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阿根廷磺脲类药物治疗的2型糖尿病患者样本中低血糖的患病率:糖尿病管理的真实疗效和护理模式(RECAP-DM)研究

Prevalence of hypoglycemia among a sample of sulfonylurea-treated patients with Type 2 diabetes mellitus in Argentina: The real-life effectiveness and care patterns of diabetes management (RECAP-DM) study.

作者信息

Gonzalez Claudio, Monti Cyntia, Pinzon Adolfo, Monsanto Homero, Ejzykowicz Flavia

机构信息

Merck & Co., Inc., Kenilworth, NJ, USA.

MSD, Argentina.

出版信息

Endocrinol Diabetes Nutr (Engl Ed). 2018 Dec;65(10):592-602. doi: 10.1016/j.endinu.2018.05.014. Epub 2018 Jul 31.

Abstract

AIM

Strict blood glucose control in the treatment of diabetes can sometimes lead to hypoglycemia. The main aim of this study was to assess the prevalence of hypoglycemia among patients receiving sulfonylureas alone, or in combination with metformin, for the treatment of Type 2 Diabetes Mellitus (T2DM) in Argentina.

METHODS

This is a real life, multi-center, retrospective, and cross-sectional study based on clinical chart reviews including cross-sectional data, and evaluation of patient questionnaires of T2DM patients (>30 years), treated with sulfonylureas alone or in combination with metformin, during a routine clinic visit in 16 medical centers across Argentina. Socio-demographic and clinical parameters were collected from medical records, as well as hypoglycemic events from both the medical records and the patient questionnaires. The glycated hemoglobin (HbA) levels were obtained from medical records as well as a blood test.

RESULTS

The study included a total of 397 patients with a mean age of 62.5 years, diagnosed for 9.9 years, and 54.2% male. Mean HbA levels were 8.1%, (65mmol/mol) at enrolment, with 36.4% being in control (HbA<7%, (53mmol/mol). Patients with HbA<7%, (53mmol/mol) were significantly older, diagnosed at older age, and had lower triglyceride levels. Almost 50% reported hypoglycemic episodes that were mostly mild, and with women more likely to report them. The large majority (86%) were on combined metformin and sulfonylureas, most commonly Glibenclamide (48.6%). Patients on combined therapy were significantly younger and more likely to have uncontrolled diabetes.

CONCLUSIONS

This study demonstrated that out of a sample of 397 patients with T2DM treated with sulfonylureas alone or in combination with metformin in Argentina, around 50% of them reported symptoms of hypoglycemia induced by sulfonylureas, and one third of them achieved target HbA<7% levels.

摘要

目的

糖尿病治疗中严格的血糖控制有时会导致低血糖。本研究的主要目的是评估在阿根廷接受单独使用磺脲类药物或联合二甲双胍治疗2型糖尿病(T2DM)的患者中低血糖的发生率。

方法

这是一项基于临床病历回顾的真实生活、多中心、回顾性横断面研究,包括横断面数据以及对T2DM患者(年龄>30岁)的患者问卷评估,这些患者在阿根廷16个医疗中心的常规门诊就诊期间单独使用磺脲类药物或联合二甲双胍进行治疗。从医疗记录中收集社会人口统计学和临床参数,以及医疗记录和患者问卷中的低血糖事件。糖化血红蛋白(HbA)水平从医疗记录以及血液检测中获得。

结果

该研究共纳入397例患者,平均年龄62.5岁,诊断时间9.9年,男性占54.2%。入组时平均HbA水平为8.1%(65mmol/mol),36.4%的患者血糖得到控制(HbA<7%,(53mmol/mol)。HbA<7%(53mmol/mol)的患者年龄显著更大,确诊时年龄更大,甘油三酯水平更低。近50%的患者报告有低血糖发作,大多为轻度,女性更易报告。绝大多数(86%)患者使用二甲双胍和磺脲类药物联合治疗,最常用的是格列本脲(48.6%)。联合治疗的患者年龄显著更小,糖尿病控制不佳的可能性更大。

结论

本研究表明,在阿根廷397例单独使用磺脲类药物或联合二甲双胍治疗的T2DM患者样本中,约50%的患者报告有磺脲类药物引起的低血糖症状,其中三分之一的患者HbA水平达到<7%的目标值。

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