A Clinical Research Of Treatment Of Diabetic Kidney Disease With TwHF Combined With Inhibitor Of RAS

BackgroundsDiabetic Kidney Disease(DKD)is one of the most common complication of Diabetes,and is also the major cause of DSRD.Recently,the morbidity of Diabetes and DKD in China has been increasing.There has been no effective treatment that cures DKD,and the available actions to take includes active control of hyperglycemia,strictly control of BP,adjustment of Lipid metabolism disorder,Antiplatelet agglomeration,treatment of obesity,quit of smoking,etc.Many large research has proven that ACEI or ARB could not only lower the blood pressure but also lower the level of urine protein,and bring extra benefits of slowing down the process of nephrosis.On the other hand,they also have side-effects like hyperkalemia,transient reducing GFR,etc.Multiple cases of clinical trials and animal experiments have proven that TwHF have the effects of anti-inflammatory.immunosuppression.protecting Sertoli cells and reducing urine protein.Even though some research had found TwHF could lower the urine protein,the follow-up time was short,and there was rare research of treatment of DKD with TwHF combined with Inhibitor of RAS.And the function of TwHF of patients with DKD and more than stage 3 of CKD is still short of clinical data.This research aims at exploring the effectiveness and safety of TwHF combined with Inhibitor of RAS in the treatment of DKD,and to investigate the effects that TwHF has on DKD patient with more than stage 3 CKD.Objectives1.Investigating the effectiveness and safety of TwHF combined with Inhibitor of RAS in the treatment of patients with DKD.2.Exploring the effects that TwHF has on DKD patient with more than stage 3 CKD.MethodsWe enrolled patients who were diagnosed as DKD with Class IV and had been given standard DKD treatment including inhibitor of RAS for at least 3 months without significant improving of urine protein among outpatients in nephropathy department of PUMCH,and regularly followed up for 12 months during 2013-2017,with intact clinical data.These patients were given TwHF besides the original treatment.We collected their clinical data and retrospectively analyzed their clinical performance,follow-up data,treatment and prognosisof the 1st,3rd,6th,and 12th months after enrolled.Results1.All 30 patients enrolled with the onset age of 57.5�9.6,ACR 2774.5�2012.6mg/g Cr,SCr 150.7�95.1umol/L,eGFR(CKD-EPI)56.9�27.8 ml/min/1.73m2,follow up for 12 months,and the decreased percentage of ACR in the 1st,3rd,6th,and 12th months are 38.1%,57.8%,51.0%,61.7%(p<0.05 in the 3rd,6th,and 12th months).SCr in the 12th month decreased 15.lml/min/1.73m2 compared to the baseline,which did not show specific effect on renal function.2.17 DKD patients reached CKD stage 3,the decreased percentage of ACR in the 1th,3rd,6th,and 12th months are35.4%?50.5%?43.6%?57.5%(p>0.05).The eGFR in the 12th month decreased 7.08 ml/min/1.73m2,Anddecreased 0.59 ml/min/1.73m2 per month in average(p>0.05).3.The Alb of all patients drop 3.7g/L(p<0.05)after the first month of treatment,and returned to baseline level at the 12th month.ALT,WBC,HGB,PLT and Alb in other period of treatment shows no statistical difference compared to baseline.Conclusions1.TwHF combined with Inhibitor of RAS could significantly decrease ACR in patients with DKD Class IV.2.TwHF combined with Inhibitor of RAS could decrease ACR in patients with DKD and more than stage 3 CKD.And it might also slow down the decrease of eGFR.