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    Clinical Medications and Safety Analysis of Traditional Chinese Medicine for Post-Infection Cough
    XIE Ziyue, WANG Chengxiang, HU Yanpeng, LI Lei, CUI Herong
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 507-512.   DOI: 10.19803/j.1672-8629.20250025
    Abstract3045)      PDF(pc) (1413KB)(195)       Save
    Objective To analyze the prescription patterns and safety of traditional Chinese medicine (TCM) in treating post-infection cough (PIC). Methods The clinical data of PIC cases treated in the Respiratory Department of Beijing University of Chinese Medicine Third Affiliated Hospital between October 12, 2022 and May 22, 2024 was retrieved and screened. Frequency statistics, association rules, and complex network analyses were performed using the Ancient and Modern Medical Case Cloud Platform (V2.3.7) to investigate medication patterns, involving frequency, dosage, medicinal properties, herbal pair compatibility, and core prescriptions. The safety of these medications was evaluated via literature review. Results A total of 227 PIC patients were included, involving 365 medical records, 365 prescriptions, 146 herbs, and the total number of times herbal drugs were used was 5 915. Frequently-used herbs included Banxia (Pinelliae Rhizoma), Kuxingren (Armeniacae Semen Amarum), and Gancao (Glycyrrhizae Radix et Rhizoma. Medicinal properties were predominantly warm, neutral and cold, flavors were bitter, pungent, and sweet, and meridian tropisms focused on the lung, spleen, and stomach. Association rules identified 13 frequently-used herbal pairs-Ganjiang (Zingiberis Rhizoma)-WuweiZi (Schisandrae Chinensis Fructus) (co-occurrence count: 254) and Banxia-Kuxingren (249). The core prescription for PIC comprised 14 herbs: Banxia, Ganjiang, Kuxingren, Ziwan (Asteris Radix), Baibu (Stemonae Radix), Gancao, Baiqian (Cynanchi Stauntonii Rhizoma), Huangqin (Scutellariae Radix), Jiegeng (Platycodonis Radix), Yiyiren (Coicis Semen), Fuling (Poria), WuweiZi, Tinglizi (Descurainiae Semen), and Chantui (Cicadae Periostracum). Prescription dosages primarily ranged from 100 to 299 g (94.79%), with 15 to 19 herbs per prescription (76.16%). Safety evaluation indicated a low incidence of adverse reactions. Conclusion TCM treatments for PIC focus on resolving phlegm and suppressing cough while integrating strategies of dispersing, descending, astringing, draining, clearing, and tonifying. Its safety profile is favorable, and precise dosage control is critical to minimizing risks.
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    Research Progress in Antiviral Targets and Active Ingredients of Traditional Chinese Medicine
    CUI Mengyao, LI Shuran, XIE Dan, YANG Xiaowei, LIU Xian, CUI Xiaolan, GENG Zihan, GUO Shanshan
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 481-487.   DOI: 10.19803/j.1672-8629.20250099
    Abstract2564)      PDF(pc) (1366KB)(250)       Save
    Objective To elucidate the mechanisms of traditional Chinese medicine(TCM) that are characterized by multi-component, multi-target, and multi-pathway interactions, and identify bioactive components with antiviral, anti-inflammatory, and immunomodulatory properties in order to provide references for developing efficient and low-toxicity TCM formulations. Methods Modern techniques, including network pharmacology, molecular docking, high-throughput drug screening, integrative pharmacology, and structural biology, were reviewed to explore their applications in antiviral research on TCM. The binding capacity of TCM components to viral proteins and host targets, potential active ingredients in TCM formulations, and molecular pathways regulated by targets were summarized. Results TCM compounds such as flavonoids, alkaloids, glycosides, polysaccharides, and organic acids exhibited antiviral effects by directly targeting viral invasion/replication-related proteins or modulating host targets involved in immune responses and inflammatory pathways. Conclusion TCM can not only directly inhibit viral proliferation and kill viruses, but also suppress excessive immune reactions post-infection. Additionally, it enhances immunity through immunoregulation, offering indirect antiviral benefits.
