抗纤维化狭窄治疗克罗恩病的专家共识：定义、诊断和治疗目标的标准化。
An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease.
机构信息
Cleveland, OH, USA.
Münster, Germany.
出版信息
Aliment Pharmacol Ther. 2018 Aug;48(3):347-357. doi: 10.1111/apt.14853. Epub 2018 Jun 19.
BACKGROUND
Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD.
AIM
To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease.
METHODS
An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting.
RESULTS
Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials.
CONCLUSIONS
Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.
背景
纤维性狭窄是克罗恩病（CD）的常见并发症，约影响所有患者的一半。目前尚无特定的抗纤维化治疗方法；然而，目前正在评估几种治疗方法。由于缺乏用于狭窄 CD 的标准化定义、诊断方式、临床试验资格标准、终点和治疗目标，因此药物开发受到阻碍。
目的
为 CD 狭窄的抗纤维化治疗方法制定标准化的定义、诊断和治疗目标。
方法
由 15 名胃肠病学家和放射科医生组成的跨学科专家小组。使用改良的 RAND/加利福尼亚大学洛杉矶分校适宜性方法，对来自系统评价和专家意见的 109 项候选项目进行了匿名评分，这些项目主要针对小肠狭窄，评分结果为不适当、不确定或适当。在第二轮和第三轮投票之前，作为一个小组讨论了调查结果。
结果
纤维性狭窄定义为管腔狭窄、壁增厚和狭窄前扩张的组合。吻合口（先前肠切除吻合部位）和初发小肠狭窄的定义相似；然而，吻合口狭窄的壁厚度存在不确定性。磁共振成像被认为是定义纤维性狭窄和评估治疗反应的最佳技术。有症状的狭窄定义为腹胀、痉挛、饮食限制、恶心、呕吐、腹痛和餐后腹痛。在 24-48 周内需要进行干预（内镜球囊扩张或手术）被认为是药物试验的适当终点。
结论
CD 狭窄的诊断和治疗反应的共识标准应告知临床实践和试验设计。
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