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    长效与短效重组人生长激素治疗儿童生长激素缺乏症的疗效与安全性模式比较

    Comparison of Efficacy and Safety Patterns Between Long-Acting and Short-Acting Recombinant Human Growth Hormone in Children with Growth Hormone Deficiency

      摘要
    • 摘要:
      目的  比较长效聚乙二醇重组人生长激素(polyethylene glycol recombinant human growth hormone，PEG-rhGH)与短效重组人生长激素(recombinant human growth hormone，rhGH)治疗儿童生长激素缺乏症(growth hormone deficiency，GHD)的疗效及其对身体质量指数(body mass index，BMI)、甲状腺功能、糖代谢的影响，为临床个体化用药提供参考。
      方法 采用回顾性分析，纳入90名GHD儿童，其中PEG-rhGH组和rhGH组各45例，分析2组身高、身高标准差积分(height standard deviation score，Ht SDS)、年化生长速率、身高标准差积分变化量(ΔHt SDS)、胰岛素样生长因子-1(insulin-like growth factor-1，IGF-1)、BMI、甲状腺功能、空腹血糖、空腹胰岛素等指标变化。
      结果 线性混合效应模型分析显示，2组患儿身高和Ht SDS均较治疗前显著改善(P<0.001)。治疗前12个月内2组身高无显著差异，从第15个月开始，rhGH组身高显著优于PEG-rhGH组，并在第21、24个月保持此差异(P<0.05)。2组间Ht SDS无显著差异。在生长动力方面，2组年化生长速率均在治疗的前3个月达到峰值(12.44 cm vs 11.96 cm)；在治疗7~9个月时，rhGH组年化生长速率显著高于PEG-rhGH组(P=0.034)，该时间段内△Ht SDS亦显著更优(P=0.038)，其余时间段2组间无显著差异。PEG-rhGH组治疗后BMI显著升高，在12个月与rhGH组差异显著(P=0.005)，24个月时差异消失。2组治疗前后T4、TSH、胰岛素水平无显著变化，T3、空腹血糖随时间变化显著但均在正常范围。
      结论 长效PEG-rhGH与短效rhGH均能有效促进GHD患儿生长，且在实现标准化追赶生长(Ht SDS)上疗效相当。rhGH在长期身高增益上可能更具优势，而PEG-rhGH需更关注早期BMI变化。2种药物对甲状腺功能及糖代谢影响较小，安全性良好。

       

      Abstract:
      OBJECTIVE To compare the efficacy of long-acting polyethylene glycol recombinant human growth hormone(PEG-rhGH) versus short-acting recombinant human growth hormone(rhGH) in children with growth hormone deficiency(GHD) and their effects on body mass index(BMI), thyroid function, and glucose metabolism, so as to provide references for individualized clinical medication.
      METHODS In this retrospective study, 90 children with GHD were enrolled, including 45 cases each in the PEG-rhGH and rhGH groups. Changes in height, height standard deviation score(Ht SDS), annualized growth velocity, change in Ht SDS(ΔHt SDS), insulin-like growth factor-1(IGF-1), BMI, thyroid function, fasting blood glucose, and fasting insulin were analyzed.
      RESULTS Linear mixed-effects model analysis revealed significant improvements in height and Ht SDS in both groups after treatment(P<0.001). No significant difference in height was observed between the 2 groups within the first 12 months of treatment. Starting from the 15th month, the rhGH group showed significantly greater height than the PEG-rhGH group, and this difference was maintained at the 21st and 24th months(P<0.05). No significant difference in Ht SDS was found between the groups. Regarding growth dynamics, the annualized growth velocity peaked within the first 3 months in both groups(12.44 cm vs 11.96 cm). During the 7–9 month treatment period, the rhGH group exhibited a significantly higher annualized growth velocity than the PEG-rhGH group(P=0.034), accompanied by a greater ΔHt SDS(P=0.038). No significant intergroup differences were observed in other periods. BMI increased significantly after treatment in the PEG-rhGH group, showing a significant difference compared to the rhGH group at 12 months(P=0.005), which disappeared by 24 months. No significant changes were observed in T4, TSH, or insulin levels between the 2 groups before and after treatment. Although significant changes in T3 and fasting blood glucose were noted within groups, all values remained within the normal range.
      CONCLUSION Both long-acting PEG-rhGH and short-acting rhGH effectively promote growth in children with GHD and demonstrate comparable efficacy in Ht SDS. The rhGH regimen may offer a greater advantage in long-term height gain, whereas PEG-rhGH requires closer monitoring of early BMI changes. Both medications have minimal impact on thyroid function and glucose metabolism, demonstrating good safety profiles.

       

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