Registration System for Growth Hormone (GH) Treatment with Standardized Immunoreactive GH Values in Japan.

Tanaka, Toshiaki; Takano, Kazue; Hanew, Kunihiko; Nishi, Yoshikazu; Igarashi, Yutaka; Hirano, Takeshi; Saito, Tomohiro; Tachibana, Kunihide; Yokoya, Susumu; Fukui, Kenji; Shimatsu, Akira; Hizuka, Naomi; Tsushima, Takahiro; Irie, Minoru

doi:10.1507/endocrj.45.459

Cited by 21 publications

(19 citation statements)

References 9 publications

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“…In addition, GHD is a rare childhood disorder, making it difficult to conduct a largescale study. However, as there are very strict criteria for GHD that must be fulfilled to receive GH treatment in Japan [26], the diagnosis of GHD in this study is expected to be accurate. The best measure of the overall effectiveness of GH in treating short stature is adult height; however, sufficient adult height data are not currently available in this study.…”

Section: Fig 5 Treatment Effect Of Gh Over 4 Years On Igf-i Sds In Tmentioning

confidence: 95%

An observational study of the effectiveness and safety of growth hormone (Humatrope<sup>®</sup>) treatment in Japanese children with growth hormone deficiency or Turner syndrome

et al. 2013

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Section: Fig 5 Treatment Effect Of Gh Over 4 Years On Igf-i Sds In Tmentioning

confidence: 95%

An observational study of the effectiveness and safety of growth hormone (Humatrope<sup>®</sup>) treatment in Japanese children with growth hormone deficiency or Turner syndrome

et al. 2013

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“…The peak values of serum GH concentration (C max ) were standardised with the formula established by the Foundation for Growth Science in Japan to adjust for the inter-assay kit variations (26). However, recent changes have resulted in the use of a new standard, WHO 98/574, in Japan, whereby vales are to be revised by multiplying by 0.6 (27).…”

Section: Gh Determinationmentioning

confidence: 99%

A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency

Chihara

Shimatsu²,

Hizuka³

et al. 2007

eur j endocrinol

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Objective: The international, first-line diagnostic test for adult GH deficiency is the insulin tolerance test (ITT), which is contraindicated in some patients due to severe adverse events. Alternatives such as GH-releasing hormone combined with arginine or GH-releasing peptides (GHRP) have been proposed. We validated the use of GHRP-2 for diagnosing adult GH deficiency (GHD). Methods: Seventy-seven healthy subjects and 58 patients with peak GH!3 mg/l by ITT were enrolled. After overnight fasting, a 100 mg dose of GHRP-2 was administered intravenously; blood samples were taken during the subsequent 2 h and GH measured by immunoradiometric assay. Results: Serum GH peak occurred within 60 min after GHRP-2 administration in all subjects. GH responses to GHRP-2 were not affected by gender, but were slightly lower in elderly subjects and those with adiposity, although these did not influence diagnosis of GHD. Repeated tests showed favourable reproducibility. Peak GH concentrations after GHRP-2 were significantly (P!0.001) lower in patients (1.36G2.60 mg/l) than the healthy group (84.6G60.9 mg/l) with no difference between hypothalamic and pituitary diseases. Serum GH concentration at the point where sensitivity of response crossed with specificity ranged from 15 to 20 mg/l. A cut-off value of 15 mg/l for diagnosing GHD with GHRP-2 corresponded to the diagnostic value of 3 mg/l in the ITT. Conclusions: The GHRP-2 provocative test showed favourable reproducibility and was mildly influenced by age and adiposity. Severe GH deficiency could be diagnosed with high reliability using a 15 mg/l (9 mg/l when GH calibrated with recombinant World Health Organization 98/574 standard) cut-off for peak GH concentration.

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“…The Foundation evaluates the candidate's eligibility for GH treatment according to certain diagnostic criteria for GH deficiency, TS and other pertinent disorders [21]. Physicians are encouraged to register each candidate for GH treatment at the Foundation using an application form which includes the candidate's pre-treatment anthropometric measurements, karyotypes (in the case of TS), presence or absence of puberty, and evidence of informed consent from each subject regarding the use of the data for scientific purposes.…”

Section: Subjectsmentioning

confidence: 99%

“…However, no reports have verified this speculation with large cohort study data. In this study we evaluated the trends in age and anthropometric data of girls with TS in Japan at initiation of GH treatment using data collected at the Foundation for the Growth Science, Japan [21].…”

mentioning

confidence: 99%

Trends in Age and Anthropometric Data at Start of Growth Hormone Treatment for Girls with Turner Syndrome in Japan

et al. 2008

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Abstract. The purpose of this study is to evaluate the trends in age and anthropometric data for girls with Turner syndrome (TS) at start of growth hormone (GH) treatment in Japan. The data for analysis were obtained from a retrospective cohort, the Foundation for Growth Science, Japan. We analyzed trends in starting age of GH treatment for girls with TS in Japan after dividing subjects (n = 1,478) into three registration periods: 1991-1994, 1995-1999 and 2000-2004. We also assessed the ratio of the subpopulation of subjects under five years of age. As results, the mean age (standard deviation (SD)) at start of GH treatment was significantly different among the three groups (10.95 (3.63), 10.15 (3.39) and 8.78 (3.61), p<0.0001). The proportion of the subjects under five years of age increased significantly over time (5.11%, 7.11% and 16.85%, p<0.0001). Mean (SD) height SD scores were also significantly different (-3.41 (0.87), -3.26 (0.81) and -3.17 (0.79), p<0.0001). However, the proportions of the karyotype of 45,X were not significantly different among the three groups (p = 0.25). We concluded that age and shortness at initiation of GH treatment had been improving over time. However, these favorable trends have not fully met the conditions recommended by international clinical guidelines for TS.

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Registration System for Growth Hormone (GH) Treatment with Standardized Immunoreactive GH Values in Japan.

Cited by 21 publications

References 9 publications

An observational study of the effectiveness and safety of growth hormone (Humatrope<sup>®</sup>) treatment in Japanese children with growth hormone deficiency or Turner syndrome

An observational study of the effectiveness and safety of growth hormone (Humatrope<sup>®</sup>) treatment in Japanese children with growth hormone deficiency or Turner syndrome

A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency

Trends in Age and Anthropometric Data at Start of Growth Hormone Treatment for Girls with Turner Syndrome in Japan

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