1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Association between phthalates and high-density lipoprotein-related inflammatory indicators
Yanzi ZHANG ; Xiuling ZHU ; Kai LI ; Wenqian ZENG ; Bing GUO
Journal of Army Medical University 2025;47(16):1940-1949
Objective To investigate the association of urinary phthalate metabolites with 4 high-density lipoprotein-cholesterol(HDL-C)-related inflammatory indicators[lymphocyte/HDL-C ratio(LHR),monocyte/HDL-C ratio(MHR),neutrophil/HDL-C ratio(NHR),and platelet/HDL-C ratio(PHR)],and to explain their possible biological mechanisms.Methods The 4 573 adult participants from the National Health and Nutrition Examination Survey(NHANES)were subjected,and then generalized linear regression(GLM),restricted cubic spline(RCS),and weighted quantile sum(WQS)regressions were performed to explore the potential associations of phthalates mono-exposures and mixed exposures,respectively,with the HDL-C-related inflammation metrics.Results Nine urinary phthalate metabolites were significantly positively associated with at least 1 inflammatory marker,while 1 metabolite(MEP)showed a negative association with an inflammatory indicator(LHR).Some exposure metabolites showed a nonlinear association with outcome inflammatory indicators.WQS regression revealed varying weight contributions of individual metabolite to each inflammatory outcome.Subgroup analyses indicated differential association effects of phthalates with HDL-C-related inflammatory metrics across gender,age,and BMI populations.Conclusion There are associations between phthalate exposure and HDL-C-related inflammation indicators,but further studies are needed to reveal the underlying mechanisms.
4.Field-driven medical micro-robots:application prospect of continuously optimizing material preparation process
Wenqian XIAO ; Hongjuan HAN ; Haocheng YANG ; Bo LI ; Binyan HE
Chinese Journal of Tissue Engineering Research 2025;29(10):2097-2104
BACKGROUND:Micro-robots have the characteristics of small size,flexibility,and strong targeting,and can complete complex tasks in a single or clustered manner in a narrow environment.With the continuous optimization of materials,preparation processes,and driving approaches,they have shown increasingly important application value in the field of biomedicine. OBJECTIVE:To analyze the application of field-driven micro-robots in medical field and to look forward to their application prospect. METHODS:Using"microrobots,nanorobots,drivers,biomedical,medical"as Chinese keywords and"microrobots,micro-robots,nanorobots,micromachine,microswimmer,medical"as English keywords,WanFang Data and PubMed databases were searched,respectively.The search time range was from January 2010 to January 2024,and a small number of long-term articles were included.Through reading the titles and preliminarily screening the abstracts,the repetitive studies,low-quality journals,and irrelevant literature were excluded.After reading the entire text,66 papers were finally included for review. RESULTS AND CONCLUSION:Field-driven medical micro-robots mainly include magnetic,optical,thermal,ultrasonic,and multi-mixed factor-driven robots.Field-driven robots have been used in intestinal diagnosis,drug targeting therapy,and stem cell therapy.Medical micro-robots are currently only used in a small number of clinical applications,but most of which are still in the theoretical and experimental stages.Medical micro-robots will face many challenges in future,such as large-scale preparation,precise control of micro-robots,recycling or degradation in vivo,whether the materials used will cause adverse reactions to the human body,and the related minimally invasive medical procedures.
5.Health literacy prediction models based on machine learning methods: a scoping review
PAN Xiang ; TONG Yingge ; LI Yixuan ; NI Ke ; CHENG Wenqian ; XIN Mengyu ; HU Yuying
Journal of Preventive Medicine 2025;37(2):148-153
Objective:
To conduct a scoping review on the types, construction methods and predictive performance of health literacy prediction models based on machine learning methods, so as to provide the reference for the improvement and application of such models.
Methods:
Publications on health literacy prediction models conducted using machine learning methods were retrieved from CNKI, Wanfang Data, VIP, PubMed and Web of Science from inception to May 1, 2024. The quality of literature was assessed using the Prediction Model Risk of Bias ASsessment Tool. Basic characteristics, modeling methods, data sources, missing value handling, predictors and predictive performance were reviewed.
