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Interferon-alpha and transfer factor in the treatment of multiple sclerosis: a double-blind, placebo-controlled trial. AUSTIMS Research Group.

机译:干扰素-α和转移因子在多发性硬化症治疗中的作用:一项双盲,安慰剂对照试验。 AUSTIMS研究小组。

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摘要

The role of interferon-alpha (IFN-alpha) and transfer factor (TF) in the treatment of multiple sclerosis was investigated in a prospective, multi-centric, three year, double-blind, placebo-controlled trial. One hundred and eighty two patients with clinically definite multiple sclerosis were randomised into three treatment groups whose compositions were found to be similar for demographic and prognostic variables including HLA status. Subcutaneous injections of IFN-alpha (3 x 10(6) units), TF (0.5 units) manufactured from leucocytes of cohabiting donors, or placebo were given twice weekly for two months, once weekly for 10 months then fortnightly for 24 months. One hundred and fifty three patients completed the injection regimen. There was no significant difference in the progression of disability for multiple sclerosis patients in either the IFN-alpha or TF-treated groups compared with the placebo group. Similarly, change in visual evoked responses (VER), and in number of oligoclonal bands (OCB) and the level of myelin basic protein (MBP) in the cerebrospinal fluid (CSF) over the trial period did not differ significantly between the three groups. However, the IFN-alpha-treated group had significantly more reported adverse drug reactions and patient withdrawals than either of the other two groups.
机译:在一项前瞻性,多中心,三年,双盲,安慰剂对照试验中,研究了干扰素-α(IFN-α)和转移因子(TF)在多发性硬化症治疗中的作用。 182名临床上明确的多发性硬化症患者被随机分为三个治疗组,其组成在人口统计学和预后变量(包括HLA状态)方面相似。皮下注射由同居供体的白细胞或安慰剂制成的IFN-α(3 x 10(6)单位),TF(0.5单位),每周两次,持续两个月,每周一次,持续10个月,然后每两周一次,持续24个月。 153名患者完成了注射方案。与安慰剂组相比,IFN-α或TF治疗组的多发性硬化症患者的残疾进展无显着差异。同样,在试验期间,三组之间的视觉诱发反应(VER),脑脊髓液(CSF)的寡克隆带(OCB)数量和髓鞘碱性蛋白(MBP)水平的变化也没有显着差异。但是,与其他两组相比,IFN-α治疗组报告的药物不良反应和患者撤药明显增加。

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