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    Effect of Shufeng Jiedu Capsules on the Production of Specific Antibodies against Influenza A H1N1 Virus and the Mechanisms
    LI Xinying, BAO Lei, LI Shuran, ZHAO Ronghua, SUN Jing, XIE Dan, BAO Yanyan, GUO Shanshan, CUI Xiaolan, GENG Zihan
    Chinese Journal of Pharmacovigilance    2025, 22 (8): 841-850.   DOI: 10.19803/j.1672-8629.20250170
    Abstract2435)      PDF(pc) (3192KB)(835)       Save
    Objective To explore the effects of Shufeng Jiedu capsules (SFJD) on the humoral immune response in mice with non-lethal influenza A virus (H1N1) infection and the mechanisms using an in vitro model. Methods A mouse model of non-lethal H1N1 infection was established. Mice were randomly divided into the normal, PR8 model, positive drug oseltamivir-phosphate (27.5 mg·kg-1·d-1), SFJD medium-dose (1.144 g·kg-1·d-1), and SFJD high-dose groups (2.288 g·kg-1·d-1). Each group was then divided into five time-point subgroups: Days 0, 2, 4, 6, and 8. The drug was administered by gavage from day 0 to day 4. At each time point, the mice were euthanized for sample collection. Lung and body weights were measured to calculate the lung index. Total IgA, IgM, and IgG in bronchoalveolar lavage fluid were detected using a high-throughput liquid phase protein chip multiplex assay. H1N1-specific IgA, IgM, and IgG were measured via enzyme-linked immunosorbent assay (ELISA). On day 8, viral loads in lung tissues were assessed by real-time fluorescence quantitative PCR (Real-time PCR). Lung images were obtained using Micro-CT. The percentage of B cells in peripheral blood and bronchoalveolar lavage fluid was analyzed by flow cytometry. Human bronchi epithelial cells (BEAS-2B) were allocated into 6 groups: normal control, virus infection, positive drug (62.5 μmol·L-1), SFJD high-dose (15.6 μg·mL-1) and SFJD medium-dose (7.8 μg·mL-1). Murine lung epithelial-12 cells (MLE12) were divided into five groups: normal control, virus infection, positive drug (250 μmol·L-1), SFJD high-dose (62.5 μg·mL-1) and SFJD medium-dose (31.3 μg·mL-1). Western blot was employed to evaluate the impact of SFJD on expression levels of B cell activating factor (BAFF) in respiratory epithelial cells. Results SFJD reduced the lung index of H1N1 infected mice from day 4 to day 8 (P<0.05), viral load on day 8 (P<0.01), and alleviated inflammatory lesions. It increased the proportion of B cells in peripheral blood and lung tissues (P<0.01, P<0.001), decreased total IgA levels in bronchoalveolar lavage fluid on day 8, increased total IgM levels (P<0.01), and reduced specific IgA secretion on day 4 (P<0.0001) while promoting specific IgM (P<0.0001) and IgG (P<0.0001) secretion on day 8. SFJD also inhibited BAFF expression in respiratory epithelial cell lines (P<0.05, P<0.001). Conclusion Early administration of SFJD in case of H1N1 infection can restore the peripheral blood B cell proportion, promote their infiltration into lung tissues, enhance specific IgM and IgG secretion, and exert antiviral effects. Additionally, SFJD regulates the humoral immune response post-infection by inhibiting BAFF expression in respiratory epithelial cells and by preventing excessive B cell activation.
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    Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model
    SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing
    Chinese Journal of Pharmacovigilance    2024, 21 (2): 121-126.   DOI: 10.19803/j.1672-8629.20230388
    Abstract2065)      PDF(pc) (1550KB)(1161)       Save
    Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg-1·d-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg-1·d-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg-1·d-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg-1·d-1 and from 1.2 to 2.4 mL·kg-1·d-1, respectively, which were equivalent to 0.4-0.8 mL·kg-1·d-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg-1·d-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12.
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    Progress in Clinical and Pharmacological Research of Angong Niuhuang Pills
    BAI Xue, CHEN Yafei, TANG Tian, LIU Zhejun, WANG Guoyu, TAN Tianyang
    Chinese Journal of Pharmacovigilance    2025, 22 (3): 349-356.   DOI: 10.19803/j.1672-8629.20240592
    Abstract1889)      PDF(pc) (1259KB)(12742)       Save
    Objective To evaluate the clinical efficacy of Angong Niuhuang pills in the past three years and explore their pharmacological mechanisms in order to provide a reference for subsequent research. Methods By analyzing the latest data on clinical research, the therapeutic effects of Angong Niuhuang pills against such diseases as cerebral hemorrhage, cerebral infarction, craniocerebral injury, heatstroke, sepsis, viral encephalitis and pneumonia were summerized. Additionally, current pharmacological research was reviewed to analyze the mechanisms of action of Angong Niuhuang pills. Results The study found that Angong Niuhuang pills were highly effective in treating the aforementioned diseases. Pharmacological research suggested that they worked through multiple mechanisms, including anti-inflammation, antioxidation, anti-apoptosis, regulation of autophagy and mitochondrial dysfunction, inhibition of pyroptosis and ferroptosis, and regulation of metabolic products and gut microbiota. Conclusion This study has evaluated the clinical efficacy and pharmacological mechanism of Angong Niuhuang pills in the treatment of various diseases and confirmed their therapeutic effect and multi-target characteristics, providing data for subsequent research and clinical applications.
