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吡格列酮与阿卡波糖对糖尿病患者肾脏结局的影响:一项随机对照研究。

Renal Outcomes of Pioglitazone Compared with Acarbose in Diabetic Patients: A Randomized Controlled Study.

作者信息

Chen Yu-Hsin, Tarng Der-Cherng, Chen Harn-Shen

机构信息

Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.

Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.

出版信息

PLoS One. 2016 Nov 3;11(11):e0165750. doi: 10.1371/journal.pone.0165750. eCollection 2016.

Abstract

OBJECTIVE

To assess the effect of pioglitazone on renal outcome, including urinary albumin excretion and estimated glomerular filtration rate (eGFR), in diabetic patients.

DESIGN

A prospective, randomized, open-labeled, controlled study.

SETTING

Taipei Veterans General Hospital.

PATIENTS

Sixty type 2 diabetic patients treated with sulfonylureas and metformin, whose glycated hemoglobin (HbA1c) levels were between 7% and 10% and eGFR was between 45 and 125 mL/min/1.73 m2.

INTERVENTION

The patients were randomized to receive acarbose or pioglitazone and followed up for 6 months. Thirty patients were randomly assigned to receive acarbose, and 30 patients were assigned to receive pioglitazone.

MEASUREMENTS

The primary study endpoint was the changes in the urinary albumin-to-creatinine ratio (UACR). The secondary endpoint was the changes in eGFR and other parameters.

RESULTS

After 6 months of treatment, the mean changes in UACR were -18 ± 104 and 12 ± 85 (p = 0.25, between groups) for the acarbose and pioglitazone groups, respectively. The mean changes in eGFR were 0 ± 14 and -7 ± 16 mL/min/1.73 m2 (p = 0.09, between groups) for the acarbose and pioglitazone groups, respectively. The reductions in HbA1c were similar in both groups. Fasting blood glucose was lower in the pioglitazone group than in the acarbose group. Significant body weight gain was observed in the pioglitazone group as compared with the acarbose group (1.3 ± 2.8 vs. -0.6 ± 1.5 kg, p = 0.002).

CONCLUSION

In type 2 diabetic patients who were treated with sulfonylureas and metformin and possessed HbA1c levels between 7% and 10%, additional acarbose or pioglitazone for 6 months provided similar glycemic control and eGFR and UACR changes. In the pioglitazone group, the patients exhibited significant body weight gain.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01175486.

摘要

目的

评估吡格列酮对糖尿病患者肾脏结局的影响,包括尿白蛋白排泄和估算肾小球滤过率(eGFR)。

设计

一项前瞻性、随机、开放标签、对照研究。

地点

台北荣民总医院。

患者

60例接受磺脲类药物和二甲双胍治疗的2型糖尿病患者,糖化血红蛋白(HbA1c)水平在7%至10%之间,eGFR在45至125 mL/(min/1.73 m²)之间。

干预措施

患者被随机分为接受阿卡波糖或吡格列酮治疗,并随访6个月。30例患者被随机分配接受阿卡波糖治疗,30例患者被分配接受吡格列酮治疗。

测量指标

主要研究终点是尿白蛋白与肌酐比值(UACR)的变化。次要终点是eGFR和其他参数的变化。

结果

治疗6个月后,阿卡波糖组和吡格列酮组UACR的平均变化分别为-18±104和12±85(组间p = 0.25)。阿卡波糖组和吡格列酮组eGFR的平均变化分别为0±14和-7±16 mL/(min/1.73 m²)(组间p = 0.09)。两组HbA1c的降低相似。吡格列酮组的空腹血糖低于阿卡波糖组。与阿卡波糖组相比,吡格列酮组观察到显著的体重增加(1.3±2.8 vs. -0.6±1.5 kg,p = 0.002)。

结论

在接受磺脲类药物和二甲双胍治疗且HbA1c水平在7%至10%之间的2型糖尿病患者中,额外使用阿卡波糖或吡格列酮6个月可提供相似的血糖控制以及eGFR和UACR变化。在吡格列酮组中,患者出现了显著的体重增加。

试验注册

ClinicalTrials.gov NCT01175486。

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