英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展

朱扣柱; 王燕; 缪丽燕

doi:10.6039/j.issn.1001-0408.2023.24.21

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英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展

综述 | 更新时间：2023-12-22

- 英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展
- Advances in therapeutic drug monitoring of infliximab in patients with Crohn disease
- 中国药房 2023年34卷第24期页码：3068-3072
- 作者机构：
  
  1.苏州大学附属第一医院药学部，江苏苏州　215006
  2.江南大学附属儿童医院药学部，江苏无锡　214023
  3.苏州大学药学院，江苏苏州　215123
- 作者简介：
  
  主管药师，博士。研究方向：单克隆抗体的个体化给药。E-mail：zhukouzhu@163.com
  主任药师，教授，博士生导师，博士。研究方向：药物临床个体化。E-mail：miaolysuzhou@163.com
- 基金信息：
  
  苏州市姑苏卫生人才培养项目(GSWS2019001)
- DOI：10.6039/j.issn.1001-0408.2023.24.21
  中图分类号： R969.3
- 纸质出版日期：2023-12-30，
  
  收稿日期：2023-05-15，
  
  修回日期：2023-11-22，
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朱扣柱,王燕,缪丽燕.英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展 ^Δ[J].中国药房,2023,34(24):3068-3072.

ZHU Kouzhu,WANG Yan,MIAO Liyan.Advances in therapeutic drug monitoring of infliximab in patients with Crohn disease[J].ZHONGGUO YAOFANG,2023,34(24):3068-3072.
朱扣柱,王燕,缪丽燕.英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展 ^Δ[J].中国药房,2023,34(24):3068-3072. DOI： 10.6039/j.issn.1001-0408.2023.24.21.

ZHU Kouzhu,WANG Yan,MIAO Liyan.Advances in therapeutic drug monitoring of infliximab in patients with Crohn disease[J].ZHONGGUO YAOFANG,2023,34(24):3068-3072. DOI： 10.6039/j.issn.1001-0408.2023.24.21.

摘要

英夫利西单抗（IFX）是目前临床广泛用于治疗克罗恩病（CD）的肿瘤坏死因子α抑制剂，但其常规剂量难以获得较佳疗效，建议疗效欠佳的患者进行治疗药物监测（TDM）以指导临床决策。本文综述了IFX的药动学特点、暴露-效应关系、药动学差异的影响因素、TDM方法等内容。IFX不经肝肾代谢，在CD诱导期和维持期均具有明显的暴露-效应关系，疾病活动度、白蛋白和抗IFX抗体（ATI）等因素影响其体内暴露。建议CD维持期患者通过TDM将IFX谷浓度保持在3 μg/mL以上，对于疾病程度重、白蛋白水平低下、形成ATI等患者应考虑增加IFX剂量或缩短给药间隔，以提高IFX的疗效。建议同一患者采用同一种检测方法进行IFX的TDM。

Abstract

Infliximab （IFX）， tumor necrosis factor-α inhibitor， is widely used in clinical practice for treating Crohn disease （CD）， but it is difficult to obtain the optimal therapeutic effect according to the conventional dose. It is recommended to perform therapeutic drug monitoring （TDM） for patients with poor therapeutic efficacy to guide clinical decisions. This paper reviews the pharmacokinetic characteristics of IFX， exposure-response relationship， the influencing factors of pharmacokinetic differences， and analytical methods in TDM. It is found that IFX doesn’t undergo liver or kidney metabolism， exhibits obvious exposure-response relationships in both the induction and maintenance phases of CD treatment； disease activity， albumin， antibodies to IFX （ATI） and other factors influence IFX’s exposure. It is recommended that trough concentration of IFX in the maintenance period should be kept above 3 μg/mL； the dose of IFX should be increased or medication interval should be shortened for patients with severe disease， low albumin levels and ATI formation， to promote therapeutic efficacy of IFX. It is suggested to use the same detection method for TDM of IFX in the same patient.

关键词

英夫利西单抗克罗恩病治疗药物监测暴露-效应关系药动学差异

Keywords

Crohn diseasetherapeutic drug monitoringexposure-response relationshippharmacokinetic variation

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