Department of Gastroenterology and Hepatology, Institute of Social and Preventive Medicine, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.
Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1352-7. doi: 10.1097/meg.0b013e32833eaa8a.
Antitumor necrosis factor a agents have significantly improved the management of Crohn's disease (CD), but not all patients benefit from this therapy. We used data from the Swiss Inflammatory Bowel Disease Cohort Study and predefined appropriateness criteria to examine the appropriateness of use of infliximab (IFX) in CD patients.
EPACT II (European Panel on the Appropriateness of CD Therapy, 2007; www.epact.ch) appropriateness criteria have been developed using a formal explicit panel process combining evidence from the published literature and expert opinion. Questionnaires relating to EPACT II criteria were used at enrollment and follow-up of all Swiss Inflammatory Bowel Disease Cohort Study patients. A step-by-step analysis of all possible indications for IFX therapy in a given patient allowed identification of the most appropriate indication and final classification in a single appropriateness category (appropriate, uncertain, inappropriate).
Eight hundred and twenty-one CD patients were prospectively enrolled between November 2006 and March 2009. IFX was administered to 146 patients (18%) at enrollment and was most frequently used for complex fistulizing disease and for the maintenance of remission induced by biological therapy. IFX therapy was considered appropriate in 44%, uncertain in 44%, and inappropriate in 10% of patients.
In this cohort, 9 out of 10 indications for IFX therapy were clinically generally acceptable (appropriate or uncertain) according to EPACT II criteria. Uncertain indications resulted mainly from the current more liberal use of IFX in clinical practice as compared with the EPACT II criteria.
抗肿瘤坏死因子 a 制剂显著改善了克罗恩病（CD）的治疗效果，但并非所有患者均从该治疗中获益。我们利用瑞士炎症性肠病队列研究的数据和预先确定的适宜性标准，来评估英夫利昔单抗（IFX）在 CD 患者中的应用是否适宜。
EPACT II（欧洲 CD 治疗适宜性专家组，2007 年；www.epact.ch）适宜性标准是采用正式的明确专家组流程制定的，该流程结合了已发表文献和专家意见中的证据。瑞士炎症性肠病队列研究的所有患者在入组和随访时都使用了与 EPACT II 标准相关的问卷。对患者的所有可能 IFX 治疗指征进行逐步分析，可确定最适宜的指征，并将其最终分类到一个适宜性类别（适宜、不确定、不适宜）中。
2006 年 11 月至 2009 年 3 月期间，前瞻性纳入了 821 例 CD 患者。入组时，146 例患者（18%）接受了 IFX 治疗，最常用于治疗复杂瘘管性疾病和维持生物治疗诱导的缓解。IFX 治疗被认为适宜的占 44%，不确定的占 44%，不适宜的占 10%。
根据 EPACT II 标准，该队列中 90%的 IFX 治疗指征在临床上通常是可接受的（适宜或不确定）。不确定的指征主要源于目前 IFX 在临床实践中的应用比 EPACT II 标准更为宽松。
