Factors associated with the development of intestinal strictures or obstructions in patients with .Crohn's disease
Factors associated with the development of intestinal strictures or obstructions in patients with .Crohn's disease
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DOI：
10.1111/j.1572-0241.2006.00463.x
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发表时间：
2006-05-01
影响因子：
9.8
通讯作者：
Sandborn, William J.
中科院分区：
文献类型：
--
作者：
Lichtenstein, Gary R.;Olson, Allan;Sandborn, William J.
目的：理论上存在的问题是，克罗恩病（CD）的快速管腔愈合与治疗，如英夫利西单抗增加肠狭窄，狭窄或梗阻（SSO）的风险。方法：数据进行了分析，从正在进行的观察TREAT（克罗恩病的治疗，资源，评价和评估工具）注册表和ACCENT I（克罗恩病临床试验评价英夫利西单抗在一个新的长期治疗方案）研究。研究者将SSO报告为不良事件或严重不良事件。结果：在TREAT中，与仅接受其他治疗的患者相比，接受英夫利西单抗治疗的患者的SSO发生率显著较高（1.95起事件/100患者年vs 0.99起事件/100患者年; p < 0.001）。然而，使用多变量分析，英夫利西单抗治疗与SSO的发生无关。事件发生时的CD严重程度（风险比（HR）= 2.35，95%置信区间（CI）1.35-4.09）; CD持续时间（HR = 1.02，95% CI 1.00-1.04）;回肠疾病（HR = 1.56，95% CI 1.04-2.36）;和新使用皮质类固醇（HR = 2.85，95% CI 1.23-6.57）与SSO相关。在ACCENT I中，与接受间歇性治疗的患者相比，接受英夫利西单抗维持治疗的患者中未报告SSO增加，尽管英夫利西单抗累积暴露的中位值较高。此外，有没有增加SSO的发展与快速粘膜愈合（愈合在10周）。结论：虽然未经调整的分析表明，患者接受英夫利西单抗的两倍可能发展SSO，多变量分析调整其他因素表明，只有疾病的持续时间，疾病的严重程度，回肠疾病，和新的皮质类固醇的使用显着与SSO的发展。
OBJECTIVE: Theoretical concern exists that rapid luminal healing in Crohn's disease (CD) with therapies like infliximab increases the risk of intestinal stenosis, stricture, or obstruction (SSOs).METHODS: Data were analyzed from the ongoing observational TREAT (the Crohn's Therapy, Resource, Evaluation, and Assessment Tool) Registry and ACCENT I (A Crohn's Disease Clinical Trial Evaluating Infliximab in a New Long-Term Treatment Regimen) study. Investigators reported SSOs as adverse events or serious adverse events.RESULTS: In TREAT, SSOs occurred at a significantly higher rate in patients treated with infliximab compared with patients who received other treatments only (1.95 events/100 patient-years vs 0.99 events/100 patient-years; p < 0.001). Using multivariable analyses, however, infliximab therapy was not associated with SSO development. CD severity at the time of event onset (hazard ratio (HR) = 2.35, 95% confidence internal (CI) 1.35-4.09); CD duration (HR = 1.02, 95% CI 1.00-1.04); ileal disease (HR = 1.56, 95% CI 1.04-2.36); and new corticosteroid use (HR = 2.85, 95% CI 1.23-6.57) were associated with SSOs. In ACCENT I, no increase in SSOs was reported in patients who received infliximab maintenance therapy compared with those who received episodic therapy, despite higher median cumulative infliximab exposure. Additionally, there was no increase in SSO development with rapid mucosal healing (healing at week 10).CONCLUSIONS: Although unadjusted analyses suggested that patients who received infliximab were twice as likely to develop SSOs, multivariable analysis adjusting for other factors demonstrated that only disease duration, disease severity, ileal disease, and new corticosteroid use were significantly associated with SSO development.