A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis

被引:52
作者
Green, JRB
Mansfield, JC [1 ]
Gibson, JA
Kerr, GD
Thornton, PC
机构
[1] Royal Victoria Infirm, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England
[2] City Gen Hosp, Dept Gastroenterol, Stoke On Trent ST4 6QG, Staffs, England
[3] Staffordshire Gen Infirm, Stafford, England
[4] Royal Shrewsbury Hosp, Shrewsbury, Salop, England
[5] Biorex Labs Ltd, Enfield, Middx, England
关键词
D O I
10.1046/j.1365-2036.2002.01150.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background: Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine. Aim: To compare the safety and efficacy of balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity. Methods: Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary. Results: Fifty-seven patients were randomized: 28 to receive balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the balsalazide group due to adverse events (2/28 vs. 9/29, P = 0.041). These data confirm that balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups. Conclusions: This study confirms the better tolerability of balsalazide compared to sulfasalazine, and supports the use of balsalazide in ulcerative colitis of all grades of severity.
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页码:61 / 68
页数:8
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