Fockens P, Mulder C J, Tytgat G N, Blok P, Ferwerda J, Meuwissen S G, Tuynman H A, Dekker W, Gasthuis K, van Hees P A
Department of Gastroenterology, Academic Medical Centre, Amsterdam, Netherlands.
Eur J Gastroenterol Hepatol. 1995 Nov;7(11):1025-30. doi: 10.1097/00042737-199511000-00003.
To investigate a possible dose-effect relationship with two dosages of oral slow-release mesalazine in patients with quiescent ulcerative colitis.
One hundred and sixty-nine patients with ulcerative colitis in remission were treated with either 1.5 or 3.0 g/day mesalazine for 1 year or until relapse into active colitis.
Fewer of the 3.0 g dose group relapsed than of the 1.5 g dose group (33 compared with 46%). This difference failed to reach statistical significance (P = 0.057). A significant relationship between age and relapse rate was established. No dose-related adverse events were found. Three serious drug-related adverse events were, however, reported. All of the serious adverse reactions resolved after the medication was discontinued.
There is a trend for high doses of oral mesalazine to be more effective in prevention of relapse of ulcerative colitis. These higher doses are not associated with a higher incidence of adverse reactions.
研究两种剂量的口服缓释美沙拉嗪在静止期溃疡性结肠炎患者中可能存在的剂量效应关系。
169例缓解期溃疡性结肠炎患者分别接受每日1.5克或3.0克美沙拉嗪治疗，为期1年或直至复发为活动性结肠炎。
3.0克剂量组的复发率低于1.5克剂量组（分别为33%和46%）。但这一差异未达到统计学显著性（P = 0.057）。年龄与复发率之间建立了显著关系。未发现与剂量相关的不良事件。然而，报告了3例严重的药物相关不良事件。停药后所有严重不良反应均得到缓解。
高剂量口服美沙拉嗪在预防溃疡性结肠炎复发方面有更有效的趋势。这些较高剂量与不良反应发生率较高无关。
