甘精胰岛素与预混胰岛素治疗2型糖尿病的疗效和安全性比较

Comparison of efficacy and safety in treatment of type 2 diabetic mellitus between glargine quaque and mixed insulin

目的在口服降糖药不能良好控制血糖的情况下,加用每日1次甘精胰岛素或加用每日2次预混胰岛素治疗,比较这两种方案的疗效和低血糖的风险。方法40例用口服降糖药血糖控制不良的2型糖尿病患者随机分为甘精胰岛素组(简称甘精组)和预混胰岛素组(诺和灵30R,简称预混组),每组各20例。所有患者在原有的口服降糖药不变的基础上,甘精组每晚10时注射甘精胰岛素1次;预混组每日早晚餐前分别注射诺和灵30R预混胰岛素。根据空腹血糖(FBG)的水平,每周调整胰岛素剂量,以FBG小于5.6 mmol/L为治疗目标,共治疗16周。观察血糖控制和低血糖发生情况。结果治疗后两组的FBG在4周和16周都明显下降,但甘精组的下降幅度明显大于预混组,差异有统计学意义(P<0.01)。两组的糖化血红蛋白(HbA1c)在16周时也明显的下降,甘精组的下降幅度稍优于预混组,但二者的差异无统计学意义(P>0.05)。到达终点时预混组的胰岛素用量明显大于甘精组,差异有统计学意义(P<0.05)。甘精组低血糖事件明显少于预混组(甘精组3例,15%;预混组9例,45%),χ2=4.285,P<0.05。结论单用口服降糖药不能较好控制血糖时,加用每日1次甘精胰岛素或加用每日2次预混胰岛素进行治疗,均能达到明显的降糖效果。甘精胰岛素与预混胰岛素相比,降低FBG的效果更好,低血糖的发生率低,胰岛素的用量少。

Objective To compare the efficacy and the risk of hypoglycemia of glargine quaque die and mixed insulin bis in die on the condition of controUing the blood glucose unsuccessfully with oral drugs. Methods Forty type 2 diabetes patients which could not control the blood glucose successfully with drugs were divided into two groups randomly： glargine group （20 cases） and mixed insulin group （20 cases）. Without any change of oral drugs, the patients in glargine group were injected with the glargine hypodermically once at 10 O＇clock every night and the patients in mixed insulin group were injected with the mixed insulin （Novolin 30R） hypodermically before the meal of morning and evening respactively for 16 weeks. The doses of insulin were adjusted each week according to the level of fasting blood glucose （FBG） reaching the aim of less than 5.6 mmol/L. Results The FBG of two groups dropped obviously on the 4th and 16th week with the treatment, but the extent of the descent were greater in glargine group than in mixed insulin group and both of the values of P were less than 0.01. The level of HbA1c in two groups fell markedly but the difference between them were not significant （P 〉0.05）. At the end of the experiment the doses of mixed insulin group were higher than that of glargine group significantly （P〈0.05）. The incident of hypoglycemia in glargine group were lower than in mixed insulin group evidently （3 patients in glargine group, 9 patients in mixed insulin group,x^2 = 4. 285, P〈 0.05）. Conclusion On the condition of controlling the blood glucose unsuccessfully with oral drugs, both of the glargine and the mixed insulin have visible effects of controlling the FBG but the former have better efficacy,lower risk of hypoglycemia and less dose than the latter.