药物治疗监控（TDM）是优化某些治疗方法使用的决策工具。本文中，作者回顾了在患有炎症性肠病（IBD）和其他免疫介导性炎症疾病（IMID）的患者中，生物制剂主动监控的作用。他们还从临床实验室的角度讨论了TDM作为个体化医疗的组成部分的未来。这篇叙述性评论源于第五届挑战性药物治疗监控研讨会的议程，并补充了在关键审查的各个阶段确定的其他文献。主动监控旨在达到生物制剂的适宜浓度，以使患者获得并维持最佳治疗反应。在临床缓解期的患者中，主动监测也可能在降低抗肿瘤坏死因子治疗并将英夫利昔单抗单独治疗优化作为与免疫调节剂联合治疗的替代方案中发挥作用。主动监控在儿童IBD患者中应用广泛。实现儿童IBD黏膜愈合需要在引导疗法的早期期间监测英夫利昔单抗或阿达利姆单抗的浓度，并根据测量时间（周）进行剂量修正。生物治疗的最新创新包括英夫利昔单抗和阿达利姆单抗的国际标准，以实现生物活性的全球协调，并具有与常规酶联免疫吸附法相当的准确度和更快的反应时间的单测设备。尽管在IMID患者的抗肿瘤坏死因子治疗主动监控方面存在几个知识盲区，但越来越多的证据表明，它比经验优化和/或反应性TDM在IBD中具有更好的效果。增强的药代动力学建模可预测药物暴露，患者基因型技术有助于精确应用主动监控，这些被认为是优化生物治疗的关键元素。 Copyright © 2023 Wolters Kluwer Health，Inc.版权所有。

Therapeutic drug monitoring (TDM) is a decision-making tool for optimizing the use of certain therapies. In this article, the authors review the role of proactive TDM of biological agents in patients with inflammatory bowel disease (IBD) and other immune-mediated inflammatory diseases (IMID). They also discuss the future of TDM as a component of personalized medicine from the clinical laboratory perspective.This narrative review originated from proceedings of the fifth biannual Challenges in Therapeutic Drug Monitoring seminar and was supplemented by additional literature identified at various stages of critical review.Proactive TDM aims to achieve adequate concentrations of biological drugs, such that patients attain and maintain an optimal treatment response. Proactive TDM may also have a role in de-escalating anti-tumor necrosis factor therapy in patients in clinical remission and in optimizing infliximab monotherapy as an alternative to combination therapy with an immunomodulator. A major proactive TDM application is in pediatric patients with IBD. Achieving mucosal healing in children with IBD requires that infliximab or adalimumab concentrations are monitored early during induction therapy, with dose modifications guided by the timing (week) of measurement. Recent innovations in biological therapy include international standards for infliximab and adalimumab for the global harmonization of bioactivity and monotest devices with an accuracy equivalent to that of conventional enzyme-linked immunosorbent assays and quicker turnaround times.Despite several knowledge gaps regarding proactive TDM of anti-tumor necrosis factor therapy in patients with IMID, growing evidence suggests that it is associated with better outcomes than empiric optimization and/or reactive TDM in IBD. Enhanced pharmacokinetic modeling to predict drug exposure and patient genotyping for the precise application of proactive TDM are considered key elements to optimize biological therapy in the future.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.