Clinical Operations, Modern Insulin and Devices, Novo Nordisk A/S, Soeborg, Denmark.
Clin Ther. 2009 Dec;31(12):2906-14. doi: 10.1016/j.clinthera.2009.12.014.
Recombinant human growth hormone (GH) is used for the treatment of several conditions associated with growth retardation and metabolic dysfunction. These patients are typically diagnosed and treated from childhood, and treatment adherence in children might be problematic. To potentially improve treatment adherence in children who self-inject GH, it is important that devices for the administration of GH are simple to learn to use, simple to use, and well accepted by patients and their parents or guardians.
This study compared the usability and acceptability of the Norditropin FlexPro pen and NovoFine needles (Novo Nordisk A/S, Bagsvaerd, Denmark) for the administration of GH in pediatric patients with GH deficiency (GHD).
Patients aged 10 to <18 years with GHD and who were receiving daily treatment with selfinjectable GH were included in this open-label, uncontrolled usability test. Patients used the Norditropin FlexPro pen and NovoFine G32 needles to inject test medium into an injection pad; this test was repeated. For the assessment of patients' acceptance of the device, patients completed a 21-item questionnaire regarding pen performance before and during injection.
Seventy patients participated in the study (mean age, 14 years; 67% male; 23% left-handed). No significant differences in demographic characteristics (age, sex, duration of treatment with GH, current device used, and left- or right-handedness) were found between boys and girls, younger and older children, or children who had been receiving short-term (months) or long-term (years) GH treatment. Sixty-eight patients (97%) rated attachment of the needle, priming the device, dialing up the dose, and reading the scale on the device as very easy or quite easy. A total of 99% of patients rated injection of their usual dose and of a 4-mg dose as very easy or quite easy, and pushing the dose button as very easy or quite easy as well as very comfortable or quite comfortable. All of the patients rated hearing the click while performing the injection as very easy or easy. Overall, 64% of patients indicated a preference for the Norditropin FlexPro pen over the device they were currently using.
In this preliminary usability test in pediatric patients, the Norditropin FlexPro pen was perceived as reliable and easy to use and was well accepted. There was also a high level of comfort that GH had been injected properly and that the correct dose had been delivered among the children and adolescents with GHD who participated in the study.
重组人生长激素（GH）用于治疗与生长迟缓及代谢功能障碍相关的多种病症。这些患者通常从儿童期开始被诊断和治疗，儿童患者的治疗依从性可能是个问题。为了提高接受自我注射 GH 治疗的儿童患者的治疗依从性，用于 GH 给药的设备操作简单、使用方便且能被患者及其父母或监护人接受非常重要。
本研究比较了用于治疗生长激素缺乏症（GHD）的儿童患者的 Norditropin FlexPro 笔和 NovoFine 针（Novo Nordisk A/S， Bagsvaerd，丹麦）的易用性和可接受性。
纳入年龄为 10 岁至<18 岁、正在接受每日自我注射 GH 治疗的 GHD 患者，进行这项开放标签、非对照性的易用性测试。患者使用 Norditropin FlexPro 笔和 NovoFine G32 针将试验介质注入注射垫中；重复进行该操作。为评估患者对设备的接受程度，患者在注射前和注射过程中完成了一项关于笔性能的 21 项问题的调查问卷。
70 名患者参与了这项研究（平均年龄 14 岁；67%为男性；23%为左利手）。男孩和女孩、年龄较小的儿童和年龄较大的儿童、接受短期（月）或长期（年）GH 治疗的儿童之间，在人口统计学特征（年龄、性别、GH 治疗持续时间、当前使用的设备、惯用手或非惯用手）方面无显著差异。68 名患者（97%）将针头的连接、设备的预充、剂量的设定和设备上的刻度读数评为非常容易或比较容易。99%的患者将其通常剂量和 4mg 剂量的注射评为非常容易或比较容易，将推动剂量按钮评为非常容易或比较容易，也将其评为非常舒适或比较舒适。所有患者均将注射时听到咔嗒声评为非常容易或容易。总体而言，64%的患者表示更倾向于使用 Norditropin FlexPro 笔，而非他们目前正在使用的设备。
在这项儿科患者的初步易用性测试中，Norditropin FlexPro 笔被认为是可靠且易于使用的，且患者接受度良好。接受研究的 GHD 儿童和青少年也非常满意，认为 GH 已正确注射且已给予正确剂量。
