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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2017.1
- 수록면
- 368 - 379 (12page)
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Background/Aims: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) comparedto another form of high-dose mesalazine. Methods: In this multicenter, randomized, double-blind study, 280 patientswith mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependentreleasemesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease ActivityIndex (UC-DAI) at the end of the treatment period. Results: The change in the UC-DAI (mean±standard deviation) in the perprotocolset was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and −1.8±2.64 in the pH-dependent-releasemesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidenceinterval, −1.3 to −0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependentreleasemesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. Insubgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no differencein safety between the 2 treatment groups. Conclusions: Multimatrix mesalazine 4.8 g/day has higher efficacy and showsno difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.
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참고문헌 (15)
참고문헌 신청
Frieri G / 2000 / Mucosal 5-aminosalicylic acid concentration inversely correlates with severity of colonic inflammation in patients with ulcerative colitis / Gut 47:410~414
Feagan BG / 2012 / Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis / Cochrane Database Syst Rev 10:CD000544
Dignass A / 2012 / Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management / J Crohns Colitis 6:991~1030
Brunner M / 2003 / Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation / Aliment Pharmacol Ther 17:395~402
Tenjarla S / 2011 / In-vitro characterization of 5-aminosalicylic acid release from MMX mesalamine tablets and determination of tablet coating thickness / Adv Ther 28:62~72
Feagan BG / 2012 / Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis / Cochrane Database Syst Rev 10:CD000544
Dignass A / 2012 / Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management / J Crohns Colitis 6:991~1030
Brunner M / 2003 / Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation / Aliment Pharmacol Ther 17:395~402
Tenjarla S / 2011 / In-vitro characterization of 5-aminosalicylic acid release from MMX mesalamine tablets and determination of tablet coating thickness / Adv Ther 28:62~72
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