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.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Objective To evaluate the prognostic significance of the candidate selection Hangzhou criteria for liver transplantation of HCC patients undergoing hepatectomy.Methods 199 HCC patients undergoing hepatectomy between 2009 and 2011 were enrolled retrospectively.Predictors of survival were identified using the Kaplan-Meier method.The disease state was staged by the Hangzhou criteria (HC) and Milan staging systems.Calculating the area under the receiver operating characteristic (ROC) curve (AUC) evaluates the discriminatory ability for the prediction of survival of both staging system.Results Portal vein thrombosis,poor differentiation,and tumor size (＞ 8 cm) were independent risk factors for survival after hepatectomy.Milan criteria and Hangzhou criteria functioned well in predicting tumor-recurrence.For 1-year AUROC,the AUROC for Milan criteria and Hangzhou criteria are 0.602 and 0.741,respectively.For 3-year AUROC,the AUROC for Milan criteria and Hangzhou criteria are 0.643 and 0.733,respectively.Conclusions The HC were shown to be a promising survival predictor in a Chinese cohort of HCC patients after hepatectomy.