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    Effect of Yiye Anti-Influenza Capsules on Pneumonia Induced by Human Coronavirus 229E Infection in Mice
    WANG Xinwei, PENG Yifeng, SUN Jing, JI Zuen, BAO Lei, LUO Henglei, GENG Zihan, ZHANG Hujuan, LI Shuran, ZHANG Jingsheng, GUO Shanshan, CUI Xiaolan, ZHAO Ronghua
    Chinese Journal of Pharmacovigilance    2025, 22 (8): 851-855.   DOI: 10.19803/j.1672-8629.20250010
    Abstract1798)      PDF(pc) (1862KB)(405)       Save
    Objective To investigate the therapeutic effect of Yiye anti-influenza capsules (YYKLG) against pneumonia in mice infected with human coronavirus 229E (HCoV-229E). Methods A mouse model of pneumonia was established via intranasal infection with HCoV-229E. The mice were randomly divided into seven groups, including high-dose, medium-dose, and low-dose YYKLG groups (0.70 , 0.35 and 0.18 g·kg-1·d-1, respectively). The effects of YYKLG at three doses on the lung index, viral load, pulmonary bronchioles and pathological changes of lung tissues in mice were assessed. Results The lung index of mice in the high and medium dose groups of YYKLG decreased significantly, so did the viral load of lung tissues in the three dose groups. Compared with the model control group, YYKLG reduced the pathological damage to lung bronchioles and lung tissues to varied extents, and the degree of pathological damage in the high and middle dose groups was significantly different from that of the model control group. Conclusion YYKLG can improve the symptoms of pneumonia in model mice infected with the HCoV-229E virus. This study is expected to provide a reference for the treatment of respiratory diseases with traditional Chinese medicine.
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    Mechanisms of Sanhan Huashi Granules on a Respiratory Syncytial Virus and Influenza Virus and Respiratory Syncytial Virus Induced Pneumonia Model in Mice
    ZHAO Ronghua, ZHU Chunxu, SUN Jing, BAO Lei, WANG Xinwei, GENG Zihan, ZHANG Jingsheng, GUO Shanshan, LI Shuran, WANG Daohan, CUI Xiaolan
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 488-494.   DOI: 10.19803/j.1672-8629.20250031
    Abstract1777)      PDF(pc) (1870KB)(180)       Save
    Objective To study the therapeutic mechanism of Sanhan Huashi granules (SHG) on a pneumonia model induced by influenza A (H1N1) virus and respiratory syncytial virus (RSV) in mice. Methods The mice were infected with the FM1 strain of influenza A (H1N1) virus and respiratory syncytial virus (RSV) by nasal drip to construct a mouse model of viral pneumonia. Both influenza A (H1N1) virus group and the RSV group were divided into normal group, model group, Lianhua Qingwen group(LHG), SHG groups with high-dose(52.8 g·kg-1·d-1), medium-dose(26.4 g·kg-1·d-1), and low-dose (13.2 g·kg-1·d-1). And oseltamivir group was served as the control group in the influenza A (H1N1) virus group, ribavirin group was served as the control group in the RSV group. After modelling and intragastric administration, the lung tissues of the mice were taken to accurately calculate the lung index and its inhibition rate. For mice infected with the FM1 strain of influenza A (H1N1) virus, hematoxylin-eosin (HE) staining was performed on the bronchioles and lung tissues. The pathological changes were observed under a microscope, and the grades were scored by the established standards. At the same time, the levels of interleukin-4 (IL-4) and interleukin-33 ( IL-33 ) in lung tissues of mice infected with RSV were detected. Results A medium dose of SHG could significantly reduce the lung index of mice in the H1N1/FM1 model group (P <0.05), improve the pathological changes of bronchioles and lung tissues, and reduce the grade of lung and bronchial lesions while a high dose of SHG could significantly reduce the lung index of RSV-infected mice (P<0.05). The three doses of SHG could significantly increase the content of IL-4 but reduce the content of IL-33 in RSV-infected mice. The contents of IL-4 in the model group, the low-dose group, the medium-dose group and the high-dose group were(50.20±2.22),(61.63±1.34),(71.46±2.39)and(56.74±1.24)pg·mL-1 respectively, compared with(1 787.37±60.59), (1 273.10±378.04), (1 532.38±337.96) and(1 347.33±345.39)pg·mL-1 for IL-33, all of which were significantly different from those of the control group (P<0.01, P<0.05). Conclusion SHG can mitigate the severity of pathological changes of bronchioles and lung tissues of mice, significantly reduce the grade of lung and bronchial lesions, significantly lower the lung index of viral pneumonia in model mice, and increase the content of IL-4 in the lungs of mice while decreasing the content of IL-33.
