甘精胰岛素联合那格列奈治疗2型糖尿病疗效观察

目的 观察甘精胰岛素联合那格列奈治疗2型糖尿病的疗效性和安全性.方法 120例2型糖尿病患者随机分为研究组和对照组.意向性分析（ITT）人群共120例,研究组60例、对照组60例;符合方案集分析（PP）人群共108例,研究组55例、对照组53例.研究组给予甘精胰岛素和那格列奈治疗,对照组给予重组人胰岛素注射液（甘舒霖R）和低精蛋白重组人胰岛素注射液（甘舒霖N）,疗程2个月.比较2组的糖化血红蛋白（HbA1C）、空腹血糖（FBG）、餐后2h血糖（2hPG）、临床疗效和不良反应.结果 ITT人群分析,研究组总有效率为93.3％,明显高于对照组的81.7％ （P ＜0.05）;PP人群分析,研究组总有效率为96.4％,明显高于对照组的86.8％ （P ＜0.05）.与治疗前基线值比较,2组治疗后的HbA1C、FBG和2hPG均明显下降（P＜0.05）.治疗后研究组的HbA1C、FBG和2hPG均明显低于对照组（P＜0.05）.研究组和对照组分别有7例（11.7％,7/60）和22例（36.7％,22/60）出现低血糖,研究组低血糖发生率明显低于对照组（P＜0.05）.结论 那格列奈和甘精胰岛素联合用于治疗2型糖尿病,能明显降低血糖,提高临床疗效,并且低血糖发生率更低。

Therapeutic effect of insulin glargine plus nateglinide on type 2 diabetes mellitus

Objective To investigate the efficacy and safety of insulin Glargine plus nateglinide on type 2 diabetes mellitus （T2DM）.Methods 120 patients with T2DM were randomly divided into study group and control group.120 cases were in the intent to treat （ITT） analysis,60 cases in study group and 60 cases in control group.108 cases were in the per protocol set （PP） analysis,55 cases in study group and 53 cases in control group.The study group were given insulin glargine plus nateglinide,and the control group were treated with recombinant human insulin injection （commercial name：Gansulin R） and recombinant human insulin isophane injection （commercial name：Gansulin N）.All the patients were treated for 2 months.The levels of hemoglobin A1c （HbA1C）,fasting blood glucose （FBG）,postprandial blood glucose （2hPG）,clinical efficacy and adverse reaction were evaluated.Results The overall efficacy rates in ITT analysis were 93.3% in the study group and 81.7% in the control group,respectively （P 〈 0.05）.The overall efficacy rates in PP analysis were 96.4% in the study group and 86.8% in the control group,respectively （P 〈 0.05）.The levels of HbA1C,FBG and 2hPG all decreased in both groups compared with baseline （P 〈 0.05）.After treatment,the levels of HbA1C,FBG and 2hPG in the study group were significantly lower than in the control group （P 〈 0.05）.Hypoglycemia occurred in 7 cases （11.7%,7/60） in the study group and 22 cases （36.7%,22/60） in the control.The rate of hypoglycemia in the study group was significantly lower than in the control group （P 〈 0.05）.Conclusion In the treatment of T2DM,insulin glargine plus nateglinide can obviously reduce blood sugar level,improve therapeutic effect,and reduce incidence of hypoglycemia.