Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Canada.
Inflamm Bowel Dis. 2012 Sep;18(9):1785-94. doi: 10.1002/ibd.23024. Epub 2012 May 29.
We systematically reviewed and compared the efficacy and safety of once daily (OD) mesalamine to conventional dosing for induction and maintenance of remission in ulcerative colitis (UC). A literature search to January 2012 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The GRADE criteria were used to assess the overall quality of the evidence. Studies were subgrouped by formulation for meta-analysis. Eleven studies that evaluated 4070 patients were identified. The risk of bias was low for most factors, although five studies were single-blind and one was open-label. No difference was observed between the dosing strategies in the proportion of patients with clinical remission (relative risk [RR] 0.95; 95% confidence interval [CI] 0.82-1.10), clinical improvement (RR 0.87 95% CI 0.68-1.10), or relapse at 6 (RR 1.10; 95% CI 0.83-1.46) or 12 months (RR 0.92; 95% CI 0.83-1.03). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of medication adherence or adverse events between OD and conventional dosing. OD mesalamine appears to be as effective and safe as conventional dosing for both the treatment of mild to moderately active UC and for maintenance of remission in quiescent UC. The failure to demonstrate a superior rate of adherence to OD dosing may be due to the high rate of adherence observed in the clinical trials environment. Future research should assess the value of OD dosing in community settings.
我们系统地回顾和比较了每日一次(OD)美沙拉嗪与传统剂量在诱导和维持溃疡性结肠炎(UC)缓解方面的疗效和安全性。截至 2012 年 1 月的文献检索确定了所有适用的随机试验。使用 Cochrane 偏倚风险工具评估研究质量。使用 GRADE 标准评估证据的总体质量。根据制剂对研究进行亚组分析进行荟萃分析。确定了 11 项评估 4070 例患者的研究。尽管五项研究为单盲,一项为开放标签,但大多数因素的偏倚风险较低。在临床缓解(相对风险 [RR] 0.95;95%置信区间 [CI] 0.82-1.10)、临床改善(RR 0.87 95% CI 0.68-1.10)或 6 个月(RR 1.10;95% CI 0.83-1.46)或 12 个月(RR 0.92;95% CI 0.83-1.03)时接受治疗的患者比例、复发率方面,两种剂量方案之间无差异。亚组分析显示疗效无明显差异。OD 和传统剂量组之间药物依从率或不良反应发生率无显著差异。OD 美沙拉嗪在治疗轻中度活动期 UC 和维持缓解期 UC 方面似乎与传统剂量一样有效和安全。未能证明 OD 剂量组具有更高的依从率可能是由于临床试验环境中观察到的高依从率。未来的研究应该评估 OD 剂量在社区环境中的价值。