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 compare the anti-inflammation,analgesia effects of decoctions extracted from Aconiti lateralis with different leaf shapes(dahua leaf,xiaohua leaf)from different producing areas(Jiangyou,Butuo). METHODS:Animals were randomly divided into blank group(distilled water),positive group,groups of Aconiti lateralis with dahua,xiaohua leaf from Ji-angyou,groups of Aconiti lateralis with dahua,xiaohua leaf from Butuo(with dose of 5 g/kg,calculated by crude drug). The an-ti-inflammation effect of decoctions extracted from Aconiti lateralis with different variety sources and leaf shapes was investigated by xylene-induced ear swelling test (n=12) in mice and egg white-induced toe swelling test (n=10) in rats (positive drug was Dexamethasone acetate tablet,0.005 g/kg). And its analgesic effect was investigated by acetic acid-induced writhing body reaction test(n=12)and hot-plate-induced pain test(n=12)in mice(positive drug was Morphine hydrochloride tablet,0.0025 g/kg). RE-SULTS:The decoctions extracted from Aconiti lateralis with dahua,xiaohua leaf from Butuo and xiaohua leaf from Jiangyou can significantly reduce the ear swelling degree(P<0.01). The decoctions extracted from Aconiti lateralis with dahua leaf from Jiangy-ou and Butuo can significantly decrease the toe swelling degree after 6 h of medication(P<0.05). And decoctions extracted from Aconiti lateralis with xiaohua leaf from Butuo can significantly reduce the number of writhing body in mice with acetic acid-in-duced pain and prolong the pain threshold of mice with hot-plate-induced pain (P<0.05 or P<0.01). CONCLUSIONS:Aconiti lateralis with dahua and xiaohua leaf from Butuo and with xiaohua leaf from Jiangyou show better anti-inflammation effect,and Aconiti lateralis with xiaohua leaf from Butuo shows better analgesic effect.