维得利珠单克隆抗体治疗中重度溃疡性结肠炎的长期疗效及安全性的单中心回顾性观察研究

Long-term efficacy and safety analysis of vedolizumab in the treatment of moderate to severe ulcerative colitis:a single-center retrospective observational study

目的评估维得利珠单克隆抗体(VDZ)治疗中重度溃疡性结肠炎(UC)患者的长期疗效及安全性。方法回顾性收集2021年2月至2023年4月于西安交通大学第二附属医院消化内科就诊并使用VDZ治疗超过52周的中重度活动期UC患者的临床资料。观察指标为治疗52周后的临床应答率、临床缓解率、内镜黏膜愈合率和不良反应事件。结果纳入中重度UC患者21例,其中中度17例,重度4例,男性17例,女性4例,年龄为(44.2±14.3)岁,病程为60(36,103)个月。治疗52周时的临床应答率为85.7%(18/21),临床缓解率为76.2%(16/21),内镜黏膜愈合率为71.4%(15/21)。21例患者中,2例(9.5%)出现转氨酶增高,5例(23.8%)出现艰难梭菌感染,1例(4.8%)出现肠道EB病毒感染,无其他不良反应。结论VDZ对中重度活动期UC患者具有较好的长期疗效,且安全性好。

Objective To evaluate the long-term efficacy and safety of vedolizumab(VDZ)in the treatment of patients with moderate to severe ulcerative colitis(UC).Methods Clinical data of patients with moderate to severe active UC receiving VDZ treatment for more than 52 weeks at the Department of Gastroenterology of the Second Affiliated Hospital of Xi′an Jiaotong University from February 2021 to April 2023 were retrospectively collected.The observation indexes were clinical response rate,clinical remission rate,endoscopic mucosal healing rate and adverse events after 52 weeks of treatment.Results A total of 21 patients with moderate to severe UC with complete data were included in this study,including 17 moderate and 4 severe patients with a mean age of(44.2±14.3)years,17 males and 4 females,and a disease duration of 60(36,103)months.The clinical response rate,clinical remission rate,and endoscopic mucosal healing rate at week 52 were 85.7%(18/21),76.2%(16/21)and 71.4%(15/21)respectively.Of the 21 patients,2(9.5%)had increased transaminases,5(23.8%)had clostridium difficile infection and 1(4.8%)had intestinal EBV infection,with no other adverse effects.Conclusion VDZ has favorable long-term efficacy and safety in patients with moderate to severe active UC.