 24hUTP was significantly decreased at 4,8 and 12 weeks after the treatment in therapeutic group(P<0.01).The level of 24hUTP in control group was increased after the treatment,however there was no statistical significance(P<0.05),Compared with control group,24hUT was significantly decreased in therapeutic group after treatment at 8 and 12 weeks(P=0.036,0.005,respectively).?The serum albumin was significantly increased after the treatment in therapeutic group(P<0.01).However the serum albumin has no significant difference after the treatment in control group(P>0.05).Compared with control group,the serum albumin was significantly increased after the treatment in therapeutic group(P<0.01).?The serum Scr,BUN,UA,FPG,HbA1c,TC and LDL-c were decreased in therapeutic group after the treatment,however there was no statistical significance(P>0.05).Meanwhile there was no statistical significance in the control group before and after treatment(P>0.05).?The levels of serum TGF-?1 and urine Podocalyxin were significantly decreased after the treatment in therapeutic group(P<0.01).However the levels of serum TGF-?1 and urine Podocalyxin have no significant difference after the treatment in control group(P>0.05).Compared with control group,the levels of serum TGF-?1 and urine Podocalyxin were significantly decreased after the treatment in therapeutic group(P<0.01).(3)The total clinical efficacy rate of therapeutic group was 75.86%.The total clinical efficacy rate of control group was 50.00%.The total clinical efficacy rate of therapeutic group was significantly increased compared with control group(P<0.05).The TCM syndrome total score was significantly decreased after the treatment in therapeutic group(P<0.01).However the TCM syndrome total score has no significant difference after the treatment in control group(P>0.05).Compared with control group,the TCM syndrome total score was significantly decreased after the treatment in therapeutic group(P<0.01).The urine turbidity foamy,god fatigue,dry throat mouth dryness,shortness of breath lazy speech,body dropsy symptoms was significantly improved after the treatment in therapeutic group(P<0.01).(4)Safety analysis:There were no significant differences in serum routine,liver function,serum potassium and other indexes between two groups before and after treatment(P>0.05).Conclusion(1)Baoshen Tongluo Formula can reduce 24-hour urinary protein,increase serum albumin,and stabilize renal function,serum glucose and serum lipid of DKD patients at G1-3 stage with Qi and Yin deficiency and blood stasis syndrome.(2)Baoshen Tongluo Formula can effectively improve the clinical symptoms of DKD patients with deficiency of Qi and Yin combined with blood stasis syndrome at G1-3 stage,especially with turbidness and foaming of urine,fatigue,dry throat and mouth,shortness of breath and lazy speech,and edema of limbs.(3)Baoshen Tongluo Formula can decrease proteinuria and protect podocytes from injury in DKD,partly via inhibiting podocyte EMT.(4)Baoshen Tongluo prescription showed good safety and had no adverse drug reaction in the treatment of DKD. |
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