1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
2.Experimental study on novel pH-responsive manganese-based nanoprobes for ferroptosis and magnetic resonance imaging in breast cancer
Jingyi WANG ; Jiali DENG ; Yi ZHU ; Xinyi DING ; Jiajing GUO ; Zhongling WANG
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(9):1183-1193
Objective·To construct a pH-responsive manganese-based nanoprobe and explore the therapeutic efficacy of chemotherapy/ferroptosis synergistic treatment in breast cancer and the effect of pH-responsive magnetic resonance-activated imaging.Methods·BSA-MnO2@CPT(BMC)nanoprobes were prepared by biomineralization,and their physicochemical properties were characterized by transmission electron microscope(TEM)and dynamic light scattering.The magnetic resonance imaging(MRI)was used to evaluate the pH-responsive MRI T1 activation and time-dependent activation efficacy at the cellular level,with quantitative analysis of MRI T1 signal intensity.The reactive oxygen species(ROS)generation and glutathione(GSH)depletion by BMC nanoprobes were respectively detected by methylene blue(MB)and DTNB in vitro.The synergistic efficacy of chemotherapy and ferroptosis mediated by the nanoprobes in 4T1 breast cancer cells was evaluated using the Thiazolyl Blue Tetrazolium Bromide(MTT)assay.After co-incubation 4T1 cells with BMC,intracellular ROS levels were determined through the staining of ROS fluorescence indicator 2',7'-dichlorodihydrofluorescein diacetate(DCFH-DA)and the level of lipid peroxide(LPO)expression was detected by using BODIPY581/591 C11 probe.A subcutaneous xenograft tumor model of 4T1 breast cancer was established in mice,with four experimental groups:Control group(PBS group),CPT group,BSA-MnO2(BM)group,and BMC group.The pH-responsive T1 activation effect of the BMC nanoprobes was dynamically monitored in vivo,while the ferroptosis-based antitumor efficacy was evaluated by measuring tumor volume and ferroptosis biomarkers(LPO and ROS).Results·TEM revealed that the prepared BMC nanoprobes exhibited a spherical morphology with an average diameter of approximately 150 nm.The MRI results demonstrated that the nanoprobes were pH-activable,exhibiting progressively enhanced T1 signal intensity under acidic conditions,and displaying pH-dependent r1 relaxivity enhancement.These findings validated their dual pH/time-responsive activation efficacy at the cellular level.In vitro solution-level MB and DTNB assays demonstrated that the BMC nanoprobes effectively enhanced the generation of ROS and the consumption of GSH.Fluorescence staining with DCFH-DA and BODIPY581/591 C11 demonstrated that the combination of ferroptosis effect and chemotherapy significantly enhanced intracellular generation of ROS and LPO accumulation.The MTT assay demonstrated that the survival rate of tumor cells significantly decreased to 17%(P=0.003).In vivo MRI demonstrated that the T1 signal was significantly enhanced and reached its peak at 4 h after tail vein injection of the BMC nanoprobes.Furthermore,in vivo antitumor therapy showed that the BMC group exhibited upregulated levels of LPO and ROS in tumor tissues,accompanied by marked tumor suppression(P=0.009).Conclusion·The pH-responsive theranostic BMC nanoprobes enhances antitumor efficacy via the synergistic interaction of chemotherapy and ferroptosis,while enabling tumor microenvironment-activated MRI.
3.Analysis of awareness,usage,and influencing factors of smart shared traditional chinese medicine pharmacies:a case study of Nanchang city
Weijian LIU ; Bangyu ZHONG ; Xinyi DENG ; Shanshan WANG ; Chaoqun WANG ; Na TIAN
Modern Hospital 2025;25(7):1096-1099
Objective To analyze residents' awareness,usage,and influencing factors regarding smart shared Tradition-al Chinese Medicine(TCM)pharmacies in Nanchang City.Methods Descriptive analysis,one-way ANOVA,chi-square tests,and hierarchical regression analysis were employed to determine the awareness,usage,and influencing factors of shared TCM pharmacies.Results The survey revealed that the primary channel for disseminating information about smart shared TCM phar-macies is the internet.The functions of TCM decoction and delivery services were widely recognized among respondents.Conven-ience was a key advantage considered by users.Most respondents had not used smart shared TCM pharmacy services,while over half primarily utilized TCM decoction,delivery,and prescription review services.Willingness to pay for decoction and delivery services was moderate,and drug quality emerged as a critical issue for the development of smart shared TCM pharmacies.Statisti-cally significant differences in awareness were observed across age,education level,residential area,household registration type,occupation,and household income(P<0.05).Age,occupation,residential area,and household registration significantly influ-enced usage frequency(P<0.05).The primary drivers of usage behavior were the functional value of smart shared TCM phar-macies rather than demographic characteristics.Conclusion It is recommended that the government,hospitals,and enterprises collaborate to establish a service framework for smart shared TCM pharmacies that ensures"visible quality,reliable delivery,and affordable pricing".
