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生长激素治疗管理的进展:聚焦于诺德人体生长激素笔式注射器 Flexpro®。

Developments in administration of growth hormone treatment: focus on Norditropin® Flexpro®.

作者信息

Yuen Kevin C J, Amin Rakesh

机构信息

Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Medicine, Oregon Health and Science University, Portland, Oregon, USA.

出版信息

Patient Prefer Adherence. 2011 Mar 10;5:117-24. doi: 10.2147/PPA.S10985.

Abstract

Recombinant human growth hormone is used for the treatment of growth failure in children and metabolic dysfunction in adults with growth hormone deficiency. However, conventional growth hormone therapy requires daily subcutaneous injections that may affect treatment adherence, and subsequently efficacy outcomes. To enhance potential treatment adherence, improved ease of use of growth hormone delivery devices and long-acting growth hormone formulations are now being developed. Flexpro(®), approved by the US Food and Drug Administration in March 2010, is the most recent pen device developed by Novo Nordisk A/S to deliver Norditropin(®). It is a multidose, premixed, preloaded, disposable pen device that requires relatively less force to inject and does not require refrigeration after initial use. Dose adjustments can be optimized by small dose increments of the pen delivery device at 0.025 mg, 0.05 mg and 0.1 mg. In addition, for patients with needle anxiety, NovoFine(®) needles, some of the shortest and thinnest available, and Autocover(®), which hides the needle during injections, can be used with the Flexpro pen device. This article reviews the Norditropin Flexpro pen device in the context of other growth hormone delivery devices, sustained-release growth hormone formulations in development, and future prospects.

摘要

重组人生长激素用于治疗儿童生长发育迟缓以及成人生长激素缺乏症的代谢功能障碍。然而,传统的生长激素疗法需要每日皮下注射,这可能会影响治疗依从性,进而影响疗效。为提高潜在的治疗依从性,目前正在研发使用更便捷的生长激素给药装置和长效生长激素制剂。Flexpro(®)于2010年3月获得美国食品药品监督管理局批准,是诺和诺德公司(Novo Nordisk A/S)研发的用于注射诺德生长激素(Norditropin®)的最新笔式装置。它是一种多剂量、预混、预装、一次性使用的笔式装置,注射所需力度相对较小,初次使用后无需冷藏。笔式给药装置可按0.025mg、0.05mg和0.1mg的小剂量增量进行剂量优化调整。此外,对于有针头焦虑的患者,可将诺和纤细针(NovoFine®)(市面上最短最细的针头之一)和在注射过程中可隐藏针头的自动针盖(Autocover®)与Flexpro笔式装置配合使用。本文结合其他生长激素给药装置、正在研发的缓释生长激素制剂以及未来前景,对诺德生长激素Flexpro笔式装置进行了综述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c08d/3063658/7247777fc8f2/ppa-5-117f1.jpg

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