优泌乐50和诺和锐30治疗初诊断2型糖尿病的自身交叉试验

A Self-crossover Controlled Clinical Study of Ispro Mix 50/50 and Aspart Mix 30/70 in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

目的观察优泌乐50和诺和锐30治疗初诊断2型糖尿病疗效。方法选择56例初诊断2型糖尿病患者,随机分为两组,进行优泌乐50和诺和锐30的交叉对照试验。观察治疗后空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)、胰岛素(RI)用量、体重指数(BMI)、低血糖的发生情况等各项指标的变化,从而比较治疗效果。结果两组空腹血糖控制水平相似,而优泌乐50组餐后血糖控制优于诺和锐30组,且HbA1c水平更低,RI用量也少,差异有统计学意义(P<0.05)。两组低血糖发生率差异无统计学意义(P>0.05),但优泌乐50白天低血糖发生较多(P<0.05),诺和锐30夜间低血糖发生较多(P<0.05)。结论优泌乐50和诺和锐30治疗2型糖尿病均疗效肯定,但优泌乐50对餐后血糖的控制存在优势,胰岛素用量更少,且夜间低血糖事件较少。

OBJECTIVE To evaluate the efficacy of lispro Mix 50/50 and aspart Mix 30/70 in patients with newly diagnosed type 2 diabetes mellitus. METHODS Outpatients and inpatients（n=56） with newly diagnosed type 2 diabetes mellitus were treated with ispro mix 50/50 or aspart mix 30/70 respectively, in a randomly self-crossover controlled clinical test. After treatment, the following indicators were observed and compared： fasting plasma glucose（FPG）, postprandial plasma glucose （2h-PG）, glycosylated hemoglobin （HbAlc）, the total amount of insulin, body mass index（BMI） and the incidence of hypoglycemia. RESULTS The levels of fasting plasma glucose was not different between two groups. However, the control of postprandial plasma glucose and HbAlc was significantly more effective in Lispro Mix 50/50 group than in other groups（P〈0.05）. Furthermore, the total amount of insulin was lower in Lispro Mix 50/50 group （P〈0.05）. The incidence of hypoglycemia was not statistically different between the two groups （P〉0.05）. But the hypoglycemia of ispro mix 50/50 happened more in the daytime, and the hypoglycemia of aspart Mix 30/70 happened more in the night. CONCLUSIONS Lispro mix 50/50 and aspart Mix 30/70 are both effective in treatment of type 2 diabetes. But Lispro mix 50/50 is more effective in the control of postprandial plasma glucose and the total amount of insulin and makes less nighttime hypoglycemic episodes.