Mesalazine modified-release tablets in the treatment of ulcerative colitis in remission phase: a multi-center, single-blinded and randomized controlled study / 中华消化杂志

ABSTRACT

Objective To evaluate the efficacy and safety of mesalazine modified-release tablets in the maintenance treatment of patients with ulcerative colitis (UC) in remission phase.Methods This study was a multi-center,single-blinded and randomized controlled study.From November 2010 to August 2012,251 patients with UC from 18 hospitals were enrolled.According to the randomization table,all patients were divided into the mesalazine modified-release tablets group (n 126) and the mesalazine enteric-coated tablets group (n=125).The course of treatment were both 48 weeks.The primary efficacy parameter of the two groups including the rate of non-recurrence of bloody stool,and the secondary efficacy parameter including period of non-recurrence of bloody stool,period of non-recurrence of UC,incidence of adverse events and adverse drug reactions were observed.The GENMOD model was applied to calculate 95％ confidence interval (CI) of the rate of non-recurrence of bloody stool of the two groups.If the lower limits was over-10％ of the setting,it indicated that the former was not inferior to the latter.Results In 48 weeks of maintenance treatment,the rate of non-recurrence of bloody stool of themesalazinemodified-release tablets group was 82.99％(95％CI 73.53％ to 92.45％) and 73.30％ (95％ CI 64.04％ to 82.56％) in the mesalazine enteric-coated tablets group,respectively,and the difference between the two groups was 9.69％(95％CI-1.15％ to 20.53％ (＞-10％)) which indicated the mesalazine modified-release tablets group was not inferior to the mesalazine enteric-coated tablets group.There was no significant difference in the period of non recurrence of bloody stool and period of non recurrence of UC between the two groups (both P＞0.05).The incidence of adverse events was 48.78％ (60/123) in the mesalazine modified-release tablets group and 48.00％ (60/125) in the mesalazine enteric-coated tablets group,and the difference was not statistically significant (P=0.902).The incidence of adverse reactions was 16.26 ％ (20/123) in the mesalazine modified release tablets group and 13.60 ％ (17/125) in the mesalazine enteric-coated tablets group.There was no statistically significant difference (P =0.556).Conclusion Mesalazine modified release tablets can help maintain long-term remission in patients with UC,and can be used as a safe and effective alternative medicine in the treatments of UC in remission phase.