药代动力学的研究重组人胰岛素样生长因子I (rhIGF-I) / rhIGF-binding蛋白质3复杂管理患者生长激素不敏感综合征。

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Camacho-Hubner C,玫瑰,泼里斯马,Sleevi M,斯托尔霍奇金淋巴瘤,Miraki-Moud F, F Minuto, Frystyk J, Rogol,艾伦·G,大梁,野蛮

药代动力学的研究重组人胰岛素样生长因子I (rhIGF-I) / rhIGF-binding蛋白质3复杂管理患者生长激素不敏感综合征。

中国性金属底座。2006年4月,91(4):1246 - 53年。Epub 2006 1月10。

PubMed ID

16403822 (在PubMed

]

文摘

背景:GH不敏感综合征(ghi),莱伦氏综合症,表现为严重的身材矮小,高血清GH水平,和非常低的血清IGF-I和IGF-binding蛋白质3 (IGFBP-3)水平与GH受体的基因缺陷有关。重组体人(rh) IGF-I治疗剂量的80 - 120年microg /公斤给sc每天两次在这些病人有效地促进经济增长。我们已经调查了新开发的药物,rhIGF-I / rhIGFBP-3 rhIGF-I和rhIGFBP-3 1:1摩尔复杂。目的:研究的目的是确定IGF-I管理后的药物动力学rhIGF-I / rhIGFBP-3青少年与全球健康行动计划和评估其安全性和耐受性。设计:这是一个开放性临床研究。背景:研究在一般大学教学医院的儿科病房。参与者:4名患者(一女,三个男性;平均年龄14.9岁;平均身高sd得分,-4.9),证实了分子诊断ghi同意参与这项研究。干预:rhIGF-I / rhIGFBP-3管理在一个单一的sc注入0.5和1.0毫克/公斤。dose (equivalent to 100 and 200 microg/kg rhIGF-I) after breakfast with a 2-d interval between doses. RESULTS: IGF-I levels reached a maximum between 19 +/- 8.3 and 15 +/- 6.2 h for the low and high doses, respectively. The circulating IGF-I levels obtained with the low and high doses were similar, although a discrete dose-dependent increase in circulating IGF-I levels was observed. The IGF-I half-life in four subjects after a dose of 0.5 mg/kg rhIGF-I/rhIGFBP-3 was estimated to be 21+/- 4 h. There were no acute adverse events reported, and all blood glucose measurements were normal. CONCLUSION: These data demonstrated that the rhIGF-I/rhIGFBP-3 complex was effective in increasing levels of circulating total and free IGF-I into the normal range for a 24-h period after a single sc administration in patients with GHIS, and that administration of rhIGF-I/rhIGFBP-3 was safe and well tolerated.

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药物

rhIGFBP-3