1.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
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 of Zhejiang University. Science. B 2025;26(9):897-914
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*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
2.Vaccination status and influencing factors among medical staff in Zhejiang province
Yang SONG ; Xiaoxia QIU ; Mengnan JIANG ; Yalin ZHAI ; Qiang WEI ; Hua GU
Chinese Journal of Experimental and Clinical Virology 2021;35(1):84-88
Objective:To understand the basic situation of vaccination of medical staff engaged in infectious disease related work, analyze the influencing factors of vaccination, and provide reference for the vaccination of occupational population.Methods:A self-designed questionnaire was designed to investigate the staff engaged in infectious disease related work in the disease control and hospital systems of 11 cities in Zhejiang Province. The contents of the questionnaire included the basic information of the medical staff, the vaccination situation after work and its influencing factors and vaccination willingness. A total of 1 446 valid questionnaires were collected. Chi square test and multivariate logistic regression were used to analyze the influencing factors of whether or not they had been vaccinated with work-related vaccine after engaging in infectious disease-related work.Results:Of the respondemts, had been vaccinated with work-related vaccines after engaging in infectious diseases related work, and the vaccines with the highest coverage rate were hepatitis B vaccine, influenza vaccine, measles vaccine, etc. Work organization, position, unit level and working years related to pathogenic microorganism experiment are the influencing factors for medical personnel to vaccinate work-related vaccine after they are engaged in infectious disease related work; 90.04% of the respondents indicated that they would like to be vaccinated.Conclusions:The vaccination rate of work-related vaccine was low after the medical staff began to work on infectious diseases. The main influencing factors of whether the medical staff were vaccinated with work-related vaccine after they were engaged in the work-related vaccine of pathogenic microorganisms were the working organization, position, unit level and working years related to pathogenic microorganism experiment.
3.Investigation and analysis on the preservation capacity of pathogen resources in China
Yalin ZHAI ; Yuanyuan ZHAO ; Xudong CAO ; Mengying LIU ; Mengnan JIANG ; Qiang WEI
Chinese Journal of Experimental and Clinical Virology 2021;35(5):514-518
Objective:To grasp the current situation of operation and management of pathogen preservation center in China, analyze the problems and put forward corresponding countermeasures and suggestions, so as to provide technical support for national preservation.Methods:All kinds of preservation centers designated by the National Health Commission were surveyed by questionnaire.Results:First-class public institution accounted for 78.6% (11/14), second-class public institution accounted for 21.4% (3/14), independent departments accounted for 28.6%(4/14), and non-independent departments accounted for 71.4%(10/14); the average annual fund of the preservation center is 17.081 5 million, with an average of 1.22 million; in the four-level pathogenic microorganism management document system prepared by the preservation center, management manuals accounted for 32.3% (219/678), procedure documents accounted for 10.5% (71/678), standard operating procedures accounted for 29.5% (200/678), and record forms accounted for 27.7% (188/678). At present, there are 216 staff members, including 70.8% (153/216) part-time staff members and 29.2% (63/216) full-time staff members. Scientific research institutions accounted for 56.6% (60/106); cooperative research sharing accounted for 92.9% (13/14) and public welfare sharing accounted for 57.1% (8/14); The ownership of material derivatives and data specified in the sharing agreement accounted for 84.6% (11/13), the preset dispute resolution accounted for 84.6% (11/13), and the agreed revenue sharing proportion accounted for 69.2% (9/13).Conclusions:The preservation center of pathogenic microorganism in China is wholly in good operation, and has actively played a supporting role in sharing resources. Under the needs of the national biosafety strategy, it is suggested to strengthen the independence and professional capacity-building of the preservation center, continuously improve the diversity and standardization of resource sharing, and promote the healthy and sustainable development of the preservation center in China.

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