4.Clinical practice status of nutrition support care among specialized nurses in ICUs
Xinyi ZHOU ; Jianhua SUN ; Haibo DENG ; Lei WANG ; Xiaojie WANG ; Yu WANG ; Ranxun AN ; Manna SHAO ; Ni YANG ; Yufen MA ; Yuan XU
Chinese Journal of Nursing 2025;60(20):2514-2519
Objective To investigate the current nursing practice of nurses specializing in nutritional support in ICUs and analyze their influencing factors in order to improve the training program and promote the development of standardized and precise nursing practice.Methods Convenience sampling method was used to select nutritional support nurses in ICUs in 29 provinces(autonomous regions and municipalities)from October 2023 to March 2025,and the self-developed questionnaire on nursing practice behaviors of nutritional support nurses in ICUs was used to conduct the survey.SPSS 21.0 software was used for descriptive analysis and multiple linear regression analysis.Results A total of 774 questionnaires were distributed,and 766 valid questionnaires were collected,with a recovery rate of 98.97%,and the score of the questionnaire on nursing practice behaviors of nurses specializing in nutritional support in ICU was(90.41±1 1.82).The results of multiple linear regression analysis showed that gender,presence of a nutritional support nursing team in the hospital,a standardized process of nutritional support nursing in the department,clear positional responsibilities of the nutritional support nursing team members,and inclusion of the nutritional support status of the patients in the quality management of the department were the factors influencing the nursing practice behavior scores of the nurses specializing in nutritional support in ICUs(P<0.05).Conclusion Nurses in the ICUs have a high level of nursing practice behavior,but there is a need for further standardization in parenteral nutrition infusion and monitoring of complications.ICU nursing managers should formulate improvement strategies to address the weaknesses of clinical practice,strengthen nutritional support training,and improve the quality management program,and further improve the practical ability of nurses specializing in nutritional support.
5.Extracellular vesicles derived from synovial fluid in patients with rheumatoid arthritis promote angiogenesis of HUVEC
Kaibo WANG ; Chuanhao XU ; Yanbin TIAN ; Tai TENG ; Fengmei TAN ; Chi ZHANG ; Hong DENG ; Yanmeng LI ; Qin YANG ; Xinyi WANG ; Mei HAN
Immunological Journal 2025;41(2):72-79
Objective To investigate the effects of extracellular vesicles(EVs)derived from synovial fluid of rheumatoid arthritis(RA)patients on angiogenesis of human umbilical vein endothelial cells,and to preliminarily explore the underlying mechanisms.Methods Synovial fluid samples of knee joint were collected from 20 patients with RA and 20 patients with osteoarthritis(OA)in this study.EVs were purified using ultracentrifugation.The morphology and size of EVs were observed by transmission electron microscopy and nanoparticle tracking analysis.CD9,CD63,cytochrome c(Cyt-c),vascular endothelial growth factor(VEGF),lysyl oxidase(LOX),matrix metalloproteinase 2(MMP2),tumour necrosis factor alpha(TNF-α),transforming growth factor beta1(TGF-β1)in EVs were detected using Western blot.Human umbilical vein endothelial cells(HUVEC)were treated with the EVs.The growth,migration and angiogenesis of HUVEC were observed by CCK8 assay,TranswellTM chamber assay,scratch test and matrigel angiogenesis assay,respectively.The effect of EVs on the PI3K/AKT pathway in HUVEC was assessed using Western blot.Results Both EVs from RA synovial fluid(RA-EVs)and OA synovial fluid(OA-EVs)were cup-shaped,mainly between 30-400 nm in diameter,expressing CD63 and CD9,but not Cyt-c.RA-EVs carried more VEGF,LOX,MMP2,TNF-α and TGF-β1 than OA-EVs.Compared with the OA-EVs intervention,RA-EVs significantly promoted the proliferation,migration,and angiogenesis of HUVECs,as well as upregulated PI3K/AKT phosphorylation.The inhibitor of PI3K suppressed angiogenesis induced by EVs.Conclusion EVs in synovial fluid of RA carried more cytokines and enzymes that related angiogenesis and inflammation.These EVs exert their pro-angiogenic effects by activating the PI3K/AKT pathway,then contributing to the pathological progression of RA.
