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在A1chieve研究中,从基础-餐时胰岛素方案转换过来的2型糖尿病患者使用双相门冬胰岛素30的安全性和有效性。

Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study.

作者信息

Dieuzeide Guillermo, Chuang Lee-Ming, Almaghamsi Abdulrahman, Zilov Alexey, Chen Jian-Wen, Lavalle-González Fernando J

机构信息

Centro de Atención Integral en Diabetes, Endocrinología y Metabolismo, Chacabuco, Province of Buenos Aires, Argentina.

Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.

出版信息

Prim Care Diabetes. 2014 Jul;8(2):111-7. doi: 10.1016/j.pcd.2013.07.005. Epub 2013 Aug 14.

Abstract

AIMS

Biphasic insulin aspart 30 allows fewer daily injections versus basal-bolus insulin regimens, which may improve adherence and treatment outcome. This sub-analysis of the observational A1chieve study assessed clinical safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes previously receiving basal-bolus insulin regimens.

METHODS

A1chieve was an international, open-label, 24-week study in people with type 2 diabetes starting/switching to biphasic insulin aspart 30, insulin detemir or insulin aspart. This sub-analysis assessed patients switching from insulin glargine- or neutral protamine Hagedorn insulin-based basal-bolus insulin regimens to biphasic insulin aspart 30.

RESULTS

1024 patients were included. At 24 weeks, glycated haemoglobin and fasting plasma glucose were significantly reduced from baseline in both cohorts (all p<0.001). The proportion reporting any hypoglycaemia, major hypoglycaemia or nocturnal hypoglycaemia was significantly reduced after 24 weeks (all p<0.05). No serious adverse drug reactions were reported. Both cohorts had significantly improved health-related quality of life (HRQoL; p<0.001).

CONCLUSIONS

24 weeks after switching from basal-bolus insulin regimens to biphasic insulin aspart 30, glycaemic control and HRQoL were significantly improved, and hypoglycaemia was significantly reduced. This suggests that people with type 2 diabetes inadequately controlled on basal-bolus insulin regimens can consider biphasic insulin aspart 30.

摘要

目的

与基础-餐时胰岛素方案相比,门冬胰岛素30双相制剂每日所需注射次数更少,这可能会提高依从性和治疗效果。这项对观察性A1chieve研究的亚分析评估了门冬胰岛素30双相制剂在之前接受基础-餐时胰岛素方案的2型糖尿病患者中的临床安全性和有效性。

方法

A1chieve是一项针对开始使用/改用门冬胰岛素30双相制剂、地特胰岛素或门冬胰岛素的2型糖尿病患者的国际开放标签、为期24周的研究。该亚分析评估了从甘精胰岛素或中性鱼精蛋白锌胰岛素基础-餐时胰岛素方案改用门冬胰岛素30双相制剂的患者。

结果

共纳入1024例患者。在24周时,两个队列的糖化血红蛋白和空腹血糖均较基线水平显著降低(所有p<0.001)。报告有任何低血糖、严重低血糖或夜间低血糖的比例在24周后显著降低(所有p<0.05)。未报告严重药物不良反应。两个队列的健康相关生活质量(HRQoL)均有显著改善(p<0.001)。

结论

从基础-餐时胰岛素方案改用门冬胰岛素30双相制剂24周后,血糖控制和HRQoL显著改善,低血糖显著减少。这表明在基础-餐时胰岛素方案控制不佳的2型糖尿病患者可考虑使用门冬胰岛素30双相制剂。

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