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195例溃疡性结肠炎患者英夫利昔单抗治疗的长期结局及反应预测因素:一项来自韩国的基于医院的队列研究

Long-term outcomes of infliximab treatment and predictors of response in 195 patients with ulcerative colitis: a hospital-based cohort study from Korea.

作者信息

Seo Hyungil, Chang Kiju, Lee Sun-Ho, Song Eun-Mi, Kim Gwang-Un, Seo Myeongsook, Lee Ho-Su, Hwang Sung-Wook, Yang Dong-Hoon, Kim Kyung-Jo, Ye Byong Duk, Byeon Jeong-Sik, Myung Seung-Jae, Yang Suk-Kyun, Park Sang Hyoung

机构信息

a Department of Gastroenterology , University of Ulsan College of Medicine, Asan Medical Center , Seoul , Korea.

b Health Screening and Promotion Center , University of Ulsan College of Medicine, Asan Medical Center , Seoul , Korea.

出版信息

Scand J Gastroenterol. 2017 Aug;52(8):857-863. doi: 10.1080/00365521.2017.1323229. Epub 2017 May 14.

Abstract

BACKGROUND

Large-scale studies regarding the long-term efficacy of infliximab (IFX) treatment in non-Caucasian patients with ulcerative colitis (UC) are lacking.

STUDY

We analyzed the long-term outcomes of IFX in 195 Korean UC patients who received scheduled IFX treatments at Asan Medical Center. IFX failure was defined as IFX discontinuation due to colectomy or non-response to IFX, and additionally UC-related hospitalization or a need for rescue corticosteroids during the course of IFX.

RESULTS

Between December 2006 and October 2016, a total of 3101 infusions of IFX were administered to 195 patients over a median period of 21 months. At the end of the follow-up, 86 patients (44.1%) were still receiving IFX without failure. IFX was stopped in 73 (37.4%) patients due to colectomy (23 patients, 11.8%), non-response to IFX (35 patients, 17.9%) or other reasons such as adverse events or patients' preferences (15 patients, 7.7%). An additional 36 (18.5%) patients experienced IFX failure during follow-up due to a need for rescue corticosteroids (13 patients, 6.7%), UC-related hospitalization (8 patients, 4.1%), or both (15 patients, 7.7%). The survival free of IFX failure was 58.1% at 1 year, 50.7% at 3 years and 44.8% at 5 years. In a multivariate regression analysis, cytomegalovirus colitis within 3 months before IFX initiation was a predictor of IFX failure (hazard ratio 1.57; 95% confidence interval 1.04-2.37; p = .032).

CONCLUSIONS

The long-term efficacy of IFX in a large, real-life cohort of Korean UC patients appears to be comparable to that in previously published Western studies.

摘要

背景

关于英夫利昔单抗(IFX)治疗非白种人溃疡性结肠炎(UC)患者的长期疗效,目前缺乏大规模研究。

研究

我们分析了195例在峨山医学中心接受定期IFX治疗的韩国UC患者的IFX长期治疗结果。IFX治疗失败定义为因结肠切除术或对IFX无反应而停用IFX,此外还包括在IFX治疗过程中因UC相关住院或需要使用挽救性皮质类固醇激素。

结果

2006年12月至2016年10月期间,195例患者共接受了3101次IFX输注,中位治疗时间为21个月。随访结束时,86例患者(44.1%)仍在接受IFX治疗且未出现治疗失败。73例(37.4%)患者因结肠切除术(23例,11.8%)、对IFX无反应(35例,17.9%)或其他原因(如不良事件或患者偏好,15例,7.7%)而停用IFX。另外36例(18.5%)患者在随访期间因需要使用挽救性皮质类固醇激素(13例,6.7%)、UC相关住院(8例,4.1%)或两者皆有(15例,7.7%)而出现IFX治疗失败。IFX治疗无失败的生存率在1年时为58.1%,3年时为50.7%,5年时为44.8%。在多因素回归分析中,IFX开始治疗前3个月内发生巨细胞病毒性结肠炎是IFX治疗失败的一个预测因素(风险比1.57;95%置信区间1.04 - 2.37;p = 0.032)。

结论

在一大群真实生活中的韩国UC患者中,IFX的长期疗效似乎与先前发表的西方研究结果相当。

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