摘要:
Objective To evaluate the efficacy, safety, and adherence of once daily versus multiple daily Mesala-zine therapy for mild to moderate ulcerative colitis. Methods The databases of PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, CBM and WanFang were searched ( by Mar. 2018 ) to identity relevantly published studies about once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis. According to in-clusion and exclusion criteria, two reviewers independently screened the literature, extracted data and quality evalua-tion. Statistical analysis was performed by RevMan 5. 2 software. Results A total of 14 studies including 4 126 patients were enrolled. Meta-analysis results showed that there was no significant difference in the remission rate of once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis in induction trials (RR=1. 06, 95% CI:0. 98-1. 14, P=0. 17); there was no statistical difference in the incidence of adverse reactions (RR=0. 89, 95% CI:0. 74-1. 07, P=0. 23) . There was no significant difference in the remission rate of once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis in maintenance trials ( RR=1. 01, 95% CI: 0. 97 -1. 06, P=0. 53); there was no statistical difference in the incidence of adverse reactions (RR=1. 02, 95% CI: 0. 95-1. 09, P=0. 83). In induction trials, once daily Mesalazine was superior to multiple daily Mesalazine in the treatment of mild to moderate ulcerative colitis (RR=1. 17, 95% CI: 1. 07-1. 27, P=0. 0003). Funnel plot showed that the symmetry of the graph was good, and the possibility of publication bias was small. Conclusion There are no differences in efficacy and safety between once daily and multiple daily Mesalazine therapy for mild to moderate ulcerative colitis. But once daily Mesalazine is better than multiple daily Mesalazine in adherence. Due to limited quantity and quality of included studies, the above conclusions are needed to be validated by more high quality studies.%目的 系统评价顿服与分次口服美沙拉嗪对治疗轻-中度溃疡性结肠炎疗效、安全性及依从性.方法 计算机检索Web of Science、PubMed、Cochrane Library、Embase、中国知网、CBM、维普、万方数据库中顿服与分次口服治疗轻-中度溃疡性结肠炎对比的随机对照试验(RCTs),检索时间从建库到2018年3月,并追查纳入文献的参考文献.由2名研究者按照纳入与排除标准独立筛选文献、提取资料、质量评价,对同质研究使用RevMan 5. 2软件进行Meta分析.结果 共纳入14个RCTs,共计4 126例患者. Meta分析结果显示:在活动期,顿服和分次口服美沙拉嗪治疗轻-中度溃疡性结肠炎缓解率差异无统计学意义( RR=1. 06,95% CI:0. 98~1. 14,P=0. 17),不良反应发生率相比,差异无统计学意义(RR=0. 89,95% CI:0. 74~1. 07,P=0. 23);在缓解期,顿服和分次口服美沙拉嗪治疗轻-中度溃疡性结肠炎缓解率差异无统计学意义(RR=1. 01,95% CI:0. 97~1. 06,P=0. 53),不良反应发生率相比,差异无统计学意义(RR=1. 02,95% CI:0. 95~1. 09,P=0. 83).在活动期,顿服在依从性上优于分次口服美沙拉嗪治疗轻-中度溃疡性结肠炎(RR=1. 17,95% CI:1. 07 ~1. 27,P=0. 0003).漏斗图结果显示,图形对称性较好,存在发表偏倚可能性小.结论 顿服与分次口服美沙拉嗪治疗轻-中度溃疡性结肠炎疗效及引起的不良反应相当.顿服可提高患者服药依从性,更值得推荐.受纳入研究质量的限制,上述结论尚需开展更多高质量研究加以验证.