用ocrelizumab治疗的多发性硬化症患者优化前期治疗:一个随机对照试验
Naghmeh Abbasi Kasbi, Ali Rezaei, Reyhaneh Montazeri
1Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
在治疗多发性硬化症 (MS) 时,标准的皮质类固醇治疗方案在预防输液相关反应 (INRR) 方面更有效. 降低剂量可能适合某些患者,因为严重反应在各组之间没有显著差异.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 多发性硬化症 (MS) 管理涉及疾病修饰疗法 (DMT),可能导致输液相关反应 (INRR).
- 皮质类固醇用于预防INRR,但具有长期健康风险.
- 优化安全需要平衡INRR预防,尽量减少在DMT期间的皮质类固醇暴露,如ocrelizumab (Xacrel).
研究的目的:
- 为了比较标准与调整的低剂量皮质类固醇前期治疗在接受ocrelizumab的MS患者中降低INRRs的有效性.
- 为了评估安全性,并尽量减少皮质类固醇的暴露.
主要方法:
- 一个单盲随机临床试验,涉及200名先前接受过ocrelizumab治疗的成年多发性硬化患者.
- 两个组:标准 (100毫克IV甲基prednisolone) 和调整 (8毫克IV德克萨米他) 前期治疗.
- 在输注后24小时内监测INRR的发生率和严重程度;使用Chi-square和逻辑回归进行统计分析.
主要成果:
- 与调整后的疗法相比,标准疗法显著降低了INRR发生率 (40.6%),而调整后的疗法则 (78.8%,p<0.01).
- 和喉刺激在调整后的组中更频繁 (p<0.01).
- 在严重的INRR中没有显著差异;INRR史强烈预测了未来的反应 (OR 6.27).
结论:
- 标准的皮质类固醇前期治疗在MS的ocrelizumab输注期间更有效地预防INRR.
- 对于某些患者,如果严重反应没有显著差异,可以考虑减少皮质类固醇治疗方案.
- 患者的INRR病史是风险管理中的关键因素.
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