Mei Wei-Qun, Hu Hui-Zhen, Liu Ying, Li Zhi-Chen, Wang Wei-Guo
Wei-Qun Mei, Hui-Zhen Hu, Wei-Guo Wang, Department of Gastroenterology, No. 117 Hospital of PLA, Hangzhou 310021, Zhejiang Province, China.
World J Gastroenterol. 2015 May 21;21(19):6044-51. doi: 10.3748/wjg.v21.i19.6044.
To compare the efficacy and safety of biological agents for the treatment of active ulcerative colitis (UC).
PubMed, MEDLINE, EMBASE and the Cochrane library were searched to screen relevant articles from January 1996 to August 2014. The mixed treatment comparison meta-analysis within a Bayesian framework was performed using WinBUGS14 software. The proportions of patients reaching clinical response, clinical remission and mucosal healing in induction and maintenance phases were analyzed as efficacy indicators. Serious adverse events in maintenance phase were analyzed as safety indicators.
The meta-analysis results showed that biological agents achieved better clinical response, clinical remission and mucosal healing than placebo. Indirect comparison indicated that in induction phase, infliximab was more effective than adalimumab in inducing clinical response (OR = 0.41, 95%CI: 0.29-0.57), clinical remission (OR = 0.33, 95%CI: 0.19-0.56) and mucosal healing (OR = 0.33, 95%CI: 0.19-0.56), and golimumab in inducing clinical response (OR = 0.66, 95%CI: 0.39-2.33) and mucosal healing (OR = 2.15, 95%CI: 1.18-4.22). No significant difference was found between placebo and biological agents regarding their safety.
All biological agents were superior to placebo for UC treatment in both induction and maintenance phases with a similar safety profile, and infliximab had a better clinical effect than the other biological agents.
比较生物制剂治疗活动期溃疡性结肠炎(UC)的疗效和安全性。
检索PubMed、MEDLINE、EMBASE和Cochrane图书馆,以筛选1996年1月至2014年8月的相关文章。使用WinBUGS14软件在贝叶斯框架内进行混合治疗比较荟萃分析。将诱导期和维持期达到临床缓解、临床缓解和黏膜愈合的患者比例作为疗效指标进行分析。将维持期的严重不良事件作为安全性指标进行分析。
荟萃分析结果显示,生物制剂在临床缓解、临床缓解和黏膜愈合方面比安慰剂更好。间接比较表明,在诱导期,英夫利昔单抗在诱导临床缓解(OR = 0.41,95%CI:0.29 - 0.57)、临床缓解(OR = 0.33,95%CI:0.19 - 0.56)和黏膜愈合(OR = 0.33,95%CI:0.19 - 0.56)方面比阿达木单抗更有效,在诱导临床缓解(OR = 0.66,95%CI:0.39 - 2.33)和黏膜愈合(OR = 2.15,95%CI:1.18 - 4.22)方面比戈利木单抗更有效。在安全性方面,安慰剂和生物制剂之间未发现显著差异。
在诱导期和维持期,所有生物制剂治疗UC均优于安慰剂,安全性相似,且英夫利昔单抗的临床效果优于其他生物制剂。