1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.Genetic disease diagnosis and treatment in Shanghai: Survey and countermeasures for clinical genetics specialist training.
Xiaoju HUANG ; Lin HAN ; Li CAO ; Taosheng HUANG ; Duan MA ; Jian WANG ; Wenjuan QIU ; Fanyi ZENG ; Luming SUN ; Chenming XU ; Songchang CHEN ; Xinyu KUANG ; Hong TIAN
Chinese Journal of Medical Genetics 2026;43(4):241-247
OBJECTIVE:
To investigate the current status of clinical genetics specialization development and the diagnostic and therapeutic capabilities for hereditary diseases across medical institutions in Shanghai, and to assess the necessity and feasibility of establishing training bases for clinical genetics specialists.
METHODS:
By employing a cross-sectional survey design, the Clinical Genetics Committee of Shanghai Medical Association has conducted questionnaire surveys from March to April 2025 across 54 healthcare institutions in Shanghai (including 33 tertiary hospitals and 21 secondary hospitals). The survey involved administrative departments and medical personnel from 15 clinical specialties. The survey has covered current genetic disease diagnosis and treatment practices, relevant and specialised disease types, genetic department establishment, testing capabilities, personnel teams, and training requirements.
RESULTS:
The results revealed that 78.0% of clinical departments surveyed had treated patients with hereditary disorders. Shanghai possesses diagnostic and therapeutic expertise for over 95% of hereditary diseases listed in its rare disease catalogue, reflecting both the practical clinical demand for such conditions and the city's overall diagnostic and therapeutic strengths in this field. Nevertheless, significant disparities exist in the development of genetics departments across different tiers of healthcare institutions. Resources for genetic testing capabilities (including molecular, cellular, and biochemical testing) are also unevenly distributed across different tiers of hospitals. The survey further revealed that only 26.0% of departments believe that their current physician structure fully meets the diagnostic and treatment demands. Over 90% of departments consider standard training for clinical genetic specialists necessary, with 74.0% expressing willingness to participate in establishing training bases. Based on above findings and thorough deliberation, the Clinical Genetics Committee of the Shanghai Medical Association proposes advancing specialist training and discipline development through establishing a standard training system. The committee has drafted a three-year training protocol featuring a "joint training"-centered model, recommending a pilot-first, dynamically optimized strategy for steadily advancing training base development.
CONCLUSION
Shanghai faces substantial demand for genetic disease diagnosis and treatment, yet exhibits shortcomings in clinical genetics specialization development, resource allocation, and talent pipeline cultivation. To establish a standard training system holds significant practical importance and is underpinned by a broad demand.
Humans
;
China
;
Surveys and Questionnaires
;
Genetic Diseases, Inborn/genetics*
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Cross-Sectional Studies
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Genetics, Medical/education*
;
Genetic Testing
4.TGF-β1-engineered Biomimetic Platelet Nanoparticles for Targeted Therapy of Ischemic Stroke
Li-Qi CHEN ; Tian-Fang KANG ; Guo-Jun HUANG ; Ting YIN ; Ai-Qing MA ; Lin-Tao CAI ; Hong PAN
Progress in Biochemistry and Biophysics 2026;53(3):697-710
