三种胰岛素强化治疗方案的短期疗效和安全性比较

Comparison of efficacy and safety of three regiments of transient intensive insulin therapy

目的比较三餐前注射预混胰岛素类似物（预混组），短效胰岛素类似物加睡前长效胰岛素类似物（类似物组）以及普通人胰岛素加睡前中效胰岛素（普通组）治疗2型糖尿病患者的短期疗效和安全性。方法住院的2型糖尿病患者随机采用三种胰岛素强化治疗方案，在三餐前及睡前指间全血血糖达标后进行动态血糖监测，比较整体血糖控制水平、低血糖发生率，以及达标时间和胰岛素使用量等。结果在三餐前及睡前全血血糖控制相同的情况下，预混组、类似物组和普通组达标时间分别为（8．3±2．5）、（9．1±3．8）和（8．4±1．7）天（P〉0．05）；胰岛素使用量分别为（O．63±0．13）、（0．69±0．20）和（0．68±0．24）U·kg^-1·d^-1（P〉0．05）；动态血糖监测的72h平均血糖值分别为（8．3±2．1）、（7．5±1．9）和（6．8±0．8）mmol／L（P〉0．05）；早餐后3h血糖曲线下面积分别为（27．7±11．5）、（27．6±8．3）和（24．0±3．1）mmol·L^-1·h（P〉0．05）；血糖CV分别为（3．1±2．1）、（2．9±1．6）和（2．1±1．6）mmol／L（P〉0．05）；低血糖（≤3．9mmol／L）发生率分别为67％、87％和80％（P〉0．05），多出现在凌晨0：00-4：00（55％），而且没有患者出现低血糖症状。结论三种胰岛素强化治疗方案控制血糖的短期临床疗效和安全性没有明显差别，但需要更加关注监测夜间血糖。

Objective To compare the efficacy and safety of three regiments of transient intensive insulin therapy for type 2 diabetes mellitus： thrice preprandial injection of premixed insulin aspart 30, thrice preprandial injection of insulin aspart and injection of glargine at bedtime, thrice preprandial injection of regular insulin and injection of NPH at bedtime. Methods Patients were randomly divided into 3 groups, treated with 3 kinds of intensive insulin therapy. After achieving the target goal, continuous glucose monitoring system was used to compare the blood glucose level, therapeutic time, dosage of insulin, occurrence of hypoglycemia. Results Detected by continuous glucose monitoring system, there was no statistical difference in average blood glucose [ （8.3 ± 2.1,7.5 ±1.9, 6.8 ± 0.8 ） mmol/L, P 〉 0.05 ], blood glucose area under curve 3 hours （ AUC1-3 ） after breakfast, therapeutic time [ （8.3 ± 2.5, 9.1 ± 3.8, 8.4± 1.7） d, P 〉 0.05 ], dosage of insulin [ （0.63 ±0.13, 0.69 ± 0.20, 0.68 ± 0.24） U· kg^-1· d^- 1, p 〉 0.05 ~, and occurrence of hypoglycemia （67 %, 87%, 80%, P 〉 0.05） among three kinds of transient intensive insulin therapy. There were no patients complaining of hypoglycemic symptom. Conclusion The short-term efficacy and safety among three intensive insulin therapeutic methods are similar. More attention should be paid to monitor the blood glucose during sleep.