耐用医疗设备在Courage-ALS中的使用,这是ALS的第三阶段,多中心,随机临床试验
Stacy A Rudnicki1, Elisa Giacomelli2, Katherine Herder1
1Cytokinetics Incorporated, South San Francisco, California, USA.
Muscle & nerve
|January 19, 2026
概括
耐用医疗设备 (DME) 在临床试验中经常被肌缩侧面硬化症 (ALS) 患者使用. 然而,使用DME并没有影响试验结果,并且显示了区域差异,建议在将其作为试验终点之前谨慎使用.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 医疗器械 医疗器械
背景情况:
- 肌缩侧面硬化症 (ALS) 需要耐用医疗设备 (DME) 来支持患者.
- 在CORAGE-ALS试验中,评估了reldesemtiv在ALS患者的疗效和安全性.
研究的目的:
- 描述DME在Curage-ALS试验中的使用情况.
- 评估DME使用是否可以在未来的ALS临床试验中成为相关的终点.
主要方法:
- 一个多中心,双盲,随机,安慰剂对照试验 (COURAGE-ALS) 涉及482名参与者.
- 探索性结果包括DME的处方原因,使用范围,类型和区域差异.
主要成果:
- 34.4%的参与者在基线使用了DME; 47.1%的参与者在第24周开始使用新的DME.
- 手动轮椅是最常见的DME. 基线和新的DME使用与较低的功能评分和生活质量相关.
- 较少的激活治疗没有影响DME的使用;观察到区域差异.
结论:
- 在临床试验中,DME通常由ALS患者使用.
- 在DME接入的地理差异及其临床影响需要进一步调查.
- 应该仔细考虑使用DME作为ALS研究中的试验终点.
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