实炎方联合英夫利西单抗对中度活动期克罗恩病患者肠道屏障功能的影响

Inflammatory-modulating herbal formula combined with infliximab for improving intestinal barrier function in patients with moderately active Crohn's disease

摘要:

目的 探讨实炎方联合英夫利西单抗对中度活动期克罗恩病（CD）患者肠道屏障功能的影响。方法 选取2020年1月—2025年1月在上海中医药大学附属曙光医院确诊的84例中度活动期CD患者，根据随机数字表法分为对照组（英夫利西单抗治疗）和观察组（在对照组基础上联合实炎方治疗），每组42例。比较两组患者的临床疗效、疾病评分、肠道屏障指标、肠道菌群、炎症水平、不良反应及随访结果。结果 观察组总有效率高于对照组（P <0.05）。观察组治疗前后克罗恩病活动指数（CDAI）、克罗恩病内镜下严重程度指数评分的差值均大于对照组（P <0.05）。观察组治疗前后闭锁蛋白、紧密连接蛋白-1的差值均大于对照组（P <0.05）。观察组治疗前后双歧杆菌、乳酸杆菌、肠球菌和肠杆菌的差值均大于对照组（P <0.05）。观察组治疗前后肿瘤坏死因子α、高敏C反应蛋白、白细胞介素-6的差值均大于对照组（P <0.05）。观察组与对照组不良反应总发生率比较，差异无统计学意义（P >0.05）。观察组CDAI维持缓解率高于对照组（P <0.05）；观察组与对照组复发率比较，差异无统计学意义（P >0.05）。结论 实炎方联合英夫利西单抗能显著改善中度活动期CD患者的肠道屏障功能，调节肠道菌群及控制炎症，疗效确切且安全性良好。

Abstract:

Objective To investigate the effects of Shiyan Formula combined with infliximab on intestinal barrier function in patients with moderately active Crohn's disease (CD).Methods A total of 84 patients with moderately active CD diagnosed at Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital between January 2020 and January 2025 were selected. Using a random number table, they were divided into a control group (treated with infliximab) and an observation group (treated with infliximab plus Shiyan Formula), with 42 patients in each group. Clinical efficacy, disease scores, intestinal barrier parameters, gut microbiota, inflammation levels, adverse reactions, and follow-up outcomes were compared between the two groups.Results The overall response rate was higher in the observation group than in the control group (P < 0.05). The changes in Crohn's disease activity index (CDAI) and Crohn's disease endoscopic severity index scores before and after treatment were greater in the observation group than in the control group (P < 0.05). The changes in occludin and tight junction protein-1 levels before and after treatment were greater in the observation group than in the control group (P < 0.05). The differences in Bifidobacteria, Lactobacilli, Enterococci and Enterobacteriaceae levels before and after treatment in the observation group were all greater than those in the control group (P < 0.05). The differences in tumor necrosis factor-α, high-sensitivity C-reactive protein and interleukin-6 levels before and after treatment in the observation group were all greater than those in the control group (P < 0.05). There was no statistically significant difference in the overall incidence of adverse reactions between the observation group and the control group (P > 0.05). The CDAI sustained remission rate in the observation group was higher than that in the control group (P < 0.05); there was no statistically significant difference in recurrence rates between the observation group and the control group (P > 0.05).Conclusion The combination of Shiyan Formula and infliximab can significantly improve intestinal barrier function, regulate the gut microbiota and control inflammation in patients with moderately active CD, with good efficacy and safety.