Department of Surgery, Oncology and Gastroenterology (DISCOG), Gastroenterology Unit, University of Padova-Azienda Ospedaliera di Padova, Padova, Italy.
Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK.
J Crohns Colitis. 2021 May 4;15(5):733-741. doi: 10.1093/ecco-jcc/jjaa226.
Despite randomized controlled trials [RCTs] and trial-based meta-analyses, the optimal rescue therapy for patients with acute glucorticosteroid-refractory ulcerative colitis [UC], to avoid colectomy and improve long-term outcomes, remains unclear. We conducted a network meta-analysis examining this issue.
We searched MEDLINE, EMBASE, EMBASE Classic and the Cochrane central register up to June 2020. We included RCTs comparing ciclosporin and infliximab, either with each other or with placebo, in patients with glucorticosteroid-refractory UC.
We identified seven RCTs containing 534 patients [415 in head-to-head trials of ciclosporin vs infliximab]. Risk of colectomy at ≤ 1 month was reduced significantly with both treatments, compared with placebo (relative risk [RR] of colectomy with infliximab vs placebo = 0.37; 95% confidence interval [CI] 0.21-0.65, RR with ciclosporin vs placebo = 0.40; 95% CI 0.21-0.77). In terms of colectomy between > 1 month and < 1 year, both drugs ranked equally [P-score 0.75]. Neither treatment was more effective than placebo in reducing the risk of colectomy at ≥ 1 year. Both ciclosporin and infliximab were significantly more efficacious than placebo in achieving a response. Neither treatment was more effective than placebo in inducing remission, nor more likely to cause serious adverse events than placebo.
Both ciclosporin and infliximab were superior to placebo in terms of response to therapy and avoiding colectomy up to 1 year, with no significant differences in efficacy or safety between the two. Ciclosporin remains a valid option to treat refractory UC patients, especially those who do not respond to previous treatment with infliximab, or as a bridge to other biological therapies.
尽管有随机对照试验[RCTs]和基于试验的荟萃分析，但对于急性糖皮质激素难治性溃疡性结肠炎[UC]患者，为避免结肠切除术并改善长期结局，最佳的抢救治疗方法仍不清楚。我们进行了一项网络荟萃分析来研究这个问题。
我们检索了 MEDLINE、EMBASE、EMBASE Classic 和 Cochrane 中心注册库，检索时间截至 2020 年 6 月。我们纳入了比较环孢素和英夫利昔单抗，或两者与安慰剂，治疗糖皮质激素难治性 UC 患者的 RCTs。
我们确定了 7 项 RCT，包含 534 名患者[415 名患者在环孢素与英夫利昔单抗的头对头试验中]。与安慰剂相比，这两种治疗方法均显著降低了 1 个月内结肠切除术的风险（英夫利昔单抗与安慰剂相比的结肠切除术风险比[RR]为 0.37；95%置信区间[CI] 0.21-0.65，环孢素与安慰剂相比的 RR 为 0.40；95%CI 0.21-0.77）。在 1 个月至<1 年之间的结肠切除术方面，两种药物的疗效相当[P 评分 0.75]。在≥1 年内，两种药物都没有比安慰剂更有效地降低结肠切除术的风险。环孢素和英夫利昔单抗在实现缓解方面均明显优于安慰剂。两种治疗方法都不如安慰剂更能诱导缓解，且发生严重不良事件的风险也不比安慰剂高。
环孢素和英夫利昔单抗在治疗反应和避免 1 年内结肠切除术方面均优于安慰剂，两种药物在疗效和安全性方面没有显著差异。环孢素仍然是治疗难治性 UC 患者的有效选择，尤其是那些对先前的英夫利昔单抗治疗无反应的患者，或作为其他生物治疗的桥梁。
