德克萨米他12周用于减轻接受化疗的患者的疲劳:第三期,安慰剂控制,随机对照试验
Venkatraman Radhakrishnan1, Vidhya Gopalakrishnan2, Gundrathi Vamsi Vihari3
1Department of Medical Oncology, Cancer Institute (WIA), Adyar, Chennai, Tamil Nadu, India. venkymd@gmail.com.
概括
德克萨米他没有有效地减少癌症相关的疲劳或改善接受息化疗的患者的生活质量. 需要进一步的研究,以找到更好的疲劳管理策略,为癌症患者.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 与癌症相关的疲劳是接受息化疗的患者常见和衰弱的症状.
- 在疲劳管理中使用类固醇的长期疗效和安全性尚未得到充分证实.
研究的目的:
- 评估12周的德克萨米他治疗与安慰剂对癌症相关疲劳的疗效和安全性,在接受息化疗的患者中.
- 评估德克萨米他对该患者群体生活质量 (QOL) 的影响.
主要方法:
- 一个III期,开放标签,安慰剂对照随机试验,涉及126名患有固体恶性瘤的患者.
- 患者每天接受4毫克德克萨米他松或安慰剂,持续12周.
- 使用标志性疲劳程度评估 (SAFE) 和EORTC FA-12等级来评估疲劳;使用EORTC QLQ-C30.0来测量QOL.
主要成果:
- 在6周或12周内,德甲和安慰剂组之间的平均SAFE分数没有显著差异.
- 安慰剂组在12周后报告了FA-12尺度上的更好的角色功能 (P=0.02).
- 德克萨米他组经历了更多的便秘和社会后果,整体不良事件没有显著差异.
结论:
- 在接受缓性化疗的患者中,每天服用4毫克德克萨米松12周并没有显著减少与癌症相关的疲劳或改善QOL.
- 替代干预措施是必要的,以有效地管理疲劳在这个患者群体.
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