目的 探讨维得利珠单抗联合沙利度胺治疗重度溃疡性结肠炎的临床疗效。方法 选取2022年1月—2024年1月华北医疗健康集团邢台总医院和沧州市中心医院收治的86例重度溃疡性结肠炎患者，按随机数字表法分为对照组和治疗组，每组各43例。对照组睡前顿服沙利度胺片，初始剂量50 mg/d，根据患者耐受性每周递增25 mg，直至100 mg/d维持。在对照组基础上，治疗组静脉滴注注射用维得利珠单抗，300 mg/次，加入250 mL生理盐水，持续滴注≥30 min，给药方案为第0、2、6、14周分别给药1次。两组均治疗14周。比较两组临床疗效，治疗前后主要症状评分、改良的Mayo、Geboes和炎症性肠病问卷（IBDQ）评分及血清可溶性细胞间黏附分子1（sICAM-1）、CXC趋化因子配体9（CXCL9）和粪便中钙卫蛋白（CP）、几丁质酶3样蛋白1（CHI3L1）水平。结果 治疗后，治疗组总有效率为95.35%，明显高于对照组的81.40%（P＜0.05）。治疗后，两组主要症状（腹泻、脓血便、腹痛）评分、改良的Mayo评分、Geboes评分及血清sICAM-1、CXCL9和粪便中CP、CHI3L1水平均显著降低（P＜0.05），且这些指标均以治疗组下降更明显（P＜0.05）。治疗后，两组IBDQ评分均显著增加（P＜0.05），且治疗组IBDQ评分比对照组显著增加（P＜0.05）。结论 应用维得利珠单抗联合沙利度胺治疗重度溃疡性结肠炎，能有效促进患者体内炎症反应和肠道炎症损伤减轻，降低疾病活动度，促使患者症状减轻和生活质量好转，且具有较好的安全性。

Objective To explore the clinical efficacy of vedolizumab combined with thalidomide in treatment of severe ulcerative colitis. Methods A total of 86 patients with severe ulcerative colitis admitted to Xingtai General Hospital of North China Medical and Health Group and Cangzhou Central Hospital from January 2022 to January 2024 were enrolled and divided into control group and treatment group by random number table method, with 43 cases in each group. The control group received oral Thalidomide Tablets taken once before bedtime at an initial dose of 50 mg/d; the dose was increased by 25 mg per week according to the patient’s tolerance until a maintenance dose of 100 mg/d was achieved. On the basis of the control regimen, the treatment group was additionally administered intravenous infusion of Vedolizumab for injection at 300 mg per time, diluted in 250 mL normal saline and infused continuously for no less than 30 minutes. The administration was performed at Weeks 0, 2, 6 and 14, respectively. Both groups received treatment for 14 weeks. The clinical efficacy, main symptom scores, modified Mayo scores, Geboes scores, Inflammatory Bowel Disease Questionnaire (IBDQ) scores, serum levels of soluble intercellular adhesion molecule‑1 (sICAM‑1) and C‑X‑C motif chemokine ligand 9 (CXCL9), as well as fecal levels of calprotectin (CP) and chitinase‑3‑like protein 1 (CHI3L1) were compared between the two groups before and after treatment. Results After treatment, the total effective rate of the treatment group was 95.35%, which was significantly higher than 81.40% of the control group (P < 0.05). After treatment, the scores of main symptoms (diarrhea, mucopurulent stool, abdominal pain), modified Mayo scores, Geboes scores, serum sICAM‑1 and CXCL9 levels, and fecal CP and CHI3L1 levels in both groups were significantly decreased (P < 0.05), with more prominent reductions observed in the treatment group (P < 0.05). The IBDQ scores of both groups were significantly increased after treatment (P < 0.05), and the increase was markedly greater in the treatment group than in the control group (P < 0.05). Conclusion For patients with severe ulcerative colitis, the combined therapy of vedolizumab and thalidomide can effectively alleviate systemic inflammatory responses and intestinal inflammatory injury, reduce disease activity, relieve clinical symptoms and improve quality of life, with a favorable safety profile.

R975

河北省医学科学研究课题项目（20220386）