英夫利西单抗联合巯嘌呤类药物与单药治疗炎症性肠病疗效比较的meta分析

Comparison on Efficacy of Infliximab Combined With Mercaptopurine and Monotherapy for Inflammatory Bowel Disease: A Meta-analysis

背景:生物制剂英夫利西单抗(IFX)对炎症性肠病(IBD)的治疗已取得显著疗效,然而仍有部分患者在治疗过程中出现病情加重、复发、并发症等。目的:系统评价IFX与巯嘌呤类药物(AZA或6-MP)联合治疗IBD的效果和安全性。方法:计算机检索MEDLINE、Embase、Pub Med、Science Direct数据库,纳入IFX联合AZA/6-MP与单药治疗IBD的随机对照试验。采用Rev Man 5.3软件对纳入文献行meta分析。结果:共纳入5篇文献。Meta分析显示,与IFX单药组相比,联合用药组临床缓解率(RR=1.26,95%CI:1.08～1.48;Z=2.90,P=0.004)、内镜缓解率(RR=1.28,95%CI:1.02～1.60;Z=2.17,P=0.03)均显著增高,而严重不良反应(RR=0.85,95%CI:0.58～1.27;Z=0.78,P=0.44)和一般不良反应(RR=1.09,95%CI:1.00～1.19;Z=1.90,P=0.06)均无明显差异。与AZA/6-MP单药组相比,联合用药组临床缓解率(RR=1.87,95%CI:1.52～2.31;Z=5.83,P<0.000 01)、内镜缓解率(RR=1.99,95%CI:1.51～2.62;Z=4.93,P<0.000 01)均显著增高。结论:对于IBD患者,IFX与AZA/6-MP联合用药的临床缓解率、内镜缓解率均显著优于IFX或AZA/6-MP单药治疗,且不良反应无明显差异。

Background： The biological agent infliximab（ IFX） is remarkably effective for the treatment of inflammatory bowel disease（ IBD）,however,there are still some patients suffering aggravation,recurrence,complications and so on. Aims：To systematically evaluate the efficacy and safety of IFX combined with mercaptopurine（ AZA or 6-MP） for the treatment of IBD. Methods： Randomized controlled trials of IFX combined with AZA/6-MP for the treatment of patients with IBD were retrieved from MEDLINE,Embase,Pub Med,Science Direct database. Meta-analysis was conducted by Rev Man 5. 3 software. Results： Five randomized controlled studies were enrolled. Meta-analysis showed that the rates of clinical remission（ RR = 1. 26,95% CI： 1. 08-1. 48; Z = 2. 90,P = 0. 004）,endoscopic remission（ RR = 1. 28,95% CI： 1. 02-1. 60; Z = 2. 17,P = 0. 03） were significantly increased in IFX ＋ AZA/6-MP group than in IFX monotherapy group,however,no significant differences in severe side effect（ RR = 0. 85,95% CI： 0. 58-1. 27; Z = 0. 78,P = 0. 44） and general side effect（ RR = 1. 09,95% CI： 1. 00-1. 19; Z = 1. 90,P = 0. 06） were found between the two groups.Compared with AZA/6-MP monotherapy group,clinical remission rate（ RR = 1. 87,95% CI： 1. 52-2. 31; Z = 5. 83,P 0. 000 01） and endoscopic remission rate（ RR = 1. 99,95% CI： 1. 51-2. 62; Z = 4. 93,P 〈 0. 000 01） were significantly increased in IFX ＋ AZA/6-MP group. Conclusions： IFX combined with AZA/6-MP is more effective than IFX or AZA/6-MP monotherapy in the treatment of IBD,and no significant difference in side effects is found.