精蛋白重组人胰岛素注射液与门冬胰岛素30注射液治疗2型糖尿病的有效性和安全性比较

目的比较精蛋白重组人胰岛素注射液(诺和灵30R)与门冬胰岛素30注射液(诺和锐30)治疗2型糖尿病(T2DM)的有效性及安全性。方法入选72例血糖控制不达标的T2DM患者,随机分为诺和灵30R组(n=35)与诺和锐30组(n=37),治疗前和24周后测定糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2小时血糖(2hPG)水平、血脂、体重、体脂含量和BMI值变化,记录不良事件和低血糖事件发生率。结果治疗24周后,两组患者HbA1c、FPG和2hPG水平均明显降低(P<0.01),诺和锐30组2hPG水平明显低于诺和灵30R组。诺和灵30R治疗后体重和BMI值有显著增加,而诺和锐30组体重及BMI值治疗前后差异无统计学意义。结论在治疗T2DM有效性及安全性方面,诺和锐30要优于诺和灵30R。

Efficacy and Safety of Protamine Recombinant Human Insulin Injection and Insulin Aspart 30 Injection in Treatment of T2DM

Objective To compare the efficacy and safety of protamine recombinant human insulin injection （Novolin 30R） and insulin aspart 30 injection （NovoMix 30） in the treatment of type 2 diabetes mellitus （T2DM）. Methods 72 patients with T2DM were randomly divided into Novolin 30R group （n=35） and NovoMix 30 group （n=37）, to measure HbA1c, FPG, 2hPG, lipids, body weight, body fat, and BMI, and to record the adverse events and hypoglycemia incidence. Results The HbA1C, FPG and 2hPG levels decreased significantly in both groups compared with the baseline levels （all P〈0.01）. The 2hPG level in NovoMix 30 group was significantly lower than that in Novolin 30R group after 24 weeks of treatment. The body weight and BMI values increased significantly in Novolin 30R group after treatment. Conclusions NovoMix 30 is more safe and effective than Novolin 30R in the treatment of type 2 diabetes mellitus.