Frasier S D, Rudlin C R, Zeisel H J, Liu H H, Long P C, Senior B, Finegold D N, Bercu B B, Marks J F, Redmond G P
Department of Pediatrics, UCLA.
Am J Dis Child. 1992 May;146(5):582-7. doi: 10.1001/archpedi.1992.02160170062016.
Sixty-nine growth hormone-deficient patients were treated for 1 year with somatotropin (recombinant DNA-derived human growth hormone) produced in mouse cells. The growth velocity of the 50 patients (72%) in whom the effectiveness of this growth hormone could be evaluated increased from a mean (+/- SD) of 3.5 +/- 1.1 to 8.7 +/- 1.6. cm/y. An enhanced rate of weight gain was also observed. Bone age was not unduly accelerated. One of 66 patients developed antibodies to recombinant growth hormone, which did not affect the response to therapy. No patient developed antibodies to host cell proteins. An increased insulin response to a standard glucose load, without any change in glucose tolerance, was observed after 1 year of treatment. This authentic sequence human growth hormone preparation produced in mammalian cells is both effective and safe in the treatment of children with growth hormone deficiency.
69例生长激素缺乏患者接受了用小鼠细胞生产的生长激素(重组DNA衍生的人生长激素)治疗1年。在50例(72%)可评估该生长激素疗效的患者中,生长速度从平均(±标准差)3.5±1.1厘米/年增加到8.7±1.6厘米/年。还观察到体重增加速率加快。骨龄未过度加速。66例患者中有1例产生了针对重组生长激素的抗体,但这并未影响治疗反应。没有患者产生针对宿主细胞蛋白的抗体。治疗1年后,观察到对标准葡萄糖负荷的胰岛素反应增加,而葡萄糖耐量无任何变化。这种在哺乳动物细胞中生产的真实序列人生长激素制剂在治疗生长激素缺乏儿童方面既有效又安全。