维得利珠单抗对活动期溃疡性结肠炎81例疗效和安全性的单中心回顾性研究  

The efficacy and safety of vedolizumab in the treatment of 81 cases of active ulcerative colitis:a single center retrospective study

作　　者：唐健[1] 黄钊鹏 邓钧 黄梓城 刁娜 杨洪生 晁康[1] 高翔[1] Tang Jian;Huang Zhaopeng;Deng Jun;Huang Zicheng;Diao Na;Yang Hongsheng;Chao Kang;Gao Xiang(Department of Gastroenterology,the Sixth Affiliated Hospital of Sun Yat-sen University,Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases,Guangzhou 510655,China)

机构地区：[1]中山大学附属第六医院消化内科,广东省结直肠盆底疾病研究重点实验室,广州510655

出　　处：《中华消化杂志》2023年第2期117-121,共5页Chinese Journal of Digestion

摘　　要：目的评估维得利珠单抗(VDZ)治疗活动期溃疡性结肠炎(UC)的疗效和安全性。方法回顾性选择2020年11月1日至2022年10月30日于中山大学附属第六医院消化内科接受VDZ治疗并完成14周随访的81例UC患者。收集患者的临床资料,包括年龄、病程、UC疾病活动度等。VDZ疗效评价包括主要和次要疗效评价指标,主要疗效评价指标为VDZ治疗14周后临床缓解率,次要疗效评价指标包括治疗14周后临床应答率、无激素缓解率、内镜缓解率,以及治疗52周后临床应答率、临床缓解率、无激素缓解率、继发性失应答率。记录治疗期间的不良反应。以治疗14周后是否达到临床缓解为因变量,采用单因素分析影响VDZ临床缓解的危险因素,二分类logistic回归分析进行多因素分析,明确VDZ诱导临床缓解的独立危险因素。采用卡方检验和Wilcoxon符号秩和检验进行统计学分析。结果81例UC患者中,年龄为40.0岁(29.0岁,53.5岁),病程为42.5个月(22.5个月,94.7个月);轻度活动期患者占21.0%(17/81),中度活动期患者占64.2%(52/81),重度活动期患者占14.8%(12/81)。治疗14周后,梅奥评分总分由基线水平7.0分(6.0分,9.0分)降至1.0分(0.0分,3.0分),差异有统计学意义(Z=-6.87,P<0.001);临床应答率为84.0%(68/81),临床缓解率为69.1%(56/81);合并使用糖皮质激素治疗的17例患者中,10例患者达到无激素缓解;内镜缓解率为34.8%(23/66)。43例患者继续随访至治疗52周,UC患者的梅奥评分总分由基线水平7.0分(6.0分,9.0分)降至0.0分(0.0分,1.0分),差异有统计学意义(Z=-3.25,P<0.001);临床应答率为69.8%(30/43),临床缓解率为65.1%(28/43);合并使用糖皮质激素治疗的13例患者中,10例患者达到无激素缓解;继发性失应答率为15.2%(5/33)。单因素分析结果显示,既往使用糖皮质激素是VDZ治疗14周后临床缓解的危险因素(χ^(2)=5.88,P=0.015)。多因素logistic回归分析显示,既往使用糖皮质激素是VDZ�Objective To evaluate the efficacy and safety of vedolizumab(VDZ)in the treatment of active ulcerative colitis(UC).Methods From November 1,2020 to October 30,2022,at the Department of Gastroenterology,the Sixth Affiliated Hospital of Sun Yat-sen University,81 UC patients who received VDZ treatment and completed a 14-week follow-up were retrospectively selected.The clinical data of patients,including age,disease duration,disease activity of UC were collected.The VDZ efficacy evaluation included primary and secondary efficacy indicators.The primary efficacy indicator was the clinical remission rate after 14 weeks of VDZ treatment,and the secondary efficacy indicators included the clinical response rate,steroids-free remission rate,endoscopic remission rate after 14 weeks of treatment as well as the clinical response rate,clinical remission rate,steroids-free remission rate,secondary loss of response rate after 52 weeks of treatment.The adverse reactions during the treatment were recored.Taking clinical remission after 14 weeks of treatment as the dependent variable,univariate analysis was performed to identify the risk factors affecting clinical remission of VDZ.Binary logistic regression analysis was used for multivariate analysis to determine the independent risk factors of VDZ-included clinical remission.Chi-square test and Wilcoxon signed-rank test were used for statistical analysis.Results Among the 81 UC patients,the age was 40.0 years old(29.0 years old,53.5 years old)and the disease duration was 42.5 months(22.5 months,94.7 months).The proportion of patients with mild active UC was 21.0%(17/81),the proportion of patients with moderate active UC was 64.2%(52/81),and the proportion of patients with severe active UC was 14.8%(12/81).After 14 weeks of treatment,the total Mayo score decreased from baseline level of 7.0(6.0,9.0)to 1.0(0.0,3.0),and the difference was statistically significant(Z=-6.87,P<0.001).The clinical response rate was 84.0%(68/81)and the clinical remission rate was 69.1%(56/81)after 14 weeks

关 键 词：结肠炎 溃疡性 维得利珠单抗 疗效 安全性 

分 类 号：R574.62[医药卫生—消化系统]