ObjectivePost-ischemic acute inflammation and the subsequent persistent dysregulation of the immune microenvironment represent major pathological drivers that aggravate neuronal injury and severely restrict functional recovery following ischemic stroke. Although current reperfusion therapies partially restore blood flow, they fail to effectively modulate the secondary inflammatory cascade and oxidative stress, which remain critical barriers to neurological restoration. To address this challenge, this study aimed to engineer and systematically evaluate a biomimetic nanosystem composed of transforming growth factor-β1 (TGF-β1)-loaded platelet membrane-camouflaged lipid nanoparticles (PLP). This nanosystem was designed to achieve dual lesion-targeted delivery and immune microenvironment remodeling. By verifying its spatiotemporal accumulation, anti-inflammatory activity, and neuroprotective efficacy, we sought to establish an integrated therapeutic strategy that simultaneously enables lesion targeting, immune regulation, and functional recovery after ischemic injury. MethodsThe physicochemical properties of PLP, including hydrodynamic particle size, zeta potential, structural stability, and morphology, were characterized using dynamic light scattering, zeta potential analysis, and transmission electron microscopy. The preservation of platelet membrane-derived adhesion and immunoregulatory proteins was confirmed by SDS-PAGE through comparative analysis of protein band profiles between PLP and native platelet membranes. The in vitro biological activities of PLP were evaluated using two complementary cellular models. LPS-induced M1-polarized RAW264.7 macrophages were employed to assess inflammatory modulation, while oxygen glucose deprivation/reperfusion (OGD/R)-induced BV2 microglial cells and SH-SY5Y neuronal cells were utilized to investigate neuroinflammatory regulation and neuronal protection. For in vivo validation, a transient middle cerebral artery occlusion (tMCAO) mouse model was established to mimic ischemia-reperfusion injury. The spatiotemporal biodistribution and lesion-targeting capability of the PLP were monitored through live fluorescence imaging. Therapeutic efficacy was comprehensively evaluated by triphenyltetrazolium chloride (TTC) staining, glial fibrillary acidic protein (GFAP) immunofluorescence analysis, body weight monitoring, and neurological severity score (NSS) assessment. ResultsPLP nanoparticles displayed a uniform spherical morphology, nanoscale particle size distribution, and stable negative surface charge, indicating favorable colloidal stability and circulation potential. SDS-PAGE results confirmed the effective retention of key platelet membrane proteins associated with endothelial adhesion, immune evasion, and inflammatory regulation, demonstrating the successful biomimetic construction. Optimal therapeutic concentrations were determined in OGD/R-induced BV2 cells, where PLP exhibited excellent cytocompatibility and anti-inflammatory activity.In vitro experiments demonstrated that PLP significantly inhibited the polarization of RAW264.7 macrophages toward the pro-inflammatory M1 phenotype and markedly reduced neuronal apoptosis under ischemia-reperfusion conditions. In vivo fluorescence imaging revealed that PLP rapidly accumulated in the ischemic brain hemisphere and maintained prolonged retention for up to 7 d, suggesting enhanced lesion-specific targeting and sustained drug release. Compared with control group, PLP treatment significantly reduced cerebral infarct volume, attenuated reactive astrogliosis, improved weight recovery, and accelerated neurological functional restoration, as reflected by significantly improved NSS scores. ConclusionThis study establishes a multifunctional biomimetic nanoplatform that integrates platelet membrane-mediated active targeting with the anti-inflammatory, antioxidative, and neuroprotective properties of TGF-β1. The PLP system enables rapid lesion homing and long-term retention while synergistically regulating the post-stroke inflammatory microenvironment by suppressing pro-inflammatory immune activation, reducing neuronal apoptosis, and limiting excessive astrocyte reactivity. Importantly, this study proposes a conceptually therapeutic paradigm that combines targeted delivery with immune microenvironment remodeling to achieve comprehensive neurovascular protection. These findings provide strong experimental evidence supporting the translational potential of biomimetic nanotherapeutics as next-generation precision interventions for ischemic stroke.
5.The Thrombectomy Dilemma in Stroke Patients With Active Cancer: To Treat or Not to Treat?
