粪钙卫蛋白对接受生物制剂治疗克罗恩病患者疾病活动度的评估价值
| 作 者：袁冰清, 陈彦君, 刘骥, 谢依彤, 董如芳, 冯子钦, 陈卫昌 |
| 单 位：苏州大学附属第一医院 |
| 基金项目：国家自然科学基金；江苏省基础研究计划自然科学基金青年基金项目 |
| 摘 要： |
| 背景：克罗恩病（CD）是一种慢性复发性胃肠道炎症性疾病，近年来生物制剂被广泛应用于CD的治疗，疾病活动度的准确评估对治疗决策至关重要。相较于传统内镜评估，粪钙卫蛋白（FC）检测简便，且能反映肠道炎症程度，逐渐成为研究和临床实践关注的焦点。目的：探讨FC对接受生物制剂治疗CD患者疾病活动度的评估价值。方法：回顾性收集2016年1月1日—2025年6月30日于苏州大学附属第一医院诊断为CD并接受生物制剂治疗者的临床资料，包括FC以及同时段其他实验室、内镜、影像学检查结果。分别采用克罗恩病活动指数（CDAI）和克罗恩病简化内镜评分（SES-CD）评估临床和内镜下疾病活动度。采用ROC曲线评估FC对CD患者临床和内镜下活动期的预测价值。结果：共217例接受生物制剂治疗的CD患者（其中158例行多次FC检测）纳入研究，FC和CDAI评分资料完整者共479例次，FC和SES-CD评分资料完整者共103例次。结肠受累者的FC水平显著高于结肠未受累者（P=0.003）。有与无肛周病变/穿透性病变者（P=0.138）、有与无狭窄者（P=0.756）的FC水平差异无统计学意义。治疗过程中，FC水平与CDAI评分和SES-CD评分均显著相关（ρ=0.481, 0.525, P均<0.001）。FC预测临床活动期的曲线下面积（AUC）为0.710（P<0.001），临界值为342.10 μg/g时，敏感性和特异性分别为0.648和0.700；预测内镜下活动期的AUC为0.775（P<0.001），临界值为103.67 μg/g时，敏感性和特异性分别为0.727和0.867。结论：接受生物制剂治疗的CD患者FC水平因病变部位而异，结肠受累者高于结肠未受累者。FC水平与CD临床或内镜下活动度具有相关性，对疾病活动度有较高的评估价值。 |
| 关键词：Crohn病； 粪钙卫蛋白； 生物制剂； 疾病活动度； ROC曲线 |
Value of Fecal Calprotectin in Assessing Disease Activity in Crohn′s Disease Patients Treated With Biological Agents
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| Abstract: |
| Background: Crohn′s disease (CD) is a chronic relapsing inflammatory disorder of the gastrointestinal tract. Biological agents have been widely used in the treatment of CD in recent years, and accurate assessment of disease activity is crucial for therapeutic decision-making. Compared with conventional endoscopic evaluation, fecal calprotectin (FC) test is convenient and can reflect the severity of intestinal inflammation, which has gradually become a focus in research and clinical practice. Aims: To investigate the value of FC in assessing disease activity in CD patients treated with biological agents. Methods: A retrospective study was conducted on CD patients who were treated with biological agents and admitted at the First Affiliated Hospital of Soochow University from January 1, 2016 to June 30, 2025. Data on FC level as well as concurrent laboratory, endoscopic and imaging findings were collected. Crohn′s disease activity index (CDAI) and simple endoscopic score for Crohn′s disease (SES-CD) were used to assess clinical and endoscopic disease activity, respectively. The predictive values of FC for clinical and endoscopic activity were evaluated using ROC curve analysis. Results: A total of 217 patients treated with biological agents were enrolled (158 patients underwent multiple FC tests). Complete data of FC combined with CDAI score were available for 479 cases, and complete data of FC combined with SES-CD score were available for 103 cases. FC levels were significantly higher in patients with colonic involvement than in those without colonic involvement (P=0.003). There were no significant differences in FC levels between patients with and without perianal/penetrating disease (P=0.138), as well as between those with and without stricturing disease (P=0.756). FC levels were correlated with both CDAI and SES-CD scores during biological therapies (ρ=0.481, 0.525, all P<0.001). The area under the curve (AUC) of FC for predicting clinical activity was 0.710 (P<0.001; cutoff value: 342.10 μg/g, sensitivity: 0.648, specificity: 0.700). The AUC for predicting endoscopic activity was 0.775 (P<0.001; cutoff value: 103.67 μg/g, sensitivity: 0.727, specificity: 0.867). Conclusions: FC levels in CD patients treated with biological agents vary according to lesion location, with higher levels observed in those with colonic involvement, and are correlated with both clinical and endoscopic activity, indicating a good predictive value for assessing disease activity in CD patients. |
| Keywords: Crohn Disease; Fecal Calprotectin; Biological Agents; Disease Activity; ROC Curve |
| 投稿时间：2025-10-30 |
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