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首页> 外文期刊>Endocrine journal >An observational study of the effectiveness and safety of growth hormone (Humatrope~®) treatment in Japanese children with growth hormone deficiency or Turner syndrome
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An observational study of the effectiveness and safety of growth hormone (Humatrope~®) treatment in Japanese children with growth hormone deficiency or Turner syndrome

机译：生长激素缺乏症或特纳综合征的日本儿童中生长激素（Humatrope〜®）治疗的有效性和安全性的观察性研究

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摘要

This study assessed the effectiveness and safety of growth hormone (GH; Humatrope~®) therapy in Japanese children with GH deficiency (GHD) or Turner syndrome (TS) enrolled in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). GeNeSIS is an open-label, multinational, multicenter, observational study conducted in 30 countries. In this interim report, there were 1129 GH treatment-naive children with GHD, with a mean chronological age (± standard deviation) of 8.75 (3.32) years, and 90 girls with TS, with a mean chronological age of 8.93 (3.67) years. The mean height standard deviation score (SDS) increased from -2.73 (0.63) SD and -2.71 (0.63) SD at study entry to -2.22 (0.68) SD and -2.20 (0.60) SD after 1 year of treatment in the GHD and TS groups, respectively. In both groups, mean height SDS increased further with each year of treatment to 4 years; however, the magnitude of change in height SDS declined with time. The mean insulin-like growth factor-I SDS increased from below the mean of the reference population at study entry to a level similar to (GHD group) or higher than (TS group) the mean of the reference population during the 4-year treatment period. The incidence of serious adverse events (AEs), treatment-related AEs, and AEs related to glucose intolerance was low in both groups (0.1 % to 3.0%). In conclusion, GH treatment in Japanese children with GHD or TS resulted in increased growth over a 4-year treatment period with a favorable safety profile; however, the improvements in growth declined with time.
机译：这项研究评估了生长激素（GH; Humatrope〜®）治疗对矮身症国际研究遗传学和神经内分泌学（GeNeSIS）招募的日本GH缺乏症（GHD）或Turner综合征（TS）儿童的有效性和安全性。 GeNeSIS是在30个国家/地区进行的开放标签，跨国，多中心，观察性研究。在本中期报告中，有1129名未接受过GH治疗的GHD儿童，其平均年龄（±标准差）为8.75（3.32）岁，有90名患有TS的女孩，其平均年龄为8.93（3.67）岁。 。在GHD和GHD中治疗1年后，平均身高标准差评分（SDS）从研究开始时的-2.73（0.63）SD和-2.71（0.63）SD上升至-2.22（0.68）SD和-2.20（0.60）SD。 TS组分别。在两组中，平均身高SDS随着治疗的每一年进一步增加至4年。但是，高度SDS的变化幅度随时间下降。在4年的治疗期间，平均胰岛素样生长因子-I SDS从研究开始时的参考人群平均值以下增加至类似于（GHD组）或高于（TS组）参考人群平均值的水平期。两组的严重不良事件（AEs），治疗相关的AEs和与葡萄糖耐受不良相关的AEs的发生率均较低（0.1％至3.0％）。总之，在日本的GHD或TS儿童中进行GH治疗可在4年的治疗期内增加生长，并具有良好的安全性。但是，增长的改善随着时间的推移而下降。

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  • 来源
    《Endocrine journal》 |2013年第1期|57-64|共8页
  • 作者

    Shigeru Tai; Toshiaki Tanaka; Tomonobu Hasegawa; Keiichi Ozono; Hiroyuki Tanaka; Susumu Kanzaki; Susumu Yokoya; Kenji Fujieda; Kazuo Chihara; Yoshiki Seino;

  • 作者单位

    Tai Clinic, 3-19-11, Tsukuda, Nishiyodogawa-ku, Osaka 555-0001, Japan Medical Science, Eli Lilly Japan K.K., Kobe 651-0086, Japan;

    rnTanaka Growth Clinic, Tokyo 154-0004, Japan;

    rnDepartment of Pediatrics, Keio University School of Medicine, Tokyo 160-8582, Japan;

    rnDepartment of Pediatrics, Graduate School of Medicine, Osaka University, Suita 565-0871, Japan;

    rnDepartment of Pediatrics, Okayama Saiseikai General Hospital, Okayama 700-8511, Japan;

    rnDivision of Pediatrics and Perinatology, Tottori University Faculty of Medicine, Yonago 683-8503, Japan;

    rnDepartment of Medical Subspecialties, National Center for Child Health and Development, Tokyo 157-8535, Japan;

    rnDepartment of Pediatrics, Asahikawa Medical College, Asahikawa 078-8510, Japan;

    rnHyogo Prefectural Kakogawa Medical Center, Kakogawa 675-8555, Japan;

    rnOsaka Kosei-nenkin Hospital, Osaka 553-0003, Japan;

  • 收录信息 美国《科学引文索引》(SCI);美国《化学文摘》(CA);
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

    growth hormone; growth hormone deficiency; turner syndrome;

    机译：生长激素;生长激素缺乏症;特纳综合征;

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