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基于内镜检查结果严重程度比较他克莫司与抗肿瘤坏死因子药物治疗激素难治性活动性溃疡性结肠炎的单中心、开放标签队列研究

Tacrolimus versus anti-tumor necrosis factor agents for steroid-refractory active ulcerative colitis based on the severity of endoscopic findings: a single-center, open-label cohort study.

作者信息

Matsumoto Satohiro, Kawamura Haruna, Nishikawa Takeshi, Sagihara Noriyoshi, Miyatani Hiroyuki, Mashima Hirosato

机构信息

Department of Gastroenterology, Saitama Medical Center, Jichi Medical University, Saitama, Saitama, Japan.

出版信息

Clin Exp Gastroenterol. 2017 Sep 26;10:249-258. doi: 10.2147/CEG.S143224. eCollection 2017.

DOI:10.2147/CEG.S143224
PMID:29026326
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5627753/
Abstract

BACKGROUND AND AIMS

At Saitama Medical Center, for remission induction in active ulcerative colitis (UC) patients with endoscopic evidence of severe disease, we tend to preferentially use tacrolimus (TAC) over anti-tumor necrosis factor (TNF)-α agents. We conducted this study to evaluate the validity of our therapeutic strategies.

PATIENTS AND METHODS

This retrospective study was conducted in 52 steroid-refractory active UC patients with a Clinical Activity Index (CAI) score of ≥7 who were receiving remission induction therapy with TAC or anti-TNF-α agents. The patients were divided into a TAC treatment group (TAC group, n = 29) and an anti-TNF-α agent treatment group (anti-TNF group, n = 23). The CAI, Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and incidence of events (relapse, hospitalization and surgery) were retrospectively analyzed.

RESULTS

At treatment initiation, the CAI score was 12.6 in the TAC group and 11.5 in the anti-TNF group ( = 0.09), while the corresponding values of the UCEIS were 6.5 and 5.1, respectively ( = 0.0035). The clinical remission rate at 12 weeks was 55% (65% when only the subgroup that received rapid induction therapy was included in the analysis) in the TAC group and 57% in the anti-TNF group, with no significant difference. The cumulative event-free rates at 1, 6 and 12 months were 65.5%, 39.4%, and 39.4%, respectively, in the TAC group and 95.7%, 77.2% and 71.7%, respectively, in the anti-TNF group ( = 0.0037).

CONCLUSION

Rapid induction therapy with TAC tended to be selected for active UC patients with endoscopic evidence of severe disease, and the present study supported the validity of this therapeutic approach. However, transition to the remission-maintenance phase was more favorable in the anti-TNF group.

摘要

背景与目的

在埼玉医疗中心,对于有严重疾病内镜证据的活动性溃疡性结肠炎(UC)患者进行缓解诱导时,我们倾向于优先使用他克莫司(TAC)而非抗肿瘤坏死因子(TNF)-α药物。我们开展本研究以评估我们治疗策略的有效性。

患者与方法

本回顾性研究纳入了52例类固醇难治性活动性UC患者,其临床活动指数(CAI)评分≥7,正在接受TAC或抗TNF-α药物的缓解诱导治疗。患者被分为TAC治疗组(TAC组,n = 29)和抗TNF-α药物治疗组(抗TNF组,n = 23)。对CAI、溃疡性结肠炎内镜严重程度指数(UCEIS)以及事件发生率(复发、住院和手术)进行回顾性分析。

结果

治疗开始时,TAC组的CAI评分为12.6,抗TNF组为11.5(P = 0.09),而UCEIS的相应值分别为6.5和5.1(P = 0.0035)。TAC组12周时的临床缓解率为55%(仅将接受快速诱导治疗的亚组纳入分析时为65%),抗TNF组为57%,无显著差异。TAC组1、6和12个月时的累积无事件发生率分别为65.5%、39.4%和39.4%,抗TNF组分别为95.7%、77.2%和71.7%(P = 0.0037)。

结论

对于有严重疾病内镜证据的活动性UC患者倾向于选择TAC进行快速诱导治疗,本研究支持了这种治疗方法的有效性。然而,抗TNF组向缓解维持期的过渡更有利。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85e0/5627753/026e81c6f1b0/ceg-10-249Fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85e0/5627753/73709e142b10/ceg-10-249Fig1.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85e0/5627753/026e81c6f1b0/ceg-10-249Fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85e0/5627753/73709e142b10/ceg-10-249Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85e0/5627753/30c78e9e16bd/ceg-10-249Fig2.jpg
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