6.Self-assembled drug-loaded nanoprobes for pyroptosis sensitization and chemical exchange saturation transfer imaging in breast cancer
Jiali DENG ; Jiajing GUO ; Jingyi WANG ; Xinyi DING ; Yi ZHU ; Zhongling WANG
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(3):271-281
Objective·To prepare self-assembled drug-loaded nanoprobes with activatable chemical exchange saturation transfer(CEST)imaging capability,and evaluate their imaging performance and therapeutic potential for photodynamic-sensitized pyroptosis in breast cancer in vivo and in vitro.Methods·GC nanoprobes co-loaded with gemcitabine(Gem)and chlorin e6(Ce6)were constructed by using a self-assembly strategy.The physicochemical properties of the GC nanoprobes were characterized by scanning electron microscopy(SEM)and dynamic light scattering(DLS).The pH-/time-dependent CEST activation and drug release profiles were investigated.The 2',7'-dichlorodihydrofluorescein diacetate(DCFH-DA)probe was used to detect the generation of reactive oxygen species(ROS),and enzyme-linked immunosorbent assay(ELISA)was used to detect the release of inflammatory factors such as interleukin-1β(IL-1β)and IL-18 in mouse breast cancer 4T1 cells after treatment with GC nanoprobes with synergistic laser irradiation.Immunofluorescence was performed to detect immunogenic cell death(ICD)markers,including calreticulin(CRT)and high mobility group box 1 protein(HMGB1).The 4T1 breast cancer mouse models were established to validate tumor-specific CEST activation and evaluate anti-tumor efficacy by measuring tumor volume and detecting inflammatory factors and ICD markers.Results·SEM and DLS confirmed the uniform spherical morphology of the GC nanoprobes.The CEST imaging results showed that the nanoprobes had excellent pH-concentration and time-dependent activation imaging effects both in the simulated acidic microenvironment and at the cellular level in vitro.The drug release from this drug-loaded nanoprobe was 80%at pH 5.0,which was significantly higher than at pH 7.4(P=0.003).DCFH-DA fluorescence staining demonstrated that GC-mediated photodynamic therapy induced a significant generation of ROS.Analysis of pyroptosis-related factors revealed a marked increase in the release levels of IL-1β and IL-18(both P<0.05),along with elevated fluorescence expression of CRT and HMGB1.The in vivo CEST imaging results showed that the CEST signal at the tumor site was significantly enhanced,peaking at 4 h with tail vein injection of GC.The GC nanoprobes with synergistic laser irradiation group showed markedly elevated inflammatory factors(IL-1β,IL-18),changed ICD biomarkers(HMGB1 and CRT),and significant tumor suppression,compared to the PBS control group(all P<0.05).Conclusion·The GC nanoprobes enables specific CEST imaging-guided photodynamic therapy,effectively inducing pyroptosis and precise ablation of breast cancer.
7.Current status of external validation of risk prediction models in the nursing field in China: a scoping review
Xinyi ZHOU ; Liyun ZHU ; Yuan XU ; Jianhua SUN ; Haibo DENG ; Lei WANG ; Xiaojie WANG ; Ni YANG ; Manna SHAO ; Yufen MA
Chinese Journal of Modern Nursing 2025;31(1):100-105
Objective:To describe the current status and research methods of external validation studies of risk prediction models conducted by nursing scholars in China.Methods:Using the search terms "predictive model, external validation, nursing, risk prediction, external validation, nursing" this study searched eight databases (China Biology Medicine disc, China National Knowledge Infrastructure, Wanfang Data, VIP, Embase, PubMed, CINAHL, and Web of Science) for studies published up to June 2023. Literature was imported into EndNote software for organization and deduplication. Two researchers independently conducted initial and secondary screenings by reading the titles, abstracts, and full texts of studies according to inclusion and exclusion criteria. Descriptive analysis was conducted on the included studies under the framework of the Joanna Briggs Institute (JBI) scoping review methodology.Results:A total of 70 studies (15 dissertations and 55 journal articles), primarily published from 2021 to 2023, were included. Among 246 risk prediction models constructed by nurses, 28.5% (70/246) underwent external validation. The models focused on issues such as infection, cognitive impairment, skin injury, thrombosis, and malnutrition. Most studies were conducted in single-center settings (71.4%, 50/70), with temporal validation being the most common type (67.1%, 47/70). The majority of models were presented as nomograms, though some studies had methodological issues in validation.Conclusions:In recent years, new prediction models for specific diseases or endpoints have continued to emerge from nursing research in China, yet few have undergone external validation for clinical application, and the quality and methods of validation require improvement. Future researchers should standardize and strengthen the external validation and optimization of risk prediction models, focusing on clinical applicability to enhance the practical value of these models.
