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一项为期16周的研究,比较维格列汀与格列齐特对二甲双胍单药治疗控制不佳的2型糖尿病患者餐后脂蛋白浓度和氧化应激的影响。

A 16-week study to compare the effect of vildagliptin versus gliclazide on postprandial lipoprotein concentrations and oxidative stress in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

作者信息

Hissa Marcelo R Nasser, Cavalcante Lilian Loureiro Albuquerque, Guimarães Sergio Botelho, Hissa Miguel Nasser

机构信息

Department of Surgery, Postgraduate Program, UFC, Fortaleza, Ceara Brazil.

Department of Surgery, Head, LABCEX, UFC, Fortaleza, Ceara Brazil.

出版信息

Diabetol Metab Syndr. 2015 Jul 11;7:62. doi: 10.1186/s13098-015-0058-8. eCollection 2015.

Abstract

BACKGROUND

Diabetes is closely linked with coronary artery disease, either by means of direct effects of hyperglycemia, or indirectly by its frequent association with dyslipidemia. Any treatment for diabetes that has beyond the capacity of reduce glycated hemoglobin, the propensity to improve lipid profile and reduce weight will bring many benefits to patients.

METHOD

We compare the effects of vildagliptin with the gliclazide on lipid profile before and after a standardized meal test, on glycemic control and oxidative stress in diabetic patients using metformin without adequate glycemic control. This is a prospective study of 16 weeks with diabetic patients using metformin without adequate glycemic control. Patients were randomized to receive gliclazide 30-120 mg/day or vildagliptin 100 mg/day.

RESULTS

36 patients were randomized, with no loss of follow up. Regarding the lipid profile the difference observed at the end of the study was a higher HDL level in the vildagliptin group compared with gliclazide fasting (62.3 vs. 51.3 mg/dL, p = 0.021) and postprandial (62.9 vs. 51.1 mg/dL, p = 0.015). We also observed a variation of negative weight (decrease the end compared to the beginning) of the vildagliptin and a positive (increase) in the gliclazide (-0.3 vs. +1.4 Kg, p = 0.048). The decrease in A1c was lower in the vildagliptin group compared to gliclazide (-1.7 vs.-2.3 %, P = 0.031), however there was no difference in the number of patients reaching target glycated hemoglobin <7 % (50 vs. 61.1 %, p = 0.738). Only the group of vildagliptin presented at the end of the study compared to the beginning, decreased insulin values (599.6 vs.705, 59 pg/ml, p = 0.021), glucagon (46.6 vs.65, 2 pg/ml, p = 0.004) and the marker of oxidative stress TBARS (8.0 vs. 9.0 nmol MDA/ml, p = 0.035).

CONCLUSION

Vildagliptin showed some advantages in addition to metformin in relation to addition of gliclazide. Patients treated with vildagliptin had a higher HDL at the end of the study, less variance in weight, reduced insulin and glucagon as well as reduction of oxidative stress.

摘要

背景

糖尿病与冠状动脉疾病密切相关,这要么是通过高血糖的直接作用,要么是通过其与血脂异常的频繁关联间接导致的。任何超出降低糖化血红蛋白能力、改善血脂谱和减轻体重能力的糖尿病治疗方法都将给患者带来诸多益处。

方法

我们比较了维格列汀与格列齐特在标准化餐后试验前后对血脂谱的影响,以及对使用二甲双胍但血糖控制不佳的糖尿病患者的血糖控制和氧化应激的影响。这是一项针对使用二甲双胍但血糖控制不佳的糖尿病患者进行的为期16周的前瞻性研究。患者被随机分为接受30 - 120毫克/天的格列齐特或100毫克/天的维格列汀治疗。

结果

36名患者被随机分组,无失访情况。关于血脂谱,在研究结束时观察到的差异是,维格列汀组的高密度脂蛋白水平高于格列齐特组,空腹时(62.3对51.3毫克/分升,p = 0.021)和餐后(62.9对51.1毫克/分升,p = 0.015)。我们还观察到维格列汀组体重有负变化(与开始时相比结束时减少),而格列齐特组体重有正变化(增加)(-0.3对 +1.4千克,p = 0.048)。与格列齐特相比,维格列汀组糖化血红蛋白的降低幅度较小(-1.7对-2.3%,P = 0.031),然而,达到糖化血红蛋白目标值<7%的患者数量没有差异(50对61.1%,p = 0.738)。与开始时相比,仅维格列汀组在研究结束时胰岛素值降低(599.6对705.59皮克/毫升,p = 0.021)、胰高血糖素降低(46.6对65.2皮克/毫升,p = 0.004)以及氧化应激标志物丙二醛(TBARS)降低(8.0对9.0纳摩尔丙二醛/毫升,p = 0.035)。

结论

与添加格列齐特相比,维格列汀在二甲双胍基础上显示出一些优势。接受维格列汀治疗的患者在研究结束时高密度脂蛋白水平更高,体重变化更小,胰岛素和胰高血糖素降低,氧化应激也减轻。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b985/4499917/9004ef0b87bc/13098_2015_58_Fig1_HTML.jpg

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