Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in Children Born Small for Gestational Age
This study was
conducted to assess the long-term efficacy and safety of GH treatment in
children born SGA. One hundred and twenty prepubertal SGA children who did not
achieve catch-up growth with height remained less than –2 standard
deviations (SD) below gender-specific height were enrolled in this two-year,
randomized, dose-comparative study followed by an extension study of up to 10
years. Daily subcutaneous injections of 0.23 mg/kg/week
[low-dose (LD) group] or 0.46 mg/kg/week [high-dose (HD)
group] somatropin were given for 104 weeks. Dosing in the extension study
was≤0.46 mg/kg/week. The main outcome measures
were change in height SD score (ΔHT-SDS), height velocity, insulin-like
growth factor (IGF)-1, and IGF-1/IGF binding protein-3 (IGFBP-3) molar
ratio. ΔHT-SDS at week 104 was 0.91±0.53 and 1.52±0.64
in the LD and HD groups (intergroup p<0.0001), respectively, and
continued in an upward trend throughout the extension study, remaining
above+2 for those who received treatment for a total of 7 years or more.
At week 104, significant improvements were observed in height velocity, IGF-1
SDS, and IGF-1/IGFBP-3 molar ratio. Adult HT-SDS was
–0.81±1.68 for boys and –0.82±1.05 for girls
(p=0.9837). Glucose metabolism and thyroid function were within the
nor...
Source: Hormone and Metabolic Research - Category: Endocrinology Authors: Wu, Wei Gong, Chunxiu Li, Yuchuan Hu, Yuhua Gong, Haihong Fu, Junfen Huang, Ke Li, Pin Luo, Xiaoping Tags: Original Article: Endocrine Care Source Type: research
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