西格列汀与阿卡波糖治疗单用二甲双胍血糖控制不佳的新诊断2型糖尿病对照观察

Comparison of efficacy of sitagliptin versus acarbose combined with metformin for newly-diagnosed type 2 diabetes mellitus patients

目的观察单用二甲双胍血糖控制不佳的新诊断2型糖尿病患者加用西格列汀或阿卡波糖后降糖的有效性和安全性。方法选择2013年1月~2014年4月140例单用二甲双胍12周以上血糖控制不达标的新诊断2型糖尿病患者,随机分为西格列汀组（70例）与阿卡波糖组（70例）,随访12周,观察血糖等各项指标变化及不良反应情况。结果治疗12周后,西格列汀组与阿卡波糖组空腹血糖（FPG）、餐后2 h血糖（2h PG）、糖化血红蛋白（Hb A1c）均较治疗前明显降低（P〈0.05）。西格列汀组2h PG、Hb A1c较阿卡波糖组下降明显（P〈0.05）;两组空腹胰岛素水平均较治疗前升高,西格列汀组空腹胰岛素升高幅度大于阿卡波糖组（P〈0.05）;阿卡波糖组BMI较基线明显下降。西格列汀组胃肠道副反应发生率低于阿卡波糖组,且服药依从性明显优于阿卡波糖组。结论与阿卡波糖相比,西格列汀与二甲双胍合用在新诊断的2型糖尿病患者中降糖效果较明显,而且依从性好、副反应更少。而阿卡波糖与二甲双胍合用在减轻体重方面有较好效果。

Objective To assess the efficacy and safety of sitagliptin added to metformin in newly-diagnosed type 2 diabetes mellitus （T2DM） with poor glycemic control by metformin alone. Methods The 140 newly-diagnosed T2DM patients with poor glycemic control by metfomin monotherapy for 12 weeks were randomLy divided into the sitagliptin group and acarbose group. The two groups were respectively administered sitagliptin and aearbose additionally for 12 weeks （n=70）. The fasting plasma glucose （FPG）, two-hour postprandial plasma glucose （2hPG）, hemoglobin A1C （HbAlc）, fasting plasma insulin, homeostatic model assessment of insulin resistance index （HOMA-IR）, body mass index （BMI）, the incidence of hypoglycemia and gastrointestinal adverse reactions in both groups were observed. Results After the 12-week treatment, the levels of FPG, 2 h PG and HbAlc were decreased in both two groups. Compared with the acarbose group, the level of 2hPG and HbAIC decreased significantly in the sitagliptin group. After treatment the level of fasting plasma insulin was increased in both groups. Compared with acarbose group, the level of fasting plasma insulin of sitagliptin group were significantly improved. The BMI of acarbose group decreased significantly. The sitagliptin group had better compliance and lower incidence of gastrointestinal adverse. Conclusion Compared with acarbose group, the combination of metformin with sitagliptin is more effective for the treatment of newly-diagnosed T2DM patients with better compliance and lower incidence of adverse reactions. Acarbose combined with metformin is more effective with weight control.