一种局部的毒药配方改善了化疗引起的外周神经病变:一项试点随机临床研究
Sonia Servitja1, Maria Castro-Henriques2, Iñaki Álvarez-Busto3,4
1Servicio de Oncología Médica, Hospital del Mar, 08003, Barcelona, Spain. sservitja@psmar.cat.
概括
一种局部药物配方显著降低了患者手中的化疗诱导的周围神经病变 (CIPN),并改善了他们的生活质量 (QoL). 这项研究提出了一种有前途的新方法,用于在癌症治疗期间管理CIPN.
科学领域:
- 在瘤学瘤学.
- 神经学 神经学
- 皮肤病学 皮肤病学
背景情况:
- 化疗诱导的周围神经病变 (CIPN) 影响了多达80%的接受税或剂的患者,影响了治疗坚持和生活质量 (QoL).
- CIPN的特点是外围感知神经末端的敏感性增加.
- 目前对CIPN的管理策略有限,需要新的治疗方法.
研究的目的:
- 评估局部药物配方在预防CIPN.的有效性.
- 评估局部药物配方在化疗期间对患者的QoL的影响.
- 进行概念验证,双盲,随机化,多中心临床试验.
主要方法:
- 142名接受TAXAN和/或基化疗的患者被随机分配到两个手臂.
- 参与者每天要么在手上涂上保湿,要么在手上涂上有毒药剂.
- 在神经病症状出现时,应用频率增加到每天两次;CIPN诊断遵循CTC AE v5.0标准.
主要成果:
- 毒药组显示手部CIPN发生率明显较低 (13%对32%,p=0.03).
- 两组之间没有观察到CIPN发病率在脚部有显著差异 (67%对73%,p=0.1).
- 使用毒药配方的患者报告了较少的麻烦的神经病症症状 (39%vs60%,p=0.0017) 和经历了更多的化学疗程没有CIPN.
结论:
- 一种毒药配方的局部应用有效地减少了手中的CIPN发生率.
- 毒药配方提高了接受化疗的患者的生活质量.
- 这些发现支持在更大规模的确认性临床研究中进一步调查.
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