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索马帕西坦笔式注射器和洛那培戈生长激素自动注射器的可用性和偏好评估:一项针对美国青少年患者及其护理人员的模拟使用研究结果

Usability and Preference Evaluation of the Somapacitan Pen-Injector and Lonapegsomatropin Autoinjector: Results of a US-Based Simulated-Use Study with Adolescent Patients and Caregivers.

作者信息

Medina Johan, Ter-Borch Gitte, Kelepouris Nicky, Hamilton Sophie, Gonczi Maya, Hansen Jørgen Vinsløv, Akhtar Shahid

机构信息

Medical & Science, Devices & Digital Health, Novo Nordisk A/S, Søborg, Denmark.

Usability Engineering, Devices and Delivery Solutions, Novo Nordisk A/S, Hillerød, Denmark.

出版信息

Patient Prefer Adherence. 2025 Apr 23;19:1119-1131. doi: 10.2147/PPA.S505952. eCollection 2025.

DOI:10.2147/PPA.S505952
PMID:40296897
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12035412/
Abstract

PURPOSE

To compare the preference and ease of use/learning how to use, of the somapacitan (Sogroya) pen-injector and the lonapegsomatropin (Skytrofa) autoinjector among adolescents with growth-related disorders (GRDs) and caregivers of individuals with GRDs.

PATIENTS AND METHODS

This was a randomized, open-label, multicenter, usability-based preference and handling study with a crossover design. Participants recruited were adolescents aged 10-17 years with a GRD, able to self-administer growth hormone (GH) or perform some of substeps required; and caregivers aged ≥18 years and regular care providers for individuals with GRDs. Participants completed a series of simulated injections using both devices and completed a Device Handling and Preference Assessment Questionnaire (DHPAQ). Training time and time to prepare and inject with each device were also evaluated.

RESULTS

Seventy participants were recruited overall; 35 in each of the adolescent and caregiver groups. Most (78.6%) participants preferred the somapacitan device to the lonapegsomatropin device (95% confidence interval [CI] 67.1-87.5). The lonapegsomatropin device was preferred by 14.3% of participants, and 7.1% indicated no preference. Most participants indicated that somapacitan device was easy to use (97.1% [95% CI 90.1-99.7]) and learn how to use (95.7% [95% CI 88.0-99.1]). The same was reported for the lonapegsomatropin device by 57.1% (95% CI 44.8-68.9) and 54.3% (95% CI 41.9-66.3%) of participants, respectively. Average time taken to complete training for the somapacitan device and to prepare and inject was shorter than that for the lonapegsomatropin device (5.9 min vs 24.0 min, and 0.9 vs 10.6 min, respectively).

CONCLUSION

The somapacitan device was preferred over the lonapegsomatropin device among adolescents with GRDs and caregivers of individuals with GRDs. Individuals receiving GH treatment via the somapacitan device may be more likely to have higher treatment adherence than those using the lonapegsomatropin device.

摘要

目的

比较生长相关疾病(GRD)青少年及GRD患者的照护者对索马帕西坦(Sogroya)笔式注射器和洛那普索马促生长素(Skytrofa)自动注射器的偏好以及使用/学习使用的难易程度。

患者与方法

这是一项采用交叉设计的随机、开放标签、多中心、基于可用性的偏好和操作研究。招募的参与者为年龄在10 - 17岁、患有GRD且能够自行注射生长激素(GH)或完成部分所需子步骤的青少年,以及年龄≥18岁且为GRD患者提供定期照护的照护者。参与者使用两种设备完成一系列模拟注射,并完成一份设备操作与偏好评估问卷(DHPAQ)。还评估了使用每种设备的培训时间以及准备和注射所需时间。

结果

总共招募了70名参与者,青少年组和照护者组各35名。大多数(78.6%)参与者更喜欢索马帕西坦设备而非洛那普索马促生长素设备(95%置信区间[CI] 67.1 - 87.5)。14.3%的参与者更喜欢洛那普索马促生长素设备,7.1%表示无偏好。大多数参与者表示索马帕西坦设备易于使用(97.1% [95% CI 90.1 - 99.7])且易于学习如何使用(95.7% [95% CI 88.0 - 99.1])。分别有57.1%(95% CI 44.8 - 68.9)和54.3%(95% CI 41.9 - 66.3%)的参与者对洛那普索马促生长素设备也给出了相同评价。完成索马帕西坦设备培训以及准备和注射的平均时间短于洛那普索马促生长素设备(分别为5.9分钟对24.0分钟,以及0.9分钟对10.6分钟)。

结论

在患有GRD的青少年及GRD患者的照护者中,索马帕西坦设备比洛那普索马促生长素设备更受青睐。通过索马帕西坦设备接受GH治疗的个体可能比使用洛那普索马促生长素设备的个体更有可能具有更高的治疗依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/39606989d5da/PPA-19-1119-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/d57f40f9c5e4/PPA-19-1119-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/94486df1f7e2/PPA-19-1119-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/39606989d5da/PPA-19-1119-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/d57f40f9c5e4/PPA-19-1119-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/94486df1f7e2/PPA-19-1119-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af5/12035412/39606989d5da/PPA-19-1119-g0003.jpg

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本文引用的文献

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2
Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.每周索马帕坦治疗 GH 缺乏症:REAL 3 研究的 4 年疗效、安全性和治疗/疾病负担结果。
J Clin Endocrinol Metab. 2023 Sep 18;108(10):2569-2578. doi: 10.1210/clinem/dgad183.
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Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.
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J Clin Endocrinol Metab. 2022 Nov 25;107(12):3378-3388. doi: 10.1210/clinem/dgac513.
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Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results.Lonapegsomatropin 在儿童生长激素缺乏症中的安全性和疗效:enliGHten 试验 2 年结果。
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