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阿达木单抗治疗中重度克罗恩病的疗效和安全性分析

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目的 评估阿达木单抗(ADA)治疗中重度克罗恩病(CD)的疗效及安全性,并探讨英夫利西单抗(IFX)治疗失败转ADA二线治疗的有效性.方法 回顾性分析2019年1月至2022年12月80例确诊为中重度CD患者的临床资料,随机分为对照组和观察组各40例,对照组予维得利珠单抗治疗,观察组予ADA治疗并随访52周.比较两组患者治疗第12、26、52周的疾病活动改善情况和整体不良事件情况,同时评估一线治疗组和IFX治疗失败的二线治疗组在第4、12、26、52周的疗效差异.结果 两组患者第12、26、52周的临床应答率及第12周的缓解率比较,差异有统计学意义(P<0.05).观察组第4、12、26、52周的炎症性肠病问卷(IBD-Q)评分与治疗前比较,差异有统计学意义(P<0.05).21例ADA一线治疗患者和19例IFX治疗失败ADA二线治疗患者CRP、ESR、CDIA、IBD-Q、临床应答率、临床缓解率、内镜应答率、内镜缓解率及黏膜愈合率比较,差异无统计学意义(P>0.05).结论 ADA单抗治疗中重度CD患者疗效显著,同时ADA也可推荐作为IFX治疗失败的二线生物制剂治疗.
Objective To evaluate the efficacy and safety of adalimumab (ADA) in the treatment of moderate to severe Crohn's disease (CD),and to explore the efficacy of switching to ADA as second-line treatment after failure of infliximab (IFX). Methods The clinical data of 80 patients with moderate to severe CD diagnosed from January 2019 to December 2022 were retrospectively analyzed. They were randomly divided into the control group and the observation group,with 40 cases in each group. The improvement of disease activity and overall adverse events were compared between the two groups at 12,26,and 52 weeks of treatment,and the differences in efficacy between the first-line treatment group and the second-line treatment group after IFX treatment failure were evaluated at 4,12,26,and 52 weeks. Results There were significant differences in clinical response rate at 12,26,52 weeks and remission rate at 12 weeks between the two groups (P<0.05). The scores of inflammatory bowel disease questionnaire (IBD-Q) in the observation group at 4,12,26 and 52 weeks were significantly different from those before treatment (P<0.05). There were no significant differences in C-reactive protein (CRP),erythrocyte sedimentation rate (ESR),Crohn's disease activity index (CDIA),IBD-Q,clinical response rate,clinical remission rate,endoscopic response rate,endoscopic remission rate and mucosal healing rate between 21 patients with first-line ADA treatment and 19 patients with ADA who failed IFX treatment as second-line treatment (P>0.05). Conclusion ADA monoclonal antibody is effective in the treatment of moderate to severe CD patients,and ADA can also be recommended as a second-line biological agent for IFX.

Crohn's diseaseAdalimumabEfficacySafetyQuality of life

吴巧艳、钟静静、丁小云、邵利红、姚雪洁、蒋琦

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315000 宁波大学附属第一医院

克罗恩病 阿达木单抗 疗效 安全性 生活质量

2024

浙江临床医学
浙江中医药大学 浙江省科普作家协会医学卫生委员会

浙江临床医学

影响因子:0.52
ISSN:1008-7664
年,卷(期):2024.26(11)