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英夫利昔单抗治疗难治性袋炎和袋相关性克罗恩病并发症的疗效:一项比利时病例系列研究。

Efficacy of infliximab in refractory pouchitis and Crohn's disease-related complications of the pouch: a Belgian case series.

机构信息

Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium.

出版信息

Inflamm Bowel Dis. 2010 Feb;16(2):243-9. doi: 10.1002/ibd.21037.

Abstract

BACKGROUND

Up to 25% of inflammatory bowel disease (IBD) patients undergoing surgery with an ileal pouch-anal anastomosis (IPAA) will develop chronic pouchitis not responding to antibiotics. In case reports, thiopurine analogs and infliximab (IFX) have been proposed as effective therapy in this setting. We analyzed the long-term efficacy of IFX in Belgian patients with refractory pouch complications.

METHODS

We identified 28 IPAA patients who received IFX for refractory luminal inflammation (pouchitis and/or pre-pouch ileitis, n = 25) and/or pouch fistula (n = 7). Patients with elements of Crohn's disease after review of the colectomy specimen were excluded. Clinical response was defined as complete in case of cessation of diarrhea, blood loss, and abdominal pain, and as partial in case of marked clinical improvement. Fistula response was defined as complete in case of cessation and as partial in case of reduction of fistula drainage.

RESULTS

Eighty-two percent of patients were concomitantly treated with immunomodulatory agents. At week 10 following start of IFX, 88% of patients with refractory luminal inflammation showed clinical response (14 partial, 8 complete), while 6 patients (86%) showed fistula response (3 partial, 3 complete). The mPDAI dropped significantly from 9.0 (interquartile range [IQR] 8.0-10.0) to 4.5 (3.0-7.0) points (P < 0.001). After a median follow-up of 20 (7-36) months, 56% showed sustained clinical response while 3 out of 7 fistula patients showed sustained fistula response. Five patients needed permanent ileostomy.

CONCLUSIONS

In this series, IFX was effective long-term in IPAA patients with refractory luminal inflammation and pouch fistula. These results warrant a prospective multicenter randomized controlled trial.

摘要

背景

多达 25%接受回肠贮袋肛管吻合术(IPAA)的炎症性肠病(IBD)患者会出现对抗生素无反应的慢性贮袋炎。在病例报告中,已提出硫嘌呤类似物和英夫利昔单抗(IFX)在这种情况下是有效的治疗方法。我们分析了 IFX 在比利时患有难治性贮袋并发症的患者中的长期疗效。

方法

我们确定了 28 名接受 IFX 治疗难治性腔炎症(贮袋炎和/或贮袋前回肠炎,n = 25)和/或贮袋瘘(n = 7)的 IPAA 患者。在回顾结肠切除术标本后,排除了具有克罗恩病特征的患者。临床反应定义为腹泻、失血和腹痛停止,部分反应定义为明显的临床改善。瘘管反应定义为瘘管引流停止,部分反应定义为减少。

结果

82%的患者同时接受免疫调节剂治疗。在开始 IFX 治疗后的第 10 周,88%的难治性腔炎症患者表现出临床反应(14 例部分反应,8 例完全反应),而 6 例患者(86%)表现出瘘管反应(3 例部分反应,3 例完全反应)。mPDAI 从 9.0(四分位距 [IQR] 8.0-10.0)显著下降至 4.5(3.0-7.0)点(P < 0.001)。在中位随访 20(7-36)个月后,56%的患者持续表现出临床反应,7 例瘘管患者中有 3 例持续表现出瘘管反应。5 名患者需要永久性回肠造口术。

结论

在本系列中,IFX 在 IPAA 患者中对难治性腔炎症和贮袋瘘有效,且疗效持久。这些结果需要前瞻性多中心随机对照试验来验证。

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