目的:系统评价半夏泻心汤及其加减方治疗溃疡性结肠炎的临床疗效及安全性。方法:按Cochrane系统评价方法,计算机检索CBM,CNKI,VIP及万方等数据库,查找应用半夏泻心汤及其加减方治疗溃疡性结肠炎的随机对照试验和半随机对照试验。对符合条件的RCT,在资料提取和质量评价后,应用RevMan 5.1软件进行Meta分析,并应用GRADE系统对证据质量和等级推荐来分级。结果:共纳入8项研究,736例患者。Meta分析结果显示:总有效率OR合并=3.87[OR=3.87,95%CI(2.47,6.05),P〈0.000 01];具有较好的安全性。GRADE系统评价结果显示,证据水平均为C级,推荐等级为弱推荐。结论:就本次系统评价结果显示,半夏泻心汤及其加减方治疗溃疡性结肠炎有较好疗效且安全性高,不良反应少。但仍需关键性结局评价指标进行验证,鉴于纳入的研究质量较低,且存在发表性偏倚,上述结论尚需进一步开展大规模、高质量的并且具有中医特色的研究来验证。
Objective:To evaluate the effectiveness and safety of Jiajian Banxia Xiexin decoction for ulcerative colitis(UC).Method: All randomized controlled trials(RCTs) and quasi-RCTs on Jiajian Banxia Xiexin decoction for UC were searched in the VIP,CNKI,CBM disc and Wan fang.The quality of RCTs meeting inclusion criteria was evaluated and the related data were extracted;meta-analyses were performed with RevMan 5.1 software,and then the GRADE system was used to rate the level of evidence and strength of recommendations.Result: A total of 8 trials were included in this study,including 736 cases.Meta-analyses showed that: total effective rate OR=3.87,95% CI(2.47,6.05),and had a better security.Based on GRADE,the level of evidence was grade C,and the strength of recommendations was weak.Conclusion: The present evidences show that: Jiajian Banxia Xiexin decoction has a better efficacy and safety,but key outcome should be evaluated.For the low quality and potential publication bias of included study,large-scale,the studies of high-quality researches and with TCM features should be performed.