Comparison of Efficacy and Safety of Infliximab and Ustekinumab in First-line Biological Therapy for Moderate-to-severe Inflammatory Bowel Disease:An Indirect Meta-analysis
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背景:随着生物制剂种类的增加,治疗中重度克罗恩病(CD)和中重度溃疡性结肠炎(UC)的一线生物制剂需要更精准的定位.目的:系统性评价英夫利西单抗(IFX)和乌司奴单抗(UST)在中重度CD和中重度UC一线生物治疗中的疗效和安全性.方法:检索中国知网、万方、维普、中国科学引文数据库、PubMed、Web of Science、Embase、ClinicalTrials、Cochrane Library等数据库中IFX和UST治疗中重度CD和UC的随机对照试验(RCT),检索时间为建库至2023年12月.采用间接meta分析比较IFX与UST治疗中重度CD和UC的疗效和安全性.结果:最终纳入11项RCT.IFX诱导和维持中重度CD的临床缓解率与UST相比差异无统计学意义(P>0.05),严重不良事件和严重感染发生率差异亦无统计学意义(P>0.05).IFX诱导和维持中重度UC的临床缓解率与UST相比差异无统计学意义(P>0.05),严重不良事件和严重感染发生率差异亦无统计学意义(P>0.05).结论:在中重度CD患者中,IFX和UST可作为一线生物治疗的平行选择,考虑到IFX可增加患者感染结核的风险,推荐UST作为首选疗法.在中重度UC患者中,IFX是有效、安全的一线生物制剂,UST可作为一线生物治疗的选择之一.
Background:With the increasing diversity of biological agents,the first-line biological agents for moderate-to-severe Crohn's disease(CD)and ulcerative colitis(UC)requires more precise positioning.Aims:To systematically evaluate the efficacy and safety of infliximab(IFX)and ustekinumab(UST)as first-line options for moderate-to-severe CD and UC.Methods:Randomized controlled trials(RCTs)on IFX and UST in treatment of moderate-to-severe CD and UC were retrieved from CNKI,Wanfang data,VIP,Chinese Science Citation Database and PubMed,Web of Science,Embase,ClinicalTrials,Cochrane Library from the date of database establishment to December 2023.An indirect meta-analysis was conducted to compare the efficacy and safety of IFX and UST in treatment of moderate-to-severe CD and UC.Results:Eleven RCTs were enrolled.No significant differences in clinical remission and maintenance rates of moderate-to-severe CD were found between IFX group and UST group(P>0.05),and no significant differences in serious adverse events and serious infection rates were found between these two groups(P>0.05).No significant differences in clinical remission and maintenance rates of moderate-to-severe UC were found between IFX group and UST group(P>0.05),and no significant differences in serious adverse events and serious infection rates were found between these two groups(P>0.05).Conclusions:Both IFX and UST can be served as first-line biological therapy for patients with moderate-to-severe CD.In view of the fact that IFX can increase the risk of tuberculosis,UST is recommended as first-line therapy for moderate-to-severe CD.For moderate-to-severe UC,IFX is an effective and safe first-line biological therapy,and UST can be served as an alternative.
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