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    Potential Targets and Components of Jinhua Qinggan Granules against Respiratory Viral Infections
    LIU Xian, ZHANG Yu, BAI Yinglu, CUI Mengyao, YANG Xiaowei, XIE Dan, GENG Zihan, SUN Jing, LI Shuran, BAO Lei, ZHAO Ronghua, XU Xiaolong, GUO Shanshan
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 501-506.   DOI: 10.19803/j.1672-8629.20250086
    Abstract1751)      PDF(pc) (2583KB)(399)       Save
    Objective To identify the bioactive components in Jinhua Qinggan granules (JHQGs) that interact with the PACT protein in order to provide references for the development of antiviral drugs. Methods High-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was employed to detect the blood components of JHQGs. A CM5 chip blank control group and JHQG group were set up. The PACT protein was immobilized on the CM5 chip, and surface plasmon resonance (SPR) technology was used for the fishing and recovery of JHQGs with the PACT protein chip. Ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) was used to identify the components in the recovered samples and detect the bioactive components in JHQGs that could specifically bind to the PACT protein. Molecular docking was performed on the identified components to evaluate binding energies. Results A total of 14 bioactive components were identified out of JHQGs. In the positive ion mode, six active components were identified, namely glycyrrhetinic acid, puerarin, baicalein, formononetin, vitexin, and 6-O-methylwogonoside. In the negative ion mode, eight active components were identified, namely artemetin, 3α-hydroxyglycyrrhetinic acid, baicalin, genistein, (-)-MenthylO-Beta-D-Glucoside, catechin, paeoniflorin, and licoflavone A. Among them, the four components with stronger binding affinity to the PACT protein were baicalin, glycyrrhetinic acid, paeoniflorin, and licoflavone A, with binding affinities of -7.1, -6.9, -6.6, and -6.5, respectively. Conclusion For the first time, the PACT protein chip combined with UPLC-Q-TOF-MS has been effectively used to identify the ligand compounds in JHQGs that bind to PACT protein, suggesting that the PACT protein could serve as a potential target for the anti-respiratory viral activity of JHQGs.
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    Risk Signal Mining and Experimental Observations of Febuxostat Cardiotoxicity
    WANG Xue, DING Xueli, LU Chengjin, CHEN Siying, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian
    Chinese Journal of Pharmacovigilance    2024, 21 (11): 1201-1208.   DOI: 10.19803/j.1672-8629.20240393
    Abstract1709)      PDF(pc) (2112KB)(470)       Save
    Objective To evaluate the US spontaneous reporting system of cardiac adverse events of febuxostat, analyze the risks and provide data for safe use of uric acid-lowering drugs. Methods Based on the FAERS database reports of cardiac adverse events of febuxostat from Q1 2004 to Q3 2021, the risk signals were evaluated. In a rat model of hyperuricemia, high dose (7.2 mg·kg-1) and low dose (3.6 mg·kg-1) groups of febuxostat were set up to observe the uric acid level, related cardiac indexes and histopathology in biochemical tests. Results A total of 5 001 adverse reaction reports and 15 989 adverse reactions were retrieved from the FAERS database for febuxostat, and 992 of the adverse reactions with cardiac relevance had 18 cardiac risk signals. Febuxostat cardiotoxicity was more common in males and usually occurred among those over 65. In animal experiments, a significant reduction in uric acid levels was observed in rats administered with febuxostat in a hyperuricemic state, indicating a good uric acid-lowering effect. Such cardiac indicators as AST, CK and cTn-I increased, while LDH and CK-MB levels decreased. MASSON staining showed that the febuxostat groups appeared to have different degrees of fibrosis, with pronounced blue collagen deposition. Conclusion In the clinical use of febuxostat for the treatment of hyperuricemia, cardiac risks ought to be considered to ensure rational use of febuxostat in different clinical populations.
