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.Pharmacodynamic Substances and Mechanisms of Xinglou Chengqi Tang in Treating Post-stroke Complications: A Review
Yujin ZHANG ; Xiangzhuo LIU ; Zhouyang CHEN ; Zihao SONG ; Xinyi LIU ; Yizhi YAN ; Chaoya LI ; Yingyan FANG ; Shasha YANG ; Xueqin CHENG ; Zhou XIE ; Sijie TAN ; Peng ZENG ; Yue ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):327-337
Stroke is the leading cause of death and disability among adults in China, and its common complications include digestive system abnormalities, cognitive impairment, depression, stroke-associated pneumonia, and hemiplegia. The combination of traditional Chinese and Western medicine has great potential in treating post-stroke complications. Xinglou Chengqitang (XLCQT) is a representative prescription of alleviating the disease in the upper part by treating the lower part. It has definite therapeutic effect and high safety. Clinically, XLCQT is often used to treat stroke and its complications. However, the quantity and quality of clinical trials of XLCQT in treating post-stroke complications need to be improved. Additionally, since the basic research is weak, the material basis and multi-target mechanism for the efficacy of this prescription are unknown. This article reviews XLCQT in terms of the pharmacodynamic basis, medicinal properties, safety evaluation, and progress in clinical research and mechanisms in treating post-stroke complications. This article summarizes 22 key active ingredients of XLCQT in treating acute stroke complicated with syndrome of phlegm heat and fu-organ excess. Among these key active ingredients, resveratrol, kaempferol, luteolin, chrysoeriol, apigenin, (+)-catechin, and adenosine have good pharmacokinetic properties and high bioavailability. The mechanisms of XLCQT in treating post-stroke complications are complex, including inflammatory response, brain-gut axis, hypothalamic-pituitary-adrenal (HPA) axis, intestinal flora, neurotrophic factors, autophagy, oxidative stress, and free radical damage. This review helps to deeply understand the pharmacodynamic basis and mechanisms of XLCQT in treating post-stroke complications and provides a theoretical basis for the clinical application of XLCQT against post-stroke complications and the development of drugs.
3.Zuogui Wan Improve Ovarian Inflammatory Microenvironment and Stemness of Ovarian Germline Stem Cells in Ovarian Aging via cGAS/STING Signaling Pathway
Yunling ZHENG ; Xinyi PAN ; Zuang LI ; Yixuan WANG ; Junyi AN ; Yuxin ZOU ; Mengting XIAO ; Zheng CHEN ; Ling ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):1-10
ObjectiveTo investigate the mechanism of Zuogui Wan (ZGW) in improving ovarian inflammatory microenvironment and stemness of ovarian germline stem cells (OSCs) for treating ovarian aging via the cyclic guanosine monophosphate/adenosine monophosphate synthase (cGAS)/stimulator of interferon genes (STING) signaling pathway. MethodsForty C57BL/6 female mice were randomly divided into a blank group, a model group, a low-dose ZGW group (2.7 g·kg-1), a high-dose ZGW group (5.4 g·kg-1), and an estradiol valerate group (0.15 mg·kg-1), with 8 mice in each group. Except the blank group, all other groups received a single intraperitoneal injection of cyclophosphamide at 120 mg·kg-1 to establish an ovarian aging mouse model. After successful modeling, each group was continuously administered for 4 weeks, once daily. The physiological status of the mice was observed, and the ovarian index was calculated. The estrus cycle of the mice was monitored. Hematoxylin-eosin (HE) staining was used to observe pathological changes in ovarian tissue. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum sex hormone levels. Serum inflammatory factors interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and mouse interleukin-6 (IL-6) levels were detected using kits. Western blot was used to detect the protein expression of ovarian cGAS, STING, p-STING, TANK-binding kinase 1 (TBK1), p-TBK1, interferon-induced transmembrane protein 3 (Fragilis), and Vasa homolog protein (MVH). Quantitative real-time polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of inflammatory factors in ovarian tissue. Immunofluorescence double labeling was performed to locate OSCs in ovarian tissues, and fluorescence intensities of OSCs markers MVH and octamer binding transcription factor 4 (Oct4) were calculated. ResultsCompared with the blank group, the model group showed reduced body weight, ovarian wet weight, and ovarian index (P<0.01) and a disordered estrus cycle (P<0.01). In addition, the levels of serum follicle-stimulating hormone (FSH), TNF-α, IL-6, and IL-1β were increased (P<0.01), while anti-Müllerian hormone (AMH) and estradiol (E2) levels were decreased (P<0.01). The protein expression of cGAS, p-STING/STING, and p-TBK1/TBK1 in ovarian tissue was increased (P<0.05, P<0.01), while that of OSCs stemness factors MVH and Fragilis was reduced (P<0.01). Immunofluorescence indicated a reduction in MVH and Oct4 expression in OSCs (P<0.01). The mRNA expression of inflammatory factors TNF-α, IL-6, and IL-1β in ovarian tissue was increased (P<0.05, P<0.01). Compared with the model group, the treatment groups exhibited improved body weight, ovarian wet weight, and ovarian index (P<0.05) and a reduced rate of estrus cycle disorder (P<0.05, P<0.01). The levels of serum FSH, TNF-α, IL-6, and IL-1β were decreased (P<0.05, P<0.01), while AMH and E2 levels were increased (P<0.01). The protein expression levels of cGAS, p-STING/STING, and p-TBK1/TBK1 in ovarian tissue were decreased (P<0.05), while the protein expression of MVH and Fragilis was increased (P<0.05), and the fluorescence intensities of MVH and Oct4 were increased (P<0.05, P<0.01). The mRNA expression of inflammatory factors in ovarian tissue was decreased (P<0.05). ConclusionZGW alleviate ovarian inflammatory response, regulate ovarian microenvironment homeostasis, and maintain stemness of OSCs in ovarian aging mice probably by modulating the cGAS-STING signaling pathway, thereby improving ovarian function and delaying ovarian aging.
4.Relationship of screen time and sleep duration with screening myopia among junior and senior high school students
CHEN Xinyi, WANG Yun, ZENG Xia
Chinese Journal of School Health 2026;47(3):430-433
Objective:
To explore the relationship of screen time and sleep duration with screening myopia among junior and senior high school students, so as to provide evidence for the prevention and control of myopia among students.
Methods:
From March to October 2024, 429 junior and senior high school students from a district of Guangzhou were selected using stratified cluster random sampling method. Standardized logarithmic visual acuity chart was used for vision assessment, while Questionnaire for the Physical Health Monitoring System of Students in Guangzhou was employed to collect students screen time and sleep duration. The Chi square test was used to compare differences across different groups, and binary Logistic regression analysis was employed to analyze the association of screen time and sleep duration with screening myopia.
Results:
The overall prevalence of screening myopia was 79.5%, with significant differences across educational stage, sex, screen time and sleep duration groups( χ 2=41.64, 9.75, 23.89 , 8.17, all P <0.05).Binary Logistic regression analysis revealed that, compared to the high screen time & insufficient sleep group, the low screen & sufficient sleep group ( OR=0.25, 95%CI =0.09-0.68), the low screen & insufficient sleep group ( OR= 0.27 , 95%CI =0.13-0.56), and the high screen & sufficient sleep group ( OR=0.26, 95%CI =0.10-0.70) exhibited significantly lower screening myopia risks (all P <0.05). After adjusting for sex and educational stage, low screen time & insufficient sleep was significantly associated with screening myopia ( OR=0.48, 95%CI =0.23-0.98); the multiplicative interaction term was statistically significant ( OR=0.99,95%CI =0.98-1.00)(both P <0.05).
Conclusion
The interaction effect between screen time and sleep duration in relation to screening myopia suggests a need to focus on daily routines and screen use habits among junior and senior high school students for ensuring sufficient sleep and limiting screen exposure.
5.Monitoring and management of adverse reactions to pegylated interferon alpha-2b for treatment of chronic hepatitis B
Xinyi LI ; Weijiang YE ; Danlei CHEN ; Jiawei ZHANG
Journal of Clinical Hepatology 2026;42(2):414-419
Pegylated interferon α-2b (PEG-IFN-α-2b) is currently a first-line drug for the treatment of chronic hepatitis B virus infection and is widely used in clinical practice. This drug has multiple effects of inhibiting viral replication, regulating immunity, and improving liver function, and some patients can achieve clinical cure. However, it often causes various adverse reactions during treatment, which are important factors for compromising treatment compliance and efficacy. This article systematically reviews the adverse reactions and their mechanisms during PEG-IFN-α-2b therapy for chronic hepatitis B, including influenza-like symptoms, peripheral blood cytopenia, thyroid dysfunction, and neuropsychiatric symptoms, and it also summarizes the monitoring and management strategies for these adverse reactions, in order to provide evidence-based guidance for clinical decision-making and emphasize the importance of individualized treatment.
