Department of Gastroenterology & Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland; Healthcare Evaluation Unit, Institute of Social & Preventive Medicine (IUMSP), Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.
J Crohns Colitis. 2009 Dec;3(4):241-9. doi: 10.1016/j.crohns.2009.05.002. Epub 2009 Jul 14.
Biological therapy has dramatically changed management of Crohn's disease (CD). New data have confirmed the benefit and relative long-term safety of anti-TNFα inhibition as part of a regular scheduled administration programme. The EPACT appropriateness criteria for maintenance treatment after medically-induced remission (MIR) or surgically-induced remission (SIR) of CD thus required updating.
A multidisciplinary international expert panel (EPACT II, Geneva, Switzerland) discussed and anonymously rated detailed, explicit clinical indications based on evidence in the literature and personal expertise. Median ratings (on a 9-point scale) were stratified into three assessment categories: appropriate (7-9), uncertain (4-6 and/or disagreement) and inappropriate (1-3). Experts ranked appropriate medication according to their own clinical practice, without any consideration of cost.
Three hundred and ninety-two specific indications for maintenance treatment of CD were rated (200 for MIR and 192 for SIR). Azathioprine, methotrexate and/or anti-TNFα antibodies were considered appropriate in 42 indications, corresponding to 68% of all appropriate interventions (97% of MIR and 39% of SIR). The remaining appropriate interventions consisted of mesalazine and a "wait-and-see" strategy. Factors that influenced the panel's voting were patient characteristics and outcome of previous treatment. Results favour use of anti-TNFα agents after failure of any immunosuppressive therapy, while earlier primary use remains controversial.
Detailed explicit appropriateness criteria (EPACT) have been updated for maintenance treatment of CD. New expert recommendations for use of the classic immunosuppressors as well as anti-TNFα agents are now freely available online (www.epact.ch). The validity of these criteria should now be tested by prospective evaluation.
生物疗法极大地改变了克罗恩病（CD）的治疗方法。新的数据证实了抗 TNFα 抑制作为定期治疗方案的一部分的益处和相对长期安全性。因此，需要更新 EPACT 对 CD 缓解后（MIR）或手术后缓解（SIR）的维持治疗的适宜性标准。
一个多学科的国际专家小组（EPACT II，瑞士日内瓦）讨论并匿名评估了详细、明确的临床指标，这些指标基于文献中的证据和个人专业知识。中位数评分（9 分制）分为三个评估类别：适宜（7-9 分）、不确定（4-6 分和/或意见不一致）和不适宜（1-3 分）。专家根据自己的临床实践对适宜的药物进行排名，而不考虑成本。
对 392 项 CD 维持治疗的具体适应证进行了评分（MIR 200 项，SIR 192 项）。硫唑嘌呤、甲氨蝶呤和/或抗 TNFα 抗体在 42 种适应证中被认为是适宜的，占所有适宜干预措施的 68%（MIR 的 97%和 SIR 的 39%）。其余适宜的干预措施包括美沙拉嗪和“观望”策略。影响小组投票的因素是患者特征和先前治疗的结果。结果支持在任何免疫抑制治疗失败后使用抗 TNFα 药物，而早期主要使用仍存在争议。
已经更新了 CD 维持治疗的详细明确的适宜性标准（EPACT）。关于经典免疫抑制剂和抗 TNFα 药物的新专家建议现在可以在网上（www.epact.ch）免费获得。现在应该通过前瞻性评估来检验这些标准的有效性。
