目的 探究五味苦参肠溶胶囊联合英夫利西单抗治疗中重度溃疡性结肠炎（UC）的疗效。方法 选自2022年6月—2024年6月湖南中医药大学第二附属医院收治的中重度UC患者90例，依据组间匹配原则分为对照组和治疗组，每组各45例。对照组给予注射用英夫利西单抗，分别于0、2、6、8周注射1次，剂量为3～5 mg/kg。治疗组在对照组基础上口服五味苦参肠溶胶囊，1.6 g/次，3次/d。两组患者均治疗8周。观察两组患者临床疗效，比较治疗前后两组患者超敏C反应蛋白（hs-CRP）、肿瘤坏死因子-α（TNF-α）、血管细胞黏附分子-1（VCAM-1）、白细胞介素-10（IL-10）、CD3⁺、CD4⁺、CD8⁺、二胺氧化酶（DAO）、内毒素（ET）和D-乳酸水平（D-LA）水平，及Mayo评分。结果 治疗后，治疗组总有效率明显高于对照组（95.56% vs 75.56%，P＜0.05）。治疗后，两组hs-CRP、TNF-α、VCAM-1、CD8⁺、DAO、ET和D-LA水平明显下降，而IL-10、CD3⁺和CD4⁺水平明显升高（P＜0.05），且治疗后治疗组炎症因子水平、免疫功能和肠道屏障功能均好于对照组（P＜0.05）。治疗后，两组患者Mayo评分比治疗前明显下降（P＜0.05），且治疗后治疗组Mayo评分下降幅度均大于对照组（P＜0.05）。结论 UC患者在常规干预基础上联合五味苦参肠溶胶囊与英夫利西单抗治疗，可显著提高治疗效果、改善机体炎症与免疫功能，增强肠道屏障，促进临床症状恢复。

Objective To explore the curative effect of Wuwei Kushen Enteric-Coated Capsules combined with infliximab in treatment of moderate and severe ulcerative colitis. Methods Patients (90 cases) with moderate and severe ulcerative colitis in the Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine from June 2022 to June 2024 were divided into control and treatment group based on the principle of inter-group matching, and each group had 45 cases. Patients in the control group were administered with Infliximab for injection, which were injected once at weeks 0, 2, 6 and 8 with a dose of 3 — 5 mg/kg. Patients in the treatment group were po administered with Wuwei Kushen Enteric-Coated Capsules on the basis of the control group, 1.6 g/time, three times daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical evaluations were evaluated, and the levels of hs-CRP, TNF-α, VCAM-1, IL-10, CD3⁺, CD4⁺, CD8⁺, DAO, ET and D-LA, and Mayo scores in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was significantly higher than that in the control group (95.56% vs 75.56%, P < 0.05). After treatment, the expression levels of hs-CRP, TNF-α, VCAM-1, CD8⁺, DAO, ET and D-LA were significantly decreased in two groups, while the levels of IL-10, CD3⁺ and CD4⁺ were significantly increased (P < 0.05). After treatment, the levels of inflammatory factors, immune function and intestinal barrier function in the treatment group were better than those in the control group (P < 0.05). After treatment, the Mayo scores in two groups were significantly decreased compared with those before treatment (P < 0.05), and the decrease in the treatment group was more significant than that in the control group (P < 0.05). Conclusion On the basis of routine intervention, the combination of Wuwei Kushen Enteric-Coated Capsules and infliximab can significantly improve the therapeutic effect, improve the inflammation and immune function, strengthen the intestinal barrier, and promote the recovery of clinical symptoms.

R975

湖南省中医药管理局科学基金资助项目（B2023095）；湖南省中医药管理局科学基金资助项目（C2024017）