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英夫利昔单抗和阿达木单抗预防克罗恩病患者术后复发有效性的比较:一项开放标签的试点研究。

Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn's disease: an open-label, pilot study.

作者信息

Tursi A, Elisei W, Picchio M, Zampaletta C, Pelecca G, Faggiani R, Brandimarte G

机构信息

Gastroenterology Service, ASL BAT, Via Torino, 49, 76123, Andria, BT, Italy,

出版信息

Tech Coloproctol. 2014 Nov;18(11):1041-6. doi: 10.1007/s10151-014-1177-1. Epub 2014 Jun 12.

Abstract

BACKGROUND

Endoscopic and clinical recurrence of Crohn's disease (CD) appears in up to 80 and 30 % of patients, respectively, 1 year after surgery. Both infliximab (IFX) and adalimumab (ADA) have been demonstrated to be effective in reducing the possibility of recurrence after surgery, but head-to-head studies have not been performed so far. The aim of this open-label prospective study was to compare endoscopic, histological and clinical recurrence after 1 year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence.

METHODS

Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy.

RESULTS

Twenty consecutive CD patients (9 males and 11 females; median age 32.5 years, range 20-39 years) were enrolled after undergoing curative ileocolonic resection. Among the 10 patients treated with IFX, 2 (20 %) had endoscopic recurrence compared to 1 (10 %) in the group of 10 ADA patients (p = 1.0). Three out of 10 (30 %) IFX patients and 2 out of 10 (20 %) ADA patients had histological recurrence (p = 1.0). No significant clinical differences were found between the two groups.

CONCLUSIONS

IFX and ADA were similar in preventing histological, endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients.

摘要

背景

克罗恩病(CD)术后1年,内镜复发率和临床复发率分别高达80%和30%。英夫利昔单抗(IFX)和阿达木单抗(ADA)均已被证明可有效降低术后复发的可能性,但迄今为止尚未进行过直接比较的研究。本开放标签前瞻性研究的目的是比较IFX或ADA作为术后预防用药治疗1年后,高危复发CD患者的内镜、组织学和临床复发情况。

方法

连续入选接受根治性回结肠切除术的CD患者,随机接受IFX或ADA治疗1年。共同主要终点为治疗12个月后的内镜、组织学和临床复发情况。

结果

连续20例接受根治性回结肠切除术的CD患者(9例男性,11例女性;中位年龄32.5岁,范围20 - 39岁)入组。在接受IFX治疗的10例患者中,2例(20%)出现内镜复发,而在接受ADA治疗的10例患者组中有1例(10%)出现内镜复发(p = 1.0)。10例IFX患者中有3例(30%)出现组织学复发,10例ADA患者中有2例(20%)出现组织学复发(p = 1.0)。两组之间未发现显著的临床差异。

结论

在高危CD患者根治性回结肠切除术后,IFX和ADA在预防组织学、内镜和临床复发方面效果相似。

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