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.Celastrol-loaded ginsenoside Rg3 liposomes boost immunotherapy by remodeling obesity-related immunosuppressive tumor microenvironment in melanoma.
Hongyan ZHANG ; Jingyi HUANG ; Yujie LI ; Wanyu JIN ; Jiale WEI ; Ninghui MA ; Limei SHEN ; Mancang GU ; Chaofeng MU ; Donghang XU ; Yang XIONG
Acta Pharmaceutica Sinica B 2025;15(5):2687-2702
Obesity usually exacerbates the immunosuppressive tumor microenvironment (ITME), hindering CD8+ T cell infiltration and function, which further represents a significant barrier to the efficacy of immunotherapy. Herein, a multifunctional liposomal system (CR-Lip) for encapsulating celastrol (CEL) was utilized to remodel obesity-related ITME and improve cancer immunotherapy, wherein Ginsenoside Rg3 (Rg3) was detected interspersed in the phospholipid bilayer and its glycosyl exposed on the surface of the liposome. CR-Lip had a relatively uniform size (116.5 nm), facilitating favorable tumor tissue accumulation through the interaction between Rg3 and glucose transporter 1 overexpressed in obese tumor cells. Upon reaching the tumor region, CR-Lip was found to induce the immunogenic cell death (ICD) of HFD tumor cells. Notably, the level of PHD3 in HFD tumor cells was effectively boosted by CR-Lip to effectively block metabolic reprogramming and increase the availability of major free fatty acids fuel sources. In vivo, experiments studies revealed that the easy-obtained nano platform stimulated enhanced the production of various cytokines in tumor tissues, DC maturation, CD8+ T-cell infiltration, and synergistic anticancer therapeutic potency with aPD-1 (tumor inhibition rate = 82.1%) towards obesity-related melanoma. Consequently, this study presented an efficacious approach to tumor immunotherapy in obese mice by encompassing tumor eradication, inducing ICD, and reprogramming metabolism. Furthermore, it offered a unique insight into a valuable attempt at the immunotherapy of obesity-associated related tumors.
3.A Case of Rhabdomyolysis in a Patient with Dermatomyositis after Intravenous Injection of Gadopentetate Dimeglumine
Herald of Medicine 2025;44(7):1169-1171
A patient with anti-MDA5-positive dermatomyositis complicated by hepatic dysfunction developed rhabdomyolysis after an intravenous injection of gadopentetate dimeglumine for magnetic resonance imaging.Analysis of clinical manifestations and medication correlation confirmed gadopentetate dimeglumineinduced rhabdomyolysis.Gadopentetate dimeglumine can cause rhabdomyolysis in dermatomyositis patients.Clinical conditions should be closely monitored when using gadopentetate dimeglumine to guard against adverse reactions.
4.Distribution and drug resistance of pathogens causing surgical site infections in 53 hospitals of Suzhou City from 2020 to 2023:a surveillance report
Yu ZHU ; Meijuan JIN ; Limei CAI ; Junji ZHANG ; Wei DING ; Shukai ZHU ; Xiaochao SONG
Chinese Journal of Nosocomiology 2025;35(22):3452-3456
OBJECTIVE To retrospectively investigate the incidence of surgical site infection(SSI),distribution and drug resistance of pathogens in 53 hospitals of Suzhou area from 2020 to 2023 so as to provide strategies for pre-vention and control of the hospital-associated infections in Suzhou area.METHODS The data regarding the SSI,distribution and drug resistance of pathogens were statistically analyzed through Suzhou City Regional Hospital In-fection Surveillance Platform.RESULTS The incidence of SSI was 0.24%among the 53 hospitals from 2020 to 2023.Staphylococcus aureus,Enterococcus faecalis,Staphylococcus epidermidis,Enterococcus faecium and Staphylococcus haemolyticus ranked the top 5 species of gram-positive bacteria;Escherichia coli,Klebsiella pneumoniae,Pseudomonas aeruginosa,Enterobacter cloacae and Acinetobacter baumannii ranked the top 5 spe-cies of gram-negative bacteria.There were significant differences in the distributions of S.aureus,K.pneumoniae and A.baumannii in the superficial,deep and organ cavities(P<0.05).The isolation rate of carbapenem-resistant Acinetobacter baumannii(CRAB)was 69.23%,and the isolation rate of methicillin-resistant Staphylococcus au-reus(MRSA)was 42.14%.The drug resistance rate of the S.aureus strains to oxacillin reached up to 40.24%;the drug resistance rates of the A.baumannii to imipenem and meropenem reached up 63.00%and 65.80%,re-spectively.The drug resistance rates of the K.pneumoniae strains to imipenem and meropenem approximated to 30%,and the drug resistance rate to tigecycline was 19.84%.CONCLUSIONS The total incidence of SSI shows a downward trend in the 53 hospitals of Suzhou area.The S.aureus is the major species of pathogens,and some of the pathogens show high drug resistance rates.