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    Regulation of cellular and gene therapies at home and abroad
    ZHAO Peipei, WEN Baoshu
    Chinese Journal of Pharmacovigilance    2024, 21 (9): 1019-1024.   DOI: 10.19803/j.1672-8629.20240160
    Abstract1597)      PDF(pc) (1350KB)(812)       Save
    Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry. Methods The ways in which cellular and gene therapy products were regulated in the US, Japan and Europe were compared by reviewing regulations and literature. The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development. Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States, Japan and Europe, China's regulatory system can be upgraded by means of innovative regulatory concepts, integration of review resources, more international exchanges and cooperation as well as intensified efforts.
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    Research Advances in the Pathogenesis of Cytokine Release Syndrome Induced by CAR-T Cell Therapy
    REN Yuke, JIANG Hua, LI Lulu, LI Shuangxing, HUO Guitao, YANG Yanwei, ZHANG Di, HUANG Ying, GENG Xingchao, LIN Zhi, QU Zhe
    Chinese Journal of Pharmacovigilance    2025, 22 (7): 735-741.   DOI: 10.19803/j.1672-8629.20250258
    Abstract1560)      PDF(pc) (1222KB)(497)       Save
    Objective To investigate the mechanisms, grading, and management strategies of cytokine release syndrome (CRS) in chimeric antigen receptor T-cell (CAR-T) therapy in order to enhance the safety and efficacy of CAR-T cell therapy. Methods By reviewing studies currently available, the pathogenesis of CRS was analyzed, involving the key cytokines and signaling pathways before the grading criteria for and clinical approaches to CRS were summarized. Results CRS, a common adverse reaction in CAR-T therapy, involved the activation of cytokines (e.g., IL-6, IL-1, IFN-γ) and signaling pathways (e.g., JAK-STAT, NF-κB). Grading systems that guided clinical interventions were available, but targeted therapies required more optimization. Conclusion A better understanding of CRS mechanisms will facilitate the development of novel targeted drugs while improving the safety/efficacy of CAR-T therapy.
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    Research progress on animal models of allergic rhinitis
    SUN Qiyue, GUO Shanshan, ZHAO Ronghua, BAO Lei, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing
    Chinese Journal of Pharmacovigilance    2024, 21 (3): 241-245.   DOI: 10.19803/j.1672-8629.20230654
    Abstract1554)      PDF(pc) (1226KB)(1238)       Save
    Objective To summarize the research progress on animal models related to allergic rhinitis (AR), providing a reference for further understanding of AR pathogenesis and drug evaluation. Methods Based on a literature review from both domestic and international sources, the types of AR animal models, their characteristics, modeling methods, criteria for successful models, and evaluation indicators were summarized. Results Animal models for allergic rhinitis include both Western medicine pathological models and traditional Chinese medicine combination models. Commonly used animals include guinea pigs, mice, rats, and New Zealand rabbits. Conclusion This review provides insights into existing AR animal models, their methods, and evaluation criteria, offering valuable guidance for future AR research.
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    Therapeutic effect of aerosol inhalation of BD-77 against mycoplasma pneumoniae infection in mice
    SUN Jing, ZHAO Ronghua, GUO Shanshan, GAO Shuangrong, BAO Lei, GENG Zihan, LI Shuran, SUN Qiyue, XU Zhou, QIN Guangyuan, PAN Yujie, TAN Qiuxia, LONG Zhongyi, HUANG Chenggang, CUI Xiaolan
    Chinese Journal of Pharmacovigilance    2024, 21 (3): 253-256.   DOI: 10.19803/j.1672-8629.20230797
    Abstract1446)      PDF(pc) (1636KB)(310)       Save
    Objective To evaluate the therapeutic effect of aerosol inhalation of BD-77 against mycoplasma pneumoniae (MP) infection in mice. Methods Balb/c mice were randomly divided into the normal control group, model control group, azithromycin control group (42 mg·kg-1·d-1), BD-77 high dose group (75 mg·mL-1, 15 min), and BD-77 low dose group (37.5 mg·mL-1, 15 min). The mouse model of mycoplasma pneumoniae pneumonia (MPP) was induced by intranasal infection with MP. After four consecutive days of aerosol inhalation, the therapeutic effect of BD-77 was evaluated based on the lung index, lung inhibition rate, and pathological changes of lung tissues. The contents of interleukin (IL)-6, IL-1β, tumor necrosis factor α (TNF-α) in lung tissues and the level of C reactive protein (CRP) in serum were also detected using ELISA method. Results Both doses of BD-77 aerosol administration could decrease the lung index and the release of IL-6, IL-1β and TNF-α in lung tissues, ameliorate pulmonary inflammation and reduce serum CRP levels. Conclusion Aerosol inhalation of BD-77 preparation is effective for MPP in mice. This study provides data for the development of BD-77 as a drug for prevention and treatment of MPP.
