Ciresi Alessandro, Cicciò Floriana, Radellini Stefano, Guarnotta Valentina, Calcaterra Anna Maria, Giordano Carla
Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
Int J Endocrinol. 2017;2017:8469680. doi: 10.1155/2017/8469680. Epub 2017 May 28.
To evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with growth hormone deficiency (GHD).
32 GHD children (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, 16 patients) or TIW (group B, 16 patients) GHT for 12 months.
Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during OGTT, glycosylated hemoglobin (HbA1c), lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), and the insulin sensitivity index (ISI).
After 12 months, both groups showed a significant and comparable improvement in height ( < 0.001) and IGF-I ( < 0.001). As regards the metabolic parameters, in both groups, we found a significant increase in fasting insulin ( < 0.001 and = 0.026) and Homa-IR ( < 0.001 and = 0.019). A significant increase in fasting glucose ( = 0.001) and a decrease in ISI ( < 0.001) and DIo ( = 0.002) were only found in group A.
The TIW regimen is effective and comparable with the daily regimen in improving auxological parameters and has a more favorable metabolic impact in GHD children. This trial is registered with ClinicalTrials.gov NCT03033121.
评估两种不同的每周注射方案对生长激素缺乏症(GHD)患儿的生长学和代谢影响是否相似。
32名GHD患儿(25名男性,平均年龄10.5±2.2岁)被随机分配接受每日(A组,16例患者)或每周三次(TIW,B组,16例患者)生长激素治疗12个月。
生长学参数、胰岛素样生长因子-I(IGF-I)、口服葡萄糖耐量试验(OGTT)期间的血糖和胰岛素、糖化血红蛋白(HbA1c)、血脂谱、口服处置指数(DIo)、胰岛素抵抗的稳态模型评估估计值(Homa-IR)以及胰岛素敏感性指数(ISI)。
12个月后,两组患儿的身高(P<0.001)和IGF-I(P<0.001)均有显著且相当的改善。关于代谢参数,两组患儿的空腹胰岛素(P<0.001和P = 0.026)和Homa-IR(P<0.001和P = 0.019)均显著升高。仅在A组中发现空腹血糖显著升高(P = 0.001),ISI(P<0.001)和DIo(P = 0.002)降低。
TIW方案在改善生长学参数方面有效且与每日方案相当,对GHD患儿的代谢影响更有利。本试验已在ClinicalTrials.gov注册,注册号为NCT03033121。