英夫利昔单抗与环孢素A治疗急性重症溃疡性结肠炎长期疗效与安全性的Meta分析

Long-term efficacy and safety of infliximab versus cyclosporine A in treatment of acute severe ulcerative colitis:A meta-analysis

目的系统性分析比较英夫利昔单抗(IFX)与环孢素A(CsA)治疗急性重症溃疡性结肠炎(ASUC)长期疗效和安全性的优劣。方法检索Pubmed、Embase、Cochrance Library、中国知网、万方、维普和中国生物医学文献数据库,收集比较IFX和CsA治疗ASUC的随机对照研究(RCT)和队列研究。采用Review Manager 5.3软件进行数据分析,同时进行亚组分析和敏感性分析。结果共纳入10篇文献,其中3篇为RCT,7篇为队列研究。患者总数1345例,其中IFX组549例,CsA组796例。Meta分析结果显示:IFX组的1年和5年结肠切除率均显著低于CsA组(1年:OR=0.63,95%CI:0.41~0.98,P=0.04;5年:OR=0.60,95%CI:0.41~0.88,P=0.01),但两者的3年结肠切除率比较差异无统计学意义(OR=0.78,95%CI:0.54~1.11,P=0.85)。安全性方面,IFX和CsA两组间药物不良事件和死亡率比较差异均无统计学意义(不良事件:OR=1.03,95%CI:0.60~1.74,P=0.92;死亡率:OR=0.82,95%CI:0.30~2.28,P=0.18);IFX组的严重不良事件发生率显著高于CsA组(OR=1.46,95%CI:1.04~2.05,P=0.03),非RCT亚组中IFX组显著高于CsA组(OR=1.78,95%CI:1.13~2.70,P=0.01),RCT亚组中无统计学差异(OR=1.17,95%CI:0.71~1.90,P=0.54)。结论IFX治疗ASUC的长期疗效可能优于CsA,但严重不良事件发生率可能高于CsA。

Objective To systemically review the long-term efficacy and safety of Infliximab(IFX)and cyclosporine A(CsA)as rescue therapy in acute severe ulcerative colitis(ASUC).Methods PubMed,EMBASE,Cochrane Library,CNKI,Wanfang,Weipu database and SinoMed were searched to identify all randomized control trials(RCT)and cohort studies.The long-term efficacy and safety of IFX and CsA in ASUC were compared.Review Manager 5.3 was used for statistical analysis,sub-group analysis and sensitivity analysis were also performed.Results A total of 10 studies were included,with 3 RCT and 7 cohort studies.Total patient number was 1345,with 549 in the IFX group and 796 in the CsA group.Meta-analysis showed that the 1-year and 5-year colectomy rates were significantly lower in IFX group comparing to CsA group(1-year colectomy:OR=0.63,95%CI:0.41~0.98,P=0.04,5-year colectomy:OR=0.60,95%CI:0.41~0.88,P=0.01),while no significant difference was found in 3-year colectomy rate(OR=0.78,95%CI:0.54~1.11,P=0.85).There were no significant differences between IFX and CsA in drug-related adverse events or mortality(Adverse event:OR=1.03,95%CI:0.60~1.74,P=0.92,mortality:OR=0.82,95%CI:0.30~2.28,P=0.18).Severe adverse events were significantly higher in IFX group than those in CsA group(OR=1.46,95%CI:1.04~2.05,P=0.03)and non-RCT studies(OR=1.78,95%CI:1.13~2.7,P=0.01),while no significant difference was found among three RCTs(OR=1.17,95%CI:0.71~1.9,P=0.54).Conclusion IFX may have better long-term efficacy in treatment of ASUC comparing to CsA,while severe adverse events may be higher than CsA.