摘要:
Objective To compare the efficacy and safety of Infliximab(IFX) and enteral nutrition(EN) combined with IFX in the treatment of Crohn's disease (CD) by Meta-analysis. Methods PubMed, Embase, Ovid, Cochrane Library,WanFang Database,CNKI, VIP Database were in database searching for clinical trials performing therapy of IFX and EN in CD. Clincal efficacy rate,recurrence rate and adverse reaction rate were selected by two subjects inde-pendently. RCT studies were evaluated by the System Evaluator's manual recommended by the Cochrane Collaboration and the qualities of cohort studies were evaluated according to the Newcastle-Ottawa Scale (NOS) literature quality assessment method. Meta-analysis was performed by Review Manager 5.3 software. Results A total of 8 articles inclu-ding 668 cases of CD were accord with conditions (306 cases for experimental group) and (362 cases for control group). Meta-analysis showed that the clinical efficacy rate of IFX combined with EN was higher than that of IFX mono-therapy (OR=2.38,95% CI:1.65-3.42,Z=4.66,P<0.00001). Total adverse reaction rate: there was no sta-tistically significant difference between the combination group and the IFX group (OR=0.73,95% CI:0.12-4.45, Z=0.34,P=0.73). The recurrence rate was lower in the combination group than that in the IFX group(OR=0.31, 95% CI:0.18-0.53,Z=4.25, P<0.0001). Conclusion Combination therapy of IFX and EN is more effective than IFX monotherapy,meanwhile the recurrence rate of IFX is lower and there is no statistically significant difference in adverse reaction between the two groups.%目的 运用Meta分析比较英夫利昔单抗(Infliximab,IFX)和肠内营养(enteral nutrition,EN)联用治疗克罗恩病(Crohn's disease,CD)的疗效和安全性.方法 通过计算机检索数据库PubMed、Embase、Ovid、Cochrane Library、万方数据库(WanFang)、中国知网(CNKI)、维普数据库(VIP),检索有关IFX和IFX+EN治疗中-重度CD的对照试验,由两人分别独立对其有效率、复发率、不良反应发生率等指标进行数据提取.对随机对照试验(randomized controlled trial, RCT)的研究按Cochrane协作网推荐的系统评价员手册进行质量评价,对所纳入队列研究根据Newcastle-Ottawa Scale(NOS)文献质量评价方法,运用Review Manager 5.3软件对纳入研究的提取数据进行Meta分析.结果 共有8篇研究文章纳入,CD患者共计668例,试验组(IFX联合EN)306例,对照组(IFX)362例.Meta分析结果显示:IFX联合EN治疗CD的临床治疗有效率高于IFX组(OR=2.38, 95% CI: 1.65 ~3.42, Z=4.66,P<0.00001);总不良反应发生率:联合用药组与IFX组比较,差异无统计学意义(OR=0.73,95% CI:0.12~4.45,Z=0.34, P=0.73).复发率:联合用药组低于IFX治疗组(OR=0.31,95% CI:0.18~0.53, Z=4.25, P<0.0001).结论 对于中-重度CD患者,IFX与EN联用治疗较IFX治疗更有效,且复发率更低,不良反应差异无统计学意义.