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

被引:13
作者
Caron, Benedicte [1 ,2 ]
Jairath, Vipul [3 ,4 ,5 ]
D'Amico, Ferdinando [6 ,7 ,8 ]
Paridaens, Kristine [9 ]
Magro, Fernando [10 ,11 ,12 ]
Danese, Silvio [6 ,7 ]
Peyrin-Biroulet, Laurent [1 ,2 ]
机构
[1] Univ Lorraine, Nancy Univ Hosp, Dept Gastroenterol, 1 Allee Morvan, F-54511 Nancy, France
[2] Univ Lorraine, Nancy Univ Hosp, INSERM, NGERE U1256, 1 Allee Morvan, F-54511 Nancy, France
[3] Western Univ, Dept Med, London, ON, Canada
[4] Western Univ, Dept Epidemiol & Biostat, London, ON, Canada
[5] Alimentiv Inc, London, ON, Canada
[6] IRCCS Osped San Raffaele, Gastroenterol & Endoscopy, Milan, Italy
[7] Univ Vita Salute San Raffaele Milano, Milan, Italy
[8] Humanitas Univ, Dept Biomed Sci, Milan, Italy
[9] Ferring Int Ctr, St Prex, Switzerland
[10] Univ Porto, Fac Med, Unit Pharmacol & Therapeut, Dept Biomed, Porto, Portugal
[11] Sao Joao Univ Hosp Ctr CHUSJ, Dept Clin Pharmacol, Porto, Portugal
[12] Univ Porto, Fac Med, Ctr Hlth Technol & Serv Res CINTESIS, Porto, Portugal
关键词
definition; mild; moderate; predictive factor; ulcerative colitis; RELEASE ORAL MESALAMINE; INFLAMMATORY-BOWEL-DISEASE; 400 MG TABLETS; DOUBLE-BLIND; BECLOMETHASONE DIPROPIONATE; MESALAZINE TABLETS; BUDESONIDE FOAM; MMX MESALAZINE; DOUBLE-DUMMY; EFFICACY;
D O I
10.1002/ueg2.12283
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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.
引用
收藏
页码:854 / 867
页数:14
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