Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia.
Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia.
Gastroenterology. 2015 May;148(5):938-947.e1. doi: 10.1053/j.gastro.2015.01.026. Epub 2015 Jan 22.
BACKGROUND & AIMS: Crohn's disease (CD) usually recurs after intestinal resection; postoperative endoscopic monitoring and tailored treatment can reduce the chance of recurrence. We investigated whether monitoring levels of fecal calprotectin (FC) can substitute for endoscopic analysis of the mucosa.
We analyzed data collected from 135 participants in a prospective, randomized, controlled trial, performed at 17 hospitals in Australia and 1 hospital in New Zealand, that assessed the ability of endoscopic evaluations and step-up treatment to prevent CD recurrence after surgery. Levels of FC, serum levels of C-reactive protein (CRP), and Crohn's disease activity index (CDAI) scores were measured before surgery and then at 6, 12, and 18 months after resection of all macroscopic Crohn's disease. Ileocolonoscopies were performed at 6 months after surgery in 90 patients and at 18 months after surgery in all patients.
Levels of FC were measured in 319 samples from 135 patients. The median FC level decreased from 1347 μg/g before surgery to 166 μg/g at 6 months after surgery, but was higher in patients with disease recurrence (based on endoscopic analysis; Rutgeerts score, ≥i2) than in patients in remission (275 vs 72 μg/g, respectively; P < .001). Combined 6- and 18-month levels of FC correlated with the presence (r = 0.42; P < .001) and severity (r = 0.44; P < .001) of CD recurrence, but the CRP level and CDAI score did not. Levels of FC greater than 100 μg/g indicated endoscopic recurrence with 89% sensitivity and 58% specificity, and a negative predictive value (NPV) of 91%; this means that colonoscopy could have been avoided in 47% of patients. Six months after surgery, FC levels less than 51 μg/g in patients in endoscopic remission predicted maintenance of remission (NPV, 79%). In patients with endoscopic recurrence at 6 months who stepped-up treatment, FC levels decreased from 324 μg/g at 6 months to 180 μg/g at 12 months and 109 μg/g at 18 months.
In this analysis of data from a prospective clinical trial, FC measurement has sufficient sensitivity and NPV values to monitor for CD recurrence after intestinal resection. Its predictive value might be used to identify patients most likely to relapse. After treatment for recurrence, the FC level can be used to monitor response to treatment. It predicts which patients will have disease recurrence with greater accuracy than CRP level or CDAI score.
克罗恩病（CD）通常在肠切除术后复发；术后内镜监测和针对性治疗可降低复发机会。我们研究了粪便钙卫蛋白（FC）的监测水平是否可以替代黏膜的内镜分析。
我们分析了在澳大利亚 17 家医院和新西兰 1 家医院进行的一项前瞻性、随机、对照试验中收集的 135 名参与者的数据，该试验评估了内镜评估和逐步治疗对预防术后 CD 复发的效果。在手术前以及手术后 6、12 和 18 个月测量 FC、血清 C 反应蛋白（CRP）和克罗恩病活动指数（CDAI）评分水平。90 名患者在手术后 6 个月进行回结肠镜检查，所有患者在手术后 18 个月进行检查。
对 135 名患者的 319 个样本进行了 FC 测量。FC 中位数从术前的 1347μg/g 降至术后 6 个月的 166μg/g，但在疾病复发（基于内镜分析；Rutgeerts 评分，≥i2）患者中高于缓解（分别为 275 和 72μg/g；P＜0.001）。6 个月和 18 个月时的 FC 联合水平与 CD 复发的存在（r=0.42；P＜0.001）和严重程度（r=0.44；P＜0.001）相关，但 CRP 水平和 CDAI 评分则不然。FC 水平＞100μg/g 提示内镜复发，其敏感性为 89%，特异性为 58%，阴性预测值（NPV）为 91%；这意味着可以避免 47%的患者进行结肠镜检查。在内镜缓解的患者中，术后 6 个月 FC 水平＜51μg/g 可预测缓解维持（NPV，79%）。在 6 个月时内镜复发的患者中，进行升级治疗后，FC 水平从 6 个月时的 324μg/g 下降至 12 个月时的 180μg/g 和 18 个月时的 109μg/g。
在这项前瞻性临床试验数据的分析中，FC 测量具有足够的敏感性和 NPV 值，可监测肠切除术后 CD 复发。其预测值可用于确定最有可能复发的患者。在复发后进行治疗时，FC 水平可以用于监测治疗反应。它预测疾病复发的准确性优于 CRP 水平或 CDAI 评分。
