| Objective:To observe the clinical effect of early diabetic nephropathy treated by TangYiShen Capsule by means of randomized, double-blind, ran-open-parallel control clinical way.Method:A randomized controlled trial method to meet the 192 cases of early diabetic nephropathy and in accordance with Chinese Qi and Yin Deficiency, phlegm and blood stasis were randomly divided into treatment group of 144 patients and the control group of 48 patients. The two groups were treated with diabetes food, protein intaking between 0.8g/kg/d and 1.0g/kg/d. To choose fitting athletics method, according to sickness grade, to control blood glucose and insulin releasing function, take lower sugar medication or insulin injection,meanwhile, two groups treated with depressor except ARB and ACEI to control blood pressure under 140/90mmHg.The treatment group was treated with TangYiShen Capsule, 4x0.5g,3 times daily. The control group was treated with KeLuoXin Capsule,4x0.5g,3 times daily, all treated for 12 weeks. To observe the changes of FBG,PBG,HbA1c,TRF,and blood-fat(TC,TG,HDL,LDL),meanwhile check safety index:Routine blood and urine test, liver function(ALT,AST),renal function(BUN,Cr).After observetion,To compare two groups,before and after for each group.Result:l.The treatment group, there were 2 cases deduced lab index caused no recheck, expulsion rate was 1.4%, the control group has 3 case gave up. Expulsion rate 6.3%.There is non meaning about difference of expulsion rate in statistics(p>0.05).2.It was obvious improvement in the treatment group after 12 weeks,efficiency of the treatment group was 99.3%. The cure-markedly effective was 80.28%,the control group was 100%,70.04%. There is meaning in statistics(p<0.05).3.It was reduced clinical symptom of two group(p<0.05).The treatment group, there were a improvement in dizzy,lassitude,numbness of body,cardiopalmus,etc.(p<0.05).indicated TangYiShen Capsule has obvious improvement in symptoms.4.After treatment,two group were all lower UAE,TRF. There was meaning in statistics(p<0.05) in 12 weeks' treatment.Both TangYiShen Capsule and KeLuoXin Capsule had improved renal function.compare two groups, TangYiShen Capsule was better than KeLuoXin Capsule.5.Two groups' TC,TG,LDL were distinctly decline after treatment.There was significance in statistics(p<0.05) in two groups. TangYiShen Capsule and KeLuoXin Capsule were all better in improvement of blood fat metabolism.Two group comparation, the treatment group were better than the control group.6.TangYiShen Capsule and KeLuoXin Capsule were all lower FBG,PBG, HbAlc after treatment. There was significance in statistics(p<0.05) in two groups, TangYiShen Capsule and KeLuoXin Capsule were all better in improvement of blood sugar.The treatment group was better than the control group.7.During observation,there were no abnormal event (discomfort response) combined with medication. Safety check was normal.Conclusion:TangYiShen Capsule has improvement to treat early diabetic nephropathy symptoms.Compated with the control group, TangYiShen Capsule can decline patients' UAE,TRF,FBG.PBG, HbA1c,TC,TG,LDL, improvement of renal function,lower blood fat,control blood sugar.It has better clinical effect in early diabetic nephropathy. |