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.Formulation and Analysis of the Standard on High-alert Medications Management
Wenya SHAN ; Kuifen MA ; Xiaoyi DU ; Jin LU ; Jiancun ZHEN ; Xiaoyang LU
Herald of Medicine 2025;44(3):412-415
To standardize the management of high-alert medications in medical institutions and ensure their safe and ef-fective use,based on relevant national regulations and normative documents,international high-alert medication management guidelines,and expert opinions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the develop-ment of the Pharmaceutical Supply Services—Key Drugs Management—High-alert Medications.This article elaborated on the for-mulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of high-alert medications,thereby enhancing the management level of high-alert medications and ensuring the safe and effective use of medications for pa-tients.
3.Health economic analysis and medical cost analysis of children with severe hepatitis B in China: A retrospective study from 2016 to 2022
Qijun SHAN ; Xudong MA ; Yujie CHEN ; Guanghua ZHOU ; Sifa GAO ; Jialu SUN ; Fuping GUO ; Feng ZHANG ; Dandan MA ; Guoqiang SUN ; Wen ZHU ; Xiaoyang MENG ; Guiren RUAN ; Yuelun ZHANG ; Xutong TAN ; Dawei LIU ; Yi WANG ; Chang YIN ; Xiang ZHOU
Chinese Medical Journal 2025;138(5):562-567
Background::Hepatitis B poses a heavy burden for children in China, however, the national studies on the distributional characteristics and health care costs of children with severe hepatitis B is still lacking. This study aimed to analyze the disease characteristics, health economic effects, and medical cost for children with severe hepatitis B in China.Methods::Based on patient information in the Hospital Quality Monitoring System, cases with severe hepatitis B were divided into four groups according to age, and the etiology and symptoms of each group were quantified. The cost of hospitalization was calculated for cases with different disease processes, and severity of disease. The spatial aggregation of cases and the relationship with health economic factors were analyzed by Moran’s I analysis. Results::The total number of children discharged with hepatitis B from January 2016 to April 2022 was 1603, with an average age of 10.5 years. Liver failure cases accounted for 43.48% (697/1603) of total cases and cirrhosis cases accounted for 11.23% (180/1603). According to the grouping of disease progression, there were 1292 cases without associated complications, and the median hospitalization cost was $818.12. According to the spatial analysis, the aggregation of cases was statistically significant at the prefectural and provincial levels in 2019, 2020, and 2021 (all P <0.05). The number of severe cases was negatively correlated with gross domestic product (Moran’s I <0) and percentage of urban population (Moran’s I <0), and positively correlated with the number of pediatric beds per million population (Moran’s I >0). Conclusion::The number of severe hepatitis B cases is low in areas with high gross domestic product levels and high urban population ratios, and health care costs have been declining over the years.
4.Textual Research and Clinical Application Analysis of Classic Formula Fangji Fulingtang
Xiaoyang TIAN ; Lyuyuan LIANG ; Mengting ZHAO ; Jialei CAO ; Lan LIU ; Keke LIU ; Bingqi WEI ; Yihan LI ; Jing TANG ; Yujie CHANG ; Jingwen LI ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):270-277
The classic formula Fangji Fulingtang is from ZHANG Zhongjing's Synopsis of the Golden Chamber in the Eastern Han dynasty. It is composed of Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma, with the effects of reinforcing Qi and invigorating spleen, warming Yang and promoting urination. By a review of ancient medical books, this paper summarizes the composition, original plants, processing, dosage, decocting methods, indications and other key information of Fangji Fulingtang, aiming to provide a literature basis for the research, development, and clinical application of preparations based on this formula. Synonyms of Fangji Fulingtang exist in ancient medical books, while the formula composition in the Synopsis of the Golden Chamber is more widespread and far-reaching. In this formula, Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma are the dried root of Stephania tetrandra, the dried root of Astragalus embranaceus var. mongholicus, the dried shoot of Cinnamomum cassia, the dried sclerotium of Poria cocos, and the dried root and rhizome of Glycyrrhiza uralensis, respectively. Fangji Fulingtang is mainly produced into powder, with the dosage and decocting method used in the past dynasties basically following the original formula. Each bag is composed of Stephaniae Tetrandrae Radix 13.80 g, Astragali Radix 13.80 g, Cinnamomi Ramulus 13.80 g, Poria 27.60 g, and Glycyrrhizae Radix et Rhizoma 9.20 g. The raw materials are purified, decocted in water from 1 200 mL to 400 mL, and the decoction should be taken warm, 3 times a day. Fangji Fulingtang was originally designed for treating skin edema, and then it was used to treat impediment in the Qing dynasty. In modern times, it is mostly used to treat musculoskeletal and connective tissue diseases and circulatory system diseases, demonstrating definite effects on various types of edema and heart failure. This paper clarifies the inheritance of Fangji Fulingtang and reveals its key information (attached to the end of this paper), aiming to provide a theoretical basis for the development of preparations based on this formula.