6.Erchentang Ameliorates SiO2-induced Lung Injury by Regulating Oxidative Stress and Metabolic Disorders via Nrf2/HO-1 Signaling Pathway
Jun LU ; Xinyi ZHU ; Ziyi LIU ; Jixia HU ; Jialu CHEN ; Rong XIAO ; Zhibin WANG ; Chang LIU ; Fangguo LU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):32-42
ObjectiveTo observe the protective effect of Erchentang (ECT) on SiO2-induced lung injury in rats and to explore its underlying mechanism. MethodsA rat model of lung injury was established by a single intratracheal instillation of 50 mg·mL-1 SiO2 suspension. Thirty male Sprague-Dawley (SD) rats were randomly assigned to five groups: control, model, low and high-dose (4.5 g·kg-1·d-1 and 9 g·kg-1·d-1, respectively) ECT, and dexamethasone (0.2 mg·kg-1·d-1). All the groups were treated for 4 consecutive weeks. Histopathological alterations in the lung tissue were examined by hematoxylin and eosin (HE) staining. The levels of malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione peroxidase (GSH-Px) in the lung tissue were measured through biochemical assays. The expression of key molecules in the nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) pathway was determined by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR), Western blot, and immunofluorescence assay. The primary active components of ECT were identified by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and their binding affinity to Nrf2/HO-1 was assessed by molecular docking. Untargeted metabolomics of the lung tissue was performed based on UPLC-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS), and correlation analysis was performed to identify differential metabolites and parameters closely associated with the Nrf2/HO-1 pathway. ResultsCompared with the control group, the model group exhibited a reduction in body weight gain, an increase in lung index, increased MDA content, weakened SOD and GSH-Px activities in the lung tissue, down-regulated mRNA and protein levels of Nrf2 and protein levels of HO-1 and GPX4, and an up-regulated protein level of Keap1 (P<0.05, P<0.01). Treatment with ECT attenuated the SiO2-induced decline in body weight (P<0.05), alleviated inflammatory cell infiltration and silicotic nodule formation in alveoli, and reduced the MDA content and enhanced the SOD and GSH-Px activities in the lung tissue (P<0.05, P<0.01). UPLC-MS/MS and molecular docking revealed that core components of ECT, such as hesperidin and glycyrrhizic acid, displayed strong binding affinity to Nrf2/HO-1. Molecular biological experiments demonstrated that ECT promoted nuclear translocation of Nrf2, up-regulated the mRNA and protein levels of HO-1 and GPX4, and down-regulated Keap1 expression (P<0.05, P<0.01). Metabolomic analysis indicated that ECT reversed the SiO2-induced aberrant expression of metabolites, including linoleic acid and glutamine (P<0.05, P<0.01). Correlation analysis showed that Nrf2 and HO-1 were positively correlated with SOD and GSH-Px (P<0.05, P<0.01), but negatively correlated with glutamine and serine (P<0.05, P<0.01). ConclusionECT may activate the Nrf2/HO-1 pathway through its core active components, thereby regulating oxidative stress and metabolic disorders to ameliorate SiO2-induced lung injury in rats. This study provides experimental evidence for ECT in the prevention and treatment of occupational lung injury.
7.Analysis of notifiable infectious diseases in Zhejiang Province in 2024
DING Zheyuan ; YANG Yan ; FU Tianying ; LU Qinbao ; WANG Xinyi ; WU Haocheng ; LIU Kui ; LIN Junfen ; WU Chen
Journal of Preventive Medicine 2025;37(5):433-438,442
Objective:
To investigate the epidemic situation of notifiable infectious diseases in Zhejiang Province in 2024, so as to summarize the epidemic characteristics.
Methods:
Data of notifiable infectious diseases cases in Zhejiang Province from January 1 to December 31, 2024 were collected from the Infectious Disease Surveillance System of Chinese Disease Prevention and Control Information System. The epidemiological characteristics were analyzed according to the classification and transmission routes using the descriptive epidemiological method.
