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日本儿科患者对新型生长激素注射装置的患者偏好:一项开放标签研究的结果

Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients.

作者信息

Kappelgaard Anne-Marie, Mikkelsen Søren, Knudsen Thomas Kamp, Fuchs Gitte Schøning

机构信息

University of Aarhus and Growth Hormone Global Marketing, Novo Nordisk A/S, Virum, Denmark.

出版信息

J Pediatr Endocrinol Metab. 2011;24(7-8):489-96. doi: 10.1515/jpem.2011.252.

DOI:10.1515/jpem.2011.252
PMID:21932587
Abstract

BACKGROUND

Growth hormone deficiency (GHD) in children is treated with daily subcutaneous injections of GH. Poor adherence, resulting in suboptimal treatment outcomes, is common due to long-term treatment. Injection devices that are considered easy to use by patients or guardians could improve adherence.

OBJECTIVE

This study assessed the usability of the Norditropin FlexPro pen injector and NovoTwist needles (both Novo Nordisk A/S, Bagsvaerd, Denmark) in Japanese children and adolescents with GHD.

METHODS

This open-label, uncontrolled usability test included patients aged 6 to < or = 18 years with GHD currently receiving daily injections of GH with pen injectors. Patients performed repeated injections of test medium into a foam cushion. Patients or guardians completed a questionnaire on pen handling.

RESULTS

A total of 73/74 patients (99%) rated Norditropin FlexPro easy to handle, reporting no technical complaints. In total, 60 (81%) preferred Norditropin FlexPro over their current device, with 12% preferring their current device and 7% not sure.

CONCLUSIONS

Norditropin FlexPro was perceived as easy to use and reliable, and was well accepted and preferred over the current device for the administration of GH in children and adolescents. Patients were more confident that Norditropin FlexPro delivered the right dose compared with their current device.

摘要

背景

儿童生长激素缺乏症(GHD)采用生长激素每日皮下注射治疗。由于长期治疗,依从性差导致治疗效果欠佳的情况很常见。患者或监护人认为易于使用的注射装置可能会提高依从性。

目的

本研究评估了诺和笔FlexPro注射笔和诺和锐30笔芯(均由丹麦 Bagsvaerd 的诺和诺德公司生产)在日本患有 GHD 的儿童和青少年中的易用性。

方法

这项开放标签、非对照的易用性测试纳入了年龄在 6 岁至 18 岁之间、目前正在使用笔式注射器每日注射生长激素的 GHD 患者。患者将测试介质反复注射到泡沫垫中。患者或监护人完成了一份关于笔操作的问卷。

结果

共有 73/74 名患者(99%)认为诺和笔 FlexPro 易于操作,未提出技术方面的抱怨。总计 60 名(81%)患者更喜欢诺和笔 FlexPro 而不是他们当前使用的装置,12% 的患者更喜欢他们当前的装置,7% 的患者不确定。

结论

诺和笔 FlexPro 被认为易于使用且可靠,在儿童和青少年生长激素给药方面,比当前装置更易被接受且更受青睐。与他们当前使用的装置相比,患者对诺和笔 FlexPro 能准确注射正确剂量更有信心。

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