摘要
目的:以诺和灵R为对照,采用随机对照临床试验,说明预混人胰岛素注射液优思灵R治疗2型糖尿病(Type2 diabetes mellitus,T2DM)的有效性和安全性。方法:共入选44例T2DM患者,按1∶1的比例随机分为优思灵R组(n=22)和诺和灵R组(n=22),治疗前和12周后分别测定受试者糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2h血糖(2hPG)水平,肝肾功能、体重和BMI值变化以及不良反应发生率。结果:治疗12周后,2组患者HbA1c、FPG和2hPG水平均明显降低(P≤0.05),但两组间无显著性差异(P>0.05)。治疗前后两组间血脂、肝肾功能、体重和BMI值无显著性差异(P>0.05)。结论:与诺和灵R相比,优思灵R在治疗T2DM方面具有一定的有效性和安全性,并具有良好的耐受性。
Objective：To compare the efficacy and safety of Usiling R and Novolin R in treatment of type 2 diabetes with the randomized controlled clinical trial. Methods：44 cases of T2DM were randomized into two groups （1∶1） treated with Usiling R versus Novolin R,and compared the HbA1c,FPG,2 hPG level,liver and kidney function,body weight,BMI,and the incidence of adverse events before and after 12 weeks of treatment. Results：Compared with pretreatment,at the end of 12 weeks’treatment,the decreased values of HbA1c,FPG and 2 hPG were all proved significantly in both Usiling R group and NovolinR group （P≤0.05）,but the changes of HbA1c,FPG and 2 hPG from baseline to endpoint were similar between the two treatment groups （P〉0.05）. The impact on blood lipids,liver and kidney function, body weight and BMI values had no significant difference,and between the two groups also had no significant difference（P〉0.05）. Conclusion：Usiling R and Novolin R have similar efficacy and safety profiles in the treatment of diabetic patients.
出处
《重庆医科大学学报》
CAS
CSCD
北大核心
2010年第6期945-947,共3页
Journal of Chongqing Medical University
