中国实用儿科杂志 ›› 2026, Vol. 41 ›› Issue (4): 276-285.DOI: 10.19538/j.ek2026040603

• 指南解读 • 上一篇    下一篇

《NASPGHAN儿童炎症性肠病治疗药物监测目标立场文件》2025版解读及与中国指南对比分析

  

  1. 浙江大学医学院附属儿童医院  儿童少年健康与疾病国家临床医学研究中心,浙江  杭州  310052
  • 出版日期:2026-04-06 发布日期:2026-05-12
  • 通讯作者: 张晨美,电子信箱:chzcm@zju.edu.cn

Interpretation of the 2025 NASPGHAN position paper on therapeutic drug monitoring targets in pediatric inflammatory bowel disease and comparison with the 2025 Chinese guideline#br#
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  1. Children’s Hospital,Zhejiang University School of Medicine;National Clinical Research Center for Children and Adolescents’Health and Diseases,Hangzhou  310052,China
  • Online:2026-04-06 Published:2026-05-12

摘要: 儿童炎症性肠病(IBD)应用生物制剂时,药物清除加速和药物免疫原性常导致诱导期药物暴露不足。即便患儿短期获得临床应答或临床缓解,若早期血清谷浓度未达到目标范围,后续仍易出现疗效衰减和失应答。文章解读2025版《北美儿科胃肠病学、肝病学和营养学学会(NASPGHAN)儿童炎症性肠病治疗药物监测目标立场文件》以实现药物暴露达标为核心的主动药物监测(TDM)框架,随后对照中华医学会《儿童炎症性肠病治疗药物监测实践指南(2025)》,比较抗肿瘤坏死因子-α制剂等药物的目标浓度、TDM时机、抗药物抗体分层与剂量强度策略,并归纳急性重症溃疡性结肠炎、肛瘘型克罗恩病及极早发型IBD等高风险表型的差异要点,以供国内临床实践参考。


关键词: 儿童炎症性肠病, 治疗药物监测, 生物制剂, 英夫利昔单抗, 阿达木单抗, 维得利珠单抗, 乌司奴单抗

Abstract: In the application of biologic agents for pediatric inflammatory bowel disease(IBD),accelerated drug clearance and immunogenicity often lead to subtherapeutic exposure during induction therapy. Even when short-term clinical response or clinical remission is achieved,failure of early trough concentrations to reach target may still increase the risk of subsequent loss of efficacy and loss of response. This article interprets the North American Society for Pediatric Gastroenterology,Hepatology and Nutrition(NASPGHAN)position paper on therapeutic drug monitoring(TDM)in pediatric IBD(2025 edition)to achieve a proactive exposure target-driven framework. We then compared these recommendations with the Practice Guideline for TDM in Pediatric IBD(2025)by Chinese Medical Association,focusing on target drug concentrations for anti-tumor necrosis factor-α agents and other biologics,optimal timing for TDM,stratified management of anti-drug antibodies,and dose-intensification strategies. Key differences in monitoring approaches for high-risk phenotypes-including acute severe ulcerative colitis,perianal Crohn’s disease,and very early-onset IBD- are summarized to provide reference for clinical practice in China.

Key words: pediatric inflammatory bowel disease, therapeutic drug monitoring, biologics, infliximab, adalimumab, vedolizumab, ustekinumab