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英夫利昔单抗治疗儿童克罗恩病的长期疗效:一项基于人群的研究。

Long-term outcome of treatment with infliximab in pediatric-onset Crohn's disease: a population-based study.

机构信息

Gastroenterology Unit, EPIMAD Registry, Lille University Hospital, Lille, France.

出版信息

Inflamm Bowel Dis. 2011 Oct;17(10):2144-52. doi: 10.1002/ibd.21615. Epub 2011 Feb 1.

DOI:10.1002/ibd.21615
PMID:21287665
Abstract

BACKGROUND

We examined short- and long-term benefits and safety of infliximab (IFX) in a population-based cohort of Crohn's disease (CD) patients <17 years old at diagnosis.

METHODS

The following parameters were assessed: short- and long-term efficacy of IFX, impact of drug efficacy, and mode of administration on rate of resection surgery, growth and nutritional catch-up, and adverse events (AEs).

RESULTS

In all, 120 patients (69 female) required IFX with a median duration of 32 months (Q1 = 8-Q3 = 60). Median age at diagnosis was 14.5 years (12-16) and median interval between diagnosis and IFX initiation was 41 months (22-78). Median follow-up since CD diagnosis was 111 months (75-161). Fifty patients (42%) received episodic and 70 (58%) maintenance therapy. Sixty-five (54%) patients were in the "IFX efficacy" group: 38 (32%) still receiving IFX at the last visit and 27 (22%) stopping IFX while in remission. The "IFX failure" group included 55 (46%) patients: 17 (14%) who stopped IFX due to AEs and 38 (32%) nonresponders. The risk of surgery was reduced (P = 0.009) in the "IFX efficacy" group and lower (P = 0.03) in patients with scheduled versus episodic therapy. Patients in the "IFX efficacy" group had significant catch-up growth (P = 0.04), while those in the "IFX failure" group did not. Twenty-four patients presented AEs leading to cessation of IFX in 17 of them.

CONCLUSIONS

In this population-based cohort of pediatric-onset CD, IFX treatment was effective in more than half of patients during a median follow-up of 32 months. Long-term IFX responders had a lower rate of surgery and improved catch-up in growth, especially when receiving scheduled IFX therapy.

摘要

背景

我们在一个基于人群的幼年克罗恩病(CD)患者队列中研究了英夫利昔单抗(IFX)的短期和长期疗效和安全性,这些患者在诊断时年龄均<17 岁。

方法

评估以下参数:IFX 的短期和长期疗效、药物疗效和给药方式对切除术率、生长和营养追赶以及不良事件(AE)的影响。

结果

共有 120 例(69 例女性)患者需要接受 IFX 治疗,中位治疗时间为 32 个月(Q1 = 8-Q3 = 60)。诊断时的中位年龄为 14.5 岁(12-16 岁),诊断至 IFX 起始的中位时间间隔为 41 个月(22-78)。自 CD 诊断以来的中位随访时间为 111 个月(75-161)。50 例(42%)患者接受间歇性治疗,70 例(58%)患者接受维持性治疗。65 例(54%)患者为“IFX 疗效”组:38 例(32%)在最后一次就诊时仍在接受 IFX 治疗,27 例(22%)在缓解时停止 IFX 治疗。“IFX 失败”组包括 55 例(46%)患者:17 例(14%)因 AE 停止 IFX 治疗,38 例(32%)无应答者。“IFX 疗效”组的手术风险降低(P=0.009),而计划治疗组的手术风险更低(P=0.03)。“IFX 疗效”组的患者生长追赶明显(P=0.04),而“IFX 失败”组的患者则没有。24 例患者出现 AE,导致 17 例患者停止 IFX 治疗。

结论

在这个基于人群的幼年 CD 患者队列中,IFX 治疗在中位 32 个月的随访中对超过一半的患者有效。长期 IFX 应答者的手术率较低,生长追赶较好,尤其是在接受计划 IFX 治疗时。

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