Comparison of oral with rectal mesalazine in the treatment of ulcerative proctitis

被引:107
作者
Gionchetti, P [1 ]
Rizzello, F [1 ]
Venturi, A [1 ]
Ferretti, M [1 ]
Brignola, C [1 ]
Miglioli, M [1 ]
Campieri, M [1 ]
机构
[1] Univ Bologna, Policlin S Orsola, Dipartimento Med Interna & Gastroenterol, I-40138 Bologna, Italy
关键词
mesalazine suppositories; mesalazine tablets; ulcerative proctitis; topical treatment;
D O I
10.1007/BF02236902
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
PURPOSE: The aim of our study was to compare the efficacy and safety of oral mesalazine with mesalazine suppositories in patients with active ulcerative proctitis. PATIENTS AND METHODS: A four-week, randomized, single-blind trial was performed in 58 patients with active, histologically confirmed ulcerative proctitis (less than or equal to 15 cm) to evaluate the efficacy and safety of oral 800-mg mesalazine tablets taken three times per day (n = 29) compared with 400 mg of mesalazine suppositories administered three times per day (n = 29). Patients were evaluated at study entry and after two and four weeks. Efficacy evaluations included a disease activity index, which represents a score with four variables: stools frequency, rectal bleeding, mucosal appearance, and physician's assessment of disease severity. Histologic activity was also assessed at study entry and after two and four weeks in accordance with the criteria by Truelove and Richard. Safety assessment included clinical laboratory parameters and adverse event reports. RESULTS: There were no significant differences with regard to baseline comparisons of demographics and severity between the two treatment groups. Improvement in mean disease activity index score was significantly greater with suppositories compared with oral mesalazine, both at two-week and four-week visits (mean disease activity index scores at baseline, two, and four weeks: suppositories = 7.7, 2.59, and 1.48; tablets = 7.42, 5.72, and 3.48, respectively (P < 0.001)). The rate of histologic remission was significantly greater with suppositories compared with tablets both at two and four weeks (P < 0.01). There were no significant differences in adverse events or clinical laboratory results between treatment groups. CONCLUSIONS: Results of this study indicate that treatment with mesalazine suppositories produces earlier and significantly better results than oral mesalazine in the treatment of active ulcerative proctitis.
引用
收藏
页码:93 / 97
页数:5
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