乌梅丸方加减对比5-氨基水杨酸治疗溃疡性结肠炎疗效及安全性的Meta分析

Efficacy and Safety of Wumei Pill Compared with 5-aminosalicylic Acid in the Treatment of Ulcerative Colitis:A Meta-analysis

目的:运用Meta分析的方法综合评价乌梅丸方加减对比5-氨基水杨酸治疗溃疡性结肠炎(UC)的临床疗效及安全性。方法:计算机检索CNKI、WanFang Data、SinoMed、VIP、PubMed和the Cochrane Library数据库,搜集有关乌梅丸方加减对比5-氨基水杨酸治疗UC的随机对照试验(RCT),检索时限均从建库至2019年7月,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入16个RCT,共1219例患者。Meta分析结果显示,对比5-氨基水杨酸类药物,乌梅丸方加减治疗UC在总体有效率[RR=1.24,95%CI(1.18,1.30),P<0.01]、中医证候积分[MD=-3.07,95%CI(-3.71,-2.43),P<0.01]、肠镜疗效[RR=1.26,95%CI(1.10,1.44),P<0.01]、复发率[RR=0.30,95%CI(0.15,0.60),P<0.01]、药品不良事件发生率[RR=0.23,95%CI(0.06,0.85),P<0.05]方面,差异均有统计学意义。结论:乌梅丸方加减治疗UC具有良好疗效,不仅在缓解临床症状及改善中医证候方面优于对照组,并且在复发和不良事件发生方面低于对照组。受纳入研究质量的限制,上述结论仍需更多高质量RCT加以验证。

Objective:To evaluate the therapeutic effect of Wumei pill in treating ulcerative colitis(UC)by Meta-analysis method.Methods:CNKI,WanFang Data,SinoMed,VIP,PubMed and the Cochrane Library were electronically searched to collect randomized controlled trials(RCTs)of Wumei pill compared with 5-aminosalicylic acid in the treatment of UC from inception to July 2019.Two reviewers independently screened literature,extracted data and assessed risk of bias of included studies,Meta-analysis were performed with RevMan 5.3 software.Results:There were sixteen articles enrolled,and 1219 patients were included.Compared to 5-aminosalicylic acid medicine treatment,the Wumei pill could increase effectiveness in overall curative effect(RR=1.24,95%CI 1.18 to 1.30,P<0.01)and the efficacy of colonoscopy(RR=1.26,95%CI 1.10 to 1.44,P<0.01).It could also decrease TCM syndrome score(MD=-3.07,95%CI-3.71 to-2.43,P<0.01),recurrence rate(RR=0.30,95%CI 0.15 to 0.60,P<0.01)and incidence rate of adverse events(RR=0.23,95%CI 0.06 to 0.85,P<0.05).Conclusion:The Wumei pill may have a favorable effect treating UC in alleviating clinical symptoms and improving TCM syndromes.Additionally,the recurrence and adverse events rate is relatively low.However,due to the low quality of the included studies,more high-quality RCTs should be carried out to verify and support the results.