Clinical Observation of Compound α-ketoacid Tablet in the Treatment of Type 2 Diabetes Mellitus Compli-cated with Early Diabetic Nephropathy / 中国药房

ABSTRACT

OBJECTIVE:To observe clinical efficacy and safety of compound α-ketoacid tablet in the treatment of type 2 dia-letic mellitusc(T2DM)complicated with early diabetic nephropathy. METHODS:A total of 180 T2DM patients with early nephrop-athy during Jan. 2013-Dec. 2015 selected as research objects were divided into group A,B,C according to random number table, with 60 cases in each group. Group C was given basic symptomatic treatment. Group A was additionally given Compound α-ketoac-id tablets 2.52 g orally,tid,on the basis of group C. Group B was additionally given Compound α-ketoacid tablets 5.04 g orally, tid,on the basis of group C. Three groups were treated for consecutive 24 weeks. The renal function indexes (BUN,Cr,GFR, urine ALB),blood glucose indexes (FPG,PPG,HbA1c),blood pressure indexes (SBP,DBP) and nutritional indexes (serum ALB,PA,Hb) were observed in 3 groups before and after treatment. The occurrence of ADR was recorded in 3 groups. RE-SULTSBefore treatment,there was no statistical significance in renal function indexes,blood glucose indexes,blood pressure in-dexes or nutritional indexes among 3 groups(P>0.05). After treatment,urine levels of ALB,HbA1c and SBP were decreased sig-nificantly in 3 groups;the group B was significantly lower than the group A;the group A was significantly lower than the group C. The levels of serum ALB,PA and Hb were decreased significantly in group A and C;the group B was significantly higher than the group A;the group A was significantly higher than group C,with statistical significance (P<0.05). The incidence of ADR in 3 groups were 8.3％,10.0％ and 6.7％ respectively,without statistical significance(P>0.05). CONCLUSIONS:Compound α-keto-acid tablet can significantly improve renal function,control blood glucose and blood pressure levels and complete necessary nutri-ents in T2DM patients with early nephropathy patients with good safety. High dose are more effective.