阿达木单抗对克罗恩病的疗效和安全性评估  

Evaluation of the Efficacy and Safety of Adalimumab in Crohn's Disease

作　　者：黄美兰[1] 冉志华[1] 徐锡涛[1] 童锦禄[1] 萧树东[1] 

机构地区：[1]上海交通大学医学院附属仁济医院消化内科上海市消化疾病研究所,200001

出　　处：《胃肠病学》2011年第7期413-418,共6页Chinese Journal of Gastroenterology

摘　　要：背景:国外一系列随机对照试验(RCT)比较了阿达木单抗和安慰剂治疗成人中重度克罗恩病(CD)的疗效和安全性,但目前尚无统一结论。目的:对阿达木单抗治疗成人CD的疗效和安全性行荟萃分析。方法:联机检索PubMed、EMBASE和Cochrane Library,纳入比较阿达木单抗与安慰剂治疗成人中重度CD的RCT和相关文献,应用RevMan4.2软件行荟萃分析。结果:共4篇文献纳入本荟萃分析。阿达木单抗对成人CD的诱导缓解率(OR=2.98,95%CI:1.78～4.99,P<0.0001)和维持缓解率(OR=4.79,95%CI:2.96～7.73,P<0.00001)均明显高于安慰剂组,差异有统计学意义:诱导治疗的整体不良反应发生率低于安慰剂组,差异有统计学意义(OR=0.60,95%CI:0.42～0.87,P=0.007);维持治疗的整体不良反应发生率与安慰剂组相比无明显差异(OR=1.09,95%CI:0.72～1.65,P=0.68),严重不良反应发生率低于安慰剂组,差异有统计学意义(OR=0.51,95%CI:0.33～0.80,P=0.003)。结论:阿达木单抗治疗成人CD有效且安全性较高,可作为英夫利昔单抗治疗无效或不耐受者的选择,但仍需进一步行大样本临床试验加以验证。Background： There was a series of randomized controlled trials （RCT） comparing the efficacy and safety of adalimumab with placebo in treating adult patients with moderate-to-severe Crohn＇s disease （CD）, but no consistent conclusion was obtained so far. Ahus： To perform a meta-analysis of the efficacy and safety of adalimumab in the treatment of adult CD patients. Methods： Databases including PubMed, EMBASE and the Cochrane Library were retrieved to identify the RCT and related articles, which compared the efficacy of adalimumab with placebo in treating adult patients with moderate-to-severe CD. Meta-analysis was conducted using RevMan 4.2 software. Results： Four studies fulfilling the criteria were enrolled in this study. The remission rates of adalimumab as induction therapy （OR= 2.98, 95% CI： 1.78-4.99, P〈0.0001） and maintenance therapy （OR=4.79, 95% CI： 2.96-7.73, P〈0.000 01） were both significantly higher than those of placebo. The overall adverse reaction rate of adalimumab as induction therapy was significantly lower than that of placebo （OR=0.60, 95% CI： 0.42-0.87, P=0.007）. There was no significant difference in overall adverse reaction rate between adalimumab maintenance therapy and placebo （OR=l.09, 95% Ch 0.72-1.65, P= 0.68）, however, the severe adverse reaction rate of adalimumab as maintenance therapy was significantly lower than that of placebo （OR=0.51, 95% Ch 0.33-0.80, P=0.003）. Conclusions： Adalimumab is effective and safe in treating adult patients with CD, and it may be an alternative choice for treating patients with no response or intolerance to infliximab. Further clinical trials with larger sample size are needed to verify this conclusion.

关 键 词：阿达木单抗 CROHN病 肿瘤坏死因子Α 随机对照试验 META分析 

分 类 号：R574[医药卫生—消化系统]