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阿卡波糖对使用预混胰岛素的 2 型糖尿病患者血糖变异性的影响与二甲双胍相比(AIM):一项开放标签随机试验。

The Effect of Acarbose on Glycemic Variability in Patients with Type 2 Diabetes Mellitus Using Premixed Insulin Compared to Metformin (AIM): An Open-Label Randomized Trial.

机构信息

Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.

Diabetes Institute of the Walter Reed National Military Medical Center, Bethesda, Maryland.

出版信息

Diabetes Technol Ther. 2020 Apr;22(4):256-264. doi: 10.1089/dia.2019.0290.

Abstract

Acarbose (ACA) can effectively reduce the postprandial blood glucose and has similar antidiabetic effects as metformin (MET). To our knowledge, few studies have compared the effect of ACA or MET on glucose fluctuations. In the present study, we explored the effect of ACA or MET combined with premixed insulin (INS) on glycemic control and glycemic variability (GV). This was an open-label randomized trial that was conducted in type 2 diabetic patients taking premixed insulin. The patients were assigned to 12 weeks of MET ( = 62) or ACA ( = 62) treatment combined with INS. The main outcomes were changes in GV and glycosylated hemoglobin A1c (HbA1c) compared with baseline. Compared with baseline, several GV indices (standard deviation [SD], mean amplitude of glycemic excursions [MAGE]) and blood glucose control indices (mean glucose [MG], time in range [TIR] and HbA1c) were both significantly improved in INS+ACA and INS+MET after 12-week therapy. However, coefficient of variation (CV) was significantly reduced in INS+ACA but not in INS+MET. Moreover, compared with INS+MET, INS+ACA led to a more pronounced percentage change from baseline in CV (26.3% [1.7%-44.6%] vs. 11.9% [-7.0% to 29.9%],  = 0.022), MAGE (40.5% [20.1%-60.5%] vs. 25.2% [-2.1% to 43.4%],  = 0.007) and SD (38.6% [25.2%-57.9%] vs. 30.1% [10.8%-46.5%],  = 0.041). Both MET and ACE combined with INS effectively reduced blood glucose. Compared with MET, ACA combined with INS reduced GV.

摘要

阿卡波糖(ACA)可有效降低餐后血糖,其降血糖作用与二甲双胍(MET)相似。据我们所知,很少有研究比较 ACA 或 MET 对血糖波动的影响。本研究旨在探讨阿卡波糖或二甲双胍联合预混胰岛素(INS)对血糖控制和血糖变异性(GV)的影响。这是一项在接受预混胰岛素治疗的 2 型糖尿病患者中进行的开放标签随机试验。患者被分为 12 周的 MET(n=62)或 ACA(n=62)联合 INS 治疗组。主要结局是与基线相比 GV 和糖化血红蛋白 A1c(HbA1c)的变化。与基线相比,12 周治疗后,INS+ACA 和 INS+MET 组的多个 GV 指标(标准差[SD]、血糖波动幅度[MAGE])和血糖控制指标(平均血糖[MG]、血糖达标时间[TIR]和 HbA1c)均显著改善。然而,INS+ACA 组的变异系数(CV)显著降低,而 INS+MET 组则无显著变化。此外,与 INS+MET 相比,INS+ACA 使 CV 从基线的变化百分比更显著(26.3%[1.7%-44.6%]比 11.9%[-7.0%至 29.9%],  = 0.022)、MAGE(40.5%[20.1%-60.5%]比 25.2%[-2.1%至 43.4%],  = 0.007)和 SD(38.6%[25.2%-57.9%]比 30.1%[10.8%-46.5%],  = 0.041)均有更明显的改善。MET 和 ACE 联合 INS 均可有效降低血糖。与 MET 相比,ACA 联合 INS 可降低 GV。

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