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三种预充式、一次性生长激素注射笔的直观性、易用性和偏好比较。

Comparison of intuitiveness, ease of use and preference among three prefilled, disposable growth hormone injection pens.

机构信息

Saarland University Medical Center, Department of Pediatrics, Adolescent Medicine , Kirrberger Str. 1, Geb. 9, 66421 Homburg/Saar , Germany +49 6841 1628315 ; +49 6841 1628433 ;

出版信息

Expert Opin Drug Deliv. 2013 Dec;10(12):1603-12. doi: 10.1517/17425247.2013.829451. Epub 2013 Sep 28.

Abstract

BACKGROUND

Growth hormone (GH) therapy is an effective treatment for growth failure in children. Adherence rates are often low, resulting in poor linear growth. Intuitive and easy-to-use injection devices may improve adherence.

OBJECTIVES

To determine injection time, ease of use, intuitiveness and subjects' preference for Norditropin FlexPro (FP) pen (Novo Nordisk A/S, Denmark) versus Genotropin GoQuick (GQ; Pfizer Inc., USA) and Norditropin NordiFlex (NF; Novo Nordisk) pens.

METHODS

Subjects aged ≥ 10 to < 18 years, with GH deficiency, Turner syndrome or short stature following small-for-gestational-age birth were randomized to intuitiveness (no instruction) or instruction groups. Time taken to perform an injection, dose accuracy and errors were recorded. Intuitiveness, ease-of-learning and overall preference were assessed using questionnaires.

RESULTS

Sixty-four subjects, randomized to intuitiveness (n = 32; mean [SD] age, 13.1 [2.1] years) and instruction (n = 32; 13.4 [2.0] years) groups, required less time to perform the injection with FP than with GQ (mean [SD], intuitiveness 39.8 s [17.0] vs. 65.6 s [42.9], p < 0.01; instruction 40.7 s [19.7] vs. 48.1 s [25.8], p < 0.05), and a similar amount of time with NF. NF and FP were more accurate than GQ (intuitiveness group only). Fewer errors were recorded with NF followed by FP and GQ. FP and NF were considered easier to learn than GQ in both groups. In the intuitiveness group, the majority of subjects (31/32) felt confident using FP without instruction. FP was the device of overall preference in both groups.

CONCLUSION

FP was the device that was most intuitive, easiest to use and the device of overall preference.

摘要

背景

生长激素(GH)治疗是儿童生长障碍的有效治疗方法。但治疗的依从率往往较低,导致线性生长不良。直观易用的注射装置可能会提高治疗的依从性。

目的

确定 Norditropin FlexPro(FP)笔(Novo Nordisk A/S,丹麦)与 Genotropin GoQuick(GQ;辉瑞公司,美国)和 Norditropin NordiFlex(NF;诺和诺德)笔相比,在注射时间、易用性、直观性以及患者对其的偏好方面的差异。

方法

纳入年龄≥10 岁且<18 岁、存在生长激素缺乏症、特纳综合征或小于胎龄儿出生后身材矮小的患者,按是否需要指导(直觉组,n=32;平均年龄[标准差],13.1[2.1]岁)分为两组。记录注射所需时间、剂量准确性和误差。采用问卷调查评估直觉性、易学性和总体偏好。

结果

64 名患者被随机分为直觉组(n=32;平均年龄[标准差],13.1[2.1]岁)和指导组(n=32;平均年龄[标准差],13.4[2.0]岁),结果显示,与 GQ 相比,FP 用于注射所需的时间更短(直觉组,39.8[17.0]秒 vs. 65.6[42.9]秒,p<0.01;指导组,40.7[19.7]秒 vs. 48.1[25.8]秒,p<0.05),且与 NF 所需时间相似。NF 和 FP 比 GQ 更准确(仅在直觉组中)。NF 记录的错误比 FP 和 GQ 更少。FP 和 NF 在两组中均比 GQ 更易于学习。在直觉组中,31/32 名患者在没有指导的情况下对 FP 充满信心。FP 在两组中均为总体偏好的首选设备。

结论

FP 是最直观、最易用且总体偏好最高的设备。

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