复方α-酮酸片治疗2型糖尿病合并早期糖尿病肾病的临床观察

摘要

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-SULTS:Before 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 (P0.05). 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.%目的:观察复方α-酮酸片治疗2型糖尿病(T2DM)合并早期糖尿病肾病(DN)的临床疗效及安全性.方法:选取2013年1月-2015年12月我院收治的T2DM合并早期DN患者180例作为研究对象,采用随机数字表法分为A、B、C组,各60例.C组患者给予基础对症治疗;A组患者在C组基础上口服复方α-酮酸片2.52 g,tid;B组患者在C组基础上口服复方α-酮酸片5.04 g,tid.3组患者均连续治疗24周.观察3组患者治疗前后的肾功能指标[血尿素氮(BUN)、血肌酐(Cr)、肾小球滤过率(GFR)、尿白蛋白量(尿ALB)]、血糖指标[空腹血糖(FPG)、餐后2 h血糖(PPG)、糖化血红蛋白(HbA1c)]、血压指标[收缩压(SBP)、舒张压(DBP)]、营养指标[血清白蛋白(ALB)、前白蛋白(PA)、血红蛋白(Hb)],并记录3组患者不良反应发生情况.结果:治疗前,3组患者肾功能指标、血糖指标、血压指标、营养指标比较,差异均无统计学意义(P>0.05).治疗后,3组患者的尿ALB、HbA1c、SBP水平均显著下降,且B组显著低于A组,A组显著低于C组;A、C组患者的ALB、PA、Hb水平均显著下降,且B组显著高于A组,A组显著高于C组,差异均有统计学意义(P0.05).结论:复方α-酮酸片能显著改善T2DM合并早期DN患者的肾功能,有效控制血糖、血压水平并补充必需营养物质,且具有较高的安全性,较大剂量效果更优.