在固体瘤中单独复合的多腔 vs. 标准化的腹腔营养袋-一项随机临床试验 (IKF-010)
Thorsten Oliver Goetze1, Ralf-Dieter Hofheinz2, Ingeborg Roetzer3
1Hospital Northwest, University Cancer Center Frankfurt, Frankfurt, Germany; The Frankfurt Institute of Clinical Cancer Research IKF GmbH, Frankfurt, Germany.
与传统的袋子相比,用于家庭亲肠道营养 (HPN) 的多腔袋 (MCB) 显著改善了患者的自主性,并减少了不良事件. 这种方法提高了接受HPN的癌症患者的自我管理.
科学领域:
- 在瘤学瘤学.
- 临床营养学 临床营养学
- 患者护理 患者护理
背景情况:
- 癌症患者往往需要在家中进行亲肠道营养 (HPN),造成感染和依赖护理的风险.
- 多腔袋 (MCB) 为个性化HPN提供了一个潜在的解决方案,旨在减少处理,提高患者自主性和降低感染风险.
研究的目的:
- 为了比较使用MCB单独组合的HPN的疗效和安全性,与传统的2/3腔袋相比.
- 评估对患者自主权,导管相关感染 (CRI) 和癌症患者整体安全性的影响.
主要方法:
- 一项随机对照试验 (IKF-t01/PEKANNUSS) 将基于MCB的HPN (A臂) 与晚期瘤患者的传统HPN (B臂) 进行比较.
- 主要终点:自主性率 (HPN≥70%的自我管理). 二级终点:CRIs,安全性,体重和白蛋白水平.
主要成果:
- 患者自主性显著增加MCB (52%对33%,p=0.04),特别是在ECOG≤1 (68%对42%) 的患者中.
- MCB显著降低了家庭添加剂注射的需要 (11%对96%,p<0.01) 和与HPN相关的整体不良事件 (27%对55%,p<0.01).
- 使用MCB观察到数量较低的CRI率 (13%对22%),ECOG≤1 (8%对25%) 患者的差异更为明显.
结论:
- 使用MCB单独复合的HPN是一种安全有效的治疗方法.
- MCB增强了患者自我管理HPN的能力,提高了独立性和安全性.
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