Mesalamine Once Daily Is More Effective Than Twice Daily in Patients With Quiescent Ulcerative Colitis
Mesalamine Once Daily Is More Effective Than Twice Daily in Patients With Quiescent Ulcerative Colitis
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DOI：
10.1016/j.cgh.2009.04.004
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发表时间：
2009-07-01
影响因子：
12.6
通讯作者：
Veerman, Henri
中科院分区：
文献类型：
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作者：
Dignass, Axel U.;Bokemeyer, Bernd;Veerman, Henri
背景和目的：口服美沙拉嗪（S-氨基水杨酸盐）是目前轻至中度溃疡性结肠炎的标准治疗方法。我们研究了与成熟的每日两次给药方案相比，每日一次服用缓释美沙拉嗪颗粒维持静止期溃疡性结肠炎患者缓解的有效性和安全性。方法：在这项多中心、随机、单盲、非劣效性试验中，362 名静止期溃疡性结肠炎患者被随机分配 (1:1) 至口服美沙拉嗪 2 g（每日一次）或 1 g（每日两次）的组，持续 12 个月。主要目标是根据溃疡性结肠炎疾病活动指数评分，使用 Kaplan-Meier 方法比较 1 年时的缓解率。结果：1 年时，每天一次 2 g 美沙拉嗪治疗组中 70.9% 的患者仍处于缓解状态，而每天两次 1g 美沙拉嗪治疗组中这一比例为 58.9%；这种差异具有统计学意义（P=0.024），表明与每天两次给药相比，每天一次给药的功效有所增加。自我报告的治疗依从性（通过 4、8 和 12 个月后的视觉模拟量表评分进行测量）与每日两次相比，每日一次 2 g 美沙拉嗪组的自我报告依从性显着更高（除 1 次研究访视外）（P
BACKGROUND & AIMS: Oral mesalamine (S-aminosalicylate) is the current standard of care for mild-to-moderate ulcerative colitis. We investigated the efficacy and safety of once daily administration of prolonged-release mesalamine granules in maintenance of remission in patients with quiescent ulcerative colitis, compared with the well established twice daily dosing regimen. METHODS: In this multicenter, randomized, single blind, noninferiority trial, 362 patients with quiescent ulcerative colitis were randomly assigned (1:1) to groups that were given oral mesalamine 2 g, once daily, or 1 g, twice daily, for 12 months. The primary objective was to compare remission rates at 1 year, based on the ulcerative colitis disease activity index score, using Kaplan-Meier methodology. RESULTS: At 1 year, 70.9% of the group given 2 g mesalamine once daily remained in remission vs 58.9% of the group given I g mesalamine twice daily; this difference was statistically significant (P=.024), indicating the increased efficacy of once daily, compared with twice daily, dosing. Self-reported adherence to therapy, measured by visual analog scale score after 4, 8, and 12 months, was significantly greater in the group given 2 g mesalamine once daily, compared with twice daily, at all but 1 study visit (P