5.Validation of retinoblastoma mouse model based on fluorescence imaging technology
Cailing DAI ; Wei YANG ; Limei WANG ; Jinlong DAI ; Yuying WEN ; Jianmin GUO
International Eye Science 2025;25(5):706-713
AIM: To provide references for the non-clinical evaluation of therapeutic targets or drugs for retinoblastoma, fluorescently labeled Y79 cells are injected into the vitreous body of BALB/c-nu mice to establish a retinoblastoma model, and the Melphalan treatment group is used as a positive control, which is verified by fluorescence imaging technology.METHODS: BALB/c-nu mice were intravitreous injected with GFP transfected Y79 cells(1.0×107 cell/mL, 3 μL)to establish the model. On the 27th day, the mice were randomly divided into model control group and different doses of Melphalan groups(1, 3, 10 μg/eye groups)according to the fluorescence value of in vivo imaging, with vitreous body single administrated and ocular symptoms observed daily. Slit-lamp examination was performed at 12, 20, 29, 35, 42, 48, 55, 76, and 83 d after modeling. In vivo imaging was performed on 12, 20, 27, 41, 48, 55, 62, 69, 76, and 83 d. At the last treatment, the eyeball, brain and cerebellum tissues were removed for histopathological examination.RESULTS: From the sixth day of modeling, cloud-like substances could be seen in the eyes of the animals, and the cloud-like substances occupied the whole eyeball of the mice in the model control group at the later stage, accompanied by irregular growth of blood vessels. After 27 days of modeling, the fluorescence value was detected in all the animals, and the fluorescence value continued to increase with the extension of modeling time. The fluorescence value of the tumor reached the peak after 69-83 days of modeling. Histological examination showed severe proliferation of intraocular tumor cells in the model control group, and tumor cells were observed in the brain of 1 model animal. In the 10 μg/eye Melphalan group, the fluorescence value was significantly decreased at 17 d after administration. The fluorescence value of the 3 μg/eye Melphalan group was significantly inhibited at 59 d after administration. No tumor cells were found in the brain tissue of animals in all Melphalan groups.CONCLUSION: After vitreous injection of Y79/pCDH-LUC-copGFP cells in BALB/c-nu mice, significant ocular lesions and proliferation of tumor cells were observed in the eyes. Meanwhile, Melphalan intervention significantly inhibited tumor cells in a dose-dependent manner, indicating that the mouse model of retinoblastoma was successfully constructed.
6.Overview and Analysis of Orphan Drugs Approved for Marketing in the United States, the European Union, and Japan in 2024
Shaohong WANG ; Wei ZUO ; Xin LIU ; Limei LI ; Bo ZHANG
JOURNAL OF RARE DISEASES 2025;4(4):472-477
This paper conducts a pooled analysis of information related to orphan drugs approved for marketing in 2024 by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. It systematically sorts out the scope of indications, therapeutic area distribution, and special review and approval pathways of these drugs, as well as their research and development progress and marketing status in China, thus providing a reference for researchers, regulatory authorities, and industry stakeholders in the field of rare disease drugs.
