基础胰岛素联合二甲双胍治疗2型糖尿病的短期疗效和安全性观察

Evaluation of the efficacy and safety of basal insulin combined with metformin in the treatment of type 2 diabetes mellitus

目的对口服降糖药不能很好控制血糖的2型糖尿病患者,改用二甲双胍联合(重组)甘精胰岛素(来得时、长秀霖)或诺和灵N治疗,比较3种治疗方案的疗效和安全性。方法将63例符合标准的2型糖尿病患者分为3组,分别给予诺和灵N(n=23)、来得时(n=20)、长秀霖(n=20)睡前皮下注射,三组均联合二甲双胍口服。观察住院期间空腹血糖的变化和胰岛素剂量及低血糖发生率。结果治疗后三组空腹血糖均明显下降(P<0.05),但组间比较差异无统计学意义。来得时组和诺和灵N组、来得时组和长秀霖组在出院时单位体重胰岛素用量相似,长秀霖组较诺和灵N组在出院时单位体重胰岛素用量多(P=0.017)。(重组)甘精胰岛素组低血糖发生率明显低于诺和灵N组(P<0.05)。结论对口服降糖药控制不佳的2型糖尿病患者,应用二甲双胍联合来得时或长秀霖治疗的疗效和安全性相似;来得时的短期疗效和NPH相似;来得时和长秀霖较诺和灵N有更安全的降糖效果。

Objective To compare the efficacy and safety of three kinds of treatment by using insulin glargine（Lantus1,Sanofi-Aventis）,recombinant insulin glargine（Basalin,Ganli）or human NPH（Novolin N,Novo nordisk）which were combined with metformin in T2DM with poorly controlled by oralantidiabetic drugs.Methods 63 cases of T2DM were assigned into three groups for basal insulin therapy at bedtime：human NPH insulin group（n=23）,insulin glargine group（n=20）and recombinant insulin glargine group（n=20）.Three groups were combined with metformin.The fasting blood glucose,insulin dose and incidence of hypoglycemia during hospitalization were observed.Results After treatment,The of fasting blood glucose of three groups decreased significantly（P0.05）,but there was no significant difference among them.Comparing insulin dose/weight（U/kg）when discharged from hospital,the dose in insulin glargine group was similar to that of the recombinant insulin glargine group,but the dose in the recombinant insulin glargine group was significantly more than that of the NPH group（P=0.017）.The incidence of hypoglycemic episodes in the glargine groups was significantly lower than that of the NPH group.Conclusion The efficacy and safety are similar between the treatment by using insulin glargine and recombinant insulin glargine which are combined with metformin in T2DM with poorly controlled by oralantidiabetic drugs.Short-term efficacy of insulin glargine is similar to NPH.Bedtime injection of glargine is safer than NPH.