Results:
A total of 32 types of notifiable infectious diseases with 1 858 695 cases and 392 deaths were reported in Zhejiang Province in 2024, with a reported incidence of 2 804.73/105 and a reported mortality of 0.591 5/100 000. A total of 238 infectious disease public health emergencies were reported, of which 218 (91.60%) occurred in schools and kindergartens. There were 22 types of class A and B notifiable infectious diseases reported, with incidence of 470.62/100 000 and mortality of 0.591 5/100 000. Totally 10 types of class C notifiable infectious diseases, with a reported incidence of 2 334.11/105, and no deaths were reported. Classified by transmission route, respiratory infectious diseases had the highest reported incidence of 2 423.87/100 000, among which influenza exhibited the highest reported incidence of 2 024.22/100 000. The reported incidence of intestinal infectious diseases was 312.94/105, among which the incidence of other infectious diarrhea and hand-foot-mouth disease (HFMD) were high, with reported incidences of 169.52/100 000 and 136.18/100 000, respectively. Blood-borne and sexually transmitted infectious diseases accounted for the largest number of reported deaths, among which AIDS had the highest mortality of 0.424 0/100 000. Natural and insect-borne infectious diseases exhibited a low reported incidence of 1.37/105. The reported incidence of dengue fever was 0.40/100 000, and 95.08% of the cases were imported.
Conclusions
The reported incidence of respiratory and intestinal infectious diseases and the reported mortality of AIDS were high in Zhejiang Province in 2024. It is recommended to strengthen the prevention and control of infectious diseases such as influenza, other infectious diarrhea, and HMFD in schools and kindergartens.
8.Transparency of clinical practice guidelines: A mixed methods research.
Xinyi WANG ; Youlin LONG ; Tengyue HU ; Zixin YANG ; Liqin LIU ; Liu YANG ; Yifan CHENG ; Ran GU ; Yanjiao SHEN ; Nan YANG ; Jin HUANG ; Yaolong CHEN ; Liang DU
Chinese Medical Journal 2025;138(15):1882-1884
9.Disability-adjusted life years for colorectal cancer in China, 2017-2030: A prevalence-based analysis focusing on the impact of screening coverage and the application of local weights.
Yujie WU ; Yanjie LI ; Xin WANG ; Xinyi ZHOU ; Xinxin YAN ; Hong WANG ; Juan ZHU ; Wanqing CHEN ; Jufang SHI
Chinese Medical Journal 2025;138(8):962-972
BACKGROUND:
Most studies have evaluated disability-adjusted life years (DALYs) of colorectal cancer (CRC) patients based on a set of generic disability weights (DWs). This study aimed to apply local CRC-stage-specific DWs to estimate the burden of DALYs for CRC (CRC-DALYs) in populations in China and consider the influence of local screening coverage of CRC.
METHODS:
A prevalence-based model was constructed using data from various sources. Years lived with disability (YLDs) were estimated mainly via cumulative prevalence data (based on CRC incidence rates, population numbers, and survival rates), stage-specific proportions of CRC, and DWs of the local population. Years of life lost (YLLs) were calculated based on the CRC mortality rates and standard life expectancies. CRC incidence and mortality rates for the years 2020, 2025, and 2030 were estimated by joinpoint regression, and the corresponding DALYs were predicted. The main assumption was made for CRC screening coverage. Sensitivity analyses were used to assess the impact of population, DWs, and coverage.
RESULTS:
In 2017, among the Chinese population, the estimated number of CRC-DALYs was 4,303,314 (11.9% for YLDs). If CRC screening coverage rate in China (2.3%) remains unchanged, the overall DALYs in 2030 are predicted to increase by 37.2% (45.1% of those aged ≥65 years). More optimistically, the DALYs would then decrease by 0.7% in 2030 (from 5,902,454 to 5,860,200) if the coverage could be increased to 25.0%. A sensitivity analysis revealed that using local DWs would change the base-case values by 5.7%.
CONCLUSIONS
The estimated CRC-DALYs in China using population-specific DWs were considerably lower (with a higher percentage of YLDs) than the global burden of disease (GBD) estimates (5,865,004, of 4.6% for YLDs), suggesting the impact extent of applying local parameters. Sustainable scale-up CRC screening needs to be in place to moderate the growth trend of CRC-DALYs in China.
Humans
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Colorectal Neoplasms/diagnosis*
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China/epidemiology*
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Disability-Adjusted Life Years
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Male
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Prevalence
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Female
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Middle Aged
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Aged
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Early Detection of Cancer
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Quality-Adjusted Life Years
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Adult
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Incidence
10.Molecular characterization of FGFR fusion in a large real-world population and clinical utility of bidirectional fusion.
Xinyi ZHANG ; Jing ZHAO ; Ling MA ; Yitong TIAN ; Jiaguang ZHANG ; Hejian ZHENG ; Junling ZHANG ; Runyu HE ; Luhang JIN ; Jing MA ; Mengli HUANG ; Xiao LI ; Xiaofeng CHEN
Chinese Medical Journal 2025;138(12):1510-1512


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