Yohanna KUSUMA ; Mikiya BEPPU ; Beom Joon KIM ; Sung-Chun TANG ; Mikito HAYAKAWA ; Hiroshi YAMAGAMI ; Hiroyuki KAWANO ; Teruyuki HIRANO ; Shinichi YOSHIMURA ; Hamidon BASRI ; Richard LI ; Huy Thang NGUYEN ; Deidre Anne De SILVA ; Keun-Sik HONG ; Jiann-Shing JENG ; Than G. PHAN ; Henry MA ; Bernard YAN ;
Journal of Stroke 2026;28(2):218-227
Endovascular thrombectomy for acute large-vessel occlusion in patients with active cancer remains a difficult clinical decision. Multiple cohort studies and meta-analyses indicate that, when standard imaging and clinical criteria are applied, reperfusion success is high and symptomatic intracranial hemorrhage is broadly comparable with non-cancer populations, arguing against categorical exclusion. At the same time, registries show lower 90-day functional independence and higher 90-day mortality in active-cancer cohorts—effects likely driven by malignancy-related systemic factors and pre-existing functional compromise rather than procedural harm. This narrative review synthesizes efficacy and safety signals, highlights decision-grade outcomes that are seldom reported—early neurological change, performance status around 90 days, and whether systemic anticancer therapy is started or resumed. It sets out a clinical–ethical–economic framework to support selection, consent, and aftercare, including a pragmatic pathway for under-resourced settings based on non-contrast computed tomography (CT) or single-phase CT angiography where advanced perfusion imaging or magnetic resonance imaging are unavailable. We outline an Asia–Pacific collaborative program designed to identify subgroups that may benefit from reperfusion and initiation of active cancer care.
6.Mechanism of total flavonoids of Carthamus tinctorius L.against he-patic fibrosis based on LC-MS/MS combined with network pharma-cology and pharmacology experiments
Mingqi LI ; Yinghe WANG ; Xiaolu ZHAO ; Xiaomei BAO ; Xin YUE ; Guiqiang REN ; Yue-hong MA
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(5):586-598
AIM:To elucidate the pharmacody-namic and network pharmacological mechanisms of total flavonoids of Carthamus tinctorius L.,to ex-plore their key targets and related pathways,and to clarify their mechanism of action against hepatic fibrosis.METHODS:The total flavonoids of Cartha-mus tinctorius L.were determined by LC-MS/MS and analysed for their compositions;the active in-gredients were screened by TCMSP database,SWISS ADME database and literature search;the targets related to total flavonoids of Carthamus tinctorius L.were screened by Swiss Target Predic-tion database;and the targets related to hepatic fi-brosis were screened by GeneCards database;the anti-hepatic fibrosis targets of total flavonoids of Carthamus tinctorius L.were obtained by taking the intersection of Venny.2.1.0;the protein interac-tions were analysed by STRING database;the visu-alization analysis was carried out by Cytoscape soft-ware;the GO function and KEGG pathway analysis was carried out by Metascape platform;and molec-ular docking was verified by using AutoDock soft-ware for the core targets and active ingredients.The mechanism of anti-hepatic fibrosis of total fla-vonoids of Carthamus tinctorius L.was verified by animal model and in vitro cell experiments.RE-SULTS:A total of 41 flavonoid components were identified in Carthamus tinctorius L.Through the network pharmacological analysis,149 anti-hepatic fibrosis targets of total flavonoids of Carthamus tinctorius L.were obtained,including 23 core tar-gets.The GO enrichment analyses involved a total of three aspects,namely,biological process(BP),cellular component(CC),and molecular function(MF).KEGG enrichment results showed that PI3K/Akt and MAPK are pathways involved in the devel-opment of hepatic fibrosis.Molecular docking veri-fied that the active ingredients Quercetin,Acacetin and Glabridin were tightly bound to Akt1 and HI-FIA,respectively.In animal model experiments,it was observed by HE and Masson staining that fibro-plasia was reduced,collagen deposition was re-duced,inflammatory cell infiltration was reduced,and fibrotic liver tissues were improved in total fla-vonoids of Carthamus tinctorius L.administration group.In isolated cell experiments:Western blot-ting results suggested that total flavonoids of Car-thamus tinctorius L.could decrease the hepatic fi-brosis marker factor α-SMA,Collagen1(P<0.01)and PI3K,Akt protein expression(P<0.01).CONCLU-SION:Total flavonoids of Carthamus tinctorius L.ex-erted anti-hepatic fibrosis effects through multi-components,multi-targets and multi-pathways,and their mechanism of action may be achieved by regulating the PI3K/Akt signalling pathway.