5.Textual Research and Clinical Application Analysis of Classic Formula Fangji Fulingtang
Xiaoyang TIAN ; Lyuyuan LIANG ; Mengting ZHAO ; Jialei CAO ; Lan LIU ; Keke LIU ; Bingqi WEI ; Yihan LI ; Jing TANG ; Yujie CHANG ; Jingwen LI ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):270-277
The classic formula Fangji Fulingtang is from ZHANG Zhongjing's Synopsis of the Golden Chamber in the Eastern Han dynasty. It is composed of Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma, with the effects of reinforcing Qi and invigorating spleen, warming Yang and promoting urination. By a review of ancient medical books, this paper summarizes the composition, original plants, processing, dosage, decocting methods, indications and other key information of Fangji Fulingtang, aiming to provide a literature basis for the research, development, and clinical application of preparations based on this formula. Synonyms of Fangji Fulingtang exist in ancient medical books, while the formula composition in the Synopsis of the Golden Chamber is more widespread and far-reaching. In this formula, Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma are the dried root of Stephania tetrandra, the dried root of Astragalus embranaceus var. mongholicus, the dried shoot of Cinnamomum cassia, the dried sclerotium of Poria cocos, and the dried root and rhizome of Glycyrrhiza uralensis, respectively. Fangji Fulingtang is mainly produced into powder, with the dosage and decocting method used in the past dynasties basically following the original formula. Each bag is composed of Stephaniae Tetrandrae Radix 13.80 g, Astragali Radix 13.80 g, Cinnamomi Ramulus 13.80 g, Poria 27.60 g, and Glycyrrhizae Radix et Rhizoma 9.20 g. The raw materials are purified, decocted in water from 1 200 mL to 400 mL, and the decoction should be taken warm, 3 times a day. Fangji Fulingtang was originally designed for treating skin edema, and then it was used to treat impediment in the Qing dynasty. In modern times, it is mostly used to treat musculoskeletal and connective tissue diseases and circulatory system diseases, demonstrating definite effects on various types of edema and heart failure. This paper clarifies the inheritance of Fangji Fulingtang and reveals its key information (attached to the end of this paper), aiming to provide a theoretical basis for the development of preparations based on this formula.
6.Textual Research on Historic Evolution and Ancient and Modern Application of Classic Prescription Huangqintang
Yuxin LI ; Lyuyuan LIANG ; Jialei CAO ; Tongyi HUANG ; Hejia WAN ; Bingqi WEI ; Mengting ZHAO ; Xiaoyang TIAN ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):184-191
Huangqintang, with its accurate efficacy, is a classic formula specialized in treating dysentery recommended and promoted by medical experts from successive generations, and it was included in the Catalogue of Ancient Classic Prescriptions (the Second Batch, Han Chinese medicine prescriptions) published by the National Administration of Traditional Chinses Medicine (TCM) in 2023. The method of bibliometrics was applied in this study to conduct textual research on the classic formula Huangqintang and provide a literature reference for the development of modern preparations of Huangqintang. A total of 2 026 pieces of ancient literature were searched with "Huangqintang" as the key word, and 23 pieces of effective data were selected, involving 15 ancient TCM books. The historic evolution, composition, dosage, origin, processing methods, preparation and decocting methods, efficiency, and application of Huangqintang were carefully reviewed. The results showed that Huangqintang was first recorded in the Treatise on Febrile Diseases written by ZHANG Zhongjing. It has the effect of clearing heat, stopping dysentery, regulating the middle, and downbearing counterflow and has become one of the classic formulas widely used in clinical practice. Because of its accurate efficacy, medical experts from later generations have modified it from its original composition. Though many prescriptions have different names, it is the manifestation of physicians' inheritance and development of the thought of ZHANG Zhongjing. Ancient literature showed this prescription had wide indications yet centered on digestive system diseases such as dysentery and abdominal pain. Modern applications of Huangqintang involve digestive, respiratory, ophthalmology and otolaryngology, gynecological, skin, musculoskeletal system, and connective tissue, and this prescription has great potential in treating ulcerative colitis, diarrhea, acute enteritis, and damp-heat dysentery. Through a systematic textual excavation and review of the ancient literature about Huangqintang, the paper has confirmed its key information, so as to provide a scientific basis for the clinical application and new drug development of classic formulas.
