| Objective:The slowly progress of renal function in most patients with IgA nephropathy is the reason leading patients who has primary glomerula disease to end-stage renal disease in China.At present,patients whose GFR<50ml/min with non-rapid progression IgAN,the KDIGO guidelines do not have reference for treatment recommendations,and there are few relevant clinical studies internationally.Based on the observation of the clinical efficacy of the Professor Liu Yuning in the treatment of IgAN and the "A Real-world Study to Evaluate the Efficacy of Yiqi Huatan and Tongluo Xiaoji Method in the Treatment of Chronic Kidney Disease(CKD)Stage G3-G4",we further evaluated the efficacy of Prof.Liu Yuning’s using"Yiqi Huazheng,Jiedu Tongluo" method in the treatment of IgAN with CKD stage G3-G4,to delay the progression of chronic renal disease.In order to provide a clinical reference for the treatment of IgAN with chronic renal insufficiency.Method:Using the method of bidirectional cohort study,the treatment of TCM "Yiqi Huazheng,Jiedu Tongluo" was taken as the exposure factor,and the patients were divided into treatment group(exposure Group)and control group(non-exposure group)according to the patient’s acceptance of the method.In this paper,90 patients(including 49 cases in the treatment group,41 cases in the control group)were followed up to 12 weeks and 65 patients(including 40 cases in the treatment group,20 cases in the control group)who were diagnosed with IgA nephropathy and belonged to the CKD3-4 stages at Dongzhimen Hospital affliated to Beijing University of Chinese Medicine.The changes and rates of glomerular filtration rate(eGFR,calculated by CKD-EPI formula)and serum creatinine(Scr)were compared with those of two groups of patients,the incidence of end events in two groups,the changes of urine protein quantification(24hUTP)in two groups,and the changes of TCM syndrome in the treatment group were also compared.Result:(1)Patients with 12 weeks’ follow-up:There was no significant difference in baseline values between treatment group(n=49)and control group(n=41):Age(38.45±12.31 vs 42.80±11.32 years),Scr[186.00(137.50,252.50)vs 199.00(157.50,252.65)umol/L],GFR[35.35(22.59,50.73)vs 32.53(22.50,44.12)ml/(min·1.73m2)]and 24hUTP(2.46±1.52 vs 2.09±1.20g/d).After12 weeks of treatment,renal function and proteinuria was improved in the treatment group.Compared with the baseline,the median Scr decreased 29.80umol/L(P=0.000)and the median eGFR increased 6.99ml/(min·1.73m2)(P=0.002<0.01);24hUTP reducesd 0.36±1.13g/d(P=0.029<0.05)on average.In the control group,the renal function deteriorated,the Scr increased 20.75±29.90umol/L(P=0.000)on average,and eGFR decreased 3.09±5.39ml/(min·1.73m2)on average(P=0.001<0.01);24hUTP with no significant change(P>0.05).After 12 weeks of treatment,the comparesion between treatment group and the control group:Scr:170.83±79.49 vs 229.07±76.25(umol/L),the treatment group’s Scr was significantly lower than the control group(P=0.001);eGFR:40.61(26.91,59.87)vs 29.06(19.11,36.81)(mL/mim/1.73m2),the treatment group’s eGFR was significantly higher than the control group(P=0.001);△Scr:-29.80(-49.35,1.00)vs23.00(-4.00,40.50)(umol/L)(P=0.000);△eGFR:6.99(-0.21,14.51)vs-2.89(-7.43,0.81)ml/(min.1.73m2)(P=0.000);Scr Change Rate:-18.18(-25.46,0.55)vs 11.46(-1.91,20.90)(%)(P=0.000);eGFR rate of change;24.96±32.60(27.37)vs-9.13±14.56(12.30)(%)(P=0.000);24hUTP:2.91±1.43 vs 1.97±1.32(g/d),there was no significant difference between the two groups of patients,24hUTP after 12 weeks 9 treatment(P=0.631).There were no endpoint events(end stage renal disease)in two groups.(2)Patients with 24 weeks’ follow-up:There was no significant difference in baseline values between treatment group(n=40)and control group(n=25):age(36.95±11.72 vs 39.32±13.09 years),Scr[191.00(139.85,254.25)vs 200.00(157.50,241.84)umol/L],GFR[36.17(22.52,49.75)vs 33.32(27.40,41.42)ml/(min · 1.73m2)]and 24hUTP 2.50(1.64,3.18)vs 2.36(1.89,2.61)g/d.After 12 weeks of treatment,renal function and proteinuria was improved in the treatment group.Compared with the baseline,the median Scr decreased 28.25 umol/L(P<0.01)and the median eGFR increased 8.02ml/(min 1.73m2)(P<0.01);the median 24hUTP reducesd 0.44g/d(P<0.01).In the control group,the renal function deteriorated,the median Scr increased 35.70(P=0.000),the median eGFR decreased 4.84ml/(min·1.73m2)(P=0.001<0.01);24hUTP with no significant change(P>0.05).After 24 weeks of treatment,the comparesion between treatment group and the control group:Scr:153.13(119.38,218.25)vs 256.00(168.40,364.64)(umol/L),the treatment groups’ Scr was significantly lower than the control group(P=0.001);eGFR:38.91(25.95,61.54)vs 24.63(16.72,39.62)(mL/mim/1.73m2),the treatment group’s eGFR was significantly higher than the control group(P<0.01);△Scr:-28.25(-42.13,-0.63)vs 35.70(7.90,126.60)(umol/L)(P=0.000);△eGFR:8.02(0.10,16.73)vs-4.84(-10.65,-1.39)(P=0.000);Scr Change Rate:-17.53(-27.77,-0.35)vs-19.53(-41.89,-4.47)(%)(P-=0.000);eGFR rate of change:25.81(0.34,47.68)vs-19.53(-41.89,-4.47)(%)(P=0.000);24hUTP:1.83(0.95,2.43)vsl.98(0.86,2.02)(g/d),there was no significant difference between the two groups of patients’24hUTP after 12weeks’ treatment(P>0.05).There were no endpoint events(end stage renal disease)in two groups.Conclusion:(1)Using "Yiqi Huazheng,Jiedu Tongluo”therapeutic method in the treatment of IgAN with CKD stage G3-G4 patients can improve their renal function;(2)Using Yiqi Huazheng,Jiedu Tongluo"therapeutic method in the treatment of IgAN with CKD stage G3-G4 patients can induce their TCM syndrome score;(3)Using "Yiqi Huazheng,Jiedu Tongluo"therapeutic method in the treatment of IgAN with CKD stage G3-G4 patients has some clinical effecttion on reducing the 24hUTP level. |