生物临床试验中的内镜终点和超越:克罗恩病的情况
Marlou P M Adriaanse1, Mark Löwenberg1, Geert R A M D'Haens1
1Department of Gastroenterology & Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
对于克罗恩病的简单内镜评分 (SES-CD) 建议在克罗恩病临床试验中评估内镜活动,因为其简单性和响应性. 需要进一步的研究来确定内镜反应和缓解的截止值.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验设计 临床试验设计
- 内镜评估的内镜评估
背景情况:
- 标准化内镜评估对于克罗恩病 (CD) 临床试验至关重要.
- 内镜缓解和粘膜愈合是关键的治疗目标,与改善长期结果有关.
研究的目的:
- 对克罗恩病活动的现有内镜指数进行审查.
- 推临床试验的最佳指数,并建议未来的研究方向.
主要方法:
- 目前对克罗恩病的内镜指数的审查 (CDEIS,SES-CD,易斯得分,CECDAI,鲁特杰茨得分).
- 评估指数可靠性,响应性和验证状态.
- 专家对临床试验环境中指数有用性的意见.
主要成果:
- 像CDEIS和SES-CD这样的现有指数显示出相当的可靠性和响应性,但具有局限性 (复杂性,可变性).
- 视频囊内镜指数 (路易斯分数,CECDAI) 需要进一步验证.
- 鲁特吉茨得分主要用于术后复发预测.
结论:
- 克罗恩病的简单内镜评分 (SES-CD) 是由于其简单性,与CDEIS的相关性和响应性而被认为是首选的指数.
- 未来的研究应该在CD试验中确定内镜反应和缓解的临床相关切断值,包括术后设置.
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