Results:
A total of 524 publications were retrieved, and 22 publications between 2007 and 2024 were finally enrolled. Totally 48 health literacy prediction models were involved, and 25 had a high risk of bias (52.08%), with major issues focusing on missing value handling, predictor selection and model evaluation methods. Modeling methods included regression models, tree-based machine learning methods, support vector machines and neural network models. Predictors primarily encompassed factors at four aspects: individual, interpersonal, organizational and society/policy aspects, with age, educational level, economic status, health status and internet use appearing frequently. Internal validation was conducted in 14 publications, and external validation was conducted in 4 publications. Forty-two models reported the areas under the receiver operating characteristic curve, which ranged from 0.52 to 0.983, indicating good discrimination.
Conclusion
Health literacy prediction models based on machine learning methods perform well, but have deficiencies in risk of bias, data processing and validation.
6.Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing.
Xiaoxiao GAI ; Xiaoxia SUN ; Wenqian MA ; Zhenhua LIN ; Xinyuan LI ; Chenghu LIU
Chinese Journal of Medical Instrumentation 2025;49(4):415-422
OBJECTIVE:
To investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing.
METHODS:
MTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound.
RESULTS:
Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing.
CONCLUSION
Recombinant type Ⅲ humanized collagen plays an important role in wound healing.
Humans
;
Wound Healing/drug effects*
;
Recombinant Proteins/pharmacology*
;
Animals
;
Cell Proliferation
;
Cell Movement
;
Collagen/pharmacology*
;
Vascular Endothelial Growth Factor A/metabolism*
;
Bandages
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Platelet Endothelial Cell Adhesion Molecule-1/metabolism*
;
Endothelial Cells
;
Fibroblast Growth Factors/metabolism*
7.The Implementation Dilemmas and Optimization Suggestions of the Hospital Financial System from the Perspective of Policy Coordination
Linnan XUE ; Xinrui YU ; Wenqian LI ; Wanli GUO
Chinese Health Economics 2025;44(11):99-103
Objective:It aims to further optimize the Hospital Financial System to better adapt to the high-quality development of public hospitals.Methods:The implementation difficulties of the current Hospital Financial System is analyzed to explore its optimization logic from the perspective of policy synergy.Results:The optimization of the Hospital Financial System should reflect the achievements and directions of government accounting reform,scientifically reflect the laws of fund movement and policy management requirements,and further implement the spirit of financial and accounting supervision.Conclusion:It is suggested to comprehensively optimize the Hospital Financial System from the basic principles,main tasks,and other clauses,so as to better regulate the operation of funds,improve the level of hospital financial management,and help public hospitals achieve high-quality and sustainable development.
8.Advances in research on host factors for pathogenesis of non-tuberculous mycobacterial disease
Wenqian ZENG ; Yifan HE ; Li WANG ; Wei SHA
Chinese Journal of Clinical Infectious Diseases 2025;18(1):30-36
In recent years,the incidence and prevalence of non-tuberculous mycobacterial(NTM)infections have been on the rise,posing a serious threat to public health and presenting significant challenges for disease management. Currently,the treatment outcomes for NTM disease are poor,one of the main reasons being the high resistance of NTM pathogens to various anti-mycobacterial drugs. Novel therapeutic strategies targeting the host rather than the NTM pathogens themselves may help improve cure rates and reduce mortality. This article summarizes the latest research findings on host factors related to the incidence of NTM disease,including age,pulmonary diseases,immune function,genetic factors and lifestyle,which aids in the early identification of high-risk populations and provides a theoretical basis for developing targeted prevention and treatment strategies and optimizing treatment plans.
