针用于预防化疗诱导的周围神经病变:随机对照试验的研究协议
Bin-Yan Li1, Cun-Zhi Liu1, Hang Zhou1
1International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
BMJ open
|July 29, 2025
概括
这项试点研究探讨了用于预防化疗诱导的周围神经病变 (CIPN) 的电. 结果将为对癌症患者这一有前途的干预措施进行更大规模的试验提供信息.
科学领域:
- 在瘤学瘤学.
- 神经学 神经学
- 综合医学是一个整体的医学.
背景情况:
- 化疗诱导的周围神经病变 (CIPN) 是一种常见的,剂量限制的癌症治疗的副作用,如衍生物和纳税.
- 目前对CIPN缺乏预防性干预措施,这凸显了对新型预防策略的需求.
- 针已经显示出减轻外围神经病变症状的潜力,这表明其在预防CIPN.
研究的目的:
- 评估电作为CIPN的预防措施的可行性和有效性.
- 为设计更大规模的临床试验提供数据,并为未来的CIPN预防研究提供计算能力.
- 调查电针对CIPN相关生活质量和各种次要结果的影响.
主要方法:
- 一个随机的模拟受控试验,涉及60名接受化疗的患者.
- 患者被分配到电针或假针组,在三个化疗周期中接受九次治疗.
- 主要结局:与CIPN相关的生活质量的变化 (EORTC QLQ-CIPN20);次要结局:神经毒性,失眠,抑郁,焦虑和疲劳.
主要成果:
- 当研究完成并可获得结果后,该部分应填写.
- 试点试验的主要目标是收集可行性和疗效的数据,而不是报告最终的治疗结果.
- 临时分析或最终结果将在随后的出版物中详细说明.
结论:
- 电针为预防化疗诱导的外围神经病变提供了一个潜在的策略.
- 这项试点研究的结果将指导未来对CIPN预防的更大规模临床试验的设计和功率计算.
- 需要进一步的研究,以确定电在管理CIPN中的作用的确证据.
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