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<p>Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (<i>C</i><sub>0</sub>), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug–drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.</p>

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A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月8日

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  • Shuang Liu,
  • Hongsheng Chen,
  • Zaiwei Song,
  • Qi Guo,
  • Xianglin Zhang,
  • Bingyi Shi,
  • Suodi Zhai,
  • Lingli Zhang,
  • Liyan Miao,
  • Liyan Cui,
  • Xiao Chen,
  • Yalin Dong,
  • Weihong Ge,
  • Xiaofei Hou,
  • Ling Jiang,
  • Long Liu,
  • Lihong Liu,
  • Maobai Liu,
  • Tao Lin,
  • Xiaoyang Lu,
  • Lulin Ma,
  • Changxi Wang,
  • Jianyong Wu,
  • Wei Wang,
  • Zhuo Wang,
  • Ting Xu,
  • Wujun Xue,
  • Bikui Zhang,
  • Guanren Zhao,
  • Jun Zhang,
  • Limei Zhao,
  • Qingchun Zhao,
  • Xiaojian Zhang,
  • Yi Zhang,
  • Yu Zhang,
  • Rongsheng Zhao

摘要

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug–drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.