针对炎症性肠病的个性化 (N-of-1) 临床试验:机遇和挑战
Sailish Honap1, Guangyong Zou2, Silvio Danese3
1INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France; School of Immunology and Microbial Sciences, King's College, London, United Kingdom; Department of Gastroenterology, St George's University Hospitals NHS Foundation Trust, London, United Kingdom.
N-of-1试验通过对个体患者进行随机治疗,为炎症性肠病 (IBD) 提供个性化治疗. 虽然它们在IBD中的使用是有限的,但它们具有量身定制的患者护理的潜力.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 个性化医疗是个性化的医疗.
背景情况:
- 炎症性肠病 (IBD) 在治疗反应中表现出显著的异质性.
- 传统的随机试验可能无法捕捉个体患者的变化.
- N-of-1试验为治疗评估提供了个性化的方法.
研究的目的:
- 调查N-of-1试验在治疗炎症性肠病中的实用性和潜力.
- 探索N-of-1试验如何解决IBD传统随机对照试验的局限性.
主要方法:
- 进行了对英语文献的范围审查.
- 通过PubMed搜索MEDLINE数据库,使用与IBD和N-of-1试验相关的术语进行搜索.
- 包括专注于N-of-1试验,单个病例设计或IBD个性化试验的研究.
主要成果:
- 在个性化医学中,N-of-1试验正在获得引力,但在IBD中很少使用,只确定了三项试验.
- 多个N-of-1试验可以产生可靠的个体和平均效果估计.
- N-of-1试验对研究代表性不足的IBD患者小组显示出希望,尽管研究设计可能是繁的.
结论:
- N-of-1试验提供了一个以患者为中心的方法,用于客观地评估个体治疗反应.
- 这种设计有助于在炎症性肠病中做出个性化治疗决策.
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