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.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.
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.Cloning and functional characterization of PhNAL1b from Petunia× hybrida cv. Mitchell Diploid.
Xurong YAO ; Tongrui LIU ; Lili DONG ; Xinyi DENG
Chinese Journal of Biotechnology 2025;41(2):869-880
Narrow leaf 1 (NAL1) plays an important role in plant branching, while little is known about the roles of this gene in petunias. In this study, PhNAL1b was cloned from Petunia×hybrida cv. Mitchell Diploid, with a total length of 1 767 bp, encoding a protein composed of 588 amino acid residues and containing the peptidase S64 domain. The PhNAL1b promoter region contained several elements involved in the responses to auxin, jasmonic acid, abscisic acid, and light. The expression analysis showed that PhNAL1b had the highest expression level in roots and the lowest expression level in flowers, and its transcription could be inhibited by decapitation and cytokinin. The subcellular localization analysis showed that PhNAL1b was located in the nucleus and was a nuclear protein. Virus-induced gene silencing was employed to downregulate the expression of PhNAL1b, which resulted in significant increases in branch number and plant height. The results indicated that PhNAL1b played an important role in regulating the branching of petunias. This study lays a foundation for revealing the mechanism of NAL1 in regulating branch development and provides genetic resources for plant architecture improvement.
Petunia/growth & development*
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Plant Proteins/metabolism*
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Diploidy
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Gene Expression Regulation, Plant
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Cloning, Molecular
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Promoter Regions, Genetic
5.Discrepancies between clinical sign and ultrasound-detected inflammatory lesions in psoriatic arthritis
Xiaoying SUN ; Zhibo SONG ; Yan GENG ; Xuerong DENG ; Xiaohui ZHANG ; Juan ZHAO ; Xinyi HU ; Yu WANG ; Hong HUANG ; Zhuoli ZHANG
Chinese Journal of Rheumatology 2025;29(9):750-758
Objective:To explore the distribution variation of ultrasound-detected inflammatory lesions with clinical signs in patients with psoriatic arthritis (PsA).Methods:This was based on the Peking University First Hospital Psoriatic Arthritis (PKUPsA) cohort. Patients enrolled from January 2019 to June 2024 were inchuded, patients with complete data of physical examination and ultrasonographic evaluations of 62 joints in the hand and foot. The ultrasound-detected inflammatory lesions including synovitis, tenosynovitis, enthesitis, and soft tissue inflammation were compared with joint tenderness/swelling. The χ2 test was employed to analyze differences between groups. Results:A total of 7 440 joints in 120 PsA patients were included. Overall, the proportion of joints with clinical signs (tenderness or swelling) was higher than those with ultrasound-detected inflammatory lesions [9.14%(680/7 440) vs. 7.93%(590/7 440), χ2=1 245.928, P<0.001], with more tenderness joints than swelling joints [7.72%(574/7 440) vs. 6.14%(457/7 440), χ2=3 264.45, P<0.001]. Clinical signs were primarily observed in hand proximal interphalangeal (PIP), distal interphalangeal (DIP), wrist and ankle joints, mostly in DIP2 joints [19.58%(47/240)]. Ultrasound-detected inflammatory lesions were predominantly found in metatarsophalangeal (MTP), wrist, and ankle joints, mostly in MTP2 joints (18.75%, 45/240). Clinical signs were more prevalent than ultrasound-detected inflammatory lesions in hand PIP1-3, PIP5, DIP2, and DIP5 joints ( P<0.05), whereas more frequent ultrasound-detected inflammatory lesions than clinical tenderness/swelling were in MTP1-4 joints ( P<0.05). Among ultrasound-detected inflammatory lesions, synovitis in MTP2 joints (18.75%, 45/240), tenosynovitis in ankle joints (10.00%, 24/240), enthesitis in hand DIP2 joints (8.75%, 21/240), and soft tissue inflammation in MTP4 joints (2.50%, 6/240) most commonly observed. Dactylitis was more frequently observed in toes than in fingers, with the fourth toe most commonly affected(16.67%, 40/240). Ultrasound-detected inflammatory lesions were observed in 72.37%(55/240) of fingers/toes with clinical dactylitis, mainly presenting as synovitis, tenosynovitis, or combinations of these. Conclusion:PsA exhibits significant heterogeneity in the inflammatory lesions across different joints and lesion types. The discrepancies between clinical findings and ultrasonic inflammatory changes highlight the limitations of physical examination in fully capturing the pathological features of PsA. As a critical tool for PsA evaluation, ultrasonography offers distinct advantages in detecting subclinical inflammation and differentiating inflammatory from non-inflammatory lesions.