7.Cross-sectional survey of healthcare-associated infection in 5 736 medical institutions across China in 2024
Cui ZENG ; Wuqiang GAO ; Fu QIAO ; Hui ZHAO ; Xu FANG ; Linping LI ; Xiuwen CHEN ; Jiansen CHEN ; Dan LI ; Yuan ZHOU ; Lingli YU ; Qinglan MENG ; Xia MOU ; Lijuan XIONG ; Weiguang LI ; Ding LIU ; Jiaqing XIAO ; Limei OU ; Baozhen LI ; Jun YIN ; Haojun ZHANG ; Qiang FU ; Qun LU ; Biao WU ; Ya-wei XING ; Shumei SUN ; Shuncai WANG ; Longmin DU ; Jingping ZHANG ; Wen-ying HE ; Gui CHENG ; Nan REN ; Xun HUANG ; Anhua WU
Chinese Journal of Infection Control 2025;24(11):1572-1583
Objective To understand the current situation of healthcare-associated infection(HAI)in China,pro-vide data support and decision-making basis for formulating scientific and effective strategies for HAI prevention and control.Methods A nationwide cross-sectional survey on HAI was conducted among various types and levels of medical institutions in China according to a unified protocol of bedside surveys and case investigations.Results In 2024,a total of 5 736 medical institutions and 2 751 765 patients were surveyed.Among them,34 889 HAI cases were identified,with a prevalence rate of 1.27%.The number of HAI episodes was 38 032,and case prevalence rate was 1.38%.The prevalence rate of HAI in medical institutions in different regions of China ranged from 0.66%to 2.35%.Among medical institutions of different scales,those with a bed capacity of ≥900 had the high-est incidence of HAI,reaching 1.65%.The most common infection site was the lower respiratory tract(44.66%),followed by the urinary tract(12.94%),surgical site(9.32%),upper respiratory tract(7.02%),and bloodstream infection(5.78%).The top 3 departments with the highest HAI rates were the general intensive care unit(10.02%),department of neurosurgery(5.51%),and department(group)of hematology(5.34%).A total of 23 238 strains of HAI pathogens were detected,with 10 714 strains(46.10%)from lower respiratory tract speci-mens.The top 5 detected strains were Klebsiella pneumoniae(14.76%),Pseudomonas aeruginosa(13.33%),Escherichia coli(12.79%),Acinetobacter baumannii(9.23%),and Staphylococcus aureus(7.88%).231 944 pa-tients underwent class Ⅰ incision surgery were monitored,with 1 647 cases experienced surgical site infection,and the prevalence rate of surgical site infection was 0.71%.The number of patients who should undergo pathogen de-tection(patients receiving therapeutic and therapeutic combined prophylactic antimicrobial agents)was 715 179,while the actual number was 480 492,with a pathogen detection rate of 67.18%.425 225 patients received patho-genic detection before treatment,with a detection rate of 59.46%.Conclusion The overall HAI prevalence in Chi-na is lower,showing disparities among medical institutions of different regions and scales.Therefore,precise imple-mentation of measures is necessary for HAI prevention and control,with a focus on high-risk institutions and high-risk departments,key areas,and critical procedures.All levels of medical institutions should continuously reduce the incidence of HAI by strengthening monitoring,standardizing the use of antimicrobial agents,and reinforcing basic HAI prevention and control measures.
8.Cross-sectional survey of healthcare-associated infection in 5 736 medical institutions across China in 2024
Cui ZENG ; Wuqiang GAO ; Fu QIAO ; Hui ZHAO ; Xu FANG ; Linping LI ; Xiuwen CHEN ; Jiansen CHEN ; Dan LI ; Yuan ZHOU ; Lingli YU ; Qinglan MENG ; Xia MOU ; Lijuan XIONG ; Weiguang LI ; Ding LIU ; Jiaqing XIAO ; Limei OU ; Baozhen LI ; Jun YIN ; Haojun ZHANG ; Qiang FU ; Qun LU ; Biao WU ; Ya-wei XING ; Shumei SUN ; Shuncai WANG ; Longmin DU ; Jingping ZHANG ; Wen-ying HE ; Gui CHENG ; Nan REN ; Xun HUANG ; Anhua WU
Chinese Journal of Infection Control 2025;24(11):1572-1583
Objective To understand the current situation of healthcare-associated infection(HAI)in China,pro-vide data support and decision-making basis for formulating scientific and effective strategies for HAI prevention and control.Methods A nationwide cross-sectional survey on HAI was conducted among various types and levels of medical institutions in China according to a unified protocol of bedside surveys and case investigations.Results In 2024,a total of 5 736 medical institutions and 2 751 765 patients were surveyed.Among them,34 889 HAI cases were identified,with a prevalence rate of 1.27%.The number of HAI episodes was 38 032,and case prevalence rate was 1.38%.The prevalence rate of HAI in medical institutions in different regions of China ranged from 0.66%to 2.35%.Among medical institutions of