Growth Hormone Releasing Hormone in the Assessment and Long-term Treatment of Growth Hormone Deficiency

The secretion of hGH after the administration of the analogue of growth hormone releasing hormone, GHRH (1–29)NH₂, to 8 normal adults and 41 short children has been studied. The children were classified on the basis of their hGH response to insulin-induced hypoglycaemia; 28 had severe hGH deficiency (peak serum hGH less than 7 mIU/litre) and 13 had simple short stature (peak serum hGH greater than 15 mIU/litre). The hGH response to GHRH was similar in normal adults and short stature children, but significantly lower in the hGH deficient children. In 23 (82%) of the hGH deficient children the peak serum hGH in response to GHRH was greater than 7 mIU/litre (the maximum value seen during hypoglycaemia), and in 14 (50%) the peak serum hGH in response to GHRH was greater than 15 mIU/litre. This suggests that in the majority of hGH deficient children the defect in hGH secretion results from hypothalamic GHRH deficiency. The hGH responses of the short stature children to insulin-induced hypoglycaemia were mainly in the low range of normal, and the majority showed normal hGH responses to GHRH. Eighteen prepubertal children with definite hGH deficiency have been treated for 3–18 months with twice daily, subcutaneous injections of GHRH. This has promoted linear growth in 12 children, of whom 8 showed an increment in height velocity of 2–11 cm/year. GHRH provides a valuable method for the assessment of hGH secretion, but by itself it cannot be used to establish deficient hGH secretion; this requires a stimulation test that promotes hypothalamic GHRH secretion, such as insulin-induced hypoglycaemia. GHRH is a practical alternative therapy to hGH for some hGH-deficient children.     

生长激素运动筛查试验与生长激素激发试验对生长激素缺乏症诊断价值的比较

目的 评价生长激素(GH)运动筛查试验和GH激发试验对儿童生长激素缺乏症的诊断价值.方法 选取200例身材矮小患儿,均符合身材矮小诊断标准,无骨代谢、糖尿病等其他内分泌代谢疾病.对患儿均进行GH运动筛查试验及GH激发试验.GH激发试验包括精氨酸激发试验、左旋多巴激发试验及胰岛素激发试验,本研究中所有患儿在3种GH激发试验中任选2种.2种试验均采用放射免疫法进行检测.结果 身材矮小患儿行GH运动试验和GH激发试验的GH峰值强度分别为(12.78±6.98) μg/L和(14.07±5.89) μg/L,二者GH峰值比较无显著性差异(t=1.87 P>0.05).200例患儿中GH激发试验和运动试验均阳性者29例;运动试验阳性而GH激发试验阴性者5例,运动试验存在2.5%假阳性率.2种试验方法阳性率间比较无统计学差异(χ2=0.47 P>0.05).结论 GH运动筛查试验和GH激发试验得出的结果具有很高的一致性.由于运动试验具有操作简单、安全等优点,应将GH运动筛查试验作为身材矮小患儿的首选筛查试验.     

重组人生长激素治疗颅咽管瘤术后生长激素缺乏症

目的探讨低剂量基因重组人生长激素(rhGH)治疗颅咽管瘤术后生长激素缺乏症(GHD)患儿的疗效和安全性。方法回顾性分析2008年4月-2011年4月在北京三博脑科医院内分泌门诊治疗的12例7～15岁术后病理确诊为颅咽管瘤且继发生长迟滞患儿的病例资料及随访资料。患儿均给予rhGH治疗(每晚睡前皮下注射0.1 IU.kg-1,每周5次注射),疗程3～36个月。定期检测肝功能、肾功能、激素水平等指标,并比较患儿治疗前后身高、体质量、生长速度、身高标准差计数、胰岛素样生长因子1(IGF-1)、骨龄等生长指标的改变。结果在rhGH治疗期间,12例患儿在治疗第1年生长速率增加显著,由(2.2±1.3)cm.a-1增加到(6.63±4.97)cm.a-1(P<0.01),身高标准差计数由治疗前-3.3±2.3增加到-3.2±2.8,血IGF-1治疗前为(38±64)μg.L-1,治疗后为(173±167)μg.L-1(患儿治疗后血清IGF-1水平达到正常范围),差异均有统计学意义(Pa<0.01)。治疗期间,患儿肝肾功能等均保持在正常值范围,骨龄无明显变化,随访时尚无患儿肿瘤复发。结论低剂量rhGH治疗儿童颅咽管瘤术后继发GHD是经济、有效的,在充分评估及严密监控下开展GH替代治疗是安全的。     

Biosimilar Growth Hormone

As the first wave of biopharmaceuticals is expiring, biosimilars or follow-on -protein products (FOPP’s) have emerged. Biosimilar drugs are cheaper than the originator/comparator drug. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Biosimilar soamtropin has been approved in both the US and Europe. The scientific viability of biosimilar drugs and especially growth hormone has been proven by several rigorously conducted clinical trials. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 y for pediatric indications measure up favorably to previously approved growth hormones which served as reference comparators. The Obama Administration appears to be committed to establish innovative pathways for the approval of biologics and biosimilars in the US. The cost savings in health care expenditures will be substantial as the global sales of biologics have reached $ 93 billion in 2009.     

Administration of Growth Hormone by Disposable Preloaded Syringes

ABSTRACT. The convenience of Genotropin KabiQuick, a novel single-use disposable injection system for growth hormone (GH) administration, was studied in 20 GH-treated children aged 8-16 years. The convenience of the device and tolerance to it were assessed by means of a questionnaire, which was completed by the patients and their families after a treatment period of 2 weeks. The families were asked to compare the new device with the conventional system of GH administration, involving the use of standard ampoules and ordinary syringes. The majority of patients considered the new device superior to the conventional system; 85% of patients found reconstitution easier and 70% found dosing easier. Sixty-five per cent of patients expressed a preference for using Genotropin KabiQuick for future therapy. It is concluded that Genotropin KabiQuick is well tolerated and that the majority of patients prefer it to conventional injection systems for GH administration.     

Growth Hormone Secretion and Growth Hormone Treatment in Children with Intrauterine Growth Retardation

Albertsson-Wikland, K. (Departments of Paediatrics II and Physiology, University of Gothenburg, Gothenburg, Sweden). Growth hormone secretion and growth hormone treatment in children with intrauterine growth retardation. Acta Paediatr Scand [Suppl] 349: 35, 1989.
Few children with intrauterine growth retardation (IUGR) fail to show catch-up growth during the first year of life. There may he many reasons for this, ranging from disturbances of hormone production to hormonal unresponsiveness of target cells. This report presents preliminary data on growth hormone (GH) secretion and responses to GH treatment in 16 children with IUGR and poor catch-up growth, six of whom had Silver-Russell stigmata. GH secretion was assessed by measurement of the GH response to an arginine-insulin test and determination of spontaneous GH secretion over 24 hours. GH production was heterogeneous hut, more often than expected, children showed both a low response to GH provocation and low spontaneous secretion of GH. Five out of six of the children with Silver-Russell syndrome and seven out of 10 of the children with non-Silver-Russell IUGR gained more than 2 cm in height during 1 year of treatment with GH at a dose of 0.1 IU/kg/day. These results clearly demonstrate that some children with IUGR and poor catch-up growth secrete insufficient amounts of GH, and that many of these very short children show an improvement in growth rate during treatment with physiological doses of GH.