Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis

被引:53
作者
Farup, PG
Hinterleitner, TA
Lukás, M
Hébuterne, X
Rachmilewitz, D
Campieri, M
Meier, R
Keller, R
Rathbone, B
Oddsson, E
机构
[1] Gjovik Cty Hosp, Gjovik, Norway
[2] Karl Franzens Univ Graz, Graz, Austria
[3] Charles Univ Prague, Prague, Czech Republic
[4] Hop Archet, Nice, France
[5] Hadassah Mt Scopus, Jerusalem, Israel
[6] S Orsola Univ, Bologna, Italy
[7] Kantonsspital, Liestal, Switzerland
[8] Univ Munster, Med Klin, Munster, Germany
[9] Kliniskar Rannsoknastofur, Landspitalinn, Reykjavik, Iceland
关键词
clinical trial; patient compliance; drug therapy; inflammatory bowel diseases; mesalazine; ulcerative colitis;
D O I
10.1097/00054725-200108000-00009
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background: High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 daily given as prolonged-release granules in packets of I with that of prolonged-release tablets of 0.5 g. Methods: Two hundred twenty-seven patients with mild-to-moderate ulcerative colitis were randomized to treatment with two packets twice daily (Gr-b.i.d.), I packet four times daily (Gr-q.i.d.) or 2 tablets four times daily (Ta-q.i.d.) for 8 weeks. A disease activity index (ulcerative colitis disease activity index; UC-DAI) was calculated, and the granules were defined as noninferior to the tablets if the lower limit of the 95% CI for the differences was more than -1 UC-DAI score unit. Results: Noninferiority of the granules compared with the tablets was demonstrated. The mean improvement in the UC-DAI in the treatment groups Gr-b.i.d., Gr-q.i.d., and Ta-q.i.d. were 3.2, 2.9, and 2.4, respectively; the proportion of complete responders in the three groups 39%, 37%, and 31%, respectively. There were no differences in side effects. Conclusion: Mesalazine 4 g daily given as prolonged-release granules twice and four times daily is at least as effective as prolonged-release tablets four times daily in patients with mild to moderate ulcerative colitis. The patients preferred the twice daily closing.
引用
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页码:237 / 242
页数:6
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