9.Gadd45b alleviates white matter damage in chronic ischemic rats by modulating astrocyte phenotype
Hui YU ; Yang YANG ; Ting WEI ; Wenli LI ; Wenqian LUO ; Bin LIU
Chinese Journal of Tissue Engineering Research 2025;29(36):7797-7803
BACKGROUND:Previous studies have found that growth arrest and DNA damage-inducible protein 45β(Gadd45b)is beneficial to the repair of acute cerebral ischemia,but the action mechanism is still unclear.OBJECTIVE:To investigate the effect and mechanism of Gadd45b on white matter demyelinating lesions in rats with chronic cerebral ischemia.METHODS:SD rats were randomly divided into four groups:sham operation group,model group,empty vector group,and Gadd45b overexpression group,with 15 rats in each group.Gadd45b-overexpressing lentivirus and no-load lentivirus were injected into the bilateral hippocampus and bilateral ventricles of rats.One week after lentivirus transfection,the rat model of chronic hypoperfusion cerebral ischemia was established by bilateral common carotid artery ligation.Three weeks after the bilateral common carotid artery ligation,the learning and cognitive functions of rats were evaluated by novel object recognition test.Luxol fast blue staining was used to observe the changes of myelin structure in the corpus callosum of rats.Hematoxylin-eosin staining and Nissl staining were used to observe the damage of the rat corpus callosum.Immunofluorescence staining was used to detect the expression of myelin basic protein and neurofilament protein 200 in the corpus callosum of rats.Immunofluorescence double staining was used to detect the expression of astrocyte markers GFAP/C3d and GFAP/S100A10 in rat brain tissue.ELISA was used to detect the levels of tumor necrosis factor-α and interleukin-6 in the supernatant of brain tissue.RESULTS AND CONCLUSION:(1)Gadd45b overexpression could significantly improve the learning and cognitive function of rats with chronic cerebral ischemia,and improve demyelination and pathological damage in the rat corpus callosum.(2)The results of immunofluorescence showed that Gadd45b overexpression significantly increased the expression levels of myelin basic protein and neurofilament protein 200 in the brain tissue of rats with chronic cerebral ischemia.(3)Gadd45b overexpression reduced GFAP/C3d double positive cells and increased GFAP/S100A10 double positive cells in the brain tissue of rats with chronic cerebral ischemia.(4)Gadd45b overexpression reduced the levels of tumor necrosis factor-α and interleukin-6 in the brain tissue of rats with chronic cerebral ischemia.It is concluded that Gadd45b overexpression improves cognitive dysfunction by promoting the A2 phenotype transformation of astrocytes,alleviating white matter myelin structure damage and neuroinflammation in rats with chronic cerebral ischemia.
10.ERMAP ameliorates experimental autoimmune encephalomyelitis in MOG-specific TCR transgenic mice
Jie ZHU ; Wenqian SONG ; Kezhu CHEN ; Yuandi LI ; Jie GAO ; Rong HU ; Min SU
Chinese Journal of Immunology 2025;41(6):1344-1349
Objective:To induce an experimental autoimmune encephalomyelitis(EAE)model by MOG-specific TCR trans-genic mice(2D2TCR transgenic mice),and to investigate effect of exogenous ERMAP on T cells in spleen of MOG35-55-induced 2D2TCR transgenic mice.Methods:EAE models were established in two groups of 2D2TCR transgenic mice(Control-Ig treatment for control group and ERMAP-Ig fusion protein treatment for experimental group),with 9 mice per group.Severity of spinal cord injury of MOG35-55-induced EAE in mice was assessed based on daily clinical scores(DAI),HE and LFB staining results;autoreactive T cells(CD4+Vα3.2+Vβ11+),T cell proliferation activation indicators CD69(CD4+Vα3.2+Vβ11+CD69+)and Ki67(CD4+Vα3.2+Vβ11+Ki67+),Treg(CD4+Vα3.2+Vβ11+CD25+Foxp3+)and Th17 cells(CD4+Vα3.2+Vβ11+IL-17A+)in spleen were detected by flow cytome-try;IL-17A,IL-6,IFN-γ and TGF-β expressions in spinal cord tissues were detected by qRT-PCR.Results:In MOG35-55-induced 2D2TCR transgenic mouse EAE model,ERMAP-Ig fusion protein treatment group showed milder inflammatory infiltration and demye-lination in spinal cord,decreased proportion of autoreactive T cells,decreased proportion of activated and proliferating T cells,increased proportion of Treg,inhibition of Th17 cell differentiation,less inflammatory cell aggregation and cytokine production,and increased expression of anti-inflammatory factors in spinal cord.Conclusion:ERMAP may be involved in development of EAE in 2D2TCR transgenic mice by inhibiting T cell proliferative activation and promoting Treg cell production.


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