中药灌肠联合美沙拉嗪治疗溃疡性结肠炎Meta分析

Meta-analysis of Traditional Chinese Medicine Enema Combined with Mesalazine in Treatment of Ulcerative Colitis

目的:系统评价中药灌肠联合美沙拉嗪治疗溃疡性结肠炎的临床疗效及安全性。方法:检索中国知网、万方、维普、中国生物医学数文献据库及PubMed等数据库,检索时间限定为自建库至2019年12月31日,筛选符合纳入标准的随机对照试验(RCTs),应用Cochrane风险偏倚评估工具对纳入文献进行质量学评价,并使用Review manager5.3和stata12.0软件对文献进行Meta分析。结果:共纳入29篇RCT文献,共涉及2272例患者。Meta分析结果显示,对比单用美沙拉嗪,中药灌肠联合美沙拉嗪有更好的综合疗效[OR=4.90,95%CI=(3.75,6.41),Z=11.59,P<0.00001]和肠镜下黏膜疗效[OR=2.76,95%CI=(1.61,4.73),Z=2.69,P=0.0002];13篇文献进行了安全性评价,其中3项研究未见明显不良反应,10项研究报道了在治疗期间患者出现胃肠道不良反应、头晕头痛、轻度白细胞下降等轻微不良反应。结论:对比于单用美沙拉嗪,中药灌肠联合美沙拉嗪治疗溃疡性结肠炎有更好的综合疗效和肠镜下黏膜疗效,且安全性较好。但由于文献质量不高,上述结论有待高质量研究进一步验证。

Objective:To systematically evaluate the clinical efficacy and safety of traditional chinese medicine enema combined with mesalazine in treating ulcerative colitis.Methods:Databases such as CNKI,Wanfang,VIP,CBM and Pubmed were searched.The search time was limited to database creation to December 31,2019.Randomized controlled trials(RCTs)that met the inclusion criteria were selected.The included literatures were qualitatively evaluated by Cochrane risk bias assessment tool,and the Meta-analysis was conducted by Rev Man 5.3 and Stata 12.0 software.Results:A total of 29 RCT literatures were included,involving 2272 patients.The results of Meta-analysis showed that traditional chinese medicine enema combined with mesalazine had better comprehensive curative effect[OR=4.90,95%CI=(3.75,6.41),Z=11.59,P<0.00001]and endoscopic mucosal efficacy[OR=2.76,95%CI=(1.61,4.73),Z=2.69,P=0.0002]compared with mesalazine alone.Thirteen literatures were evaluated for safety,of which three studies showed no obvious adverse reactions,ten studies reported mild adverse reactions such as gastrointestinal adverse reactions,dizziness,headache and mild leukopenia during treatment.Conclusion:Compared with mesalazine alone,traditional chinese medicine enema combined with mesalazine shows better comprehensive efficacy and endoscopic mucosal efficacy in the treatment of ulcerative colitis,and the safety is better.However,due to the low quality of the included literatures,the above conclusion needs further verification by high quality studies.