安立泽联合二甲双胍治疗2型糖尿病的疗效及安全性观察

目的观察单用二甲双胍控制血糖未达标的新诊断2型糖尿病患者,加用安立泽（沙格列汀片）降血糖的疗效及安全性。方法二甲双胍控制血糖未达标的新诊断2型糖尿病患者60例,随机分为2组。治疗组,安立泽联合二甲双胍（n=30）;对照组,格列美脲联合二甲双胍（n=30）。治疗12周后观察两组空腹血糖、餐后2 h血糖、糖化血红蛋白、糖化血红蛋白达标率、体质量指数（body mass index,BMI）、低血糖发生率、肝功能、肾功能及其他不良事件。结果安立泽联合二甲双胍与格列美脲联合二甲双胍治疗2型糖尿病均可有效降低血糖,两组空腹血糖、餐后2h血糖、糖化血红蛋白治疗后均明显下降,两组间比较无统计学意义（P〉0.05）,两组间HbA1c达标率差异无统计学意义（P〉0.05）;安立泽组未观测到低血糖事件,格列美脲组观察到11次低血糖事件,组间比较有统计学差异（P〈0.05）;安立泽组治疗后BMI稍有下降,格列美脲组治疗后BMI稍升高,但两组间BMI变化无统计学意义（P〉0.05）;两组均未观察到肝功能、肾功能损害及胰腺炎等不良事件。结论安立泽联合二甲双胍治疗新诊断的2型糖尿病患者,降糖效果好,不增加体质量,未观察到不良事件,患者医从性良好,是治疗2型糖尿病的一种理想选择。

Efficacy and Safety of Onglyza Combined with Metformin in Newly Diagnosed Type 2 Diabetic Patients

Objective To assess the efficacy and safety of Onglyza combined with metformin in newly diagnosed patiens with type 2 diabetes mellitus（T2DM）whose glycemic control were inadequate on metformin alone.Methods A total of 60 newly diagnosed T2 DM patients having inadequately control on merformin monotherapy for 12 weeks were randomly divided into treatment group accepting Onglyza/metformin conbination therapy（n=30）and control group accepting gelimepiride/metformin conbination therapy（n=30）.The change of fasting glucose,2-hour postprandial blood glucose,HbA1 c,the targeting rate of HbA1 c,body mass index（BMI）,incidence of hypoglycemia,liver function,kidney function,and other adverse events were observed after treatment of 12 weeks.Results Both Onglyza/metformin and glimepiride/metformin treatment can effectively lower blood sugar and the fasting glucose,2-hour postprandial blood glucose,HbA1 c were significantly decreased after treatment,which were not significantly different between the two groups（P〉0.05）.The targeting rate of HbA1 c between the two groups showed no significant difference（P〉0.05）.The hypoglycemic events were not observed in Onglyza group,and 11 hypoglycemic events were observed in control group which was significantly different between two groups（P〈0.01）.BMI decreased in Onglyza group and slightly elevated in control group after treatment,which was not significantly different between the two groups（P〉0.05）.Liver function,renal dysfunction and pancreatitis and other adverse events were not observed in the two groups.Conclusions The combination of Onglyza with metfotmin is effective for newly diagnosed T2 DM patients,and no adverse events were observed,and the patients have good compliance.It is a good choice for treatment of T2 DM.