维得利珠单克隆抗体维持治疗溃疡性结肠炎疗效及安全性的真实世界研究

Real-world study on the efficacy and safety of vedolizumab in the maintenance treatment of ulcerative colitis

目的评估维得利珠单克隆抗体(VDZ)维持治疗溃疡性结肠炎(UC)的疗效和安全性。方法采用回顾性病例对照研究方法。纳入2020年12月至2023年9月在浙江大学医学院附属第二医院消化内科完成VDZ(22±8)周治疗达到应答或缓解,并继续随访至(54±8)周的84例UC患者,根据使用VDZ随访至(54±8)周是否达到临床缓解分为有效组和无效组,VDZ缩短注射间隔的优化治疗者归入无效组。记录患者基线临床资料、用药史和内镜影像学资料等,利用临床改良Mayo评分、Mayo内镜评分等评估UC疾病活动度,同时记录药物相关不良反应,评估VDZ治疗达(54±8)周的疗效,分析影响患者临床缓解的因素。结果纳入随访至(54±8)周的84例UC患者,其中47例(55.95%)达到临床缓解为有效组,37例(44.05%)患者未达到临床缓解为无效组。有效组内镜缓解率为68.09%(32/47),黏膜愈合率是36.17%(17/47)。总体上,2.38%患者出现关节痛,3.57%患者出现肝功能不全,1例患者在维持治疗期间感染新冠肺炎后并发白血病死亡。结论VDZ在持续治疗UC患者并维持临床和内镜缓解方面具有一定疗效,总体安全性高,不良反应发生率低。

Objective To evaluate the efficacy and safety of vedolizumab(VDZ)monoclonal antibody in maintenance therapy for ulcerative colitis(UC).Methods A retrospective case control study was conducted,including 84 patients with active UC undergoing VDZ therapy for an average of(22±8)weeks in the Department of Gastroenterology,the Second Affiliated Hospital of Zhejiang University School of Medicine from December 2020 to September 2023.These patients achieved a response or remission by(22±8)weeks and continued follow-up until(54±8)weeks.They were divided into effective and ineffective groups based on whether they achieved clinical remission by(54±8)weeks after using VDZ;those who required optimized treatment with shortened injection intervals were included in the ineffective group.Baseline clinical data,medication history and endoscopic imaging data were recorded.The clinically modified Mayo score,Mayo endoscopic score,and other assessments were used to evaluate UC disease activity.Adverse reactions related to treatment were also recorded to assess the efficacy of VDZ treatment up to(54±8)weeks was assessed and key factors affecting clinical remission of the disease were analyzed.Results Among the 84 UC patients with followed up to(54±8)weeks,47 cases(55.95%)achieved clinical remission and were classified as the effective group,while 37 cases(44.05%)did not achieve clinical remission and were classified as the ineffective group.The endoscopic remission rate in the effective group was 68.09%(32/47),and the mucosal healing rate was 36.17%(17/47).Joint pain occurred in 2.38%of patients,hepatic dysfunction in 3.57%,and one patient died from leukemia following a COVID-19 infection during the maintenance therapy period.Conclusion VDZ has a certain efficacy in the continuous treatment of UC patients and in maintaining clinical and endoscopic remission,with generally high overall safety and a low incidence of adverse reactions.