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一种新型预填充胰岛素笔的剂量准确性和注射力评估:与一种广泛使用的预填充胰岛素笔的比较。

An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen.

机构信息

Novo Nordisk A/S, Brennum Park, DK-3400 Hillerød, Denmark.

出版信息

Expert Opin Drug Deliv. 2011 Oct;8(10):1271-6. doi: 10.1517/17425247.2011.615308. Epub 2011 Sep 2.

DOI:10.1517/17425247.2011.615308
PMID:21883036
Abstract

OBJECTIVE

FlexTouch® (FT) (Novo Nordisk A/S, Bagsværd, Denmark) is a new prefilled insulin pen with a novel injection mechanism encompassing no push-button extension at any dose-setting. This study assessed the dose accuracy and injection force of FT compared with the established Next Generation FlexPen® (NGFP) (Novo Nordisk A/S Bagsværd, Denmark).

RESEARCH DESIGN AND METHODS

Dose accuracy was measured at the minimum, medium and maximum doses (FT, 1, 40 and 80 international units (IU) and NGFP, 1, 30 and 60 IU). Injection force was measured during the injection of the maximum dose (FT, 80 IU; NGFP, 60 IU).

MAIN OUTCOMES

FT and NGFP delivered insulin accurately and consistently at all doses (mean ± s.d., FT at 1 IU, 0.98 ± 0.07; 40 IU, 39.86 ± 0.33; 80 IU, 79.76 ± 0.64; NGFP at 1 IU, 1.02 ± 0.08; 30 IU, 29.69 ± 0.30; 60 IU, 59.50 ± 0.51). FT had a significantly (p < 0.0001) lower injection force than NGFP.

CONCLUSIONS

The study demonstrated that FT and NGFP deliver insulin accurately and consistently at low, medium and high doses. The novel torque spring injection mechanism of FT results in a significantly lower injection force than NGFP and a pen requiring less thumb-pressure to inject insulin may be welcomed by many people with diabetes.

摘要

目的

FlexTouch®(FT)(丹麦诺和诺德公司)是一种新型预填充胰岛素笔,其新型注射机构在任何剂量设置时都没有推键延伸。本研究评估了 FT 与已确立的下一代 FlexPen®(NGFP)(丹麦诺和诺德公司)在剂量准确性和注射力方面的差异。

研究设计和方法

在最小、中、最大剂量(FT:1、40 和 80 国际单位(IU)和 NGFP:1、30 和 60 IU)下测量剂量准确性。在最大剂量(FT:80 IU;NGFP:60 IU)注射过程中测量注射力。

主要结果

FT 和 NGFP 在所有剂量下均能准确、一致地输送胰岛素(平均值±标准差,FT 在 1 IU 时为 0.98±0.07;40 IU 时为 39.86±0.33;80 IU 时为 79.76±0.64;NGFP 在 1 IU 时为 1.02±0.08;30 IU 时为 29.69±0.30;60 IU 时为 59.50±0.51)。FT 的注射力明显低于 NGFP(p<0.0001)。

结论

该研究表明,FT 和 NGFP 在低、中、高剂量下均能准确、一致地输送胰岛素。FT 的新型扭矩弹簧注射机构可显著降低注射力,对于许多糖尿病患者而言,使用需要施加较小拇指压力即可注射胰岛素的笔可能会受到欢迎。

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