Subcutaneous IGF-1 is not beneficial in 2-year ALS trial.
Subcutaneous IGF-1 is not beneficial in 2-year ALS trial.
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DOI：
10.1212/01.wnl.0000335970.78664.36
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发表时间：
2008-11-25
期刊：
影响因子：
9.9
通讯作者：
Thornton, C. A.
中科院分区：
文献类型：
--
作者：
Sorenson, E. J.;Windbank, A. J.;Mandrekar, J. N.;Bamlet, W. R.;Appel, S. H.;Armon, C.;Barkhaus, P. E.;Bosch, P.;Boylan, K.;David, W. S.;Feldman, E.;Glass, J.;Gutmann, L.;Katz, J.;King, W.;Luciano, C. A.;McCluskey, L. F.;Nash, S.;Newman, D. S.;Pascuzzi, R. M.;Pioro, E.;Sams, L. J.;Scelsa, S.;Simpson, E. P.;Subramony, S. H.;Tiryaki, E.;Thornton, C. A.
以往关于胰岛素样生长因子I型(IGF-1)治疗肌萎缩侧索硬化症(ALS)的临床试验一直不一致。这项第三阶段的随机、双盲、安慰剂对照研究旨在探讨IGF-1是否有益于ALS患者。来自20个医学中心的330名患者随机接受0.05 mg/kg体重的重组人IGF-1皮下注射，每天两次，或服用安慰剂，为期2年。主要的结果衡量标准是他们的手动肌肉测试分数的变化。次要结果指标包括无气管造口存活率和修订的ALS功能评定量表的变化率。采用意向处理分析。治疗2年后，两组患者在主要或次要结果指标上没有差异。胰岛素样生长因子I型对肌萎缩侧索硬化症患者没有益处。
Previous human clinical trials of insulin-like growth factor type I (IGF-1) in amyotrophic lateral sclerosis (ALS) have been inconsistent. This phase III, randomized, double-blind, placebo-controlled study was undertaken to address whether IGF-1 benefited patients with ALS. A total of 330 patients from 20 medical centers were randomized to receive 0.05 mg/kg body weight of human recombinant IGF-1 given subcutaneously twice daily or placebo for 2 years. The primary outcome measure was change in their manual muscle testing score. Secondary outcome measures included tracheostomy-free survival and rate of change in the revised ALS functional rating scale. Intention to treat analysis was used. There was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period. Insulin-like growth factor type I does not provide benefit for patients with amyotrophic lateral sclerosis.
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