二甲双胍联合维格列汀治疗2型糖尿病的短期疗效及安全性分析

Short-term effects and safety analysis of metformin combined with vildagliptin in treatment of type 2 diabetes mellitus

目的评价二甲双胍联合维格列汀治疗2型糖尿病的疗效及安全性。方法2型糖尿病患者172例，随机分为两组。对照组（85例）单用二甲双胍500mg／次、2次／d，并辅助用安慰剂；实验组（87例）治疗开始时服用二甲双胍500mg／次、2次／d，持续1周后，再给予维格列汀50mg／次，2次／d。连续观察天，有不良反应者退出观察。用维格列汀联合二甲双胍治疗，治疗前和治疗30d、90d取血，比较HbAlc、FPG、PPG、胰高血糖素、LDL—C、内脏脂肪组织来源丝氨酸蛋白酶抑制剂、内脂素等指标，同时记录用药过程中出现的不良反应。结果两组在用药30d后，血糖、血脂等指标均显著低于治疗前（均P〈0．05）。用药90d后实验组的HbA1c、PPG、胰高血糖素、TC、LDL—C、内脏脂肪组织来源丝氨酸蛋白酶抑制剂、内脂素均显著低于对照组（均P〈0．05）。在治疗初期，实验组不良反应发生率稍高于对照组，但是治疗效果显著。治疗90d后，实验组的不良反应与对照组比较，差异无统计学意义。结论在治疗2型糖尿病的过程中，维格列汀联合二甲双胍的治疗效果优于单用二甲双胍，治疗后期不良反应较少。

Objective To investigate the effects and safety analysis of metformin combined with vildagliptin in treatment of type 2 diabetes mellitus （DM）. Methods 172 type 2 diabetic patients were randomly divided into 2 groups： control groups （n=85）, only treated with metformin in dose of 500 rag/time bid with placebo, and experimental groups （n=87） treated firet with metformin in dose of 500 rag/time bid for one week and then in addition with vildagliptin in the dose of 50 mg twice a day. The treatment lasted for 90 days during which those showed severe adverse reactions were drawn out of the treatment. Before the treatment and at the 30th and 90th days of treatment blood samples were collected to measure the levels of fasting plasma glucose （FPG）, postprandial glucose （PPG）, glycated hemoglobin （HbAle）, low-density lipoprotein cholesterol （LDL-C）, high-density lipoprotein cholesterol （HDL-C）, glucagon, visceral adipose tissue-derived serine protease inhibitor （vaspin）, and visfatin. Results At the 30th day of treatment the levels of FPD and HbAlc were significantly lower than those before treatment （all P 〈0.05）, anf the levels of FPG, PPG, and glycagon of the experimental group were all significcantly lower than those of the control group （all P 〈0.05）. In the experimental group, the levels of HbAlc, FPG, PPG, glycagon, LDL-C, vaspin, and visfatin at the 90th day of treatment were all significantly lower than those at the 30th day （all P 〈0.05） . However, in the control group only the levels of FPG, PPG, and glycasgon at the 90th day were significantly lower than those at the 30th day （all P 〈0.05）. Generally no severe adverse reactions occurred during the period of treatment in these 2 groups. Conclusion The curative effect of metformin combined with vildagliptin in treatment of type 2 DM is superior to using metformin alone and with less adverse reactions.