Kappelgaard Anne-Marie, Kiyomi Fumiaki, Horikawa Reiko, Yokoya Susumu, Tanaka Toshiaki
Medical Affairs, Global Marketing GHT, Novo Nordisk A/S, Søborg, Denmark.
Horm Res Paediatr. 2014;81(4):272-9. doi: 10.1159/000358196. Epub 2014 Feb 11.
BACKGROUND/AIMS: An examination of the effects of up to 260 weeks of growth hormone (GH) therapy on metabolic parameters in Japanese children born small for gestational age (SGA).
Data were analysed from a 156-week extension of a 104-week multicentre, randomised, double-blind, parallel-group trial. Sixty-five children born SGA (age 3-<8 years) received 33 μg/kg/day (n = 31, 64.5% male) or 67 μg/kg/day (n = 34, 58.8% male) GH for 260 weeks. Changes in metabolic parameters - glucose, insulin, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol - were recorded. Alterations in weight, body mass index standard deviation score (BMI SDS) and vital signs were also evaluated.
Over 260 weeks of GH treatment, a positive correlation between Δheight SDS and Δinsulin-like growth factor-I SDS was observed. Insulin and glucose levels were generally unaffected. Favourable changes in lipid profiles were recorded, which were maintained for the study duration. No adverse alterations in weight, BMI SDS or vital signs were noted.
Long-term, continuous GH treatment in children born SGA appears to be efficacious, associated with potential benefits for several metabolic parameters and associated with no long-term safety concerns.
背景/目的：研究长达260周的生长激素（GH）治疗对日本小于胎龄（SGA）出生儿童代谢参数的影响。
对一项为期104周的多中心、随机、双盲、平行组试验的156周延长期数据进行分析。65名SGA出生儿童（年龄3至<8岁）接受33μg/kg/天（n = 31，64.5%为男性）或67μg/kg/天（n = 34，58.8%为男性）的GH治疗260周。记录代谢参数（葡萄糖、胰岛素、总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇）的变化。还评估了体重、体重指数标准差评分（BMI SDS）和生命体征的改变。
在260周的GH治疗期间，观察到身高标准差变化值（Δheight SDS）与胰岛素样生长因子-I标准差变化值（Δinsulin-like growth factor-I SDS）之间呈正相关。胰岛素和葡萄糖水平总体上未受影响。记录到血脂谱有良好变化，并在研究期间持续存在。未观察到体重、BMI SDS或生命体征有不良改变。
对SGA出生儿童进行长期、持续的GH治疗似乎是有效的，对多个代谢参数有潜在益处，且无长期安全性问题。
