Objective: To analyze the clinical efficacy and its influencing factors of vedolizumab (VDZ) in the treatment of ulcerative colitis (UC). Methods: The patients with moderately-to-severely active UC, who underwent VDZ treatment at the Second Affiliated Hospital of Wenzhou Medical University from November 2020 to November 2023 were retrospectively included. Based on whether 5-aminosalicylic acid (5-ASA) was used in combination with VDZ treatment, the patients were divided into combination group (received combination therapy of VDZ and 5-ASA) and monotherapy group (received monotherapy of VDZ). The clinical response rate and biological remission rate were analyzed at week 14. The clinical remission rate and mucosal healing rate were analyzed at week 38. The differences in efficacy of VDZ between the two groups were compared at week 14 and week 38, respectively. Multivariate logistic regression model was applied to analyze the influencing factors of clinical remission rate and mucosal healing rate in UC patients. Results: A total of 137 patients were included, including 74 males and 63 females, aged 18-76 (44±14) years old; Seventy-six cases in combination group and 61 cases in monotherapy group. At week 14 of VDZ treatment, the clinical response rate and biological remission rate were 79.6% (109/137) and 80.5% (33/41), respectively. At week 38, the clinical remission rate and mucosal healing rate were 78.8% (108/137) and 47.9% (57/119), respectively. There was no significant difference in clinical response rate and biological remission rate between combination group and monotherapy group at week 14 (both P>0.05). The clinical remission rate [85.5% (65/76) vs 70.5% (43/61), P=0.032] and mucosal healing rate [56.5% (39/69) vs 36.0% (18/50), P=0.027] were higher in combination group than those in monotherapy group at week 38. Multivariate logistic regression analysis showed that the combination therapy of VDZ and 5-ASA (OR=2.48, 95%CI: 1.02-6.03) and the clinical response at week 14 (OR=5.05, 95%CI: 1.98-12.85) were influencing factors of clinical remission rate of UC patients at week 38. Moreover, the baseline serum albumin (Alb) level ≥42.5 g/L was the influencing factor for the mucosal healing rate of UC patients at week 38 (OR=4.60, 95%CI: 2.06-10.24). Conclusions: VDZ is effective in treating UC patients. Both the combination of 5-ASA and the clinical response at week 14 are the influencing factors of the clinical remission rate at week 38. In addition, the baseline serum Alb level ≥42.5 g/L is the influencing factor of the mucosal healing rate at week 38.
目的： 分析维得利珠单抗（VDZ）治疗溃疡性结肠炎（UC）的疗效及其影响因素。 方法： 回顾性纳入2020年11月至2023年11月于温州医科大学附属第二医院接受VDZ治疗的中、重度活动期UC患者。根据VDZ治疗期间是否联用5-氨基水杨酸（5-ASA），将UC患者分为联合组（联用VDZ和5-ASA）和单药组（单用VDZ）。VDZ治疗第14周时，分析UC患者的临床应答率和生物学缓解率；第38周时，分析UC患者的临床缓解率和黏膜愈合率。分别于第14周和第38周比较2组间VDZ临床疗效的差异。采用多因素logistic回归模型分析UC患者第38周临床缓解率和黏膜愈合率的影响因素。 结果： 共纳入137例患者，男74例，女63例，年龄为18~76（44±14）岁；联合组76例，单药组61例。VDZ治疗第14周时临床应答率为79.6%（109/137），生物学缓解率为80.5%（33/41）。第38周时临床缓解率为78.8%（108/137），黏膜愈合率为47.9%（57/119）。第14周时2组间临床应答率和生物学缓解率的差异均无统计学意义（均P>0.05）；第38周时联合组的临床缓解率［85.5%（65/76）比70.5%（43/61），P=0.032］和黏膜愈合率［56.5%（39/69）比36.0%（18/50），P=0.027］均高于单药组。多因素logistic回归模型分析显示，联用5-ASA（OR=2.48，95%CI：1.02~6.03）和第14周时获得临床应答（OR=5.05，95%CI：1.98~12.85）均是UC患者第38周临床缓解率的影响因素；基线血清白蛋白水平≥42.5 g/L是UC患者第38周黏膜愈合率的影响因素（OR=4.60，95%CI：2.06~10.24）。 结论： VDZ治疗UC患者的疗效较好；联用5-ASA和第14周时获得临床应答均是第38周临床缓解率的影响因素，基线白蛋白水平≥42.5 g/L是第38周黏膜愈合率的影响因素。.