【摘要】目的 探讨使用1次/d基础胰岛素或2次/d预混胰岛素联合或未联合口服降糖药物治疗但血糖控制欠佳的T2DM住院患者采用地特胰岛素+门冬胰岛素±二甲双胍方案(胰岛素类似物组)是否优效于中性精蛋白锌胰岛素+可溶性人胰岛素±二甲双胍方案(人胰岛素组)。 方法 两组住院治疗2周并进行有效性及安全性比较。 结果 两组治疗后8个时点血糖平均值较治疗前下降，下降值两组间比较差异无统计学意义(P=0.9157)。两组不良事件、低血糖事件发生率均降低，无严重药物不良反应和严重低血糖报告，胰岛素类似物组总体低血糖事件(P=0.0056)和日间低血糖发生率(P= 0.0263)较人胰岛素组低。 结论 胰岛素类似物和人胰岛素的基础−餐时胰岛素强化治疗方案均可改善T2DM住院患者血糖水平，但胰岛素类似物治疗组总体低血糖和日间低血糖风险较人胰岛素组低。

　　【关键词】地特胰岛素;门冬胰岛素;中性精蛋白锌胰岛素;可溶性人胰岛素;基础-餐时;糖尿病，2型

Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes   GUO Xiao-hui, LI Qi-fu, SHI Yong-quan, et al. Department of Endocrinology, Peking University First Hospital, Beijing 100008, China

Corresponding author：GAO Yan, E-mail: gao-yan@medmail.com.cn

　　【Abstract】Objective To investigate if insulin detemir + insulin aspart ± metformin (insulin analogues group) is superior to NPH insulin + human soluble insulin ± metformin (human insulin group) with respect to glycaemic control in hospitalised Chinese T2DM patients uncontrolled with basal insulin once daily or premixed insulin twice daily with or without oral antidiabetic drugs. Methods Two groups were hospitalised and treated for two weeks to compare the efficacy and safety of the two regimens. Results The mean eight-point plasma glucose decreased than before treatment in two groups, and there was no significant difference of the change between two groups(P=0.9157). In two groups, the numbers of adverse events were low and there were neither serious adverse events nor severe hypoglycaemic events reported. The rates of overall hypoglycaemia (P=0.0056) and daytime hypoglycaemia (P=0.0263) were significantly lower in insulin analogues group than in human insulin group. Conclusion Both insulin analogues combination and human insulin combination comparably improved glycaemic control in hospitalised T2DM patients. Moreover, the overall and diurnal hypoglycaemic risk in insulin analogues regimen was lower than that of the human insulin regimen.

　　【Key words】Insulin detemir;Insulin aspart;Neutral protamine hagedorn (NPH) insulin;Human soluble insulin;Basal-bolus;Diabetes mellitus，type 2