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在多发性硬化症中正在进行的HSCT随机临床试验.

Matilde Inglese1, Jeffrey A Cohen2, Basil Sharrack3

  • 1Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy.

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概括

自主造血干细胞移植 (AHSCT) 对复发性缓解性多发性硬化症 (RRMS) 的疾病修饰疗法 (DMT) 显示出更高的疗效. 目前正在进行的试验调查了活跃多发性硬化症的AHSCT,旨在澄清其在治疗策略中的作用.

关键词:
临床试验中的临床试验.血液造血干细胞移植是什么多发性硬化症是多发性硬化症.

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科学领域:

  • 神经免疫学 神经免疫学
  • 血液学 血液学 血液学
  • 临床试验 临床试验

背景情况:

  • 自主造血干细胞移植 (AHSCT) 是对高度活跃的复发性缓解性多发性硬化症 (RRMS) 的新兴治疗方法.
  • 来自II期和III期随机对照试验 (RCT) 的现有证据表明,AHSCT在减少复发和减缓残疾方面可能优于传统的疾病修饰疗法 (DMT).
  • 关于在多发性硬化症 (MS) 中进行AHSCT的最佳患者选择和调节方案的不确定性仍然存在.

研究的目的:

  • 评估AHSCT与高效DMT相比的安全性和有效性,在患有活性RRMS或侵袭性MS的患者中.
  • 为了解决关于AHSCT患者选择标准和调节方案的剩余问题.
  • 确定AHSCT在多发性硬化症治疗领域的长期结果和最佳位置.

主要方法:

  • 目前正在进行的国际临床试验 (英国,美国,意大利,挪威) 正在将AHSCT与高效DMT进行比较.
  • 试验包括经验丰富的DMT和以前没有接受过治疗的患者,患有活跃的RRMS或侵袭性MS.
  • 评估重点是安全性,疗效,复发率,残疾进展和长期结果.

主要成果:

  • 第二阶段和第三阶段的RCT已经证明了AHSCT在降低复发率方面优于标准DMT.
  • 在RRMS患者中,AHSCT已经显示出延迟残疾进展的潜力.
  • 目前正在进行的试验正在积极收集关于AHSCT与高效DMT的安全性,疗效和长期结果的数据.

结论:

  • 对于高度活跃的RRMS,AHSCT代表了一个强大的治疗选择,可能比目前的标准DMT提供更大的好处.
  • 预计来自正在进行的临床试验的进一步见解将改进AHSCT患者选择和调节方案.
  • 这些试验将在确定AHSCT在多发性硬化症治疗范式的发展中的最终作用方面至关重要.