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The Multiple Sclerosis Performance Test (MSPT): An iPad-Based Disability Assessment Tool
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早期与延迟的干扰素β-1b治疗对第一次临床事件后残疾的影响,这表明多发性硬化症:对BENEFIT研究的3年随访分析.

Ludwig Kappos1, Mark S Freedman, Chris H Polman

  • 1Neurology and Department of Research, University Hospital, Basel, Switzerland. lkappos@uhbs.ch

Lancet (London, England)
|August 7, 2007
PubMed
概括

在经历第一个脱髓化事件的患者中,早期使用干扰素β-1b治疗显著延迟了临床确定的多发性硬化症 (MS) 和确定的残疾的发展. 这支持其在早期复发性复发性MS管理中的使用.

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科学领域:

  • 神经学 神经学
  • 免疫学 免疫学 免疫学
  • 临床试验 临床试验

背景情况:

  • 现有研究表明,干扰素β在第一次暗示事件后延迟转化为临床确定的多发性硬化症 (MS).
  • 在BENEFIT研究中,研究了早期与延迟的干扰素β-1b治疗对MS残疾进展的长期影响.

研究的目的:

  • 为了确定早期启动干扰素β-1b治疗是否可以防止在患有第一个暗示MS的临床事件的患者中出现确定的残疾.
  • 为了比较早期与延迟的干扰素β-1b治疗对疾病进展和患者报告的结果在三年内的疗效.

主要方法:

  • 一个双盲,安慰剂受控试验 (BENEFIT研究) 随机分配了患有第一个MS-暗示事件和MRI病变的患者,接受干扰素β-1b或安慰剂两年.
  • 随机化后,患者被跟踪了三年,比较了早期治疗和延迟治疗组 (在CDMS诊断或研究完成后开始) 的结果.
  • 主要结局包括临床确定的MS (CDMS) 的时间,证实扩展残疾状况表 (EDSS) 进展的时间,以及患者报告的功能评估 (FAMS-TOI).

主要成果:

  • 在三年内,早期的干扰素β-1b治疗显著降低了患CDMS的风险41% (p=0.0011) 和确认EDSS进展40% (p=0.022).
  • 早期治疗组的CDMS绝对风险降低为14%,而EDSS进展的绝对风险降低为8%,与延迟治疗组相比.
  • 在三年随访期间,患者报告的功能评估得分 (FAMS-TOI) 在两组治疗中保持高和稳定.

结论:

  • 早期启动干扰素β-1b治疗有效地预防了早期复发性复发性多发性硬化症患者的确诊残疾的发展.
  • 这些发现支持在MS的第一个临床表现后使用干扰素β-1b来缓解长期残疾.