门冬胰岛素联合中性鱼精蛋白胰岛素在控制餐后血糖中的作用

目的 比较门冬胰岛素(IAsp)和可溶性人胰岛素(HI)分别联合中性鱼精蛋白胰岛素(NPH)在糖尿病治疗中的有效性和安全性.方法 220例来自全国5家医院的1型(T1DM)或2型糖尿病(T2DM)患者按1:1的比例随机分为两组,分别接受IAsp或HI联合NPH治疗.以空腹血糖(FPG)、餐后2 h血糖(2h PPG)、糖化血红蛋白(HbA1c)及低血糖事件作为评价指标.结果 IAsp/NPH组[(14.6±5.3)mmol/L比(8.4±4.1)nunol/L]较HI/NPH组治疗后2 h PPG改善更为显著[(14.9±3.9)mmol/L比(10.6±3.5)mmoL/L,P<0.05],且达标率分别为50.0%、25.5%(P<0.01).治疗后IAsp/NPH组[(9.3±1.4)%比(7.7±1.3)%]和HI/NPH组[(9.2±1.2)%比(7.7±1.2)%]HbA1c明显下降,但两组比较差异无统计学意义(P=0.437).达标率分别为24.5%和14.5%(P<0.05).在Imp/NPH组未见严重低血糖事件和其他不良事件,且夜间低血糖发生率更低(IAsp/NPH:3%,HI/NPH:4%).IAap/NPH组与HI/NPH组患者胰岛素日均剂量分别是0.60/0.23 IU/kg和0.65/0.24 IU/kg.结论 IAsp联合NPH能更好地控制餐后血糖,提高患者血糖达标率且不增加夜间低血糖和不良事件的风险.

Postprandial glycemic control using insulin aspart with NPH in inadequately controlled diabetics

Objective To compare the efficacy and safety of insulin aspart (IAsp) and human insulin (HI) when applied as meal-time insulin with neutral protamine Hagedorn insulin (NPH) at bedtime in diabetics. Methods A total of 220 Chinese subjects with type 1 or type 2 diabetes from 5 dfferent hospitals were randomized by a ratio of 1:1 into two groups accepting IAsp or HI combined with NPH respectively. The main cndpoints were assessed by fasting plasma glucose (FPG), 2 hour postprandial plasma glucose (2 h PPG), HbA1c and hypoglycemia. Results A greater reduction in mean 2 h PPG was achieved in the IAsp group[(14.6±5.3)mmol/L] as compared with the HI group [(8.4±4.1)mmol/L| (P< 0.01, adjusted for baseline value, center effect and diabetes type). Significantly mare IAsp-treated subjects reached the 2 h PPG target (50.0% vs 25.5%, P <0.01). HbAlc was reduced mare in IAsp/NPH group [(9.3±1.4)% vs (7.7±1.3)%] than in HI/NPH group [(9.2±1.2)% va (7.7±1.2)%] . HbAIc target was reached by 24.5% (IAap) vs 14.5% (HI) of subjects (P<0.05). No major hypoglycemia or serious adverse events were observed for the IAsp group, Lower incidence of nocturnal hypoglycemia (IAsp/ NPH: 3% vs HI/NPH: 4%) was reported in the IAsp group. Average daily insulin doses were 0.60/0.23 (IAsp/NPH) and 0.65/0.24 (HI/NPH) IU/kg respectively. Conclusion Treatment of IAsp in basal-bolus therapy in combination with NPH provides a superior postprandial glucose control and allows mare subjects to reach the glycemic target without elevating the nocturnal hypoglycemic risk or adverse events.