7.Clinical observation of enteral nutrition support in pediatric patients after heart transplantation
Chang'e LIU ; Zhe ZHAO ; Aihong LIU ; Yuhan CHEN ; Yun HAO ; Xiaohan YUAN ; Yue MA ; Jiandang LI ; Cong WU ; Yanjuan ZHU ; Gengxu ZHOU ; Zhichun FENG ; Xiaoyang HONG
Chinese Journal of Pediatrics 2025;63(10):1126-1130
Objective:To evaluate the safety and clinical efficacy of enteral nutrition (EN) initiated within 24 h after heart transplantation in pediatric patients.Methods:A retrospective cohort study was conducted. Clinical data from 16 pediatric heart transplant recipients at the Seventh Medical Center of the Chinese People′s Liberation Army General Hospital between October 2022 and October 2024 were collected, including demographics, anthropometric measurements, biochemical markers, cytokine levels, and clinical outcomes. Based on the timing of EN initiation, the patients were divided into EN-initiated within 24 h and EN-initiated after 24 h 2 groups. Demographic data, preoperative extracorporeal membrane oxygenation (ECMO) support, physical examination indicators, laboratory parameters, and cytokine levels were compared between groups using independent samples t-test, Mann-Whitney U test, Fisher′s exact probability test. Results:The cohort comprised 16 patients (10 males and 6 females) with an age of (12.5±1.9) years. The EN-initiated within 24 h group comprised 6 cases, and the EN-initiated after 24 h group comprised 10 cases. No significant difference was observed between the two groups in age, preoperative body mass index Z-score, preoperative ECMO support, physical examination indicators, laboratory parameters (total protein, albumin, hemoglobin), or cytokine levels (all P>0.05). Compared to the EN-initiated after 24 h group, the EN-initiated within 24 h group exhibited a shorter intensive care unit stay ( t=2.65, P<0.05) and shorter mechanical ventilation duration ( t=2.23, P<0.05) than EN-initiated after 24 h group. Total hospitalization length had no significant difference ( P>0.05). At 72 h post-transplant, the EN-initiated within 24 h group had a lower interleukin-12 P70 ( t=2.46, P<0.05) and interferon-γ levels ( t=2.55, P<0.05) than EN-initiated after 24 h group. Prior to discharge, the EN-initiated within 24 h group has a lower mean skinfold thickness ( t=2.49, P<0.05) and lower mid-upper arm circumference ( t=2.36, P<0.05) compared with the EN-initiated after 24 h group. Conclusions:Initiating EN within 24 h postoperatively is safe and feasible in pediatric heart transplant recipients. Early EN may shorten the length of intensive care unit stay and mechanical ventilation while attenuating postoperative release of inflammatory cytokine.
8.Formulation and Analysis of the Standard on High-alert Medications Management
Wenya SHAN ; Kuifen MA ; Xiaoyi DU ; Jin LU ; Jiancun ZHEN ; Xiaoyang LU
Herald of Medicine 2025;44(3):412-415
To standardize the management of high-alert medications in medical institutions and ensure their safe and ef-fective use,based on relevant national regulations and normative documents,international high-alert medication management guidelines,and expert opinions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the develop-ment of the Pharmaceutical Supply Services—Key Drugs Management—High-alert Medications.This article elaborated on the for-mulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of high-alert medications,thereby enhancing the management level of high-alert medications and ensuring the safe and effective use of medications for pa-tients.
