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目的:探讨不同剂量复方α酮酸治疗早期2型糖尿病肾病的临床疗效及安全性。方法:将某院2011年1月-2013年12月收治的169例早期2型糖尿病肾病患者,按照随机分层分组法分为对照组(基础治疗组)、A组(复方α酮酸Ⅰ组)及B组(复方α酮酸Ⅱ组),观察3组治疗前后肾功能指标、血糖和血压水平、营养指标及不良反应发生率。结果:3组治疗前后空腹血糖(FPG)、餐后2 h血糖(PPG)、舒张压(DBP)、血尿素氮(BUN)、肌酐(Cr)及肾小球滤过率(GFR)无显著差异(P>0.05)。治疗后A、B组收缩压(SBP)及糖化血红蛋白(Hb Alc)低于治疗前(P<0.05),B组SBP、Hb Alc低于A组(P<0.05)。治疗后,A、B组24 h尿蛋白量低于对照组(P<0.05),治疗后B组24 h尿蛋白量低于A组(P<0.05)。治疗后对照组血清清蛋白(ALB)、前清蛋白(PA)、血红蛋白(Hb)及上臂肌围(MAMC)低于治疗前(P<0.05),治疗24周后A组血清ALB、PA、Hb及MAMC低于治疗前(P<0.05)。3组治疗期间不良反应发生率无差异(P>0.05)。结论:复方α酮酸能有效减少早期2型糖尿病肾病患者的尿蛋白量,有利于延缓肾功能损伤和控制血压,在有效避免低蛋白饮食引起营养不良的同时,不会增加不良反应发生率。
Objective: To investigate the clinical efficacy and safety of different doses of compound α-keto acid in the treatment of early type 2 diabetic nephropathy. Methods: A total of 169 patients with early type 2 diabetic nephropathy admitted to our hospital from January 2011 to December 2013 were randomly divided into control group (basic treatment group), group A (compound α-keto acid group Ⅰ ) And group B (compound α-ketoacid group Ⅱ). Before and after treatment, the renal function, blood glucose and blood pressure, nutritional indexes and the incidence of adverse reactions were observed. Results: Fasting blood glucose (FPG), postprandial blood pressure (PPG), diastolic blood pressure (DBP), blood urea nitrogen (BUN), creatinine (Cr) and glomerular filtration rate (GFR) Difference (P> 0.05). SBP and Hb Alc in treatment A and B were lower than those before treatment (P <0.05), while SBP and Hb Alc in treatment B were lower than those in treatment A (P <0.05). After treatment, the proteinuria of 24 hrs in group A and group B was lower than that of control group (P <0.05). After 24 h, the proteinuria in group B was lower than that in group A (P <0.05). Serum ALB, PA, Hb and MAMC in the control group after treatment were lower than those before treatment (P <0.05). After 24 weeks of treatment, serum ALB, PA, Hb and MAMC were lower than before treatment (P <0.05). There was no difference in the incidence of adverse reactions between the three groups (P> 0.05). CONCLUSION: Compound α-keto acid can effectively reduce urinary protein in patients with early stage type 2 diabetic nephropathy, delay renal function impairment and control blood pressure, and can effectively prevent malnutrition caused by low-protein diet without increasing the incidence of adverse reactions.