Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
J Crohns Colitis. 2021 Aug 2;15(8):1387-1398. doi: 10.1093/ecco-jcc/jjab026.
Since the 1980s, many studies have evaluated the efficacy of therapies to improve the outcomes of patients with perianal Crohn's disease. We performed a systematic review to describe the evolution of endpoints in perianal fistulizing Crohn's disease. Efficacy outcomes, definitions and measurement tools were assessed.
Electronic databases were searched up to November 1, 2020. All published randomized placebo-controlled trials enrolling patients with perianal fistula and Crohn's disease were eligible for inclusion. Ongoing randomized clinical trials were also described.
Nineteen randomized controlled trials were included. Clinical efficacy endpoints were reported in all trials. Clinical response was the most frequent primary endpoint [6/19 studies, 31.6%], followed by clinical remission in four studies [21%]. Clinical response was defined as closure of at least 50% of fistulas, while remission was defined as closure of all fistulas. A combined clinical and radiological primary endpoint was used to assess fistula healing in four studies [21%]. The Perianal Disease Activity Index was a primary endpoint in only one study [5.5%]. In addition, eight ongoing controlled trials were identified. Combined clinical and radiological remission was the most frequent primary endpoint in these studies [4/8, 50%].
In this systematic review, significant changes in outcomes used in randomized clinical trials of perianal Crohn's disease were observed. Radiological endpoints are increasingly used in perianal fistulizing Crohn's disease trials.
自 20 世纪 80 年代以来，许多研究评估了改善肛周克罗恩病患者结局的治疗效果。我们进行了一项系统综述，以描述肛周瘘管性克罗恩病的终点演变。评估了疗效结局、定义和测量工具。
电子数据库检索截至 2020 年 11 月 1 日。所有纳入肛周瘘管和克罗恩病患者的已发表随机安慰剂对照试验均符合纳入标准。还描述了正在进行的随机临床试验。
共纳入 19 项随机对照试验。所有试验均报告了临床疗效终点。临床缓解是最常见的主要终点[6/19 项研究，31.6%]，其次是 4 项研究中的临床缓解[21%]。临床缓解定义为至少 50%的瘘管闭合，而缓解定义为所有瘘管闭合。四项研究[21%]使用联合临床和影像学主要终点来评估瘘管愈合。仅有一项研究[5.5%]将肛周疾病活动指数作为主要终点。此外，还确定了 8 项正在进行的对照试验。这些研究中最常见的主要终点是联合临床和影像学缓解[4/8，50%]。
在这项系统综述中，观察到肛周克罗恩病随机临床试验中使用的结局发生了显著变化。影像学终点越来越多地用于肛周瘘管性克罗恩病试验。
