A Controlled Study Of Yiqi Qingjie Recipe Combined With Immunosuppressive Agents In The Treatment Of High-risk IgA Nephropathy

The immunoglobulin A nephropathy is the most common primary glomerulonephritis by pathological diagnosis in the world.It is a proliferation of glomerular mesangial cells jointed with the presence of IgA deposition in the mesangial area.Its estimated frequency is at least 2.5 cases per year per 100,000 adults.High risk patients show a rapid decrease in the GFR that may be associated with nephritic syndrome or crescentic glomerulonephritis.For a large amount of proteinuria reached the degree of nephrotic syndrome,support care and immunosuppressant treatment are recommended.In this regard,a considerable number of clinical randomized controlled trials in recent years have affirmed the role of supportive therapy and combined immunosuppression in reducing proteinuria and protecting renal function,but there are still problems in the adverse events and prognosis of long-term follow-up.In recent years,TCM research on IgA nephropathy have been relatively rare.Although limited clinical efficacy has been achieved,there are also a series of problems.For high-risk IgA,there are few medical researches.Yiqi Qingjie Prescription is Dai Xiwen’s experience in creating high-risk IgA nephropathy patients,and has achieved good clinical results.Based on clinical,the controlled study is to observe the effect of the combined therapy—Yi Qi Qing Jie Prescription combined with immunosuppressive therapy or only immunosuppressive therapy,to evaluate its clinical effect,safety and prognosis.Research purpose:Based on clinical,the controlled study to observe the effect of the combined therapy of high risk IgA nephropathy-Yi Qi Qing Jie Prescription combined with immunosuppressive therapy.Mainly observed these index-changes of UTP、Scr、eGFR、incidence of clinical endpoints,aiming to evaluate whether traditional Chinese medicine has positive action in therapy of high risk IgA nephropathy.Research methods:Treatment group’s patients were conformed the standard diagnostic of high risk IgA nephropathy and treated with Yi Qi Qing Jie Prescription combined with immunosuppressive therapy in Guang’anmen Hospital,China Academy of Chinese Medical Sciences before the January of 2017.Control group’s patients were 1:1 propensity score matching with immunosuppressive therapy in Peking University First Hospital.Observed over 12 months,the study collected and analyzed clinical data of patients.Mainly observed these index—changes of UTP,Scr,eGFR,incidence of clinical endpoints.The results:24hUTP:1.790(1.448,2.500)vs 1.72(0.700,2.717)(g/d)(p>0.05)and 1.656(0.786,2.654)vs0.960(0.450,2.340)(g/d)(p>0.05)。SCr:110(90,124.25)vs164(110,222)(umol/L)(p<0.01)and 110(90.75,144.5)vs169(110,263)(umol/L)(p<0.01)。eGFR:59.91(50.92,70.82)vs 46.06±26.87(ml/min/1.73m2)(p<0.01)and 61.63(45.3,80.72)vs 46.31±28.27(ml/min/1.73m2)(p<0.01)There was no significant difference in baseline indicators by propensity score matching.After 6,12 months,treatment group and control group’s 24hUTP both had significantly decline compared to baseline,as1.790(1.448,2.500)vs 1.72(0.700,2.717)(g/d)(p>0.05)andl.656(0.786,2.654)vs0.960(0.450,2.340)(g/d)(p>0.05).There was no difference of statistics in the therapeutic effect of proteinuria.After 6,12 months,treatment group’s Scr significantly decreased by control group,as110(90,124.25)vsl64(110,222)(umol/L)(p<0.01)and 110(90.75,144.5)vs169(110,263)(umol/L)(p<0.01).Treatment group’s eGFR significantly increased by control group,as 59.91(50.92,70.82)vs 46.06±26.87(ml/min/1.73m2)(p<0.01)and 61.63(45.3,80.72)vs 46.31±28.27(ml/min/1.73m2)(p<0.01).Start by 12 months after treatment,in treatment group,1 patient impaired glucose tolerance,no seriously infect.2 patients arrived the united endpoint:1 patient doubled in SCr,1 arrived ESRD.The rate of renal survival is 94.7%.In control group,1 patient seriously infected.4 patients arrived the united endpoint:2 patient doubled in SCr,1 arrived ESRD,1 renal transplant.The rate of renal survival is 88.2%.During the follow-up after 12 months,no more adverse reactions and united endpoint in treatment group.4 patients adverse reactions:1 patient femoral head necrosis,3 patients seriously infected.5 patients arrived the united endpoint in control group:4 arrived ESRD,1 renal transplant.Conclusion:1 Treatment group and control group both had significantly benefits in proteinuria.2 Yi Qi Qing Jie Prescription could reduce SCr and improve the renal function.3 Yi Qi Qing Jie Prescription could Protect high risk IgAN patients from adverse reactions and ESRD.