• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

新型预填充生长激素笔Norditropin NordiFlex(®)的用户评估：一项IV期多中心前瞻性研究。

User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study.

作者信息

Tauber Maithé, Jaquet Delphine, Jesuran-Perelroizen Monique, Petrus Marc, Bertrand Anne Marie, Coutant Regis

机构信息

Hôpital des Enfants, Toulouse.

出版信息

Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013.

DOI:10.2147/PPA.S43460
PMID:23737664
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3668964/
Abstract

UNLABELLED

BACKGROUNDAIM: In growth disorders, ensuring long-term growth hormone therapy (GHT) remains a challenge that might compromise the clinical outcome. Consequently, strategies aiming at alleviating the burden of daily injection might improve the treatment benefit. The study reported here was performed to assess the ease of use of Norditropin NordiFlex(®) (Novo Nordisk, Princeton, NJ, USA) compared with that of the devices previously used in children treated with GHT with recombinant somatropin.

METHODS

This Phase IV prospective, multicenter, open-label study was conducted in France. All patients received Norditropin NordiFlex for 6 weeks. Oral questionnaires were administered by the physician to the patients and/or the parents at inclusion and at the final visit.

RESULTS

This study included 103 patients aged between 6 and 17 years. The patients assessed Norditropin NordiFlex as significantly easier to use than their previous device (median value = 7.5, P < 0.001). Almost three-quarters of patients (64.4%) preferred Norditropin NordiFlex to their previous device. Among physicians and nurses, 73% assessed Norditropin NordiFlex training as "very easy" and 26% as "easy." Norditropin NordiFlex improved patient autonomy, with 41% of patients able to self-inject the treatment.

CONCLUSION

This study has shown that Norditropin NordiFlex is reliable, safe, and easy to use and most study patients preferred it to their previous device. These characteristics may improve the adherence to GHT.

摘要

未标注

背景与目的：在生长障碍中，确保长期生长激素治疗（GHT）仍然是一项可能影响临床结果的挑战。因此，旨在减轻每日注射负担的策略可能会提高治疗效果。本研究旨在评估诺和诺德生长激素笔（Norditropin NordiFlex，®）（美国新泽西州普林斯顿市诺和诺德公司）与先前用于接受重组生长激素治疗的儿童的装置相比的易用性。

方法

这项IV期前瞻性、多中心、开放标签研究在法国进行。所有患者接受诺和诺德生长激素笔治疗6周。在纳入研究时和末次随访时，医生向患者和/或家长发放口服问卷。

结果

本研究纳入了103名年龄在6至17岁之间的患者。患者评估诺和诺德生长激素笔比他们之前使用的装置显著更容易使用（中位数=7.5，P<0.001）。近四分之三的患者（64.4%）更喜欢诺和诺德生长激素笔而不是他们之前使用的装置。在医生和护士中，73%认为诺和诺德生长激素笔的培训“非常容易”，26%认为“容易”。诺和诺德生长激素笔提高了患者的自主性，41%的患者能够自行注射治疗药物。

结论

本研究表明，诺和诺德生长激素笔可靠、安全且易于使用，大多数研究患者更喜欢它而不是他们之前使用的装置。这些特性可能会提高对生长激素治疗的依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/15f702d90468/ppa-7-455f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/4aef43b55c74/ppa-7-455f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/ce206162ff33/ppa-7-455f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/15f702d90468/ppa-7-455f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/4aef43b55c74/ppa-7-455f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/ce206162ff33/ppa-7-455f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be7/3668964/15f702d90468/ppa-7-455f3.jpg

相似文献

1
User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study.新型预填充生长激素笔Norditropin NordiFlex(®)的用户评估：一项IV期多中心前瞻性研究。
Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013.
2
Patient Acceptance, Ease of Use, and Preference for Norditropin NordiFlex with NordiFlex PenMate: Results from an Open-Label, User Survey of Everyday Use.患者对诺和诺德生长激素Norditropin NordiFlex与NordiFlex PenMate笔的接受度、易用性及偏好：一项关于日常使用的开放标签用户调查结果
ISRN Endocrinol. 2011;2011:803948. doi: 10.5402/2011/803948. Epub 2011 Sep 20.
3
Ease of use and acceptability of a new pen device for the administration of growth hormone therapy in pediatric patients: an open-label, uncontrolled usability test.一种新的注射笔设备在儿科患者生长激素治疗中的使用便捷性和可接受性：一项开放性、非对照性使用测试。
Clin Ther. 2009 Dec;31(12):2906-14. doi: 10.1016/j.clinthera.2009.12.014.
4
Erratum: User assessment of Norditropin NordiFlex®, a new prefilled growth hormone pen: a Phase IV multicenter prospective study [Corrigendum].勘误：诺和诺德新预填充生长激素笔Norditropin NordiFlex®的用户评估：一项IV期多中心前瞻性研究[勘误]
Patient Prefer Adherence. 2013 Aug 19;7:803. doi: 10.2147/ppa.s50485. eCollection 2013.
5
Assessment of user-friendliness of the Norditropin FlexPro for pediatric patients treated with recombinant human growth hormone: results of an open-label user survey.评估诺德生长素FlexPro对接受重组人生长激素治疗的儿科患者的用户友好性：一项开放标签用户调查的结果。
J Pediatr Endocrinol Metab. 2013;26(11-12):1105-10. doi: 10.1515/jpem-2013-0071.
6
Norditropin SimpleXx: a liquid human growth hormone formulation, a pen system and an auto-insertion device.诺德生长激素简易型：一种液态人生长激素制剂、一种笔式装置和一种自动注射装置。
Horm Res. 1999;51 Suppl 3:109-12. doi: 10.1159/000053171.
7
Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients.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
J Pediatr Endocrinol Metab. 2011;24(7-8):489-96. doi: 10.1515/jpem.2011.252.
8
Product wastage from modern human growth hormone administration devices: a laboratory and computer simulation analysis.现代人生长激素给药装置的产品浪费：实验室和计算机模拟分析
Med Devices (Auckl). 2013 Aug 1;6:107-14. doi: 10.2147/MDER.S45909. eCollection 2013.
9
Comparison of intuitiveness, ease of use and preference among three prefilled, disposable growth hormone injection pens.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。
Expert Opin Drug Deliv. 2013 Dec;10(12):1603-12. doi: 10.1517/17425247.2013.829451. Epub 2013 Sep 28.
10
Comparison of injection dose force, accuracy and precision among three growth hormone injection devices.三种生长激素注射装置的注射剂量力、准确性和精密度比较。
Expert Rev Med Devices. 2013 May;10(3):321-7. doi: 10.1586/erd.13.12. Epub 2013 Apr 8.

