实体器官移植霉酚酸治疗药物监测循证指南

刘爽; 陈鸿圣; 宋再伟; 郭琦; 张相林; 石炳毅; 翟所迪; 张伶俐; 缪丽燕; 崔丽艳; 陈孝; 董亚琳; 葛卫红; 侯小飞; 姜玲; 刘龙; 刘丽宏; 刘茂柏; 林涛; 卢晓阳; 马潞林; 王长希; 吴建永; 王玮; 王卓; 徐珽; 薛武军; 张毕奎; 赵冠人; 张峻; 肇丽梅; 赵庆春; 张晓坚; 张弋; 张玉; 赵荣生

doi:10.1631/jzus.B2400069

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Research Article | Updated：2025-09-22

实体器官移植霉酚酸治疗药物监测循证指南
A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants
浙江大学学报（英文版）（B辑：生物医学和生物技术） 2025年26卷第9期页码：897-914
Affiliations：

1.Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
2.Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China
3.Kidney Transplant Quality Control Center of National Health Commission, The 8th Medical Center of Chinese PLA General Hospital,, Beijing 100000, China
4.Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, China
5.Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215006, China
6.Department of Laboratory Medicine, Peking University Third Hospital, Beijing 100191, China
7.Department of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China
8.8Department of Pharmacy, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China
9.Department of Pharmacy, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China
10.Department of Urology, Peking University Third Hospital, Beijing 100191, China
11.1Department of Pharmacy, The First Affiliated Hospital of University of Science and Technology of China, Hefei 230001, China
12.Department of Urology, General Hospital of Northern Theater Command, Shenyang 110003, China
13.Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou 350001, China
14.Department of Urology, West China Hospital, Sichuan University, Chengdu 610041, China
15.5Department of Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
16.Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China
17.7Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
18.8Department of Urology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
19.9Department of Pharmacy, The First Hospital Affiliated to Army Medical University, Shanghai 200433, China
20.0Department of Pharmacy, West China Hospital, Sichuan University, Chengdu 610041, China
21.Department of Renal Transplantation, Nephropathy Hospital, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China
22.Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha 410011, China
23.Department of Pharmacy, The 8th Medical Center of Chinese PLA General Hospital, Beijing 100000, China
24.Department of Clinical Pharmacy, The First Affiliated Hospital of Kunming Medical University, Kunming 650032, China
25.Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang 110004, China
26.6Department of Pharmacy, General Hospital of Northern Theater Command, Shenyang 110003, China
27.7Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China
28.Department of Pharmacy, Tianjin First Central Hospital, Tianjin 300192, China
29.Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
Funds：

the National Natural Science Foundation of China (NSFC)(72304007);the Huatong Guokang Medical Research Fund(2023HT010)
DOI：10.1631/jzus.B2400069
中图分类号：
CSTR：
收稿日期：2024-02-08，

修回日期：2024-07-08，

网络出版日期：2025-08-08，

纸质出版日期：2025-09-20
Accepted：

刘爽,陈鸿圣,宋再伟等.实体器官移植霉酚酸治疗药物监测循证指南[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2025,26(09):897-914.

Shuang LIU, Hongsheng CHEN, Zaiwei SONG, et al. A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants[J]. Journal of zhejiang university-science b (biomedicine & biotechnology), 2025, 26(9): 897-914.
刘爽,陈鸿圣,宋再伟等.实体器官移植霉酚酸治疗药物监测循证指南[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2025,26(09):897-914. DOI： 10.1631/jzus.B2400069.

Shuang LIU, Hongsheng CHEN, Zaiwei SONG, et al. A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants[J]. Journal of zhejiang university-science b (biomedicine & biotechnology), 2025, 26(9): 897-914. DOI： 10.1631/jzus.B2400069.

摘要

霉酚酸（mycophenolic acid，MPA）类药物是实体器官移植维持期治疗中常用的免疫抑制剂，具有重要的临床意义。由于在体内代谢存在显著的个体间及个体内差异，开展治疗药物监测（therapeutic drug monitoring，TDM）有助于MPA的个体化合理应用，充分发挥其免疫抑制效应。然而，目前国内外实体器官移植的权威指南尚未提供MPA TDM的相关循证建议。本研究旨在基于循证方法制定MPA TDM指南，为临床合理应用MPA类药物提供指导。通过采用美国国家医学院（IOM）最新指南定义，并基于世界卫生组织（WHO）指南制定基本原则和方法，本研究制定指南计划书并在国际实践指南注册平台进行注册（注册号为IPGRP-2020CN099）。经德尔菲法确定指南纳入的临床问题及结局指标，开展系统评价制定指南临床问题的循证证据，结合GRADE证据质量评价、专家意见及患者意愿与价值观，由外审专家评审后，最终形成指南推荐意见。MPA TDM循证指南共形成4个部分16条推荐意见，涉及目标人群、监测指标、检测方法、剂量方案及浓度影响因素。指南进一步明确了MPA TDM高危人群定义、MPA采样时间、监测指标曲线下面积（AUC）与谷浓度（C0）比较、目标浓度范围、监测频率及检测方法比较。此外，指南还基于不同制剂比较、初始剂量方案确定、特殊人群个体化方案调整、体重因素、基因多态性及药物相互作用等方面，对MPA类药物的合理应用提供了循证建议。开展MPA TDM时，建议结合患者个体化特征进行综合评估，并根据患者的药物暴露和临床反应进行剂量调整。基于最新循证证据、专家经验及患者意愿制定的MPA TDM指南，为实体器官移植受者接受MPA类药物治疗提供了更为全面和详细的指导，有助于推动MPA TDM在临床实践中的规范化和标准化，从而提高移植受者的治疗效果和安全性。

Abstract

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 s

olid 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 (

)

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.

关键词

Keywords

references

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Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society