6.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.
7.Angiotensin Ⅱ activates p53/SAT1 signaling pathway to induce ferroptosis in white adipocytes
Wei DENG ; Xiyan LIU ; Liyuan GUO ; Qian XU ; Kun ZHOU ; Yuanqin ZHAO ; Zhaoyue WANG ; Xiang LI ; Xin-mei DENG ; Xinyi QIN ; Zhong REN ; Zhisheng JIANG
Chinese Journal of Arteriosclerosis 2025;33(5):385-394
Aim To investigate the effect and mechanism of angiotensin Ⅱ(Ang Ⅱ)on ferroptosis in white adi-pocytes.Methods The 3T3-L1 preadipocytes were differentiated into white adipocytes by inducer stimulation.The experiment was divided into control group,Ang Ⅱ group,Ang Ⅱ+Fer-1(ferroptosis inhibitor)group and Ang Ⅱ+PFT-α(p53 inhibitor)group.Ang Ⅱ was used to treat cells.RT-qPCR and Western blot were used to detect the expression levels of ferroptosis factors and adipokines.JC-1 kit was used to detect mitochondrial membrane potential(MMP)level.Iron ion kit was used to detect intracellular iron content.Glutathione(GSH)kit was used to detect GSH content.Fer-1 and Ang Ⅱ were added to treat cells to detect the the changes of ferroptosis level.The expression of p53 and spermidine/spermine N1-acetyltransferase 1(SAT1)protein was detected.Subsequently,PFT-α and Ang Ⅱ were added to co-treat cells to detect the changes of p53 and SAT1 protein expression,and to observe the effect of inhibiting p53 expression on the expression levels of ferroptosis factors and adipokines.Results 3T3-L1 cells were successfully differentiated into white adipocytes by stimulator-induced differentiation.Ang Ⅱ induced ferroptosis in white adipocytes.RT-qPCR results showed that compared with control group,the mRNA expression of anti-ferroptosis factor glutathione peroxidase 4(GPX4),solute carrier family 7 member 11(SLC7A11)and iron regulatory protein 1(IRP-1)was down-regulated in Ang Ⅱ group,and the mRNA expression of pro-ferroptosis factor acyl-CoA synthetase of long-chain family member 4(ACSL4)was up-regulated.Western blot results showed that compared with control group,the protein expression of SLC7A11 and GPX4 was down-regulated in Ang Ⅱ group,and the protein expression of ACSL4 was up-regulated.Ang Ⅱ treatment increased the content of intracellular iron ions and decreased the levels of GSH and MMP.Compared with Ang Ⅱ group,the mRNA expression of IRP-1 and SLC7A11 was up-regulated in Ang Ⅱ+Fer-1 group.Ang Ⅱ induced changes in the expression profile of adipokines in white adipocytes.Western blot results showed that compared with control group,the protein ex-pression of pro-inflammatory adipokine leptin(LEP),resistin(RETN),interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)was up-regulated in Ang Ⅱ group,and the protein expression of anti-inflammatory adipokine adiponectin(AD-PN)and omentin 1(ITLN1)was down-regulated.In addition,Ang Ⅱ increased the protein expression of p53 and SAT1.Inhibition of p53 expression can improve the level of ferroptosis and adipokine expression in white adipocytes trea-ted with Ang Ⅱ.Western blot results showed that compared with Ang Ⅱ group,the protein expression of p53 and SAT1 was down-regulated in Ang Ⅱ+PFT-α group,the protein expression of SLC7A11 and GPX4 was up-regulated,and the protein expression of ACSL4 was down-regulated.The protein expression of ADPN was up-regulated in Ang Ⅱ+PFT-αgroup,and the protein expression of TNF-α,LEP and RETN was down-regulated.Conclusion Ang Ⅱ induces fer-roptosis in white adipocytes through activating the p53/SAT1 signaling pathway.
8.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.
9.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.
10.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".

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