天津医药

天津医药 ›› 2026, Vol. 54 ›› Issue (2): 206-210.doi: 10.11958/20251483

• 药物临床观察 • 上一篇    下一篇

英夫利西单抗和乌司奴单抗治疗中重度克罗恩病的长期疗效和安全性比较

林萍(), 王伟, 杨勇, 刘萍()   

  1. 芜湖市第一人民医院消化内科（邮编241000）
  • 收稿日期:2025-04-13 修回日期:2025-07-23 出版日期:2026-02-15 发布日期:2026-02-12
  • 通讯作者: 刘萍 E-mail:lin66222023@126.com;981260550@qq.com
  • 作者简介:林萍（1990），女，主治医师，主要从事炎症性肠病的诊治方面研究。E-mail：lin66222023@126.com
  • 基金资助:
    安徽省临床医学研究转化项目(202427B10020111)

Comparison of long-term efficacy and safety of infliximab and ustekinumab in the treatment of moderate-to-severe Crohn's disease

LIN Ping(), WANG Wei, YANG Yong, LIU Ping()   

  1. Department of Gastroenterology, the First People's Hospital of Wuhu City, Wuhu 241000, China
  • Received:2025-04-13 Revised:2025-07-23 Published:2026-02-15 Online:2026-02-12
  • Contact: LIU Ping E-mail:lin66222023@126.com;981260550@qq.com

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摘要：

目的 比较英夫利西单抗（IFX）和乌司奴单抗（UST）治疗中重度克罗恩病（CD）的长期疗效和安全性。方法 选取接受IFX或UST治疗的126例中重度CD患者的临床资料，其中IFX组84例，UST组42例。治疗54周后比较2组患者的临床缓解率、临床反应率、内镜下缓解率、治疗前后克罗恩病活动指数（CDAI）评分、Harvey-Bradshaw指数（HBI）、简化克罗恩病内镜下评分（SES-CD）、实验室指标、炎症性肠病生活质量问卷（IBDQ）评分、慢性病治疗功能评估-疲劳量表（FACIT-F）评分以及不良反应发生率。结果 2组患者在年龄、性别、体质量指数、病程、吸烟史、既往手术史、家族史、病变部位方面差异均无统计学意义（P>0.05）。治疗54周后，IFX组和UST组的临床缓解率分别为73.8%和59.5%，临床反应率分别为89.3%和83.3%，内镜下缓解率分别为57.1%和47.6%，差异均无统计学意义（P>0.05）。2组患者治疗后的CDAI评分、HBI指数和SES-CD评分均较治疗前下降（P<0.05），但2组间差异无统计学意义。2组患者治疗后C反应蛋白和粪钙卫蛋白水平较治疗前下降，白蛋白、血红蛋白较治疗前升高（P<0.05）。2组患者治疗后的IBDQ评分和FACIT-F评分差异无统计学意义，不良反应发生率相似（P>0.05）。结论 IFX和UST均能有效改善中重度CD患者的临床症状和内镜下炎症，安全性良好，且均能改善患者的生活质量。

关键词: 克罗恩病, 英夫利西单抗, 乌司奴单抗, 疗效, 安全性

Abstract:

Objective To compare the long-term efficacy and safety of infliximab (IFX) and ustekinumab (UST) in the treatment of moderate to severe Crohn's disease (CD). Methods Clinical data of 126 patients with moderate to severe CD treated with either IFX or UST were selected, including 84 patients in the IFX group and 42 patients in the UST group. After 54 weeks of treatment, clinical remission rates, clinical response rates, endoscopic remission rates, changes in Crohn's Disease Activity Index (CDAI), Harvey-Bradshaw Index (HBI), Simplified Endoscopic Scoring of Crohn's Disease (SES-CD), laboratory markers, inflammatory bowel disease quality of life (IBDQ) scores, FACIT-F scores and adverse event rates were compared between the two groups. Results There were no significant differences in patient age, gender, body mass index, disease duration, smoking history, previous surgical history, family history or disease location between the two groups of patients (P>0.05). After 54 weeks of treatment, the clinical remission rates in the IFX group and the UST group were 73.8% and 59.5%, respectively, the clinical response rates were 89.3% and 83.3%, and the endoscopic remission rates were 57.1% and 47.6%. There were no significant differences between the groups (P>0.05). After treatment, both groups showed a significant decrease in CDAI, HBI and SES-CD scores (P<0.05), with no significant differences between the groups. Both groups showed a decrease in C-reactive protein and fecal calprotectin levels, and an increase in albumin and hemoglobin levels after treatment in the two groups of patients (P<0.05). There were no significant differences in IBDQ and FACIT-F scores between the two groups of patients, and the incidence of adverse events was similar (P>0.05). Conclusion Both IFX and UST can effectively improve the clinical symptoms and endoscopic inflammation in patients with moderate to severe CD, with good safety. Both treatments can also improve the' quality of life of patients.

Key words: Crohn's disease, infliximab, ustekinumab, efficacy, safety

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