英夫利昔与硫唑嘌呤联用与单药治疗炎症性肠病的Meta分析

Inl iximab and azathioprine combination therapy vs monotherapy for inl ammatory bowel disease: A metaanalysis

目的:比较英夫利昔(infliximab,IFX)与硫唑嘌呤(azathioprine,AZA)联合用药与单药治疗中重度炎症性肠病(inflammatory bowel disease,IBD)的疗效及安全性,用以指导IBD药物方案的选择.方法:从MEDLINE、EMBASE、Pub Med、Ovid、谷歌、万方数据库、中国维普数据库、中国知网数据库以及中国生物医学文献数据库检索有关IFX与AZA联用及单药治疗IBD的随机对照试验.并对纳入文献进行质量评价和数据提取进行Meta分析.结果:按照入选标准,共纳入6篇随机对照试验文献,Meta分析结果显示:IFX与A Z A联合用药治疗I B D的临床症状缓解率(RR=1.33,95%CI:1.13-1.56,Z=3.40,P=0.0007)、内镜检测有效率(R R=1.29,95%C I:1.05-1.58,Z=2.43,P=0.02)均优于IFX单药,但两组间总体不良反应(RR=1.01,95%CI:0.91-1.10,Z=0.11,P=0.91)差异无统计学意义.联合用药治疗IBD临床症状缓解率(RR=1.84,95%CI:1.53-2.20,Z=6.54,P<0.001)、内镜检测有效率(RR=2.06,95%CI:1.65-2.62,Z=5.96,P<0.0001)均优于AZA单药,但两组间总体不良反应(RR=0.94,95%CI:0.86-1.03,Z=1.34,P=0.18)差异无统计学意义.结论:对于一线治疗无效的中重度IBD,IFX与AZA联合用药优于IFX或AZA单药治疗.联合用药对临床缓解、内镜黏膜愈合均有明显的疗效,且总不良反应与单药治疗比较差异无统计学意义.

AIM： To compare the efficacy and safety of infliximab （IFX） and azathioprine （AZA） combination therapy vs monotherapy in moderate to severe inflammatory bowel disease （IBD）.METHODS： A comprehensive literature search was performed in MEDLINE, EMBASE, PubMed, Ovid, Google, Wanfang database, Vip database,China National Knowledge Infrastructure database （CNKI） and the Chinese biomedical literature database of randomized controlled clinical trials about IFX and AZA in IBD. Data of the included studies were extracted and their quality was evaluated to conduct a meta-analysis. RESULTS： Based on the inclusion criteria, 6 prospective randomized controlled clinical studies were included in this study. Clinical remission rate and endoscopic remission rate were significantly improved in the combination group when compared with IFX or AZA monotherapy. However, there was no significant statistical difference in overall adverse reactions between the two groups. CONCLUSION： For patients with moderate to severe IBD who failed the first-line treatment, combination of IFX and AZA is superior to monotherapy. Combination therapy can improve clinical remission and endoscopic mucosal healing efficacy, although overall adverse reactions show no significant difference compared with monotherapy.