胰岛素样生长因子-I治疗肌萎缩侧索硬化症的安慰剂对照试验。欧洲肌萎缩侧索硬化症/胰岛素样生长因子-I研究组。
A placebo-controlled trial of insulin-like growth factor-I in amyotrophic lateral sclerosis. European ALS/IGF-I Study Group.
作者信息
Borasio G D, Robberecht W, Leigh P N, Emile J, Guiloff R J, Jerusalem F, Silani V, Vos P E, Wokke J H, Dobbins T
机构信息
Department of Neurology, University of Munich, Germany.
出版信息
Neurology. 1998 Aug;51(2):583-6. doi: 10.1212/wnl.51.2.583.
To test the safety and efficacy of recombinant human insulin-like growth factor-I (rhIGF-I) in ALS, 183 patients from eight European centers were randomized to receive double-blind placebo (n = 59) or rhIGF-I 0.1 mg/kg/day (n = 124) subcutaneously for 9 months. At study completion, the primary efficacy outcome measure (change in disease progression as assessed by the Appel ALS rating scale) showed no significant difference between treatment groups. RhIGF-I appeared to be safe and well-tolerated.
为了测试重组人胰岛素样生长因子-I（rhIGF-I）治疗肌萎缩侧索硬化症（ALS）的安全性和有效性，来自欧洲八个中心的183名患者被随机分为两组，分别接受皮下注射双盲安慰剂（n = 59）或rhIGF-I 0.1 mg/kg/天（n = 124），为期9个月。研究结束时，主要疗效指标（通过阿佩尔ALS评定量表评估的疾病进展变化）显示治疗组之间无显著差异。rhIGF-I似乎安全且耐受性良好。
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