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논문 기본 정보

자료유형
학술저널
저자정보
Haruhiko Ogata (Keio University Hospital) Akihiro Ohori (Inogashiradori Proctology and Gastroenterology Clinic) Haruo Nishino (Matsushima Clinic Kanagawa) Seiichi Mizushima (Clinical Development Department Mochida Pharmaceutical Co. Ltd. Tokyo) Atsushi Hagino (Clinical Development Department Mochida Pharmaceutical Co. Ltd. Tokyo) Toshifumi Hibi (Kitasato Institute Hospital)
저널정보
대한장연구학회 Intestinal research Intestinal research Vol.15 No.3
발행연도
2017.1
수록면
358 - 367 (10page)

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Background/Aims: This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day withmultiple-dose mesalazine for the maintenance of remission. Methods: In this multicenter, randomized, double-blind study,203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patientswithout rectal bleeding. Results: The proportion of patients without rectal bleeding during the 48-week treatment period in theper protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-releasemesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval,−3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-dailywith controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacyin all subgroups. There was no difference between the 2 treatment groups with regard to safety. Conclusions: A once-dailydose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily inmaintaining absence of rectal bleeding in ulcerative colitis.

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