Mosli Mahmoud H, MacDonald John K, Bickston Stephen J, Behm Brian W, Tsoulis David J, Cheng Jianfeng, Khanna Reena, Feagan Brian G
*Robarts Clinical Trials, Robarts Research Institute, Western University, London, ON, Canada; †Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; ‡Center for Inflammatory Bowel Diseases, Richmond, Virginia; §UVA Digestive Health Center of Excellence, University of Virginia Health Systems, Charlottesville, Virginia; and ‖Carolinas Medical Center, University of North Carolina Charlotte Campus, Charlotte, North Carolina.
Inflamm Bowel Dis. 2015 May;21(5):1151-9. doi: 10.1097/MIB.0000000000000396.
We performed a systematic review to evaluate the efficacy and safety of vedolizumab for induction and maintenance of remission in ulcerative colitis.
A literature search to June 2014 identified all applicable randomized trials. Outcome measures were clinical and endoscopic remission, clinical and endoscopic response, quality of life, and adverse events. The risk ratio (RR) and 95% confidence intervals (CI) were estimated for each outcome. Study quality was evaluated using the Cochrane risk of bias tool. The GRADE criteria were used to assess the quality of the evidence.
Four studies (606 patients) were included. The risk of bias was low. Pooled analyses indicated that vedolizumab was significantly superior to placebo for induction of remission (RR = 0.86, 95% CI, 0.80-0.91), clinical response (RR = 0.82, 95% CI, 0.75-0.91), endoscopic remission (RR = 0.82, 95% CI, 0.75-0.91), and for achieving remission at 52 weeks in week 6 responders (RR = 2.73, 95% CI, 1.78-4.18). GRADE analyses suggested that the overall quality of the evidence was high for induction of remission and moderate for maintenance therapy (due to sparse data consisting of 246 events). No statistically significant difference was observed in the incidence of adverse events between vedolizumab and placebo.
Vedolizumab is superior to placebo as induction and maintenance therapy for ulcerative colitis. Future studies are needed to define long-term efficacy and safety of this agent.
我们进行了一项系统评价，以评估维多珠单抗诱导和维持溃疡性结肠炎缓解的疗效和安全性。
检索截至2014年6月的文献，确定所有适用的随机试验。观察指标为临床和内镜缓解、临床和内镜反应、生活质量及不良事件。对每个观察指标估计风险比（RR）和95%置信区间（CI）。采用Cochrane偏倚风险工具评估研究质量。使用GRADE标准评估证据质量。
纳入四项研究（606例患者）。偏倚风险较低。汇总分析表明，维多珠单抗在诱导缓解（RR = 0.86，95% CI，0.80 - 0.91）、临床反应（RR = 0.82，95% CI，0.75 - 0.91）、内镜缓解（RR = 0.82，95% CI，0.75 - 0.91）以及使第6周有反应者在第52周达到缓解方面（RR = 2.73，95% CI，1.78 - 4.18）显著优于安慰剂。GRADE分析表明，诱导缓解的证据总体质量高，维持治疗的证据质量中等（由于仅有246例事件的稀疏数据）。维多珠单抗和安慰剂之间不良事件发生率未观察到统计学显著差异。
维多珠单抗作为溃疡性结肠炎的诱导和维持治疗优于安慰剂。需要进一步研究确定该药物的长期疗效和安全性。
