Calzada-León R, Altamirano N, Llanas D, Páras G, Robles-Váldes C
Unidad de Crecimiento, Instituto Nacional de Pediatría, México, D.F.
Bol Med Hosp Infant Mex. 1993 Mar;50(3):177-84.
Biosynthetic growth hormone extracted from mammalian cells was used in eight children with growth hormone deficiency, in search for a clinical safety study. Each child received 0.6 U/kg/week, subcutaneously, during a period of six months, and was evaluated monthly for clinical, anthropometric and laboratory modifications induced by the drug in a physiological or pathological way. The growth velocity increased from less that 4 cm/year to 11.2 +/- 1.08 cm/year, the bone age maintained according to the chronological age, and the anthropometric evaluation showed an harmonious and physiological growth. There was not any undesirable nor secondary changes except transient hypothyroidism in two patients, and unmasked hypophyseal hypothyroidism in another two. We concluded that biosynthetic growth hormone extracted from mammalian cells is a safety drug, and that patients with growth hormone deficiency may be treated with it in order to improve their final height expectancy.
从哺乳动物细胞中提取的生物合成生长激素被用于八名生长激素缺乏的儿童,以进行一项临床安全性研究。在六个月的时间里,每个儿童每周皮下注射0.6 U/kg,每月对药物以生理或病理方式引起的临床、人体测量和实验室变化进行评估。生长速度从每年小于4厘米增加到11.2±1.08厘米/年,骨龄与实际年龄相符,人体测量评估显示生长和谐且正常。除了两名患者出现短暂性甲状腺功能减退以及另外两名患者发现潜在的垂体性甲状腺功能减退外,未出现任何不良或继发性变化。我们得出结论,从哺乳动物细胞中提取的生物合成生长激素是一种安全的药物,生长激素缺乏的患者可以使用它来提高最终身高预期。