Sahmoud T, Hoctin-Boes G, Modigliani R, Bitoun A, Colombel J F, Soule J C, Florent C, Gendre J P, Lerebours E, Sylvester R
Institut National de la Santé et de la Recherche Médicale, INSERM, Paris, France.
Gut. 1995 Dec;37(6):811-8. doi: 10.1136/gut.37.6.811.
No reliable identification of quiescent Crohn's disease (CD) patients with a high risk of relapse is available. The aim of this study was to develop a prognostic index to identify those patients. Untreated adult patients with quiescent disease (not induced by surgery) included in three phase III clinical trials were analysed retrospectively with respect to time to relapse. Nineteen factors related to biology, disease history, and topography were investigated. A relapse was defined as either a CD Activity Index (CDAI) > or = 200, a CDAI > or = 150 but over the baseline value by more than 100, or acute complications requiring surgery. The inclusion criteria were fulfilled by 178 patients. The median follow up was 23 months. The Cox model retained the following bad prognostic factors: age < or = 25 years, interval since first symptoms > 5 years, interval since previous relapse < or = 6 months, and colonic involvement (p < 0.001). Bootstrapping confirmed the variable selection. Patients were classified into three groups with an increasing risk of relapse (p < 0.001). The worst risk group was composed of patients presenting at least three of the four bad prognostic factors. These results make possible the design of clinical trials in quiescent CD patients with a high risk of relapse.
目前尚无可靠方法来识别复发风险高的静止期克罗恩病(CD)患者。本研究旨在开发一种预后指数以识别这些患者。对三项III期临床试验中纳入的未经治疗的静止期(非手术诱导)成年患者进行复发时间的回顾性分析。研究了与生物学、疾病史和病变部位相关的19个因素。复发定义为克罗恩病活动指数(CDAI)≥200,或CDAI≥150但比基线值高出100以上,或出现需要手术治疗的急性并发症。178例患者符合纳入标准。中位随访时间为23个月。Cox模型确定了以下不良预后因素:年龄≤25岁、首次出现症状后的间隔时间>5年、上次复发后的间隔时间≤6个月以及结肠受累(p<0.001)。自展法证实了变量选择。患者被分为复发风险递增的三组(p<0.001)。风险最高的组由具有四个不良预后因素中至少三个因素的患者组成。这些结果使得针对复发风险高的静止期CD患者开展临床试验成为可能。