重组DNA衍生的甲硫氨酰人生长激素在生长激素缺乏儿童中的临床研究。

Clinical studies with recombinant-DNA-derived methionyl human growth hormone in growth hormone deficient children.

作者信息

Kaplan S L, Underwood L E, August G P, Bell J J, Blethen S L, Blizzard R M, Brown D R, Foley T P, Hintz R L, Hopwood N J

出版信息

Lancet. 1986 Mar 29;1(8483):697-700. doi: 10.1016/s0140-6736(86)91098-6.

DOI:10.1016/s0140-6736(86)91098-6

PMID:2870221

Abstract

Thirty-six children with growth hormone deficiency were treated for up to 48 months with methionyl human growth hormone (hGH) synthesised by DNA recombinant methods. The growth rate for these children increased from 3.2 +/- 1.1 cm/yr to 10.5 +/- 2.2 cm/yr (mean +/- SD). This was similar to the effect of pituitary hGH in ten GH deficient children, 3.8 +/- 1.0 to 10.1 +/- 1.1 cm/yr. Serum somatomedin C rose from 0.26 +/- 0.23 U/ml to 0.79 +/- 0.53 U/ml after 6 months of methionyl-hGH therapy, similar to the effect of pituitary hGH. The incidence of antibody formation to methionyl-hGH was higher than that observed with pituitary hGH (Kabi) but poor growth was observed only in the one patient on methionyl-hGH who acquired high-titre high-binding-capacity antibodies to hGH. No consistent changes in levels of antibodies to Escherichia coli proteins were detected. No other allergic manifestations or systemic side-effects were demonstrable.

摘要

36名生长激素缺乏的儿童接受了长达48个月的通过DNA重组方法合成的甲硫氨酰人生长激素（hGH）治疗。这些儿童的生长速率从3.2±1.1厘米/年增加到10.5±2.2厘米/年（平均值±标准差）。这与垂体hGH对10名生长激素缺乏儿童的治疗效果相似，即从3.8±1.0厘米/年增加到10.1±1.1厘米/年。甲硫氨酰-hGH治疗6个月后，血清生长调节素C从0.26±0.23 U/ml升至0.79±0.53 U/ml，与垂体hGH的效果相似。甲硫氨酰-hGH抗体形成的发生率高于垂体hGH（卡比），但仅在一名接受甲硫氨酰-hGH治疗且产生高滴度高结合能力hGH抗体的患者中观察到生长不良。未检测到针对大肠杆菌蛋白抗体水平的一致变化。未发现其他过敏表现或全身性副作用。