7.Visualization analysis of knowledge map and trends in glymphatic system research
Xingyi MA ; Huijing LI ; Juan LI ; Dongling ZHONG ; Yuan ZHANG ; Hong TANG ; Yuxi LI ; Rongjiang JIN
Chinese Journal of Tissue Engineering Research 2025;29(23):5051-5060
BACKGROUND:The clearance pathway of metabolic waste in the brain is crucial for maintaining neural homeostasis.The accumulation of metabolic waste disrupts this equilibrium,representing a common pathological feature of many central nervous system diseases.In recent years,research focusing on the glymphatic system has emerged as a hotspot in the nervous system field.OBJECTIVE:To construct a knowledge map of glymphatic system research,visually analyze the current state of research,main hotspots,and future development trends within this area.METHODS:Utilizing CiteSpace,VOSviewer,and the Bibliometrix package in the R language environment,this study conducted an in-depth visual analysis of glymphatic system-related literature from the Web of Science Core Collection database,spanning from January 2012 to March 2024.This analysis included authors,institutions,countries,journals,keywords,and co-citation frequencies.RESULTS AND CONCLUSION:A total of 687 related articles were included in this study.The number of publications in this field increased year by year,showing an explosive growth trend in the past three years.The countries,institutions,and authors with the largest number of publications in this research field were the United States,University of Rochester,and Professor Maiken Nedergaard.The journal with the highest number of publications was JOURNAL OF CEREBRAL BLOOD FLOW AND METABOLISM.The high-frequent and high-central keywords mainly focused on the mechanism such as cerebrospinal fluid hydrodynamics,neurological diseases such as Alzheimer's disease,and imaging techniques such as diffusion tensor imaging.The literature with the highest co-citation frequency was a classic review of the glymphatic system.The above results show that the research of glymphatic system is an emerging and active field,which has attracted wide attention at home and abroad and gradually expand from theoretical research to clinical practice.
8.Interpretation of the group standard for measurement technique of central venous pressure
Mingxi ZHAO ; Xin GUAN ; Hong SUN ; Hongming MA ; Yueying FENG ; Meng YU ; Dengxiu ZOU ; Hongbo LUO ; Zunzhu LI ; Jie JING ; Xinjuan WU
Chinese Journal of Nursing 2025;60(1):47-51
Central venous pressure(CVP)is a commonly used hemodynamic index in clinical practice,and the accuracy of its measurement results is influenced by the measurement technical specifications.Based on research evidence and clinical practice,this article interprets the main content of the group standard of CVP measurement technology,and proposes suggestions for its use.It aims to guide clinical nursing staff to correctly understand the principles and methods of CVP measurement,and promote the standardization of nursing practice and the accuracy of measurement results.
