文章摘要

维得利珠单抗治疗炎症性肠病的短期疗效与安全性：单中心真实世界研究

作者: 1姚嘉茵, 1彭翔, 1刘涛, 1赵俊章, 1张敏, 1胡品津, 1郅敏
1 中山大学附属第六医院消化内科，广州 510655
通讯: 郅敏 Email: zhimin@mail.sysu.edu.cn
DOI: 10.3978/j.issn.2095-6959.2022.08.009
基金: 国家自然科学基金(81900490，81670477)。

摘要

目的：明确维得利珠单抗(vedolizumab，VDZ)在炎症性肠病(inflammatory bowel disease，IBD)患者中应用的短期疗效与安全性分析。方法：回顾性收集2020年11月1日至2021年10月31日在中山大学附属第六医院使用VDZ治疗的IBD患者，记录人口基线资料。使用克罗恩病活动指数评分(Crohn’s Disease Activity Index，CDAI)评估克罗恩病(Crohn’s disease，CD)严重程度，克罗恩病简化内镜评分(Simple Endoscopic Score for Crohn’s Disease，SES-CD)评估CD内镜严重程度。使用改良Mayo评分评估溃疡性结肠炎(ulcerative colitis，UC)活动度，Mayo内镜评分评估UC内镜病变程度。同时记录VDZ治疗的不良反应。结果：CD患者39例，年龄(30.3±9.8)岁，男性占66.7%，病程(80.1±57.7)个月。VDZ治疗22周患者的C反应蛋白(C-reaction protein，CRP)[(12.8±10.0) mg/L vs (10.5±4.7) mg/L，P=0.03]及红细胞沉降率(erythrocyte sedimentation rate，ESR)[(18.1±12.0) mm/h vs (13.0±3.8) mm/h，P<0.01]较基线值显著下降，血红蛋白(hemoglobin，HGb)[(129.6±20.8) g/L vs (122.3±23.4) g/L，P<0.01]及体重指数(body mass index，BMI)[(20.2±3.3) kg/m2 vs (19.5±3.3) kg/m2，P<0.01]较基线值显著升高。临床缓解率71.4%，临床应答率87.2%，内镜缓解率29.4%，内镜应答率76.5%。UC患者13例，年龄(40.6±18.1)岁，男性占46.2%，病程(101.8±105.2)个月。VDZ治疗22周患者红细胞沉降率[(12.2±12.3) vs (28.8±26.4) mm/h，P<0.05]较基线值显著下降，血红蛋白[(118.2±16.5) vs (107.4±19.1) g/L，P<0.05]较基线值显著升高。临床缓解率53.9%，临床应答率76.9%，内镜缓解率与内镜应答率均为57.1%。VDZ不良反应率仅为0.02%(1/56)。结论：VDZ短期应用能有效诱导及维持IBD疾病缓解，不良反应率低，安全性高。
关键词： 维得利珠；克罗恩病；溃疡性结肠炎；内镜缓解

Short-term efficacy and safety of vedolizumab in the treatment of inflammatory bowel disease: A single-center real-world study

Authors: 1YAO Jiayin, 1PENG Xiang, 1LIU Tao, 1ZHAO Junzhang, 1ZHANG Min, 1HU Pinjin, 1ZHI Min
1 Department of Gastroenterology, Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou 510655, China

CorrespondingAuthor: ZHI Min Email: zhimin@mail.sysu.edu.cn

DOI: 10.3978/j.issn.2095-6959.2022.08.009

Foundation: This work was supported by the National Natural Science Foundation of China (81900490, 81670477).

Abstract

Objective: To figure out the short-term efficacy and safety of vedolizumab (VDZ) in the treatment of patients with inflammatory bowel disease (IBD). Methods: The clinical data of patients with IBD who received VDZ treatment in the Sixth Affiliated Hospital of Sun Yat-sen University from November 1st, 2020 to October 31st, 2021 were retrospectively studied, and their baseline data were collected. Crohn’s Disease Activity Index (CDAI) and Simple Endoscopic Score for Crohn’s Disease (SES-CD) were used to evaluate clinical and endoscopic severity in patients with Crohn’s disease (CD) while modified Mayo and Mayo endoscopic scores were used to evaluate clinical and endoscopic severity in patients with ulcerative colitis (UC), respectively. Meanwhile, the adverse effects of VDZ treatment were recorded. Results: A total of 39 patients with CD were included, 66.7% of which were male, with an age of (30.3±9.8) years and a disease duration of (80.1±57.7) months. C-reactive protein (CRP) [(12.8±10.0) mg/L vs (10.5±4.7) mg/L, P=0.03] and erythrocyte sedimentation rate (ESR) [(18.1±12.0) mm/h vs (13.0±3.8) mm/h, P<0.01) decreased while hemoglobin (HGb) [(129.6±20.8) g/L vs (122.3±23.4) g/L, P<0.01] and BMI [(20.2±3.3) kg/m2 vs (19.5±3.3) kg/m2, P<0.01] increased at week 22 after VDZ initiation. Clinical remission, clinical response, endoscopic remission, and endoscopic response rates for patients with CD were 71.4%, 87.2%, 29.4%, and 76.5%, respectively. A total of 13 patients with UC were included, 46.2% of which were male, with an age of (40.6±18.1) years and a disease duration of (101.8±105.2) months. ESR [(12.2±12.3) mm/h vs (28.8±26.4) mm/h, P<0.05) decreased while HGb [(118.2±16.5) g/L vs (107.4±19.1) g/L, P<0.05] increased at week 22 after VDZ initiation. Clinical remission, clinical response, endoscopic remission, and endoscopic response rates for patients with UC were 53.9%, 76.9%, 57.1%, and 57.1%, respectively. Adverse effect rate of VDZ treatment was 0.02% (1/56). Conclusion: VDZ can effectively induce and safely maintain remission of IBD. 

Keywords： vedolizumab; Crohn’s disease; ulcerative colitis; endoscopic remission

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