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中国临床药理学与治疗学 ›› 2025, Vol. 30 ›› Issue (5): 640-647.doi: 10.12092/j.issn.1009-2501.2025.04.007

• 药物治疗学 • 上一篇    下一篇

英夫利昔单抗对肛周瘘管克罗恩病疗效及安全性的真实世界研究

吴健1,方笑丽2,李明2,陈浩1,高家荣1   

  1. 1安徽中医药大学第一附属医院药学部,合肥  230031,安徽;2安徽中医药大学第一附属医院肛肠科,合肥  230031,安徽


  • 收稿日期:2024-01-08 修回日期:2024-05-23 出版日期:2025-05-26 发布日期:2025-05-13
  • 通讯作者: 高家荣,男,主任药师,博士生导师,研究方向:临床药学与药事管理。 E-mail: zyfygjr2006@163.com
  • 作者简介:吴健,男,副主任药师,主要从事临床药学工作。 E-mail: wujian7997@163.com
  • 基金资助:
    安徽省青年领军后备人才支持项目(安徽省卫健委,中发展[2022]4号);安徽省十四五省级中医优势特色专科项目(皖中医药服务秘[2021]71号)

Real-world study of the efficacy and safety of infliximab in the treatment of Crohn's disease with perianal fistula

WU Jian1, FANG Xiaoli2, LI Ming2, CHEN Hao1, GAO Jiarong1   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui, China; 2Department of Anus and Intestine Surgery, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui, China
  • Received:2024-01-08 Revised:2024-05-23 Online:2025-05-26 Published:2025-05-13

摘要:

目的:评估英夫利昔单抗(IFX)对肛周瘘管克罗恩病(PFCD)长期维持治疗的疗效及安全性。方法:回顾性收集2020年11月至2023年10月本院肛肠科收治的使用IFX治疗的PFCD患者共24例的病例资料,通过观察用药54周的临床资料对临床有效性和安全性进行评估,计算患者瘘管缓解率、临床缓解率、内镜缓解率;统计患者用药前后实验室指标变化情况;Logistic回归分析瘘管缓解的相关因素;记录IFX治疗期间出现的所有不良反应。结果:使用IFX治疗54周后,患者瘘管缓解率、临床缓解率、内镜缓解率分别为37.5%、45.83%、33.33%;用药14周瘘管有应答反应(OR=19.419,95%Cl:1.267~297.559,P=0.033)是瘘管在用药54周实现缓解的预测因素;炎症指标和营养指标与用药前相比显著改善(P<0.01);肛周疾病活动指数(PDAI)、Best克罗恩病活动指数计算法(CDAI)、克罗恩病简化内镜评分(SES-CD)与用药前相比差异有统计学意义(P<0.01);5例(20.83%)患者出现不良反应,给予对症处理后症状消失或好转,无患者出现严重不良反应。结论:IFX能够有效地促进PFCD瘘管的闭合,改善肠黏膜慢性炎症反应,缓解临床症状,改善患者的生活质量,IFX对于PFCD维持治疗的有效性和安全性良好。

关键词: 肛周瘘管克罗恩病, 英夫利昔单抗, 疗效评价

Abstract:

AIM: To evaluate the efficacy of infliximab in the maintenance of Perianal fstulizing Crohn's disease. METHODS: The clinical data of 24 patients with perianal fistula Crohn's disease (PFCD) treated with infliximab (IFX) in the Department of Anorectal Surgery of our hospital from November 2020 to October 2023 were retrospectively collected. The clinical efficacy and safety were evaluated by observing the clinical characteristics for 54 weeks. The fistula remission rate, clinical remission rate, and endoscopic remission rate of patients were calculated. The changes of laboratory indexes before and after treatment were recorded. Logistic regression was used to analyze the related factors of fistula remission. All adverse reactions occurred during IFX treatment were recorded. RESULTS: After 54 weeks of IFX treatment, the fistula remission rate, clinical remission rate, and endoscopic remission rate were 37.5%, 45.83%, and 33.33%, respectively. Fistula response at 14 weeks of treatment (OR=19.419, 95%Cl: 1.267-297.559, P=0.033) was predictive factors for fistula remission at 54 weeks of treatment. The inflammatory indexes and nutritional indexes were significantly improved compared with those before treatment (P<0.01). The scores of PDAI, CDAI and SES-CD were significantly different from those before treatment (P<0.01). Five patients (20.83%) had adverse reactions, and the symptoms disappeared or improved after symptomatic treatment, and no patient had serious adverse reactions. CONCLUSION: IFX can effectively promote the closure of PFCD fistula, improve the chronic inflammatory reaction of intestinal mucosa, alleviate clinical symptoms, and improve the quality of life of patients. IFX is effective and safe for PFCD maintenance treatment.

Key words: perianal fstulizing Crohn's disease, infliximab, clinical efficacy evaluation

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