英夫利昔单抗谷浓度、抗药抗体水平及粪便钙卫蛋白联合检测与克罗恩病活动性的相关性研究

鲁良秀; 王俊俊; 韦佳佳

doi:10.20053/j.issn1001-5094.202503210135

英夫利昔单抗谷浓度、抗药抗体水平及粪便钙卫蛋白联合检测与克罗恩病活动性的相关性研究

A Study on the Combined Monitoring of Infliximab Trough Concentration, Anti-drug Antibody Levels, and Fecal Calprotectin in Relation to Crohn’s Disease Activity

摘要

摘要: 目的探讨英夫利昔单抗（infliximab，IFX）谷浓度、抗IFX抗体（anti-infliximab antibody，ATI）水平及粪便钙卫蛋白（fecal calprotectin，FC）联合检测对克罗恩病（Crohn’s disease，CD）活动性的预测价值。方法选取浙江中医药大学附属第二医院收治的80例CD患者，收治时间为2022年1月至2024年12月，按照克罗恩病活动指数（Crohn’s disease activity index，CDAI）评分将患者分为缓解期组（n=57）和活动期组（n=23）。比较2组患者的临床资料、IFX谷浓度、ATI水平及FC；采用Pearson相关分析探究IFX谷浓度、ATI水平、FC与CDAI评分的相关性；通过二元Logistic回归分析筛选CD患者处于活动期的独立影响因素；运用受试者操作特征（receiver operating characteristic，ROC）曲线评估各指标单独及联合检测对CD活动性的预测价值。结果活动期组患者的红细胞沉降率（erythrocyte sedimentation rate,ESR）和C反应蛋白（C-reactive protein,CRP）与缓解期组相比更高（均P ＜ 0.05）；活动期组IFX谷浓度与缓解期组相比更低，而ATI水平、FC与缓解期组相比更高（均P ＜ 0.05）。Pearson相关分析显示，IFX谷浓度与CDAI评分呈负相关（P ＜ 0.05），ATI水平及FC与CDAI评分呈正相关（均P ＜ 0.05）。二元Logistic回归分析表明，IFX谷浓度、ATI水平、FC是CD患者疾病活动的独立影响因素（均P ＜ 0.05）。ROC曲线分析显示，IFX谷浓度、ATI水平、FC单独检测及三者联合检测预测CD活动性的曲线下面积（area under the curve,AUC）分别为0.784、0.791、0.808、0.976。结论 IFX谷浓度、ATI水平及FC与CD患者疾病活动性密切相关，三者联合检测可显著提高对CD活动性的预测效能。

Abstract: Objective To investigate the predictive value of combined monitoring of infliximab (IFX) trough concentration, anti-infliximab antibody (ATI) levels, and fecal calprotectin (FC) for the disease activity of Crohn’s disease (CD). Methods A total of 80 CD patients admitted to The Second Affiliated Hospital of Zhejiang Chinese Medical University from January 2022 to December 2024 were enrolled. According to the Crohn’s disease activity index (CDAI) scores, the patients were divided into a remission group (n = 57) and an active group (n = 23). Clinical data, IFX trough concentration, ATI levels, and FC were compared between the two groups. Pearson correlation analysis was used to explore the correlations of IFX trough concentration, ATI levels, and FC with CDAI scores. Binary Logistic regression analysis was performed to identify independent influencing factors for disease activity in CD patients. Receiver operating characteristic (ROC) curve analysis was applied to evaluate the predictive value of individual and combined monitoring of each indicator for CD activity. Results The erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels in the active group were significantly higher than those in the remission group (all P ＜ 0.05). IFX trough concentration in the active group was significantly lower than that in the remission group, while the ATI levels and FC were significantly higher (all P ＜ 0.05). Pearson correlation analysis showed that IFX trough concentration was negatively correlated with CDAI scores (P ＜ 0.05), and both ATI levels and FC were positively correlated with CDAI scores (all P ＜ 0.05). Binary Logistic regression analysis indicated that IFX trough concentration, ATI levels, and FC were independent influencing factors for disease activity in CD patients (all P ＜ 0.05). ROC curve analysis revealed that the areas under the curve (AUC) for predicting CD activity by individual monitoring of IFX trough concentration, ATI levels, FC, and their combined monitoring were 0.784, 0.791, 0.808, and 0.976, respectively. Conclusion IFX trough concentration, ATI levels, and FC are closely associated with disease activity in CD patients. Combined monitoring of these three parameters can significantly improve the predictive efficacy for CD activity.

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