[目的]探讨芍药汤联合西药治疗溃疡性结肠炎(UC)的有效性和安全性,为临床的使用提供科学依据。[方法]纳入芍药汤联合西药对比单用西药治疗UC的随机对照试验文献(RCTs),使用Cochrane条目对纳入文献的偏倚进行评价;收集纳入文献的基本资料、临床疗效和不良反应,对疗效和不良反应进行Meta分析。[结果]一共纳入17篇RCTs文献,所有文献都评为高风险;Meta分析结果显示:对比单用西药,芍药汤联用西药临床疗效的RR值为1.20(95%CI=1.14-1.27),差异有统计学意义(P〈0.05)。其中美沙拉嗪(Mesalazine)、柳氮磺胺吡啶(SASP)、其它药物的合并RR分别为1.15、1.28和1.19。2组不良反应发生率差异无统计学意义(RR=0.56;95%CI=0.26-1.21;P〉0.05)。漏斗图分析显示不存在发表偏倚。[结论]对比单用西药,芍药汤联用西药治疗UC有更好的临床疗效,而且具有良好的安全性,适合临床的推广使用。但由于纳入文献的质量不高,特别是隐蔽、盲法等方面存在不足,需要高质量的随机对照试验的支持。
[Objective]To explore the effectiveness and safety of Paeoniae decoction in the treatment of ulcerative colitis.[Methods]Randomized controlled trials(RCTs)about Paeoniae decoction combined with western medicine in treating ulcerative colitis were included.The risks of bias were assessed by the Cochrane scale.The characteristics,clinical efficacy and adverse events of the included trials were collected.A Meta-analysis was used to evaluate the clinical efficacy and adverse events.[Results]A total of 17 RCTs were included.The results of Meta-analysis showed that compared with the western medicine group,the RR of clinical efficacy for Paeoniae decoction group was 1.20(95%CI:1.14-1.27),with statistical significance(P〈0.05).The adverse events between two groups were statistically significant(RR=0.56,95%CI=0.26-1.21,P〉0.05).The funnel plot showed a higher homogeneity in the trials.[Conclusion]Compared with the western medicine,Paeoniae decoction had better clinical efficacy.Wumei decoction was proved to be safe,and it is suitable for clinical use.However,due to the lower quality of the design,high quality RCTs were necessary to support our results.