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首页> 外文期刊>Gastroenterology >Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis.
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Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis.

机译：对于维持溃疡性结肠炎的缓解，每天一次口服延迟口服美沙拉敏（400毫克片剂）与每天两次口服同样有效。

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BACKGROUND & AIMS: The practice of dosing mesalamines in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for maintaining remission in UC patients. METHODS: A multicenter, randomized, investigator-blinded, 12-month, active-control trial was conducted to assess the noninferiority of delayed-release mesalamine 1.6-2.4 g/day administered once daily compared with twice daily in patients with mild-to-moderate UC currently in clinical remission. The primary end point was maintenance of clinical remission at month 6. RESULTS: A total of 1023 patients were randomized and dosed. The primary objective of noninferiority was met. At month 6, 90.5% of patients receiving once-daily dosing had maintained clinical remission, compared with 91.8% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -2.3 to 4.9). At month 12, 85.4% of patients receiving once-daily dosing had maintained clinical remission, compared with 85.4% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -4.6 to 4.7). Both regimens had low rates of withdrawals as a result of adverse events and serious adverse events. CONCLUSIONS: Once-daily dosing of delayed-release mesalamine at doses of 1.6-2.4 g/day was shown to be as effective as twice-daily dosing for maintenance of clinical remission in patients with UC.
机译：背景与目的：美沙拉嗪分剂量给药用于治疗溃疡性结肠炎（UC）的实践始于柳氮磺胺吡啶，并受到磺胺吡啶的毒性驱动。直到最近，这一惯例和每天多次服用治疗UC的假设才受到质疑。进行这项研究的目的是为了确定在UC患者中，每天一次延迟释放美沙拉敏（Asacol 400 mg片剂）与每天两次给药相比维持缓解的疗效和安全性。方法：进行了一项多中心，随机，研究者盲目的12个月主动控制试验，以评估轻度至轻度患者每天一次延迟给药美沙明胺1.6-2.4 g /天与每天两次相比的非劣效性目前在临床缓解中度UC。主要终点是维持第6个月的临床缓解。结果：随机分配1023例患者。非自卑的首要目标得以实现。在第6个月，接受每日一次给药的患者中90.5％的患者保持了临床缓解，而接受每日两次给药的患者中91.8％的患者保持了临床缓解（每天两次-每天一次，从-2.3至4.9的置信区间为95％）。在第12月，接受每日一次给药的患者中有85.4％的患者保持了临床缓解，而接受每日两次给药的患者中有85.4％的患者（每天两次-每天一次，-4.6至4.7的置信区间为95％）。由于不良事件和严重不良事件，两种方案的退出率均较低。结论：对于维持UC患者的临床缓解，每天一次延迟释放美沙拉敏剂量1.6-2.4 g /天与每天两次剂量一样有效。

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