Cited 10 times in
Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | 천재희 | - |
dc.date.accessioned | 2023-04-07T01:27:12Z | - |
dc.date.available | 2023-04-07T01:27:12Z | - |
dc.date.issued | 2022-12 | - |
dc.identifier.issn | 1542-3565 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193927 | - |
dc.description.abstract | Background & aims: Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown. Methods: This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy. Results: Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids + mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P = .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P = .11) and day 90 (P = .07). Conclusions: In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation. Clinicaltrials: gov ID: NCT01941589. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | W.B. Saunders | - |
dc.relation.isPartOf | CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adrenal Cortex Hormones / therapeutic use | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Anti-Inflammatory Agents, Non-Steroidal / therapeutic use | - |
dc.subject.MESH | Biological Products* / therapeutic use | - |
dc.subject.MESH | Colitis, Ulcerative* / chemically induced | - |
dc.subject.MESH | Colitis, Ulcerative* / drug therapy | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Mesalamine / therapeutic use | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Shomron Ben-Horin | - |
dc.contributor.googleauthor | Ofir Har-Noy | - |
dc.contributor.googleauthor | Konstantinos H Katsanos | - |
dc.contributor.googleauthor | Xavier Roblin | - |
dc.contributor.googleauthor | Minhu Chen | - |
dc.contributor.googleauthor | Xiang Gao | - |
dc.contributor.googleauthor | Doron Schwartz | - |
dc.contributor.googleauthor | Jae Hee Cheon | - |
dc.contributor.googleauthor | Monica Cesarini | - |
dc.contributor.googleauthor | Daniela Bojic | - |
dc.contributor.googleauthor | Marijana Protic | - |
dc.contributor.googleauthor | Angeliki Theodoropoulou | - |
dc.contributor.googleauthor | Heba Abu-Kaf | - |
dc.contributor.googleauthor | Tal Engel | - |
dc.contributor.googleauthor | Jian Tang | - |
dc.contributor.googleauthor | Pauline Veyrard | - |
dc.contributor.googleauthor | Xiaoqing Lin | - |
dc.contributor.googleauthor | Ren Mao | - |
dc.contributor.googleauthor | Dimitrios Christodoulou | - |
dc.contributor.googleauthor | Konstantinos Karmiris | - |
dc.contributor.googleauthor | Tamara Knezevic-Ivanovski | - |
dc.identifier.doi | 10.1016/j.cgh.2022.02.055 | - |
dc.contributor.localId | A04030 | - |
dc.relation.journalcode | J02981 | - |
dc.identifier.eissn | 1542-7714 | - |
dc.identifier.pmid | 35272029 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S1542356522002130 | - |
dc.subject.keyword | 5-Aminosalycilates | - |
dc.subject.keyword | Corticosteroids | - |
dc.subject.keyword | Inflammatory Bowel Disease | - |
dc.subject.keyword | Ulcerative Colitis | - |
dc.contributor.alternativeName | Cheon, Jae Hee | - |
dc.contributor.affiliatedAuthor | 천재희 | - |
dc.citation.volume | 20 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 2868 | - |
dc.citation.endPage | 2875.e1 | - |
dc.identifier.bibliographicCitation | CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, Vol.20(12) : 2868-2875.e1, 2022-12 | - |
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