Kawalec Paweł, Mikrut Alicja, Łopuch Sylwia
J Gastroenterol Hepatol. 2014 Jun;29(6):1159-70. doi: 10.1111/jgh.12563.
The aim of this systematic review was to evaluate the efficacy and safety of biological agents (vedolizumab, abatacept, visilizumab, golimumab) in patients with active moderate to severe ulcerative colitis.
This paper was prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The systematic literature search was performed in PubMed, Embase, Cochrane Library, and other databases until December 27, 2013 to identify randomized controlled trials fulfilling the established inclusion criteria for this review.
Eight randomized controlled trials were included in the systematic review. Vedolizumab was significantly more effective compared with placebo (P < 0.05) increasing the percentage of patients with a clinical response, clinical remission and mucosal healing in the induction phase, and patients with a clinical remission and mucosal healing in the maintenance phase. Similarly, golimumab was significantly more effective than placebo (P < 0.05) regarding the percentage of patients with a clinical response and mucosal healing in the induction phase, and patients with a clinical response, clinical remission, and mucosal healing in the maintenance phase. The safety of these two biological agents was comparable with placebo during the treatment (P > 0.05). However, the efficacy of visilizumab or abatacept was related to the higher risk of treatment failure and a worse safety profile than placebo.
The results of the systematic review demonstrated that the efficacy and safety of particular biological agents are differentiated. Vedolizumab and golimumab occurred more effective, and comparably as safe as placebo in patients with active moderate to severe ulcerative colitis increasing the number of available therapeutic options.
本系统评价旨在评估生物制剂（维多珠单抗、阿巴西普、维西珠单抗、戈利木单抗）对活动期中度至重度溃疡性结肠炎患者的疗效和安全性。
本文按照系统评价和Meta分析的首选报告项目指南编写。在PubMed、Embase、Cochrane图书馆及其他数据库中进行系统文献检索，直至2013年12月27日，以确定符合本评价既定纳入标准的随机对照试验。
该系统评价纳入了8项随机对照试验。在诱导期，维多珠单抗与安慰剂相比显著更有效（P<0.05），提高了临床缓解、临床反应和黏膜愈合患者的百分比，在维持期提高了临床缓解和黏膜愈合患者的百分比。同样，在诱导期，戈利木单抗在临床反应和黏膜愈合患者百分比方面比安慰剂显著更有效（P<0.05），在维持期在临床反应、临床缓解和黏膜愈合患者百分比方面也更有效。在治疗期间，这两种生物制剂的安全性与安慰剂相当（P > 0.05）。然而，维西珠单抗或阿巴西普的疗效与治疗失败风险较高以及安全性比安慰剂差有关。
系统评价结果表明，特定生物制剂的疗效和安全性存在差异。维多珠单抗和戈利木单抗更有效，并且在活动期中度至重度溃疡性结肠炎患者中与安慰剂安全性相当，增加了可用治疗选择的数量。
