Hôpital Saint-Louis, Université Paris-Diderot, Assistance Publique-Hôpitaux de Paris, Paris, France.
Am J Gastroenterol. 2011 Apr;106(4):771-7. doi: 10.1038/ajg.2011.62. Epub 2011 Mar 8.
Rescue therapy with either cyclosporine (CYS) or infliximab (IFX) is an effective option in patients with intravenous steroid-refractory attacks of ulcerative colitis (UC). In patients who fail, colectomy is usually recommended, but a second-line rescue therapy with IFX or CYS is an alternative. The aims of this study were to investigate the efficacy and tolerance of IFX and CYS as a second-line rescue therapy in steroid-refractory UC or indeterminate colitis (IC) unsuccessfully treated with CYS or IFX.
This was a retrospective survey of patients seen during the period 2000-2008 in the GETAID centers. Inclusion criteria included a delay of <1 month between CYS withdrawal (when used first) and IFX, or a delay of <2 months between IFX (when used first) and CYS, and a follow-up of at least 3 months after inclusion. Time-to-colectomy, clinical response, and occurrence of serious adverse events were analyzed.
A total of 86 patients (median age 34 years; 49 males; 71 UC and 15 IC) were successively treated with CYS and IFX. The median (± s.e.) follow-up time was 22.6 (7.0) months. During the study period, 49 patients failed to respond to the second-line rescue therapy and underwent a colectomy. The probability of colectomy-free survival (± s.e.) was 61.3 ± 5.3% at 3 months and 41.3 ± 5.6 % at 12 months. A case of fatal pulmonary embolism occurred at 1 day after surgery in a 45-year-old man. Also, nine infectious complications were observed during the second-line rescue therapy.
In patients with intravenous steroid-refractory UC and who fail to respond to CYS or IFX, a second-line rescue therapy may be effective in carefully selected patients, avoiding colectomy within 2 months in two-thirds of them. The risk/benefit ratio should still be considered individually.
环孢素（CYS）或英夫利昔单抗（IFX）的挽救治疗是静脉内类固醇难治性溃疡性结肠炎（UC）发作患者的有效选择。在治疗失败的患者中，通常建议进行结肠切除术，但 IFX 或 CYS 的二线挽救治疗是另一种选择。本研究的目的是研究 IFX 和 CYS 作为二线挽救治疗在静脉内类固醇难治性 UC 或 CYS 或 IFX 治疗失败的不确定结肠炎（IC）患者中的疗效和耐受性。
这是一项回顾性调查，调查了 2000 年至 2008 年期间 GETAID 中心的患者。纳入标准包括 CYS 停药（首次使用时）与 IFX 之间的时间延迟<1 个月，或 IFX（首次使用时）与 CYS 之间的时间延迟<2 个月，以及纳入后至少随访 3 个月。分析了手术时间、临床反应和严重不良事件的发生情况。
共有 86 例患者（中位年龄 34 岁；49 例男性；71 例 UC 和 15 例 IC）先后接受 CYS 和 IFX 治疗。中位（±s.e.）随访时间为 22.6（7.0）个月。在研究期间，49 例患者对二线挽救治疗无反应并接受了结肠切除术。无结肠切除术生存（±s.e.）的概率在 3 个月时为 61.3±5.3%，在 12 个月时为 41.3±5.6%。一名 45 岁男性在手术后 1 天发生致命性肺栓塞。此外，二线挽救治疗期间还观察到 9 例感染并发症。
在静脉内类固醇难治性 UC 患者中，对于 CYS 或 IFX 治疗失败的患者，二线挽救治疗可能对精心选择的患者有效，在三分之二的患者中可避免在 2 个月内进行结肠切除术。仍应考虑个体的风险/获益比。