8.Thoughts on nearly a decade of high-quality development in specialized nursing for venous thromboembolism
Xiaojie WANG ; Yufen MA ; Yuan XU ; Lei WANG ; Liyun ZHU ; Yu WANG ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Ning ZHANG ; Haoran SHI ; Haibo DENG
Chinese Journal of Modern Nursing 2025;31(8):992-998
This paper summarizes the achievements of China's venous thromboembolism specialized nursing career in the past decade in nursing management, clinical nursing, talent cultivation, and discipline construction, and puts forward the outlook for the future work, with a view to providing reference for promoting the high-quality development of China's venous thromboembolism specialized nursing career.
9.Current status and influencing factors of nutrition support specialist nurses' knowledge, attitude and practice about nutrition nursing practice
Ni YANG ; Yuan XU ; Xinyi ZHOU ; Ge LIU ; Yanming DING ; Shuli GUO ; Qian LU ; Haibo DENG ; Ying LIU ; Yufen MA
Chinese Journal of Modern Nursing 2025;31(13):1698-1704
Objective:To investigate the current status of nutritional support specialist nurses' knowledge, attitude and practice about nutrition nursing practice and analyze their influencing factors, so as to provide reference for optimizing and improving the level of nutritional support specialist nurses' knowledge, attitude and practice, and constructing a training program for nutritional support specialist nurses.Methods:From October to November 2023, 557 nutritional support specialist nurses in 28 provinces, autonomous regions, and municipalities directly under the central government of China were selected for the survey using the convenience sampling method. General information questionnaire and Nutrition Nursing Practice Knowledge, Attitude and Practice Questionnaire were used to conduct the survey. Multiple linear regression was used to explore the influencing factors of knowledge, attitude and practice.Results:A total of 557 questionnaires were distributed and 507 questionnaires were effectively recovered, with an effective recovery rate of 91.0%. The nutrition nursing practice knowledge dimension scores, attitude dimension scores, and practice dimension scores of 507 nutritional support specialist nurses were 30.00 (28.00, 31.00) , 47.00 (41.00, 50.00) , (22.65±6.77) , respectively. Multiple linear regression analyses showed that education was an influencing factor in the knowledge dimension of nutrition nursing practice among nutritional support nurse specialists ( P<0.05) ; title, hospital level, and years of experience as a nutritional support nurse specialist were influencing factors in the attitude dimension of nutrition nursing practice ( P<0.05) . Conclusions:Nutritional support specialist nurses have a good knowledge base of nutrition nursing practice and a positive attitude, but their practices need to be further improved. Knowledge, attitude, and practice are affected by multiple factors such as education, title, hospital level, and number of years in the professional field. In the process of nurse specialist training, managers should pay attention to the learning needs of nurses at different levels, carry out targeted training, establish a standard workflow for nurse specialists, and emphasize the construction of talents in primary hospitals, so as to promote the high-quality development of nutrition support specialist nurses.
10.Investigation and analysis of the current status of picc-associated thrombosis prevention nursing among surgical nurses
Ning ZHANG ; Yuan XU ; Liyun ZHU ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Yufen MA ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yu WANG ; Xiaojie WANG
Chinese Journal of Modern Nursing 2025;31(17):2302-2308
Objective:To investigate the current status of peripherally inserted central catheter (PICC) -associated thrombosis prevention nursing practices among surgical nurses, and to provide a scientific basis for targeted future interventions.Methods:A convenience sampling method was used to select 3 151 surgical nurses from tertiary hospitals in 11 provinces and municipalities who attended the Surgical Nursing Academic Symposium of the Chinese Nursing Association between April and May 2023. The survey utilized a standardized questionnaire assessing current practices in PICC-associated thrombosis prevention among clinical nurses.Results:A total of 3 151 questionnaires were distributed, and 2 341 valid responses were collected, yielding a valid response rate of 74.29% (2 341/3 151) . Among the respondents, the training rate on PICC-associated thrombosis prevention was only 62.45% (1 462/2 341) , and just 1.28% (30/2 341) had received full-time (off-duty) training. The usage rate of standardized procedures for PICC-related thrombosis prevention was 92.40% (2 163/2 341) , and the risk assessment rate was 79.79% (1 868/2 341) . Compared to urology and cardiothoracic surgery departments, breast surgery departments had significantly higher rates of thrombosis risk assessment ( P<0.05) . Additionally, 56.69% (1 327/2 341) of surgical nurses used risk assessment tools specific to PICC-associated thrombosis. Among non-pharmacological prevention measures, the implementation rate of encouraging patients to perform grip strength exercises was only 68.26% (1 598/2 341) . Conclusions:The current level of PICC-associated thrombosis prevention nursing among surgical nurses needs further improvement. Efforts should be strengthened in professional training, implementation of standardized protocols, risk assessment, and non-pharmacological interventions.

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