节点文献

基因重组人生长激素治疗青春期前特发性生长激素缺乏症临床试验

Efficacy and safety of LG recombinant human growth hormone in the treatment of idiopathic growth hormone deficiency

  • 推荐 CAJ下载
  • PDF下载
  • 不支持迅雷等下载工具,请取消加速工具后下载。

【作者】 潘慧; 史轶蘩; 朱逞; 沈水仙; 姚国英; 邓洁英; 吴玉筠; 支涤静; 朱志颖; 李欣; 朱惠娟; 张殿喜; 吴勤勇;

【Author】 PAN Hui~1 SHI Yi-fan~1 ZHU Cheng~2 Shen Shui-xian~3 Yao Guo-ying~4 Deng Jie-ying~1 Wu Yu-yun~2 Zhi Di-jing~3 Zhu Zhi-yin~4 Li Xin~1 Zhu Hui-juan~1 Zhang Dian-xi~1 Wu Qin-yong~1 (1 Peking Union Hospital,PUMC,Chinese Academy Of Medical Science,Beijing 100730,China; 2 Beijing Children’s Hospital,Beijing 100045,China; 3 Shanghai Pediatric Hospital Affiliated to FuDan University,Shanghai 200032,China; 4 Shanghai Children’s Hospital,Shanghai 200040,China)

【机构】 中国医学科学院 中国协和医科大学 北京协和医院内分泌科; 北京市儿童医院; 上海复旦大学附属儿科医院; 上海市儿童医院; 中国医学科学院 中国协和医科大学 北京协和医院内分泌科 北京100730; 北京100730; 北京100045; 上海200032; 上海200040;

【摘要】 目的:评价基因重组人生长激素(rhGH)治疗青春期前特发性生长激素缺乏症(IGHD)患儿6个月的疗效和安全性。方法:对49例IGHD患儿进行rhGH治疗,每晚睡前皮下注射0.5IU·kg-1,每周分5次注射,共26周。评价治疗前后身高、生长速度、身高标准差计数(SDS)等指标。结果:在rhGH治疗期间,46例患儿生长速度由每年(2.5±1.0)cm提高到(11.5±2.5)cm(P<0.005)。身高SDS由治疗前(-4.2±1.8)增为(-3.7±1.8)。同时患儿13和26周血清胰岛素样生长因子(IGF-1)和IGF结合蛋白(IGFBP,)水平均较治疗前明显升高(P<0.05)。其体重与骨龄无明显变化。治疗后共有15.7%患儿出现甲状腺功能降低,抗hGH抗体阳性率为21.7%,但所有这些现象均未影响患者体格的线性增长。在治疗期间所有患者肝肾功能、血尿常规和代谢性指标(如血糖和血脂水平)等均保持在正常范围。结论:rhGH是治疗IGHD安全有效的药物。

【Abstract】 Objectlve:To assess the efficacy and safety of recombinant growth hormone LG Eu- tropinTMfor children with idiopathic growth hormone deficiency(IGHD).Methods:49 children with IGHD were subcutaneously injected with EutropinTMin a dose of 0.5 IU/kg/week,divided by 5 times,before sleep for 26 weeks.The primary endpoints are to measure the changes of height,growth velocity and mean height SDS pre and post therapy.Results:The mean growth velocity and mean height SDS increased from (2.45±0.97)cm/year,(-4.2±1.8)to(11.5±2.5)cm/year,(-3.7±1.8),respectively;the p values were P<0.005.The serum IGF-1 and IGFBP3 levels at the 13 and 26 weeks of the therapy in- creased significantly from the baseline levels.No bone maturation in advance and weight gain were found. 15.7% and 21.7% patients who received EutropinTMexperienced hypothyroidism and increment of low titer serum anti-rhGH antibody,respectively,all of which had no an effect on their linear body growth.No ab- normalities in the liver and kidney functions,blood and urinary tests and metabolism index were found. Condusion:This LG rhGH is an effective and safe growth stimulator in children with IGHD.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2006年05期
  • 【分类号】R725.8
  • 【被引频次】3
  • 【下载频次】232
节点文献中: 

本文链接的文献网络图示:

本文的引文网络