DPP-4抑制剂联合治疗对2型糖尿病临床疗效的系统评价

Clinical evaluation of dipeptide base peptidase 4(DPP-4)inhibitors and Metformin combination therapy intype 2 diabetes

目的探讨二甲双胍联合二肽基肽酶-4（DPP-4）抑制剂—沙格列汀治疗2型糖尿病的临床疗效及安全性。方法选取2011年2月~2013年2月于齐齐哈尔医学院附属第三医院院确诊的2型糖尿病患者50例,随机分成对照组和治疗组,每组25例。在对其进行饮食及日常锻炼指导的基础上,对照组单独给予二甲双胍治疗;治疗组采用二甲双胍联合沙格列汀治疗。治疗12周后对比两组的空腹血糖（FBS）、餐后2 h血糖（2 h PG）、糖化血红蛋白（HbA1c）、HbA1c达标率（以HbA1c〈7%为达标值）、空腹胰岛素（FINC）、体质量指数（BMI）、生化指标等的变化,并对药物不良反应如低血糖、胃肠道不适等进行记录。结果 12周后治疗组和对照组患者HbA1c下降值分别为（1.07±0.66）%、（0.71±0.48）%,治疗组HbA1c下降水平明显高于对照组,差异有显著性（t=2.2056,P〈0.05）。按照Hb1Ac〈7%为达标统计,治疗组达标率（21/25）明显高于对照组（14/25）,差异有显著性（χ2=4.6667,P〈0.05）。两组FPG、2 h PG较治疗前均明显降低,但治疗组FPG及2hPG均较对照组下降明显,差异有显著性（t=3.943,t=3.888,P均〈0.05）。两组患者的空腹胰岛素水平也较治疗前升高,但治疗组升高较对照组明显,差异有显著性（t=2.071,P〈0.05）。两组的低血糖发生率、胃肠道不良反应、体质量指数、肝肾功能、血脂水平等在治疗前后无明显差异（P〉0.05）。结论沙格列汀联合二甲双胍治疗2型糖尿病效果明显,且低血糖等不良反应发生率低。

【Objective】To observe the clinical efficacy and safety of therapy using dipeptide base peptidase 4（DPP-4） inhibitors of Saxagliptin and Metformin to type 2 diabetes. 【Methods】From February 2011 to February2013, 50 patients who had been diagnosed type 2 diabetes were assigned to control and treatment groups randomly and each group had 25 cases. Under the guide of recovery guidance of the diet and daily exercise, the control group was given Metformin alone, the treatment group was given Saxagliptin and Metformin, followed up for 12 weeks. The changes between the two groups of fasting blood glucose（FBS）, 2 h postprandial blood glucose（2 h PG）, glycated hemoglobin（HbA1c）, HbA1 c compliance rate（with the standard value for HbA1 c 7%）, fasting insulin（FINC）, body mass index（BMI）, and other biochemical markers, and recorded adverse drug reactions such as hypoglycemia,gastrointestinal discomfort were recorded and were contrasted. 【Results】After 12 weeks, the decreased HbA1 c values between treatment group and the control group were respectively（1.07 ± 0.66）%,（0.71±0.48）%, the HbA1 c levels decreased in the treatment group were significantly higher, the difference was significant statistically（t =2.2056, P〈0.05）. According the standard statistical Hb1 Ac 7%, the treatment group compliance rate（21/25） was significantly higher than the control group（14/25）, the difference was also statistically significant（χ2=4.6667, P〈0.05）. Both groups＇ FBS, 2hPG compared with before treatment were significantly lower, but the decline in treatment group was lower than the control＇s, the difference was obvious（t =3.943, t =3.888, P〈0.05）. Two groups＇ fasting insulin levels was also up clearly than the before, and the treatment one was higher than the control one, it was difference statistically（t =2.071, P〈0.05）. The changes between two groups in the incidence of hypoglycemia,gastrointestinal adverse reactions, body mass indexes, liver and kidney functions, and blood lipid levels had no statistical differences（P〉0.05）.【Conclusions】It has significant effect to treat the type 2 diabetes with Saxagliptin and Metformin, and with less adverse reactions such as a low blood sugar.