摘要
目的:评估乌司奴单克隆抗体(UST)优化治疗克罗恩病(CD)的短期临床疗效及安全性,并分析UST优化治疗的影响因素。方法:回顾性收集2021年12月—2022年7月于南京大学医学院附属鼓楼医院消化科首次接受UST治疗的CD患者的临床资料,观察疾病活动度、炎症反应指标及CD相关再住院情况,记录治疗期间所有可能与药物相关的不良反应以评估药物安全性。将所有予UST重新静脉诱导、缩短给药间期或增加药物剂量的患者分为优化组,其余为未优化组,比较两组间临床资料的差异,探究影响UST优化治疗的相关因素。结果:共纳入87例CD患者,活动期患者25例(28.7%),基线CD活动指数评分(CDAI)为105.38(76.63,154.81)分,51.7%的患者至少经历过一种生物制剂治疗失败。29例患者因监测血药浓度偏低、内镜下活动性溃疡、临床症状控制不佳、炎症反应指标高进行UST优化治疗,纳入优化组,其余58例纳入未优化组。中位随访28周,活动期患者的临床应答及缓解率分别为76.0%、68.0%,优化组和未优化组的药物持续使用率分别为96.6%、98.3%。治疗(23±2)周后,两组患者的血沉比较差异有统计学意义(Z=-2.571,P=0.010)。优化组的CD相关住院率为13.8%,未优化组为1.7%,两组差异有统计学意义(χ^(2)=5.199,P=0.040)。多因素logistic回归分析显示,狭窄型病变(B2比B1:OR=5.919,95%CI:1.036~33.832,P=0.046)、治疗第(23±2)周血沉(OR=1.124,95%CI:1.020~1.238,P=0.018)是UST优化治疗的独立影响因素。治疗期间有16例(18.4%)患者出现不良反应,所有患者均继续使用UST。结论:UST对于传统治疗或抗肿瘤坏死因子-α单克隆抗体治疗失败的CD患者仍有良好的诱导缓解作用,优化治疗可帮助部分患者再次获得临床应答,且狭窄型病变、治疗第(23±2)周血沉是影响UST优化治疗的独立因素。
Objective:To evaluate the short-term efficacy and safety of ustekinumab(UST)dose escalation in patients with Crohn's disease(CD),and analyze the influence factors of UST dose escalation.Methods:Patients who were diagnosed as CD and treated with UST in Nanjing Drum Tower Hospital,from December 2021to July 2022were enrolled.Disease activity,inflammatory response indicators and CD-related hospitalization were observed.All possible drug-related adverse events were recorded to evaluate drug safety.Patients who underwent UST reinduction and/or interval shortening to<8weeks and/or increase the dose were divided into optimized group and others were in unoptimized group according to whether required dose intensification or not.The differences in clinical data between two groups were compared to explore related factors that affect UST dose escalation.Results:A total of 87patients with CD were included,of which 25patients(29.1%)were active CD.Baseline CD active index(CDAI)was 105.38(76.63,154.81)scores,51.7%had experienced at least one failure of biologic therapy.Twenty-nine received UST dose escalation due to low blood drug concentration,endoscopic active ulcers,poor clinical symptom,high inflammatory response index.After a median follow-up of 28weeks,76.0%active CD patients achieved clinical response,68.0%achieved clinical remission.The UST retention rate of optimized group and unoptimized group were 96.6%and 98.3%.At(23±2)weeks,CRP was 3.6(2.3,5.9)mg/L,ESR 7.5(3.8,21.3)mm/1h.The difference of ESR after UST therapy between two groups was statistically significant(Z=-2.571,P=0.010).The rates of CD-related hospitalization in both groups were 13.8%and 1.7%,and the difference was statistically significant(χ^(2)=5.199,P=0.040).The multivariate logistic regression analysis showed that montreal B2(B2vs B1:OR=5.919,95%CI:1.036-33.832,P=0.046)and ESR at(23±2)weeks(OR=1.124,95%CI:1.020-1.238,P=0.018)were independent influence factors of UST dose escalation.Adverse events were reported in 16(18.4%)of 87patients,but all patients c
作者
吴松婷
朱丹丹
张平楠
李娜
王雷
张晓琦
于成功
WU Songting;ZHU Dandan;ZHANG Pingnan;LI Na;WANG Lei;ZHANG Xiaoqi;YU Chenggong(Department of Gastroenterology,Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School,Nanjing,210008,China)
出处
《中国中西医结合消化杂志》
CAS
2023年第3期173-178,共6页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
