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英夫利昔单抗或环孢素治疗急性重度溃疡性结肠炎:回顾性分析。

Infliximab or cyclosporine for acute severe ulcerative colitis: a retrospective analysis.

机构信息

North Shore Hospital, Takapuna, North Shore, New Zealand.

出版信息

J Gastroenterol Hepatol. 2012 Mar;27(3):487-92. doi: 10.1111/j.1440-1746.2011.06958.x.

Abstract

BACKGROUND AND AIM

Medical treatment of steroid-refractory ulcerative colitis (UC) is limited to either cyclosporine or infliximab. Studies comparing cyclosporine with either placebo or intravenous methylprednisone showed promise for cyclosporine, but associated it with significant toxicity. There is conflicting, but increasingly positive evidence for using infliximab. There are no studies directly comparing these two treatments. Our aim was to compare the outcomes of patients with steroid-refractory UC treated with either intravenous cyclosporine or infliximab.

METHODS

We carried out a retrospective review of inpatients with steroid-refractory UC, treated with either intravenous cyclosporine or infliximab, at Waitemata District Health Board, between January 2001 and February 2010. The primary end-points were time to colectomy, and colectomy rates at 3 and 12 months. Secondary end-points were time to discharge from initiation of treatment, steroid dependence at 12 months, and reported adverse events.

RESULTS

The total study population was 38, with 19 in the infliximab group. Follow up to 12 months was complete in all patients. At 3 months, the colectomy rate was 63% for cyclosporine, compared to 21% (P = 0.0094). By 12 months the rate was 68% and 37% for cyclosporine and infliximab, respectively (P = 0.06). Patients in the cyclosporine group required an additional 5 days in hospital (P = 0.0086). Steroid dependence at 12 months was 50% for cyclosporine versus 25% for infliximab (P = 0.36). Cyclosporine caused more adverse events (P = 0.17).

CONCLUSIONS

Infliximab improved clinical outcomes compared to the previous use of intravenous cyclosporine in patients admitted with steroid-refractory acute severe UC.

摘要

背景与目的

对类固醇难治性溃疡性结肠炎(UC)的治疗仅限于环孢素或英夫利昔单抗。比较环孢素与安慰剂或静脉甲基强的松龙的研究显示环孢素有希望,但与之相关的毒性也很大。使用英夫利昔单抗的证据越来越多,但存在争议。目前尚无直接比较这两种治疗方法的研究。我们的目的是比较静脉注射环孢素或英夫利昔单抗治疗类固醇难治性 UC 患者的结局。

方法

我们对怀塔科拉区卫生委员会 2001 年 1 月至 2010 年 2 月期间收治的接受静脉注射环孢素或英夫利昔单抗治疗的类固醇难治性 UC 住院患者进行了回顾性研究。主要终点是手术时间和 3 个月和 12 个月的手术率。次要终点是从开始治疗时的出院时间、12 个月时的类固醇依赖性以及报告的不良事件。

结果

总研究人群为 38 人,英夫利昔单抗组 19 人。所有患者均完成了 12 个月的随访。在 3 个月时,环孢素的手术率为 63%,而英夫利昔单抗组为 21%(P = 0.0094)。到 12 个月时,环孢素和英夫利昔单抗组的手术率分别为 68%和 37%(P = 0.06)。环孢素组患者住院时间额外增加 5 天(P = 0.0086)。12 个月时,环孢素组的类固醇依赖性为 50%,英夫利昔单抗组为 25%(P = 0.36)。环孢素引起的不良事件更多(P = 0.17)。

结论

与之前使用静脉注射环孢素相比,英夫利昔单抗可改善因类固醇难治性急性重度 UC 入院的患者的临床结局。

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