http://www.cnr.it/ontology/cnr/individuo/prodotto/ID12019
Two mesalazine regimens in the prevention of the post-operative recurrence of (Articolo in rivista)
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- Two mesalazine regimens in the prevention of the post-operative recurrence of (Articolo in rivista) (literal)
- Anno
- 2003-01-01T00:00:00+01:00 (literal)
- Alternative label
Caprilli R, Cottone M, Tonelli F, Sturniolo G, Castiglione F, Annese V, Papi, Viscido A, Camma C, Corrao G, Latella G. (2003)
Two mesalazine regimens in the prevention of the post-operative recurrence of
in Alimentary pharmacology & therapeutics
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- Caprilli R, Cottone M, Tonelli F, Sturniolo G, Castiglione F, Annese V, Papi, Viscido A, Camma C, Corrao G, Latella G. (literal)
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- Impact Factor: 3.900 (literal)
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- Titolo
- Two mesalazine regimens in the prevention of the post-operative recurrence of (literal)
- Abstract
- BACKGROUND: The role of mesalazine in preventing the clinical recurrence of Crohn's disease after surgery has been shown in a meta-analysis of all published studies. No clear relationship, however, has been shown between dosage and response. AIM: To evaluate whether 4.0 g/day of mesalazine may offer therapeutic advantages over 2.4 g/day in the prevention of both endoscopic and clinical post-operative recurrence of Crohn's disease. METHODS: The study was a double-blind, randomized, multi-centre, prospective, controlled clinical trial. Two hundred and six patients, submitted to first or second intestinal resection for Crohn's disease limited to the terminal ileum, with or without involvement of the caecum/ascending colon, were enrolled. Of these, 101 were randomly allocated to receive 4.0 g/day of mesalazine (Asacol, Giuliani SpA, Milan, Italy) and 105 to receive 2.4 g/day, starting 2 weeks after surgery. The primary outcome was endoscopic recurrence, at 12 months after surgery. Three different degrees of endoscopic recurrence were evaluated (endoscopic scores: > 0, > 1 and > 2). The secondary outcome was clinical recurrence, defined as a Crohn's disease activity index of more than 150 points or an increase in the Crohn's disease activity index of 100 points or more. For statistical analysis, chi-square, Wilcoxon and Cox regression model tests were used, when appropriate. RESULTS: Eighty-four patients in the 4.0 g/day group and 81 patients in the 2.4 g/day group were evaluable by endoscopy. Endoscopic recurrence of > 0 was significantly higher in the 2.4 g/day group than in the 4.0 g/day group (62% vs. 46%; P < 0.04). No difference was observed between the two groups with regard to the other two endoscopic outcomes (> 1 and > 2) or clinical recurrence. CONCLUSIONS: A 4.0 g/day regimen of mesalazine does not offer a clinically significant advantage over a 2.4 g/day regimen in the prevention of post-operative endoscopic and clinical recurrence of Crohn's disease at 1 year of follow-up.
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