多中心、随机、开放、对照研究比较甘舒霖30R和诺和灵30R治疗糖尿病的有效性和安全性

Comparison of efficacy and safety of Gansulin 30R and Novolin 30R in the treatment of type 2 diabetic patients： a multicenter randomized open controlled clinical trial

目的比较两种预混型人胰岛素制剂（甘舒霖30R与诺和灵30R）治疗2型糖尿病的有效性和安全性。方法由中国9家医院参加的多中心、随机、开放、对照临床研究，甘舒霖30R组人选2型糖尿病200例，诺和灵30R组100例，治疗12周。结果（1）治疗12周甘舒霖30R组和诺和灵30R组的HbA。c分别下降了1．08％和1．01％，2h餐后血糖分别下降了3．79和3．05mmol／L，空腹血糖分别下降2．0和2．2mmol／L，治疗前后有明显变化（均P〈0．05），但两组间比较差异无统计学意义（P〉0．05）。（2）低血糖事件分别为22％和14％，大部分为轻度。胰岛素抗体阳性率在两组间无差别。结论甘舒霖30R是一种治疗糖尿病的有效安全的胰岛素剂型。

Objective To compare the efficacy and safety of Gansulin 30R and Novolin 30R in therapy of type 2 diabetes mellitus （DM）. Methods A multicenter, randomized, and controlled clinical trial of Gansulin 30R and Novolin 30R was performed in 9 centers in China. Two hundred patients with type 2 DM received Gansulin 30R therapy and I00 patients received Novolin 30R for 12 weeks. Results （ I ） At the end of 12-week treatment, significant improvements in HbAlc, 2 h postprandial plasma glucose （2hPG） and fasting plasma glucose （FPG） levels were shown in both groups, HbAlc decreased 1. 08% and 1. 01%, 2hPG decreased 3.79 and 3.05 mmol/L and FPG decreased 2.0 and 2.2 mmol/L, in Gansulin 30R group and in Novolin 30R group respectively （ all P 〈 0.05）. No difference existed between two groups （P 〉0.05）. （2） Hypoglycemia incidences were 22% and 14% in Gansulin 30R and Novolin 30R respectively, most events were mild. The titers of anti-insulin antibodies were not obviously different between two groups. Conclusion Gansulin 30R is an effective and safe regimen in treating diabetes.