Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, PA 19104-4283, USA.
Inflamm Bowel Dis. 2010 Feb;16(2):338-46. doi: 10.1002/ibd.20997.
Treatment of patients with ulcerative colitis (UC) has traditionally focused on improving symptoms, with the main objective of inducing and maintaining symptomatic remission. However, new evidence suggests that concentrating exclusively on clinical outcome measures may not be adequate to achieve long-term treatment success. Indeed, physicians should also be assessing the reduction of endoscopic activity, with the intention of achieving complete mucosal healing (defined as the absence of all mucosal ulceration, both microscopic and macroscopic, providing a sigmoidoscopy score of 0, as assessed on the Ulcerative Colitis Disease Activity Index). As a consequence of the customary reliance on symptomatic outcome measures, relatively few clinical trials have used mucosal healing or a composite including mucosal healing as a primary endpoint. This situation may soon change as new guidelines recommend the incorporation of mucosal healing into the primary endpoint of all new clinical trials in patients with UC. These recommendations are derived, in part, from data that have illustrated a correlation between mucosal healing and several important factors including long-term remission rates, disease-related complications (e.g., risk of colorectal cancer), healthcare utilization (e.g., need for colectomy), and patient quality of life. We already have drugs available to us that can effectively induce and maintain complete mucosal healing over long periods of time. This review evaluates the effect of medical therapy on mucosal healing in patients with UC and explores the importance of this outcome measure, both from the patient's perspective and clinical trial experience. Inflamm Bowel Dis 2009.
溃疡性结肠炎（UC）患者的传统治疗方法侧重于改善症状，主要目标是诱导和维持症状缓解。然而，新的证据表明，仅关注临床结果指标可能不足以实现长期治疗成功。事实上，医生还应评估内镜活动的减少，旨在实现完全黏膜愈合（定义为无所有黏膜溃疡，包括微观和宏观，提供溃疡性结肠炎疾病活动指数的乙状结肠镜评分 0）。由于习惯性地依赖症状结果指标，相对较少的临床试验使用黏膜愈合或包括黏膜愈合的综合指标作为主要终点。这种情况可能很快就会改变，因为新的指南建议将黏膜愈合纳入 UC 患者所有新临床试验的主要终点。这些建议部分源于数据，这些数据表明黏膜愈合与包括长期缓解率、疾病相关并发症（例如，结直肠癌风险）、医疗保健利用（例如，需要结肠切除术）和患者生活质量在内的几个重要因素之间存在相关性。我们已经有可以有效诱导和长期维持完全黏膜愈合的药物。这篇综述评估了药物治疗对 UC 患者黏膜愈合的影响，并探讨了从患者角度和临床试验经验来看，这种结果指标的重要性。炎症性肠病 2009 年。
