Vuitton L, Peyrin-Biroulet L, Colombel J F, Pariente B, Pineton de Chambrun G, Walsh A J, Panes J, Travis S P L, Mary J Y, Marteau P
Besançon, France.
Vandoeuvre-lès-Nancy, France.
Aliment Pharmacol Ther. 2017 Mar;45(6):801-813. doi: 10.1111/apt.13948. Epub 2017 Jan 23.
Recently, endpoints for clinical trials have been changing from measuring clinical response to mucosal healing in ulcerative colitis. Endoscopic evaluation is the current gold standard to assess mucosal lesions and has become a major measure of therapeutic efficacy in addition to patients reported outcomes.
To achieve consensus on endoscopic definitions of remission and response for clinical trials in patients with ulcerative colitis.
In reaching the current international recommendations on an International Organization For the Study of Inflammatory Bowel Disease (IOIBD) initiative, we first performed a systematic review of technical aspects of endoscopic scoring systems. Then, to achieve consensus on endoscopic definitions of remission and response for clinical trials, we conducted a two-round vote using a Delphi-style process among fifteen specialists in the field of inflammatory bowel diseases.
The literature review showed that many endoscopic indices have been proposed to evaluate disease activity in ulcerative colitis; most are unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response or remission. At the end of the voting process, the investigators ranked initially the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) 0 for the definition of endoscopic remission, and a decrease in Mayo endoscopic score ≥1 grade or a decrease in UCEIS ≥2 points for the definition of endoscopic response in ulcerative colitis.
These international recommendations represent the first consensus on measurement indices for endoscopic outcomes in ulcerative colitis. They should be subject to prospective testing in clinical trials of ulcerative colitis.
最近，溃疡性结肠炎临床试验的终点已从衡量临床反应转变为评估黏膜愈合情况。内镜评估是目前评估黏膜病变的金标准，除了患者报告的结局外，它已成为治疗效果的主要衡量指标。
就溃疡性结肠炎患者临床试验中缓解和反应的内镜定义达成共识。
为达成目前关于国际炎症性肠病研究组织（IOIBD）倡议的国际建议，我们首先对内镜评分系统的技术方面进行了系统评价。然后，为就溃疡性结肠炎临床试验中缓解和反应的内镜定义达成共识，我们在炎症性肠病领域的15位专家中采用德尔菲法进行了两轮投票。
文献综述表明，已提出许多内镜指标来评估溃疡性结肠炎的疾病活动度；大多数未经验证，且在临床试验中使用了任意定义来界定内镜反应或缓解。在投票过程结束时，研究人员将溃疡性结肠炎内镜严重程度指数（UCEIS）0作为内镜缓解的定义，将梅奥内镜评分降低≥1级或UCEIS降低≥2分作为溃疡性结肠炎内镜反应的定义列为首选。
这些国际建议代表了对溃疡性结肠炎内镜结局测量指标的首次共识。它们应在溃疡性结肠炎的临床试验中进行前瞻性测试。
