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在对英夫利昔单抗应答不佳的溃疡性结肠炎患者中,剂量优化是有效的:一项协作性多中心回顾性研究。

Dose optimization is effective in ulcerative colitis patients losing response to infliximab: a collaborative multicentre retrospective study.

机构信息

Internal Medicine and Medical Specialties, Sapienza, University of Rome, Rome, Italy.

Internal Medicine and Hepato-Gastroenterology, University of Ioannina, Ioannina, Greece.

出版信息

Dig Liver Dis. 2014 Feb;46(2):135-9. doi: 10.1016/j.dld.2013.10.007. Epub 2013 Nov 15.

Abstract

BACKGROUND

Subjects maintained on infliximab scheduled therapy for inflammatory bowel disease may require dose optimization due to secondary loss of response. There are limited data on infliximab dose optimization for ulcerative colitis.

AIMS

To investigate dose optimization in ulcerative colitis patients with secondary loss of response.

METHODS

This was a retrospective multicentre study. Primary outcome was rapid clinical response assessed at the next administration of infliximab after dose intensification. Secondary outcomes were rapid clinical remission, and clinical response, remission and colectomy rate by week 52. Doubling the dose (10mg/kg q8 weeks) vs. shortening the dose interval (5mg/kg every 6 or 4 weeks) were compared.

RESULTS

Forty-one patients from eight centres were enrolled (15 for double dose and 26 for interval shortening). Rapid response was achieved in 37/41 patients (90.2%), while 19/41 (46.3%) achieved rapid clinical remission. At week 52, 28/41 patients were maintained in clinical remission, but 4 (9.8%) underwent colectomy. No difference was found between the two optimization strategies. Subjects achieving rapid clinical response had a significantly higher colectomy-free rate at week 52 (p=0.002).

CONCLUSION

Dose optimization of infliximab was effective to restore clinical response or remission and to prevent colectomy in ulcerative colitis patients with secondary loss of response.

摘要

背景

接受英夫利昔单抗维持治疗的炎症性肠病患者可能需要进行剂量优化,因为会出现应答丧失。溃疡性结肠炎患者英夫利昔单抗剂量优化的数据有限。

目的

探讨应答丧失的溃疡性结肠炎患者的剂量优化。

方法

这是一项回顾性多中心研究。主要结局是在剂量强化后下一次英夫利昔单抗给药时评估快速临床应答。次要结局是快速临床缓解,以及第 52 周的临床应答、缓解和结肠切除术率。比较了剂量加倍(10mg/kg q8 周)与缩短剂量间隔(5mg/kg 每 6 或 4 周)。

结果

来自 8 个中心的 41 名患者入组(15 名接受双倍剂量,26 名接受缩短间隔)。41 名患者中有 37 名(90.2%)实现了快速应答,而 19 名(46.3%)实现了快速临床缓解。第 52 周时,28 名患者保持临床缓解,但有 4 名(9.8%)进行了结肠切除术。两种优化策略之间无差异。达到快速临床应答的患者在第 52 周时无结肠切除术的累积生存率显著更高(p=0.002)。

结论

英夫利昔单抗的剂量优化可有效恢复应答或缓解,并预防应答丧失的溃疡性结肠炎患者的结肠切除术。

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