预混胰岛素和甘精胰岛素分别联合二甲双胍治疗2型糖尿病的效果观察

Comparison of efficacy and safety in the treatment of type 2 diabetic mellitus between glargine plus metformin and BlAsp30 plus metformin.

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次预混胰岛素分别联合二甲双胍治疗,比较这两种方案的疗效和不良事件。方法60例用口服降糖药血糖控制不良的2型搪尿病患者随机分为预混胰岛素组+二甲双胍组(A组)和甘精胰岛素组+二甲双胍组(B组),每组各30例。A组每日早晚餐前分别注射诺和锐30R预混胰岛素,B组每晚睡前注射甘精胰岛素1次,两组病人同时合并给予二甲双胍口服。共观察6月。观察血糖控制和不良事件发生情况。结果两组治疗后对应的不同时间点的血糖值均明显降低。与基线相比,两组中空腹血糖降低幅度相似(P=0.11),治疗6月后,A组早餐后、午餐前、晚餐后以及睡前指血糖值较B组降低(P<0.05)。A组治疗后糖化血红蛋白(HbA1C)的降低幅度更大(P=0.035)。A组轻微低血糖和症状低血糖发生率分别为B组的2.6倍和1.2倍。治疗6个月达到稳定,A组平均胰岛素剂量大于B组,差异有统计学意义(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+二甲双胍或加用每日2次预混胰岛素+二甲双胍进行治疗,均能达到明显的降糖效果。预混胰岛素与甘精胰岛素相比,降低餐后血糖和HbA1C的效果更好,但相比之下低血糖的发生率稍高,胰岛素的用量偏大。

Objective To compare the effect and safety of glargine plus metformin （ Glarg ＋ met） and B1Asp30 plus metformin （ B1Asp30 ＋ met） on type 2 diabetes mellitus （DM）. Methods A 6 - months open and random study was performed. All 60 patients with DM whose blood glucose could not be controlled successfully with OADs were randomly divided into 2 groups. One group（ group A） was injected with glargine at bedtime every night and another （ group B） with B1Asp30 before the meal of morning and evening. Both drugs were respectively injected hypodermically to patients and together with oral metformin. Blood glucose at 7 time points, HbA1 c and hypoglycemia were observed. Results Blood glucose at 7 time points of two groups dropped obviously on the 6th month with treatment, but the descent of blood glucose at after breakfast , before lunch and after dinner were greater in group B （ P 〈 0.05 ）. The level of HbA1 c was lower in B1Asp30 ＋ met group than that in glargine ＋ met group （ P = 0. 035 ）. The frequency of hypoglycemia was lower in group A than that in group B. At the end of the experiment the doses of insulin in group B were higher than that of group A （ P 〈 0.05 ）. Conclusion On the condition of controlling blood glucose unsuccessfully with oral drugs, both glargine ＋ met and B1Asp30 ＋ met have significant effects of controlling blood glucose. The latter have better efficacy in the descent of PPD and HbA1 c. But the former have lower risk of hypoglycemia and less dosage than the latter.