肌缩侧面硬化症患者的高热量肠道营养:一个随机,双盲,安慰剂控制的第二阶段试验
Anne-Marie Wills1, Jane Hubbard2, Eric A Macklin3
1Department of Neurology and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|March 4, 2014
概括
高热量肠道营养,特别是高碳水化合物/高脂肪饮食,对于肌缩性侧面硬化症患者来说似乎是安全的和可以容忍的. 这支持对这种神经退行性疾病的营养干预措施的进一步研究.
科学领域:
- 神经学 神经学
- 营养科学 营养科学
- 临床试验 临床试验
背景情况:
- 肌缩侧面硬化症 (ALS) 是一种致命的神经退行性疾病,治疗选择有限.
- 轻度肥胖和高热量饮食与相应地增加ALS患者和小鼠模型的存活率有关.
- 这项研究评估了在接受肠道营养的ALS患者中两种高热量饮食的安全性和耐受性.
研究的目的:
- 评估高碳水化合物/高脂肪 (HC/HC) 和高脂肪/高碳水化合物 (HF/HC) 高热量肠道营养饮食的安全性和耐受性.
- 为了比较这些干预措施与标准的同热量饮食在患有肌缩性侧面硬化症的患者.
- 为ALS管理中的营养干预提供初步证据.
主要方法:
- 一个双盲,安慰剂控制,随机的2期临床试验,涉及成年ALS患者接受穿皮肠道营养.
- 参与者被分配到对照饮食,高碳水化合物高热量饮食 (HC/HC) 或高脂肪高热量饮食 (HF/HC) 中4个月.
- 主要结局是安全性和耐受性,随访时间为5个月. 临床试验网站:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.gov:NCT00983983.
主要成果:
- 20名参与者开始使用研究饮食 (6个对照组,8个HC/HC,6个HF/HC).
- HC/HC组的不良事件较少 (23对42对照组,48 HF/HC) 和严重不良事件显著减少 (0对9对照组).
- 在随访期间,HC/HC组中没有死亡,而对照组中有3例死亡 (p=0.03).
结论:
- 高热量的肠道营养,特别是HC/HC饮食,在ALS患者中显示出安全性和耐受性.
- 这些发现支持进一步研究更大规模的,早期阶段的ALS临床试验中的营养干预措施.
- 这项研究强调了饮食在控制肌缩性侧面硬化症进展中的潜在作用.
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