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Efficacy and safety of growth hormone treatment in Japanese children with small-for-gestational-age short stature in accordance with Japanese guidelines
The efficacy and safety of recombinant human GH (rhGH) treatment were assessed in Japanese children with small-for-gestational-age short stature. A total of 88 patients were enrolled in the comparative and extension studies. At the end of the comparative study (24 mo), the mean height SD score for c...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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The Japanese Society for Pediatric Endocrinology
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207802/ https://www.ncbi.nlm.nih.gov/pubmed/30393439 http://dx.doi.org/10.1297/cpe.27.225 |
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author | Yokoya, Susumu Tanaka, Toshiaki Itabashi, Kazuo Osada, Hisao Hirai, Hideaki Seino, Yoshiki |
author_facet | Yokoya, Susumu Tanaka, Toshiaki Itabashi, Kazuo Osada, Hisao Hirai, Hideaki Seino, Yoshiki |
author_sort | Yokoya, Susumu |
collection | PubMed |
description | The efficacy and safety of recombinant human GH (rhGH) treatment were assessed in Japanese children with small-for-gestational-age short stature. A total of 88 patients were enrolled in the comparative and extension studies. At the end of the comparative study (24 mo), the mean height SD score for chronological age had significantly increased in the 0.23 mg/kg/wk and 0.47 mg/kg/wk groups with increments of 0.84 ± 0.42 and 1.50 ± 0.44 SD, respectively. In the extension study, the dose could be increased based on the pre-defined growth criteria. Increments in height SD scores over the 24 to 36 mo period at doses of 0.23 mg/kg/wk, 0.23 to 0.47 mg/kg/wk, and 0.47 mg/kg/wk were 0.25 ± 0.28, 0.46 ± 0.21, and 0.28 ± 0.16 SD, respectively. The growth effect increased following dose escalation even in the low responders in the initial 2-yr treatment at 0.23 mg/kg/wk, indicating the effectiveness of dose escalation in accordance with the Japanese guidelines. rhGH at 0.47 mg/kg/wk provided a greater degree of growth promotion after 24 mo. The safety profile appeared to be tolerable and was similar in all groups. Considering the increased insulin resistance, the recommendations of the regulatory authorities should be followed to minimize the risks of rhGH treatment. |
format | Online Article Text |
id | pubmed-6207802 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | The Japanese Society for Pediatric Endocrinology |
record_format | MEDLINE/PubMed |
spelling | pubmed-62078022018-11-02 Efficacy and safety of growth hormone treatment in Japanese children with small-for-gestational-age short stature in accordance with Japanese guidelines Yokoya, Susumu Tanaka, Toshiaki Itabashi, Kazuo Osada, Hisao Hirai, Hideaki Seino, Yoshiki Clin Pediatr Endocrinol Original Article The efficacy and safety of recombinant human GH (rhGH) treatment were assessed in Japanese children with small-for-gestational-age short stature. A total of 88 patients were enrolled in the comparative and extension studies. At the end of the comparative study (24 mo), the mean height SD score for chronological age had significantly increased in the 0.23 mg/kg/wk and 0.47 mg/kg/wk groups with increments of 0.84 ± 0.42 and 1.50 ± 0.44 SD, respectively. In the extension study, the dose could be increased based on the pre-defined growth criteria. Increments in height SD scores over the 24 to 36 mo period at doses of 0.23 mg/kg/wk, 0.23 to 0.47 mg/kg/wk, and 0.47 mg/kg/wk were 0.25 ± 0.28, 0.46 ± 0.21, and 0.28 ± 0.16 SD, respectively. The growth effect increased following dose escalation even in the low responders in the initial 2-yr treatment at 0.23 mg/kg/wk, indicating the effectiveness of dose escalation in accordance with the Japanese guidelines. rhGH at 0.47 mg/kg/wk provided a greater degree of growth promotion after 24 mo. The safety profile appeared to be tolerable and was similar in all groups. Considering the increased insulin resistance, the recommendations of the regulatory authorities should be followed to minimize the risks of rhGH treatment. The Japanese Society for Pediatric Endocrinology 2018-10-30 2018 /pmc/articles/PMC6207802/ /pubmed/30393439 http://dx.doi.org/10.1297/cpe.27.225 Text en 2018©The Japanese Society for Pediatric Endocrinology This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License. (CC-BY-NC-ND 4.0: http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original Article Yokoya, Susumu Tanaka, Toshiaki Itabashi, Kazuo Osada, Hisao Hirai, Hideaki Seino, Yoshiki Efficacy and safety of growth hormone treatment in Japanese children with small-for-gestational-age short stature in accordance with Japanese guidelines |
title | Efficacy and safety of growth hormone treatment in Japanese children with
small-for-gestational-age short stature in accordance with Japanese
guidelines |
title_full | Efficacy and safety of growth hormone treatment in Japanese children with
small-for-gestational-age short stature in accordance with Japanese
guidelines |
title_fullStr | Efficacy and safety of growth hormone treatment in Japanese children with
small-for-gestational-age short stature in accordance with Japanese
guidelines |
title_full_unstemmed | Efficacy and safety of growth hormone treatment in Japanese children with
small-for-gestational-age short stature in accordance with Japanese
guidelines |
title_short | Efficacy and safety of growth hormone treatment in Japanese children with
small-for-gestational-age short stature in accordance with Japanese
guidelines |
title_sort | efficacy and safety of growth hormone treatment in japanese children with
small-for-gestational-age short stature in accordance with japanese
guidelines |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207802/ https://www.ncbi.nlm.nih.gov/pubmed/30393439 http://dx.doi.org/10.1297/cpe.27.225 |
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