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观察到的与预测的糖化血红蛋白在基线时的差异以及基于维格列汀的双重口服疗法治疗 2 型糖尿病患者的治疗反应。

Difference between observed and predicted glycated hemoglobin at baseline and treatment response to vildagliptin-based dual oral therapy in patients with type 2 diabetes.

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.

Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan.

出版信息

Diabetes Res Clin Pract. 2018 Apr;138:119-127. doi: 10.1016/j.diabres.2018.02.002. Epub 2018 Feb 11.

DOI:10.1016/j.diabres.2018.02.002
PMID:29444447
Abstract

AIM

We aimed to investigate the association of difference between observed and predicted glycated hemoglobin (dopHbA1c) and HbA1c reduction after vildagliptin-based oral therapy in patients with type 2 diabetes (T2D).

METHODS

This was a prospective observational study. Adults ≥ 20 years old with T2D and HbA1c ≧7% treated with oral anti-diabetic drugs (OADs) were eligible if their OADs were shifted to vildagliptin-based dual oral therapy. Fasting plasma glucose (FPG) and HbA1c were recorded at baseline, week 12, and week 24. To determine baseline dopHbA1c, a predicted HbA1c was calculated by inserting baseline FPG into a regression equation (HbA1c = FPG ∗ 0.0225 + 4.3806) developed from linear relationship between HbA1c and FPG in an independent cohort of 3239 outpatients with T2D (dopHbA1c = observed HbA1c - predicted HbA1c). Patients were assigned to low (≦0) or high (>0) dopHbA1c group according to their baseline dopHbA1c levels. The study endpoint was changes from baseline to week 24 in HbA1c levels.

RESULTS

A total of 1224 patients were enrolled. Patients with a dopHbA1c >0 had a greater HbA1c reduction after vildagliptin-based dual oral therapy than those with a dopHbA1c ≦0 (-1.5 ± 2.0 vs. -0.4 ± 1.0%, p < 0.001). Baseline dopHbA1c was positively associated with HbA1c reduction from baseline to week 24 (β coefficient 0.883, 95% CI 0.811 to 0.955, p < 0.001), and the association remained significant after adjustment for confounders.

CONCLUSIONS

In T2D patients with an HbA1c ≧7%, a higher baseline dopHbA1c was associated with a greater HbA1c reduction after shifting to vildagliptin-based dual oral therapy.

摘要

目的

我们旨在研究接受基于维格列汀的口服治疗后,观察到的糖化血红蛋白(dopHbA1c)与预测的糖化血红蛋白(predHbA1c)之间的差异与 2 型糖尿病(T2D)患者的 HbA1c 降低之间的关联。

方法

这是一项前瞻性观察性研究。如果符合条件的 20 岁及以上 T2D 患者,其 HbA1c≥7%,且正在接受口服降糖药物(OAD)治疗,且将 OAD 转换为基于维格列汀的双联口服治疗,则可入选。在基线、第 12 周和第 24 周记录空腹血糖(FPG)和 HbA1c。为了确定基线 dopHbA1c,通过将基线 FPG 插入从 3239 例 T2D 门诊患者的 HbA1c 与 FPG 之间的线性关系中得出的回归方程(HbA1c=FPG*0.0225+4.3806)中计算预测的 HbA1c(dopHbA1c=观察到的 HbA1c-预测的 HbA1c)。根据基线 dopHbA1c 水平,将患者分为 dopHbA1c≤0 或 dopHbA1c>0 组。研究终点为 HbA1c 水平从基线到第 24 周的变化。

结果

共纳入 1224 例患者。与 dopHbA1c≤0 的患者相比,dopHbA1c>0 的患者接受基于维格列汀的双联口服治疗后,HbA1c 降低幅度更大(-1.5±2.0 比-0.4±1.0%,p<0.001)。基线 dopHbA1c 与从基线到第 24 周的 HbA1c 降低呈正相关(β系数 0.883,95%CI 0.811 至 0.955,p<0.001),且在调整混杂因素后仍有显著相关性。

结论

在 HbA1c≥7%的 T2D 患者中,较高的基线 dopHbA1c 与转换为基于维格列汀的双联口服治疗后 HbA1c 降低幅度更大相关。

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