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临床试验中轻度至中度溃疡性结肠炎的定义:系统文献回顾。

Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.

机构信息

Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Nancy, France.

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

出版信息

United European Gastroenterol J. 2022 Oct;10(8):854-867. doi: 10.1002/ueg2.12283. Epub 2022 Aug 27.

DOI:10.1002/ueg2.12283
PMID:36029157
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9557958/
Abstract

We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to treatment in clinical trials assessing 5-ASA and/or budesonide. Thirty-nine randomized controlled trials were included. The UC Disease Activity Index (UCDAI) was the most frequent score used for defining mild to moderate active UC (16 studies, 41%), followed by Clinical Activity Index in 11 studies (28.2%). Four different cut-offs were used to define mild to moderate active UC using the UCDAI. The most frequently reported predictors of good response to treatment was a mild and moderate disease activity. There is heterogeneity in the definition of mild to moderate active UC in randomized clinical trials. A standardized definition of mild to moderate active UC used for inclusion of patients in clinical trials is needed.

摘要

我们进行了一项系统评价,旨在研究轻度至中度活动溃疡性结肠炎(UC)的定义,并描述在评估 5-ASA 和/或布地奈德的临床试验中,预测治疗良好反应的指标。共纳入 39 项随机对照试验。最常使用的用于定义轻度至中度活动 UC 的评分是 UC 疾病活动指数(UCDAI)(16 项研究,41%),其次是临床活动指数(11 项研究,28.2%)。使用 UCDAI 定义轻度至中度活动 UC 时,使用了 4 种不同的截断值。报道最多的治疗良好反应的预测指标是疾病活动轻中度。随机临床试验中对轻度至中度活动 UC 的定义存在异质性。需要为临床试验中患者的纳入制定一个标准化的轻度至中度活动 UC 的定义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f55e/9557958/643dec3079e0/UEG2-10-854-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f55e/9557958/643dec3079e0/UEG2-10-854-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f55e/9557958/643dec3079e0/UEG2-10-854-g001.jpg

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Gastroenterology. 2022 Apr;162(4):1005-1018. doi: 10.1053/j.gastro.2021.12.284. Epub 2022 Jan 6.
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