JZUS - Journal of Zhejiang University SCIENCE

Journal of Zhejiang University SCIENCE B

Accepted manuscript available online (unedited version)

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

Author(s): 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
Affiliation(s): Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China; more
Corresponding email(s): zhaorongsheng@bjmu.edu.cn
Key Words: Guideline; Mycophenolic acid; Therapeutic drug monitoring; Grading of Recommendations Assessment, Development, and Evaluation (GRADE); Solid organ transplant

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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. A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants[J]. Journal of Zhejiang University Science B,in press.Frontiers of Information Technology & Electronic Engineering,in press.https://doi.org/10.1631/jzus.B2400069

@article{title="A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants",
author="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",
journal="Journal of Zhejiang University Science B",
year="in press",
publisher="Zhejiang University Press & Springer",
doi="https://doi.org/10.1631/jzus.B2400069"
}

%0 Journal Article
%T A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants
%A Shuang LIU
%A Hongsheng CHEN
%A Zaiwei SONG
%A Qi GUO
%A Xianglin ZHANG
%A Bingyi SHI
%A Suodi ZHAI
%A Lingli ZHANG
%A Liyan MIAO
%A Liyan CUI
%A Xiao CHEN
%A Yalin DONG
%A Weihong GE
%A Xiaofei HOU
%A Ling JIANG
%A Long LIU
%A Lihong LIU
%A Maobai LIU
%A Tao LIN
%A Xiaoyang LU
%A Lulin MA
%A Changxi WANG
%A Jianyong WU
%A Wei WANG
%A Zhuo WANG
%A Ting XU
%A Wujun XUE
%A Bikui ZHANG
%A Guanren ZHAO
%A Jun ZHANG
%A Limei ZHAO
%A Qingchun ZHAO
%A Xiaojian ZHANG
%A Yi ZHANG
%A Yu ZHANG
%A Rongsheng ZHAO
%J Journal of Zhejiang University SCIENCE B
%P
%@ 1673-1581
%D in press
%I Zhejiang University Press & Springer
doi="https://doi.org/10.1631/jzus.B2400069"

TY - JOUR
T1 - A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants
A1 - Shuang LIU
A1 - Hongsheng CHEN
A1 - Zaiwei SONG
A1 - Qi GUO
A1 - Xianglin ZHANG
A1 - Bingyi SHI
A1 - Suodi ZHAI
A1 - Lingli ZHANG
A1 - Liyan MIAO
A1 - Liyan CUI
A1 - Xiao CHEN
A1 - Yalin DONG
A1 - Weihong GE
A1 - Xiaofei HOU
A1 - Ling JIANG
A1 - Long LIU
A1 - Lihong LIU
A1 - Maobai LIU
A1 - Tao LIN
A1 - Xiaoyang LU
A1 - Lulin MA
A1 - Changxi WANG
A1 - Jianyong WU
A1 - Wei WANG
A1 - Zhuo WANG
A1 - Ting XU
A1 - Wujun XUE
A1 - Bikui ZHANG
A1 - Guanren ZHAO
A1 - Jun ZHANG
A1 - Limei ZHAO
A1 - Qingchun ZHAO
A1 - Xiaojian ZHANG
A1 - Yi ZHANG
A1 - Yu ZHANG
A1 - Rongsheng ZHAO
J0 - Journal of Zhejiang University Science B
SP -
EP -
%@ 1673-1581
Y1 - in press
PB - Zhejiang University Press & Springer
ER -
doi="https://doi.org/10.1631/jzus.B2400069"

Abstract
Chinese Summary
Academic Network
Reviewer Comment

Abstract: Objective: 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. Methods: The guideline plan drew 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. Results: 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, 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. Conclusions: 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.

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