地特胰岛素与NPH胰岛素治疗口服降糖药控制不佳的2型糖尿病临床比较研究

A Randomized,Parallel Study Comparing Insulin Detemir with NPH Insulin as Add-on Therapy for Type 2 Diabetes

目的:观察口服降糖药控制不佳的2型糖尿病患者分别加用地特胰岛素和NPH胰岛素治疗24周的有效性和安全性。方法:63例口服降糖药物控制不佳(HbA1c>7%)的2型糖尿病患者随机加用地特胰岛素或鱼精蛋白锌(NPH)胰岛素作为基础胰岛素,每日1次治疗24周,比较两组治疗前后糖化血红蛋白、体重、血脂的变化及低血糖的发生率。结果:两组的糖化血红蛋白、空腹血糖与基线比较均有显著下降,治疗后组间无差异。与NPH胰岛素组比较地特胰岛素组体重增加明显减少,差异有统计学意义。地特胰岛素组治疗期间全部低血糖次数较NPH胰岛素组减少54.69%(P<0.01)。结论:地特胰岛素与NPH胰岛素相比,在有效控制血糖的同时可降低低血糖发生风险,而且有减少体重增加的优势。

Objective： To assess efficacy and safety of insulin detemir or NPH insulin added to oral therapy for type 2 diabetes. Methods： Individuals （n=63） with HbAlc exceed 7% were randomized to addition of once-daily insulin detemir or NPH insulin in a parallel-group trial. Outcomes assessed included HbAlc, body weight, triglyceride, total cholesterol ,LDL-C,HDL-C and risk of hypoglycemia. Result： After 24 weeks treatment, FPG and HbAlc were both decreased than baseline, but no significantly different between two groups. Weight gain was less in detemir insulin group. Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 54.69% （P〈0.01）. Conclusion： Insulin detemir compared with NPH insulin achieves same glycaemic control with reduced hypoglycemia and less weight gain.