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 establish an HPLC method for the determination of isoniazid and explore the impact of 60Co-γ on the sta-bility of isoniazid. Methods:A Diamosil C18(2) column(250 mm×4.6 mm,5 μm) was used. The mobile phase consisted of metha-nol and 0.2% phosphoric acid(2 :98). The flow rate was 1.0 ml·min-1,and the detection wavelength was at 254 nm. The isonia-zid solutions at different accurate initial concentration(10,50,100 μg·ml-1,100 μg·ml-1+saturated N2,100 μg·ml-1+satu-rated O2,100 μg·ml-1+10% tert-butanol and isoniazid powder) were irradiated by 60Co-γ at different doses (0.3,0.6,1,2.5, 5,10 kGy). And then,the concentrations of remained isoniazid were determined by HPLC. Results: Isoniazid was in a good linear relationship within the range of 1-200 μg·ml-1(r=0.999 0) with the recoveriy of 98.13% (RSD=0.65%). The degradation rate of isoniazid was affected by the initial concentration and the radiation dose,which increased with the increase of absorption amount and increased with the concentration increase,and the powder almost had no degradation. The degradation of isoniazid+O2significantly de-creased,and that of isoniazid+N2and isoniazid+tert-butanol was inhibied to a certain extent. Conclusion:Isoniazid is sensitive to 60 Co-γ irradiation,and its degradation is higher with lower concentration and higher irradiation dose.

Objective To investigate the method of establishing a model of delay eyeblink condi-tioning ( DEC) in no surgical cynomolgus monkey and analyze the related acquisition rule.Methods Using the special monkey chairs to fix 6 adult male cynomolgus monkeys,they were sitting on the chairs and keep-ing awake,and heads could rotate freely during the whole training session.In the experiment,the 6 monkeys were trained in DEC with a tone (500 ms,85 dB) as the conditioned stimulus (CS),paired with a corneal oxygen-puff (100 ms,5 psi) as the unconditioned stimulus (US).There were 120 trials per-session,and 2 sessions per-day.During the experiments,an infrared emitter/detector attached to spectacles for eyeblink re-cording,the data of conditioned response ( CR) and startle response ( SR) were analyzed offline.Result-s Among the 6 cynomolgus monkeys,4 of them completed all of the training process of DEC and 3 monkeys had successful acquisition of DEC.The average CR rate in the last training session reached ( 64.67 ± 2.00)%,(P<0.01);1 monkey only showed a high acquisition rate( 85.00%) at the first training session, and the low CR rate in the next training sessions with the average rate of 18.16%,suggesting that the DEC model was failed to established.The SR rates in 4 cynomolgus monkeys were low with average rate of 5.47%. Conclusion Although the DEC behavior training of the cynomolgus monkey is easy to be influenced by many inside or outside factors,DEC can be obtained under the condition of non surgery and proper braking.