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.Interpretation for Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China
Zaiwei SONG ; Shuang LIU ; Rongsheng ZHAO ; Suodi ZHAI ; Xianglin ZHANG ; Youping LI ; Guanhua DU ; Yuankai SHI ; Liyan MIAO ; Lingli ZHANG ; Hongmei JING
China Pharmacy 2022;33(16):2032-2039
Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment , Development,and Evaluation (GRADE)approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ,this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ,involving evaluation prior to administration (liver and renal function ,pleural effusion and ascites , comedication,genetic testing ),pre-treatment and routine dosing regimen (pretreatment of hydration and alkalization ,urine alkalization,routine dosing regimen ),therapeutic drug monitoring (necessity,method,timing,target concentration ),leucovorin rescue(rescue timing ,rescue regimen ,rescue dose optimization ),and management of toxicities (liver and kidney function monitoring,supportive treatment ,blood purification treatment ). This article aims to summarize and interpret the recommendations of this guideline ,so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.
3.Effects of Si-Wu Decoction and its active components on cytochrome P450 in rats
Zengchun MA ; Miao LIANG ; Jiawei ZHAO ; Yuguang WANG ; Hongling TAN ; Qiande LIANG ; Xianglin TANG ; Chengrong XIAO ; Yue GAO
Chinese Pharmacological Bulletin 2015;(9):1319-1323
Aim To study the influence of Si-Wu De-coction (SWD ) and its active components on cyto-chrome P450 activity and mRNA expression in rats in order to provide an experimental basis for compatibility of SWD.Methods SWD and its active components were intragastrically administrated for seven days,the doses of SWD was 10 g · kg -1 · d -1 ,the doses of fructose,ferulic acid,ligustrazine,peoniflorin were 0.334,0.002,0.011 and 0.022 g·kg -1 ·d -1 ,re-spectively.After administration for seven days,rats were executed,and liver microsomes were prepared. The effects of SWD and its active components on cyto-chrome P450 in rats were investigated by hybrid probe and liver microsomes incubation method.The level of mRNA expression in liver was detected by real-time quantitative polymerase chain reaction using specific target primers for CYP450 genes.The level of protein expression of CYP2B1 was detected by Western blot. Results Compared with the control group,fructose significantly decreased the activity of CYP1A2, CYP2B6,CYP2C9,CYP2D6;ferulic acid significantly decreased the activity of CYP2C9,CYP2B6;ligus-trazine significantly decreased the activity of CYP1A2, CYP2C9,CYP2B6;peoniflorin significantly decreased the activity of CYP2D6,CYP2B6;fructose,ferulic acid,peoniflorin inhibited the mRNA expression of CYP2B1;fructose,ferulic acid,ligustrazine and peon-iflorin also inhibit the protein expression of CYP2B1. Conclusion Fructose,ferulic acid,peoniflorin inhib-it the activity of CYP2B1,decrease the expression lev-els of mRNA and protein of CYP2B1.
4.Analysis of the Utilization of Tripterygium Glycosides Tablet in Outpatient Department of Our Hospital
Fang LIU ; Hai JU ; Yin MIAO ; Xianglin ZHANG
China Pharmacy 2015;(23):3173-3175
OBJECTIVE:To provide for rational use of Tripterygium glycosides tablet clinically. METHODS:The utilization of Tripterygium glycosides tablet were collected from hospital information system(HIS)in our hospital during Jun. 2012-Jun. 2014. Then the data about the basic information,patients’age,departments and diagnosis,were analyzed by the Excel. RESULTS:The application of Tripterygium glycosides tablet remained stable since Jun. 2012. There were 4 600 prescriptions in average every year, and the age of patients was distributed from 11 to 90. Tripterygium glycosides tablet was mainly used in rheumatology department (52.11%),followed by TCM rheumatology department(20.62%),skin disease and venereal disease department(18.15%),ne-phrology department(3.52%)and integrated traditional and western medicine cardiology department(1.77%). It was mainly used to treat rheumatoid arthritis,Sjogren's syndrome,polymyalgia rheumatica,osteoporosis and nephrotic syndrome. CONCLUSIONS:The application of Tripterygium glycosides tablet as immunosuppressant is widely used,but the age of patient is with wide distribu-tion;the narrow gap exists between minimum effective dose and minimum lethal dose;so ADR should be concerned closely.
5.THE RECOGNITION SYSTEM OF MOVING MACHINE PRINTED MARK/NUMERAL
Yalin MIAO ; Xianglin MIAO ; Zhengzhong BIAN ; Jianlong ZHOU
Journal of Pharmaceutical Analysis 2005;17(1):15-20
This paper presents a recognition system for the automatic quality control in industrial applications. The purpose of the system is to collect the product information (e.g. Expiry-date, production identification) and verify these information for quality control. The main difficulties of the system are to make an effcient preprocessing for the acquired low resolution image and to create a simple and fast recognition method to get the product information. In this paper, we propose an effcient recognition method based on the endpoint features and structure characteristics of the numerals. The experimental results show that the proposed method is effcient, robust and reliable for recognizing machine printed numerals. The system is currently successfully working with a real application with required specifications.
6.A METHOD OF REALIZING THE VISUAL REPOSITORY BASE ON SVG STANDARD
Xianglin MIAO ; Yalin MIAO ; Quan WANG ; Jianlong ZHOU
Journal of Pharmaceutical Analysis 2005;17(1):21-24
This paper demonstrates that the visual and graphical repository can be established through extending the SVG standard, introducing C# script and customizing component into repository. The graphical system, which uses the technique of Visual Studio.Net, supports the secondary object-oriented development. It allows the user to not only add all kinds of component objects, but also add properties and functions for the object. In addition, the graphical system has a very good property of customization. It supports the C# script and the zoom in/zoom out of pictures. The file formats used in this system are XML and SVG.

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