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临床试验中炎症性肠病活动度的内镜评估

Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials.

作者信息

Khanna Reena, Ma Christopher, Jairath Vipul, Vande Casteele Niels, Zou Guangyong, Feagan Brian G

机构信息

Department of Medicine, University of Western Ontario, London, Ontario, Canada.

Department of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Robarts Clinical Trials, London, Ontario, Canada.

出版信息

Clin Gastroenterol Hepatol. 2022 Apr;20(4):727-736.e2. doi: 10.1016/j.cgh.2020.12.017. Epub 2020 Dec 15.

DOI:10.1016/j.cgh.2020.12.017
PMID:33338657
Abstract

In patients with Crohn's disease and ulcerative colitis, poor correlation between symptoms and active luminal inflammation has been well established. As a result, the field has moved towards the use of endoscopic assessment to evaluate inflammatory activity. Numerous endoscopic indices have been used for this purpose although none are completely validated. The Simple Endoscopic Score for Crohn's Disease and the Crohn's Disease Endoscopic Index of Severity have been used most frequently; however in addition to incomplete validation, they have important limitations for clinical use, including complexity of scoring and poor reliability of items such as stenosis. The Rutgeerts' score for postoperative Crohn's disease was developed primarily as a prognostic rather than evaluative tool and also requires additional validation. In ulcerative colitis, the Mayo endoscopic subscore has been used as the regulatory standard, although the Ulcerative Colitis Endoscopic Index of Severity may provide a more granular assessment of individual components of disease activity. The use of combined outcomes with patient reported outcomes (PROs) and endoscopic indices has received favor by regulatory bodies but require further validation. This review describes the indications for endoscopic assessment in trials, the indices most frequently utilized for these purposes, and potential future approaches to assessment of disease activity.

摘要

在克罗恩病和溃疡性结肠炎患者中,症状与活动性肠腔炎症之间的相关性较差,这一点已得到充分证实。因此,该领域已转向使用内镜评估来评价炎症活动。尽管没有一个完全得到验证,但已有许多内镜指数用于此目的。克罗恩病简易内镜评分和克罗恩病内镜严重程度指数使用最为频繁;然而,除了验证不完全外,它们在临床应用中还有重要局限性,包括评分复杂以及诸如狭窄等项目的可靠性较差。术后克罗恩病的鲁杰茨评分主要是作为一种预后工具而非评估工具开发的,也需要进一步验证。在溃疡性结肠炎中,梅奥内镜子评分已被用作监管标准,尽管溃疡性结肠炎内镜严重程度指数可能对疾病活动的各个组成部分提供更细致的评估。将综合结果与患者报告结局(PROs)和内镜指数相结合的方法已得到监管机构的认可,但仍需进一步验证。本综述描述了试验中内镜评估的适应证、最常用于这些目的的指数以及未来评估疾病活动的潜在方法。

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