引用本文的文献

1
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.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
Patient Prefer Adherence. 2025 Apr 23;19:1119-1131. doi: 10.2147/PPA.S505952. eCollection 2025.
2
Efficacy, safety, and patient satisfaction of norditropin and sogroya in patients with growth hormone deficiency: a systematic review and meta-analysis of randomized controlled trials.生长激素缺乏症患者使用诺泽和索马鲁肽的疗效、安全性和患者满意度：一项随机对照试验的系统评价和荟萃分析。
Endocrine. 2024 Aug;85(2):545-557. doi: 10.1007/s12020-024-03834-z. Epub 2024 Apr 24.
3

本文引用的文献

1
Evaluation of the Use of PenNeedle(®) 32G Taper in Children being Treated with Growth Hormone.使用PenNeedle(®) 32G锥形针头治疗生长激素缺乏症儿童的评估。
Clin Pediatr Endocrinol. 2008;17(1):1-7. doi: 10.1297/cpe.17.1. Epub 2008 Feb 14.
2
Clinical and humanistic aspects of growth hormone deficiency and growth-related disorders.生长激素缺乏症及相关生长障碍的临床与人文方面
Am J Manag Care. 2011 Dec;17 Suppl 18:eS4-10.
3
Patient Acceptance, Ease of Use, and Preference for Norditropin NordiFlex with NordiFlex PenMate: Results from an Open-Label, User Survey of Everyday Use.
Interventions Designed to Improve Adherence to Growth Hormone Treatment for Pediatric Patients and Their Families: A Narrative Review.旨在提高儿科患者及其家庭对生长激素治疗依从性的干预措施：一项叙述性综述。
Pharmaceutics. 2022 Nov 4;14(11):2373. doi: 10.3390/pharmaceutics14112373.
4
Clinicians' Feedback on Patient/Carer Experience After Switching of Growth Hormone Treatment in Pediatric Patients During COVID-19.临床医生关于新冠疫情期间儿科患者生长激素治疗转换后患者/照顾者体验的反馈
Patient Prefer Adherence. 2021 Sep 21;15:2113-2123. doi: 10.2147/PPA.S325914. eCollection 2021.
5
Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial.重组人生长激素一次性笔与可重复使用装置相比的易用性、偏好性和安全性：一项多中心、单臂、开放标签、转换、前瞻性IV期试验。
Patient Prefer Adherence. 2019 Dec 20;13:2195-2205. doi: 10.2147/PPA.S229536. eCollection 2019.
6
Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults.一项国际多中心试验的结果，该试验评估了一种新开发的一次性注射笔在初治儿童和成人生长激素缺乏症治疗中的易用性和偏好性。
Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014.
患者对诺和诺德生长激素Norditropin NordiFlex与NordiFlex PenMate笔的接受度、易用性及偏好：一项关于日常使用的开放标签用户调查结果
ISRN Endocrinol. 2011;2011:803948. doi: 10.5402/2011/803948. Epub 2011 Sep 20.
4
Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents.易泵™电子生长激素自动注射器的治疗依从性和患者接受度：来自 824 名儿童及其家长的调查结果。
BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.
5
Adherence remains a challenge for patients receiving growth hormone therapy.对于接受生长激素治疗的患者来说，坚持治疗仍然是一项挑战。
Pediatr Endocrinol Rev. 2009 Jun;6 Suppl 4:545-8.
6
Monitoring of concordance in growth hormone therapy.生长激素治疗一致性的监测。
Arch Dis Child. 2008 Feb;93(2):147-8. doi: 10.1136/adc.2006.114249. Epub 2007 Sep 3.
7
Understanding and meeting the needs of those using growth hormone injection devices.了解并满足使用生长激素注射装置者的需求。
BMC Endocr Disord. 2006 Oct 11;6:5. doi: 10.1186/1472-6823-6-5.
8
Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth.生长激素监测中的患者结局：给药装置对依从性和生长的影响。
Pediatr Endocrinol Rev. 2005 Feb;2 Suppl 3:327-31.
9
Pain perception after subcutaneous injections of media containing different buffers.皮下注射含有不同缓冲液的介质后的疼痛感知。
Basic Clin Pharmacol Toxicol. 2006 Feb;98(2):218-21. doi: 10.1111/j.1742-7843.2006.pto_271.x.
10
Adherence to medication.药物依从性
N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100.