Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada.
Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.
Inflamm Bowel Dis. 2018 Jul 12;24(8):1619-1623. doi: 10.1093/ibd/izy195.
Clinical trials require valid outcome measures to assess the therapeutic benefit of investigational agents. Recently, regulatory authorities have mandated the use of patient-reported outcomes in combination with an objective measure of disease activity as primary outcome measures in inflammatory bowel disease trials. Endoscopy has commonly fulfilled the latter role; however, due to the costs and complexity of these assessments, interest has emerged in the use of noninvasive biomarkers. The role of C-reactive protein, fecal calprotectin, and fecal lactoferrin in clinical research is discussed.
临床试验需要有效的结局指标来评估研究药物的治疗获益。最近，监管机构已要求将患者报告的结局与疾病活动的客观测量指标联合用于炎症性肠病的临床试验作为主要结局指标。内镜检查通常满足后者的作用；然而，由于这些评估的成本和复杂性，人们对使用非侵入性生物标志物产生了兴趣。本文讨论了 C 反应蛋白、粪便钙卫蛋白和粪便乳铁蛋白在临床研究中的作用。
