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用于儿童生长激素治疗的无针注射系统VISION(®)的临床评估

Clinical Evaluation of the Needle-free Injection System VISION(®) for Growth Hormone Therapy in Children.

作者信息

Igarashi Yutaka

机构信息

Igarashi Children's Clinic, Sendai, Japan.

出版信息

Clin Pediatr Endocrinol. 2006;15(3):117-22. doi: 10.1297/cpe.15.117. Epub 2006 Aug 2.

DOI:10.1297/cpe.15.117
PMID:24790331
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4004843/
Abstract

The aim of this study was to compare the therapeutic effects of rhGH administered either by subcutaneous needle-injection (pens) or subcutaneous needle-free jet-injection (VISION(®)). Furthermore, a survey was carried out after using VISION(®) for 12 mo. A needle-free injection group consisting of 18 subjects (11 males and 7 females, mean age 5.87 ± 2.05 yr at the start of hGH therapy) who have not used pen injectors to date, were allowed to use VISION(®) in their third to fifth years of GH therapy. In addition, a group of 8 subjects who had been using pen injectors at our clinic (6 males and 2 females, mean age 6.54 ± 2.78 at the start of GH therapy) was monitored as a control. The results indicate that there are no significant differences between the mean growth rates, growth rate SD scores or height SD scores when comparing injection devices. Furthermore, the survey of VISION(®) revealed that 70% of the subjects found it slightly or not painful at or after injection, 70% found VISION(®) very easy or easy to use, and 80% found the weight of the device appropriate. All subjects expressed a desire to continue using VISION(®) in the future. Our results suggest that there are no problems with the effectiveness of hGH treatment with VISION(®), a needle-free jet-injection device and that VISION(®) is an effective device for children who have an aversion to needle injection.

摘要

本研究旨在比较皮下注射笔注射重组人生长激素(rhGH)与无针喷射皮下注射(VISION(®))的治疗效果。此外,在使用VISION(®) 12个月后进行了一项调查。一个无针注射组由18名受试者组成(11名男性和7名女性,生长激素治疗开始时平均年龄5.87±2.05岁),他们迄今未使用过注射笔,在生长激素治疗的第三至五年允许使用VISION(®)。此外,一组8名在我们诊所一直使用注射笔的受试者(6名男性和2名女性,生长激素治疗开始时平均年龄6.54±2.78岁)作为对照进行监测。结果表明,比较两种注射装置时,平均生长速率、生长速率标准差评分或身高标准差评分之间无显著差异。此外,对VISION(®)的调查显示,70%的受试者发现在注射时或注射后轻微疼痛或不疼痛,70%的受试者认为VISION(®)非常容易或容易使用,80%的受试者认为该装置重量合适。所有受试者都表示希望未来继续使用VISION(®)。我们的结果表明,对于无针喷射注射装置VISION(®),重组人生长激素治疗的有效性没有问题,并且VISION(®)对于厌恶注射的儿童是一种有效的装置。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/7ee8fc7cefa6/cpe-15-117-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c3f538f84c66/cpe-15-117-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c93b300c082c/cpe-15-117-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/e1fbba464cd6/cpe-15-117-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/55427dd82384/cpe-15-117-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c44c4c3cbd19/cpe-15-117-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/d25a9b700578/cpe-15-117-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/b7c341ca7eb0/cpe-15-117-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/df632c893485/cpe-15-117-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/7ee8fc7cefa6/cpe-15-117-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c3f538f84c66/cpe-15-117-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c93b300c082c/cpe-15-117-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/e1fbba464cd6/cpe-15-117-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/55427dd82384/cpe-15-117-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/c44c4c3cbd19/cpe-15-117-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/d25a9b700578/cpe-15-117-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/b7c341ca7eb0/cpe-15-117-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/df632c893485/cpe-15-117-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6133/4004843/7ee8fc7cefa6/cpe-15-117-g009.jpg

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Pharmacokinetics and pharmacodynamics of a new formulation of recombinant human growth hormone administered by ZomaJet 2 Vision, a new needle-free device, compared to subcutaneous administration using a conventional syringe.与使用传统注射器皮下给药相比,通过新型无针装置ZomaJet 2 Vision给药的重组人生长激素新制剂的药代动力学和药效学。
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Jet-injected insulin is associated with decreased antibody production and postprandial glucose variability when compared with needle-injected insulin in gestational diabetic women.与皮下注射胰岛素相比,在妊娠期糖尿病女性中,喷射注射胰岛素与抗体产生减少和餐后血糖变异性降低有关。
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