9.The correlation between phase angle and sarcopenia in middle-aged and elderly patients with type 2 diabetes mellitus
Qian LI ; Hong ZHU ; Meng YE ; Yanzhe WU ; Li WU ; Weiwei MA
Journal of Capital Medical University 2025;46(2):340-347
Objective To explore the association between phase angle(PhA)and sarcopenia in middle-aged and elderly patients with type 2 diabetes mellitus(T2DM),and to evaluate its predictive value for the risk of sarcopenia in these patients.Methods We collected data from 356 middle-aged and elderly T2DM patients hospitalized in the Department of Endocrinology,Nanjing Drum Tower Hospital Group Suqian Hospital from March 2022 to June 2024,including 274 patients with diabetes only and 82 patients with T2DM combined with sarcopenia.A Logistic regression analysis was conducted to assess the relationship between phase angle and sarcopenia.The predictive value of PhA for sarcopenia in T2DM patients was analyzed using the receiver operating characteristic(ROC)curve,and the trend of PhA with the severity of sarcopenia in T2DM patients was tested by the Jonckheere-Terpstra method.Results Univariate analysis showed that the PhA value in the T2DM with sarcopenia group was significantly lower than that in the diabetes alone group,with a statistically significant difference(P<0.05).Additionally,height,body mass,body mass index(BMI),waist circumference,arm circumference,calf circumference,fasting insulin,postprandial 2 h insulin,fasting C-peptide,postprandial 2 h C-peptide,triglycerides,albumin,blood urea nitrogen,body composition indicators,6 m walking speed,muscle mass,and muscle strength-related indicators were significantly lower in the T2DM with sarcopenia group compared to the diabetes alone group.Age,duration of diabetes,glycated hemoglobin,25-hydroxyvitamin D[25-(OH)D]were significantly higher in the T2DM with sarcopenia group,with statistically significant differences(P<0.05).Multivariate Logistic regression analysis indicated that,after adjusting for other factors,PhA remained associated with sarcopenia in T2DM patients(P<0.05),with a decreased PhA increasing the risk of sarcopenia.ROC curve analysis showed that the area under the curve(AUC)for PhA predicting sarcopenia in T2DM patients was 0.769(95% CI:0.710-0.829),indicating the predictive efficacy of PhA.Trend analysis demonstrated a significant negative correlation between PhA and the severity of sarcopenia in T2DM patients(P<0.05).Conclusion The PhA is significantly associated with sarcopenia in patients with T2DM.It can serve as an early predictive and diagnostic tool for sarcopenia in individuals with T2DM.
10.Development of a knowledge-attitude-practice assessment scale for home prevention and management of parastostomy hernia in ostomy patients and the test of its reliability and validity
Yajing ZHANG ; Hui ZHU ; Hong YIN ; Yu LONG ; Yang LI ; Qiaomei ZHANG ; Hongwen MA
Chinese Journal of Nursing 2025;60(4):411-417
Objective To develop a knowledge-attitude-practice assessment scale for home prevention and man-agement of parastostomy hernia in ostomy patients,and to test its reliability and validity,to provide a reliable tool for evaluating the knowledge and practice level of home prevention and management of parastostomy hernia in pa-tients with ostomy.Methods Based on the theory of knowledge,attitude and practice,the initial scale was generat-ed through literature review,semi-structured interviews,expert correspondence,research group discussion and pre-sur-vey.From May to December 2023,685 patients with ostomy from the ostomy clinic of a tertiary hospital in Tianjin were investigated by purpose sampling method,and the reliability and validity were tested.Results A total of 673 valid questionnaires were collected,the results showed that the knowledge-attitude-practice assessment scale for pre-venting and managing parastomal hernia of ostomy patients at home included 3 dimensions of knowledge,attitude and practice,with a total of 27 items.The response rates of 2 rounds of the questionnaire were both 100%;the au-thority coefficients were all 0.915;the Kendall's coefficients of concordance were 0.279 and 0.301,respectively.The content validity index of each item was 0.875~1.000;the content validity index of the average scale level was 0.988;after 2 exploratory factor analysis,the cumulative variance contribution rate was 65.920%.The results of con-firmatory factor analysis showed that the model had a good fit,with a chi-square degree of freedom ratio(/df)of 1.945,the fitting goodness index(GFI)of 0.851,the comparative goodness of fit index(CFI)of 0.919,the root means square error of approximation(RMSEA)of 0.060.The Cronbach's alpha coefficient result of the scale is 0.957,with a test-retest reliability of 0.826 and a half reliability of 0.934.Conclusion The knowledge-attitude-practice assessment scale has good reliability and validity,and can be used as an assessment tool for home prevention and management of parastostomy hernia in ostomy patients.

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