9.Clinical observation of enteral nutrition support in pediatric patients after heart transplantation
Chang'e LIU ; Zhe ZHAO ; Aihong LIU ; Yuhan CHEN ; Yun HAO ; Xiaohan YUAN ; Yue MA ; Jiandang LI ; Cong WU ; Yanjuan ZHU ; Gengxu ZHOU ; Zhichun FENG ; Xiaoyang HONG
Chinese Journal of Pediatrics 2025;63(10):1126-1130
Objective:To evaluate the safety and clinical efficacy of enteral nutrition (EN) initiated within 24 h after heart transplantation in pediatric patients.Methods:A retrospective cohort study was conducted. Clinical data from 16 pediatric heart transplant recipients at the Seventh Medical Center of the Chinese People′s Liberation Army General Hospital between October 2022 and October 2024 were collected, including demographics, anthropometric measurements, biochemical markers, cytokine levels, and clinical outcomes. Based on the timing of EN initiation, the patients were divided into EN-initiated within 24 h and EN-initiated after 24 h 2 groups. Demographic data, preoperative extracorporeal membrane oxygenation (ECMO) support, physical examination indicators, laboratory parameters, and cytokine levels were compared between groups using independent samples t-test, Mann-Whitney U test, Fisher′s exact probability test. Results:The cohort comprised 16 patients (10 males and 6 females) with an age of (12.5±1.9) years. The EN-initiated within 24 h group comprised 6 cases, and the EN-initiated after 24 h group comprised 10 cases. No significant difference was observed between the two groups in age, preoperative body mass index Z-score, preoperative ECMO support, physical examination indicators, laboratory parameters (total protein, albumin, hemoglobin), or cytokine levels (all P>0.05). Compared to the EN-initiated after 24 h group, the EN-initiated within 24 h group exhibited a shorter intensive care unit stay ( t=2.65, P<0.05) and shorter mechanical ventilation duration ( t=2.23, P<0.05) than EN-initiated after 24 h group. Total hospitalization length had no significant difference ( P>0.05). At 72 h post-transplant, the EN-initiated within 24 h group had a lower interleukin-12 P70 ( t=2.46, P<0.05) and interferon-γ levels ( t=2.55, P<0.05) than EN-initiated after 24 h group. Prior to discharge, the EN-initiated within 24 h group has a lower mean skinfold thickness ( t=2.49, P<0.05) and lower mid-upper arm circumference ( t=2.36, P<0.05) compared with the EN-initiated after 24 h group. Conclusions:Initiating EN within 24 h postoperatively is safe and feasible in pediatric heart transplant recipients. Early EN may shorten the length of intensive care unit stay and mechanical ventilation while attenuating postoperative release of inflammatory cytokine.
10.Health economic analysis and medical cost analysis of children with severe hepatitis B in China: A retrospective study from 2016 to 2022
Qijun SHAN ; Xudong MA ; Yujie CHEN ; Guanghua ZHOU ; Sifa GAO ; Jialu SUN ; Fuping GUO ; Feng ZHANG ; Dandan MA ; Guoqiang SUN ; Wen ZHU ; Xiaoyang MENG ; Guiren RUAN ; Yuelun ZHANG ; Xutong TAN ; Dawei LIU ; Yi WANG ; Chang YIN ; Xiang ZHOU
Chinese Medical Journal 2025;138(5):562-567
Background::Hepatitis B poses a heavy burden for children in China, however, the national studies on the distributional characteristics and health care costs of children with severe hepatitis B is still lacking. This study aimed to analyze the disease characteristics, health economic effects, and medical cost for children with severe hepatitis B in China.Methods::Based on patient information in the Hospital Quality Monitoring System, cases with severe hepatitis B were divided into four groups according to age, and the etiology and symptoms of each group were quantified. The cost of hospitalization was calculated for cases with different disease processes, and severity of disease. The spatial aggregation of cases and the relationship with health economic factors were analyzed by Moran’s I analysis. Results::The total number of children discharged with hepatitis B from January 2016 to April 2022 was 1603, with an average age of 10.5 years. Liver failure cases accounted for 43.48% (697/1603) of total cases and cirrhosis cases accounted for 11.23% (180/1603). According to the grouping of disease progression, there were 1292 cases without associated complications, and the median hospitalization cost was $818.12. According to the spatial analysis, the aggregation of cases was statistically significant at the prefectural and provincial levels in 2019, 2020, and 2021 (all P <0.05). The number of severe cases was negatively correlated with gross domestic product (Moran’s I <0) and percentage of urban population (Moran’s I <0), and positively correlated with the number of pediatric beds per million population (Moran’s I >0). Conclusion::The number of severe hepatitis B cases is low in areas with high gross domestic product levels and high urban population ratios, and health care costs have been declining over the years.

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