Abstract：
BACKGROUND: Mesalazine is used as maintenance therapy in ulcerative colitis but the optimal dosage is still controversial.
OBJECTIVE: To compare the remission-maintenance efficacy and tolerability of two daily doses of oral mesalazine (4.8 g and 2.4 g) in patients with ulcerative colitis with frequent relapses in a randomized controlled trial.
METHODS: 112 ulcerative colitis patients in remission were enrolled and randomly allocated to treatment for 1 year with oral mesalazine at a daily dose of 4.8 g (n=56, Group A) or 2.4 g (n=56, Group B).
RESULTS: At the end of the 12 months, intention to treat analysis revealed persistent remission in 42 (75%) in Group A and 36 (64.2%) in Group B (p=0.3). The higher daily dose (4.8 g) proved to be significantly more effective for maintaining remission in patients under 40 years of age (90.5% Group A vs. 50% Group B; Fisher\'s exact test, p=0.0095) and in those with extensive disease (90.9% Group A vs. 46.7% Group B; Fisher\'s exact test, p=0.0064).
CONCLUSIONS: In ulcerative colitis patients younger than 40 years and/or with extensive disease, a daily dose of 4.8 g oral mesalazine results in increased rates and duration of remission compared to 2.4 g.
OBJECTIVE: To compare the remission-maintenance efficacy and tolerability of two daily doses of oral mesalazine (4.8 g and 2.4 g) in patients with ulcerative colitis with frequent relapses in a randomized controlled trial.
METHODS: 112 ulcerative colitis patients in remission were enrolled and randomly allocated to treatment for 1 year with oral mesalazine at a daily dose of 4.8 g (n=56, Group A) or 2.4 g (n=56, Group B).
RESULTS: At the end of the 12 months, intention to treat analysis revealed persistent remission in 42 (75%) in Group A and 36 (64.2%) in Group B (p=0.3). The higher daily dose (4.8 g) proved to be significantly more effective for maintaining remission in patients under 40 years of age (90.5% Group A vs. 50% Group B; Fisher\'s exact test, p=0.0095) and in those with extensive disease (90.9% Group A vs. 46.7% Group B; Fisher\'s exact test, p=0.0064).
CONCLUSIONS: In ulcerative colitis patients younger than 40 years and/or with extensive disease, a daily dose of 4.8 g oral mesalazine results in increased rates and duration of remission compared to 2.4 g.
摘要：
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