METHODS: In total, 171 Chinese short pubertal boys were recruited for this study. 96 of them received letrozole (2.5 mg/d) combined with rhGH (33.3-66.6 μg/kg.d), and the others received rhGH alone. Follow-up visits were conducted at 1, 3, 6, 9, and 12 months or regularly after the first treatment. During each visit, plasma samples were collected for clinical tests and biomedical analyses, all of which were performed according to standard protocols. This study was registered at www.chictr.org.cn under ID number ChiCTR1900026142.
RESULTS: After receiving treatment for at least 3 months, 68 boys (91 %) in the rhGH therapy group and 90 (94 %) in the letrozole combined with rhGH (letrozole+rhGH) therapy group achieved an increase in PAH, with the latter treatment leading to a more effective slowing of bone age (BA) advancement. Moreover, the increased PAH showed a significant positive correlation with treatment time in both groups, and letrozole+rhGH increased the PAH to a greater degree than rhGH alone (p=0.0023). And letrozole+rhGH not only slowed the increase in BA more efficiently than rhGH therapy alone (p=0.0025), but also achieved a higher FAH (p=0.0078).
CONCLUSIONS: Letrozole combined with rhGH treatment is a promising therapy to increase the PAH and FAH of Chinese short pubertal boys.
方法:总共,这项研究招募了171名中国青春期短男孩。其中96例接受来曲唑(2.5mg/d)与rhGH(33.3-66.6μg/kg。d),其他人单独接受rhGH。在首次治疗后1、3、6、9和12个月或定期进行随访。每次访问期间,收集血浆样本进行临床试验和生物医学分析,所有这些都是根据标准方案进行的.这项研究在www注册。chictr.org.CN在ID号ChiCTR1900026142下。
结果:接受治疗至少3个月后,rhGH治疗组的68名男孩(91%)和来曲唑联合rhGH(来曲唑rhGH)治疗组的90名男孩(94%)实现了PAH的增加,后者的治疗可以更有效地减缓骨龄(BA)的发展。此外,两组PAH的增加与治疗时间呈显著正相关,来曲唑+rhGH增加PAH的程度高于单独的rhGH(p=0.0023)。来曲唑+rhGH不仅比单独的rhGH治疗更有效地减缓BA的增加(p=0.0025),但也获得了更高的FAH(p=0.0078)。
结论:来曲唑联合rhGH治疗是一种有希望增加中国青春期矮小男孩PAH和FAH的治疗方法。