different scales,those with a bed capacity of ≥900 had the high-est incidence of HAI,reaching 1.65%.The most common infection site was the lower respiratory tract(44.66%),followed by the urinary tract(12.94%),surgical site(9.32%),upper respiratory tract(7.02%),and bloodstream infection(5.78%).The top 3 departments with the highest HAI rates were the general intensive care unit(10.02%),department of neurosurgery(5.51%),and department(group)of hematology(5.34%).A total of 23 238 strains of HAI pathogens were detected,with 10 714 strains(46.10%)from lower respiratory tract speci-mens.The top 5 detected strains were Klebsiella pneumoniae(14.76%),Pseudomonas aeruginosa(13.33%),Escherichia coli(12.79%),Acinetobacter baumannii(9.23%),and Staphylococcus aureus(7.88%).231 944 pa-tients underwent class Ⅰ incision surgery were monitored,with 1 647 cases experienced surgical site infection,and the prevalence rate of surgical site infection was 0.71%.The number of patients who should undergo pathogen de-tection(patients receiving therapeutic and therapeutic combined prophylactic antimicrobial agents)was 715 179,while the actual number was 480 492,with a pathogen detection rate of 67.18%.425 225 patients received patho-genic detection before treatment,with a detection rate of 59.46%.Conclusion The overall HAI prevalence in Chi-na is lower,showing disparities among medical institutions of different regions and scales.Therefore,precise imple-mentation of measures is necessary for HAI prevention and control,with a focus on high-risk institutions and high-risk departments,key areas,and critical procedures.All levels of medical institutions should continuously reduce the incidence of HAI by strengthening monitoring,standardizing the use of antimicrobial agents,and reinforcing basic HAI prevention and control measures.
9.A Case of Rhabdomyolysis in a Patient with Dermatomyositis after Intravenous Injection of Gadopentetate Dimeglumine
Herald of Medicine 2025;44(7):1169-1171
A patient with anti-MDA5-positive dermatomyositis complicated by hepatic dysfunction developed rhabdomyolysis after an intravenous injection of gadopentetate dimeglumine for magnetic resonance imaging.Analysis of clinical manifestations and medication correlation confirmed gadopentetate dimeglumineinduced rhabdomyolysis.Gadopentetate dimeglumine can cause rhabdomyolysis in dermatomyositis patients.Clinical conditions should be closely monitored when using gadopentetate dimeglumine to guard against adverse reactions.
10.Distribution and drug resistance of pathogens causing surgical site infections in 53 hospitals of Suzhou City from 2020 to 2023:a surveillance report
Yu ZHU ; Meijuan JIN ; Limei CAI ; Junji ZHANG ; Wei DING ; Shukai ZHU ; Xiaochao SONG
Chinese Journal of Nosocomiology 2025;35(22):3452-3456
OBJECTIVE To retrospectively investigate the incidence of surgical site infection(SSI),distribution and drug resistance of pathogens in 53 hospitals of Suzhou area from 2020 to 2023 so as to provide strategies for pre-vention and control of the hospital-associated infections in Suzhou area.METHODS The data regarding the SSI,distribution and drug resistance of pathogens were statistically analyzed through Suzhou City Regional Hospital In-fection Surveillance Platform.RESULTS The incidence of SSI was 0.24%among the 53 hospitals from 2020 to 2023.Staphylococcus aureus,Enterococcus faecalis,Staphylococcus epidermidis,Enterococcus faecium and Staphylococcus haemolyticus ranked the top 5 species of gram-positive bacteria;Escherichia coli,Klebsiella pneumoniae,Pseudomonas aeruginosa,Enterobacter cloacae and Acinetobacter baumannii ranked the top 5 spe-cies of gram-negative bacteria.There were significant differences in the distributions of S.aureus,K.pneumoniae and A.baumannii in the superficial,deep and organ cavities(P<0.05).The isolation rate of carbapenem-resistant Acinetobacter baumannii(CRAB)was 69.23%,and the isolation rate of methicillin-resistant Staphylococcus au-reus(MRSA)was 42.14%.The drug resistance rate of the S.aureus strains to oxacillin reached up to 40.24%;the drug resistance rates of the A.baumannii to imipenem and meropenem reached up 63.00%and 65.80%,re-spectively.The drug resistance rates of the K.pneumoniae strains to imipenem and meropenem approximated to 30%,and the drug resistance rate to tigecycline was 19.84%.CONCLUSIONS The total incidence of SSI shows a downward trend in the 53 hospitals of Suzhou area.The S.aureus is the major species of pathogens,and some of the pathogens show high drug resistance rates.

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