摘要
目的比较英夫利昔、免疫抑制剂及两者联合治疗克罗恩病（Crohn’s disease,CD）的疗效及安全性。方法检索Pub Med、Medline、EMBASE、ISI、SCI/SSCI/A＆HCI及Collaboration Controlled Trial Register等英文数据库,及中国知网（CNKI）、万方数据库（Wan Fang Data）、维普数据库（VIP）和中国生物医学文献数据库（CBM）等中文数据库,查找相关的临床随机对照试验（RCT）。同时检索纳入文献的参考文献。按照相关标准进行文献筛选、资料提取、评价文献质量并通过Rev Man 5.2软件对纳入的研究数据进行处理。结果 8个对照研究被纳入,共纳入研究对象1 286例,其中英夫利昔组517例,免疫抑制剂组344例,联合治疗组425例。Meta分析结果显示,10～14周、20～30周和48～52周时联合治疗组和单药治疗组的临床缓解率分别为53.4%和36.9%（OR=2.09,95%CI：1.34～3.27,P〈0.001）、57.5%和36.8%（OR=2.36,95%CI：1.82～3.05,P〈0.00001）、43.6%和31.4%（OR=1.66,95%CI：1.32～2.07,P〈0.00001）。20～30周时联合治疗组和单药治疗组的黏膜愈合率分别为48.0%和27.3%（OR=2.62,95%CI：1.81～3.81,P〈0.00001）。结论英夫利昔和免疫抑制剂联合较单药具有更好的临床疗效,更能促进黏膜愈合及改善生化指标,且不良反应的发生率无明显增加。
Objective To compare the efficacy and safety of combination therapy of Infliximab and immunosuppres- sants for patients with Crohn＇ s disease （CD）. Methods The English database, such as PubMed, Medline, EMBASE, ISI, SCI/SSCI/A＆HCI and Collaboration Controlled Trial Register, and the Chinese database, such as CNKI, WanFang Data, VIP and Chinese Biomedical Literature Database （CBM） were searched. Relevant clinical randomized controlled trials （RCT） were researched. Meanwhile the references of the included studies were retrieved. The literatures, extrac- ted data were screened, the quality of the literature was evaluated, and the data were analyzed by the RevMan 5.2 soft- ware. Results Eight studies were included in this analysis, involving 1 286 cases, included 517 eases receiving Inflix- imab, 344 cases receiving immunosuppressants, and 425 cases receiving combination therapy. Meta-analysis results showed that the clinical remission rates of combination therapy and monotherapy therapy at weeks 10 - 14, 20 ～ 30 and 48-52 were 53.4% and 36.9%（OR=2.09, 95%CI： 1.34-3.27, P〈0.001）, 57.5% and 36.8%（OR=2.36, 95% CI：1. 82 - 3. 05 , P〈0.00001）, 43.6% and 31.4% （0R=1.66, 95%CI： 1.32 ～2.07, P〈0.00001）. The mucosal healing rate of combination therapy and monotherapy therapy at weeks 20 ～ 30 were 48.0% and 27.3% （ OR = 2.62, 95% CI. 1.81 ～ 3.81, P 〈 0. 00001 ）. Conclusion Compared with the monotherapy, the combination therapy is more effective in induction and maintenance remission, mucosal healing, better improving biochemical parameters, and the relevant adverse events do not increase.
出处
《胃肠病学和肝病学杂志》
CAS
2015年第9期1066-1072,共7页
Chinese Journal of Gastroenterology and Hepatology
