乌司奴单克隆抗体治疗克罗恩病的疗效及安全性分析  

Analysis on efficacy and safety of ustekinumab in Crohn′s disease patients

作　　者：陆君涛 徐锡涛[1] 王天蓉[1] 俞文梅 冯琦[3] 严赟琦[3] 朱明明[1] 冉志华[1] 童锦禄[1] Lu Juntao;Xu Xitao;Wang Tianrong;Yu Wenmei;Feng Qi;Yan Yunqi;Zhu Mingming;Ran Zhihua;Tong Jinlu(Department of Gastroenterology,Shanghai Institute of Digestive Disease,Shanghai Inflammatory Bowel Disease Research Center,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200127,China;Department of Endocrinology,Shanghai Anda Hospital,Shanghai 201204,China;Department of Radiology,Renji Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院消化内科、上海市消化疾病研究所、上海市炎症性肠病研究中心,上海200127 [2]上海安达医院内分泌科,上海201204 [3]上海交通大学医学院附属仁济医院放射科,上海200127

出　　处：《中华炎性肠病杂志（中英文）》2023年第1期37-42,共6页Chinese Journal of Inflammatory Bowel Diseases

基　　金：申康第二轮《促进市级医院临床技能与临床创新三年行动计划》关键支撑项目(SHDC2020CR6020)。

摘　　要：目的分析乌司奴单克隆抗体(UST)治疗克罗恩病(CD)的疗效和安全性。方法采用回顾性队列研究方法,收集2020年5月至2021年9月上海交通大学医学院附属仁济医院采用UST治疗且治疗前结肠镜检查可见活动性病变的CD患者的临床资料。主要分析UST治疗第24/32周的内镜应答率和缓解率。结果共纳入36例基线处于结肠镜下活动期的CD患者,男性25例,女性11例;年龄(29.8±8.7)岁,病程38.0(15.5,66.1)个月。疾病部位:L1型(末端回肠型)4例(11.1%),L2型(结肠型)4例(11.1%),L3型(回结肠型)28例(77.8%),另外累及上消化道4例(11.1%)。患者疾病行为:非狭窄非穿透性28例(77.8%),狭窄性5例(13.9%),穿透性3例(8.3%)。(1)内镜活动性:第24/32周的内镜缓解率及应答率分别为33.3%(12/36)和63.9%(23/36)。UST一线与二线用药的内镜缓解率和应答率差异均无统计学意义(均P>0.05)。(2)临床活动性:36例患者中,基线处于临床活动期16例,临床缓解期20例。16例临床活动期患者第24/32周的临床缓解率和临床应答率分别为81.2%、93.8%。(3)影像学活动性:第24/32周27例患者经影像学评估后发现,3例L1型患者中,影像学应答或部分应答2例,无应答1例;24例L2型患者中,影像学应答5例(20.8%),部分应答19例(79.2%),无应答5例(20.8%)。19例活动性肛瘘患者中,愈合6例,部分应答2例,稳定6例,进展5例。(4)血清学和营养指标:第24/32周患者的体质量指数、血红蛋白及血清白蛋白水平较基线均显著改善(均P<0.05),但C-反应蛋白、红细胞沉降率较基线差异均无统计学意义(均P>0.05)。(5)安全性:未观察到严重不良事件及输液反应,仅2例出现不良反应。结论 UST能够有效改善CD患者内镜表现、临床症状、影像学及营养指标,同时具有较好的安全性。Objective To evaluate the efficacy and safety of ustekinumab(UST)for Crohn′s disease(CD).Methods A retrospective cohort study was conducted to collect clinical data of CD patients with active lesions in colonoscopy before the treatment of UST in Renji Hospital of Shanghai Jiaotong University School of Medicine from May 2020 to September 2021.Primary endpoint was the endoscopic response and remission rates at the 24th/32th week after the treatment of UST.Results A total of 36 CD patients who were endoscopically active at baseline[25 men,11 women;mean age,29.8±8.7 years;disease duration,38.0(15.5,66.1)months]were included.According to Montreal classification,4 patients(11.1%)were L1 type(terminal ileum),4(11.1%)were L2 type(colon),28(77.8%)belonged to L3 type(ileocolon),and upper digestive tract involvement occurred in 4(11.1%).As for disease behavior,28 patients(77.8%)had non-structuring and non-penetrating lesions;5(13.9%)had structuring lesions and 3(8.3%)had penetrating lesions.(1)Endoscopic activity:At the 24th/32th week,the endoscopic remission rate and response rate were 33.3%(12/36)and 63.9%(23/36),respectively.There was no statistically significant difference in endoscopic remission rate and response rate between first-line and second-line usages of UST(all P>0.05).(2)Clinical activity:Among the 36 patients,16 were in the clinical active phase,and 20 patients were in the clinical remission phase at baseline.The clinical remission rate and clinical response rate of 16 clinical active patients at the 24th/32th week were 81.2%and 93.8%respectively.(3)Radiological activity:Twenty-seven patients completed the radiological evaluation at the 24th/32th week.In 3 patients with L1 lesions,2 achieved response or partial response and no response in 1.In 24 patients with L3 lesions,radiological response occurred in 5 patients(20.8%),partial response in 19(79.2%),and no response in 5(20.8%).In 19 patients with active perianal fistula at baseline,6 achieved healing fistule at the 24th/32th week,2 had partial response,

关 键 词：乌司奴单克隆抗体 克罗恩病 疗效 安全性 

分 类 号：R574.62[医药卫生—消化系统]