Gastroenterology Department, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa, Madrid, Spain.
Aliment Pharmacol Ther. 2012 Jan;35(2):275-83. doi: 10.1111/j.1365-2036.2011.04934.x. Epub 2011 Dec 5.
Ciclosporin has proven to be effective in patients with corticosteroid-refractory ulcerative colitis (UC). When therapy with this drug fails, infliximab can be considered to avoid colectomy. The efficacy and safety of this sequential approach remain unknown.
To assess the efficacy and safety profile of treatment with infliximab after failure of ciclosporin in patients with a corticosteroid-refractory flare of UC.
Retrospective review of medical records of patients with a corticosteroid-refractory flare of UC who did not respond to ciclosporin and received salvage therapy with infliximab within a month of discontinuing ciclosporin. The severity of the flare and response to the treatment were graded using the Lichtiger index. Cumulative rates of colectomy were calculated using Kaplan-Meier analysis. Cox regression analysis was performed to identify predictors of colectomy. To evaluate the safety profile of this treatment strategy, any adverse event occurring after the first infusion of infliximab was considered.
The study population comprised 47 patients with corticosteroid-refractory UC treated with infliximab after failure of ciclosporin. The median baseline Lichtiger index was 13. The mean time from the last ciclosporin dose to the first infliximab infusion was 6 days. After the first infliximab infusion, 13% of patients achieved remission, and 74% partial response. Of the 35 patients who received the third infliximab infusion, 60% achieved remission, and 37% partial response. Fourteen patients (30%) underwent colectomy. The rate of adverse events was 23%. One death occurred in a 40-year-old man who failed ciclosporin and infliximab and underwent surgery 10 days after the first infliximab infusion; he died of nosocomial pneumonia.
Treatment with infliximab makes it possible to avoid colectomy in two-thirds of corticosteroid-refractory UC patients in whom ciclosporin fails. However, the rates of adverse events and mortality mean that the decision to administer sequential therapy (ciclosporin-infliximab) should be taken on an individual basis.
环孢素已被证明对皮质类固醇难治性溃疡性结肠炎（UC）患者有效。当这种药物治疗失败时，可以考虑使用英夫利昔单抗以避免结肠切除术。这种序贯治疗的疗效和安全性尚不清楚。
评估环孢素治疗失败后接受英夫利昔单抗治疗的皮质类固醇难治性 UC 患者的疗效和安全性。
回顾性分析皮质类固醇难治性 UC 患者的病历，这些患者对环孢素无反应，在停用环孢素后一个月内接受英夫利昔单抗挽救治疗。采用 Lichtiger 指数对病情严重程度和治疗反应进行分级。采用 Kaplan-Meier 分析计算结肠切除术的累积发生率。采用 Cox 回归分析确定结肠切除术的预测因素。为了评估这种治疗策略的安全性，将英夫利昔单抗首次输注后出现的任何不良事件都视为一种情况。
该研究人群包括 47 例皮质类固醇难治性 UC 患者，这些患者在环孢素治疗失败后接受英夫利昔单抗治疗。基线 Lichtiger 指数中位数为 13。从最后一次环孢素剂量到第一次英夫利昔单抗输注的平均时间为 6 天。第一次英夫利昔单抗输注后，13%的患者达到缓解，74%的患者达到部分缓解。在接受第三次英夫利昔单抗输注的 35 例患者中，60%达到缓解，37%达到部分缓解。14 例（30%）患者接受了结肠切除术。不良事件发生率为 23%。一名 40 岁男性患者在环孢素和英夫利昔单抗治疗失败后接受了手术，他在第一次英夫利昔单抗输注后 10 天死亡；他死于医院获得性肺炎。
在环孢素治疗失败的皮质类固醇难治性 UC 患者中，约三分之二的患者接受英夫利昔单抗治疗可以避免结肠切除术。然而，不良事件和死亡率的发生率意味着应根据个体情况决定是否进行序贯治疗（环孢素-英夫利昔单抗）。