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    Multiple pharmacological effects of Lingyang Ganmao Oral Liquid
    SUN Qiyue, ZHAO Ronghua, GUO Shanshan, BAO Lei, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing
    Chinese Journal of Pharmacovigilance    2024, 21 (2): 127-131.   DOI: 10.19803/j.1672-8629.20230649
    Abstract1439)      PDF(pc) (1420KB)(910)       Save
    Objective To evaluate the pharmacological effects of Lingyang Ganmao Oral Liquid at the animal level, and to provide theoretical basis and data to support clinical precision medicine. Methods Six animal models were established according to the functional indications and clinical indications of Lingyang Ganmao Oral Liquid, the pneumonia model of mice infected by influenza virus FM1 strain and Streptococcus pneumoniae, the peritoneal capillary permeability model and body twisting model of mice induced by ice acetic acid, the cough model of mice induced by ammonia water, the trachea phenol red excretion model of mice. The antiviral, antibacterial, anti-inflammatory, analgesic, relieving cough and eliminating phlegm effects of Lingyang Ganmao Oral Liquid were evaluated by observing pulmonary index, inhibitory rate of lung index, OD value of Evanslan, writhing times, coughing times and phenol red excretion. Results Lingyang Ganmao Oral Liquid 20 mL·kg-1·d-1 can significantly inhibit the increase of lung index caused by influenza virus FM1, and significantly increase the secretion of phenol red in the tracheal of mice. The lung index and peritoneal capillary permeability of Streptococcus pneumoniae infected mice were increased. Lingyang Ganmao Oral Liquid 20, 15, 10 mL·kg-1·d-1 three dose groups had significant inhibitory effect on both of them, which could significantly reduce the frequency of cough caused by ammonia water in mice and prolong the incubation period of cough. Both 20 and 15 mL·kg-1·d-1 dose groups could significantly reduce the number of writhe caused by acetic acid in mice. Conclusion Lingyang Ganmao Oral Liquid of different doses has different degrees of action and multiple pharmacological effects, including antiviral, antibacterial, anti-inflammatory, analgesic, cough and expectorant.
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    The critical role of TRP channels in the progression of viral pneumonia
    BAO Lei, GENG Zihan, LI Shuran, JI Zuen, ZHAO Ronghua, SUN Jing, GUO Shanshan, CUI Xiaolan
    Chinese Journal of Pharmacovigilance    2024, 21 (2): 137-140.   DOI: 10.19803/j.1672-8629.20230618
    Abstract1388)      PDF(pc) (1433KB)(107)       Save
    Objective To conduct a comprehensive review of the potential mechanisms of occurrence between viral pneumonia infection and the TRP channel family. Methods By searching CNKI and PubMed, the reports from the past 30 years on the relationship between the TRP channel family and viral pneumonia, as well were as discussions the underlying mechanisms were discussed. Results As ion receptor channels on the cell membrane, TRP channels can regulate the balance of calcium ions inside and outside the cell, inhibiting or accelerating virus invasion into the host. By accelerating the influx of calcium ions, they intensify cellular oxidative stress responses, speeding up cell autophagy or apoptosis. Additionally, by promoting changes in cell morphology, they enhance the cell’s response to inflammatory mediators and cytokines. Conclusion TRP channels are crucial regulatory factors in the process of viral infection of hosts, exerting direct or indirect effects on various physiological processes during the infection. Therefore, a deeper study of the TRP channel family can offer new targets for antiviral drug development, providing fresh perspectives for clinical treatment of viral pneumonia.
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    Effect of targeting c-Met/CD47 CAR-T cells on ovarian cancer cells
    WANG Rumeng, SI Qin
    Chinese Journal of Pharmacovigilance    2024, 21 (10): 1103-1112.   DOI: 10.19803/j.1672-8629.20240339
    Abstract1388)      PDF(pc) (3599KB)(335)       Save
    Objective To investigate the effect of knocking down the expression of mesenchymal-epithelial transition factor (c-Met) on proliferation, invasion, migration and apoptosis of ovarian cancer cells in vitro, prepare chimeric antigen receptor T (CAR-T) targeting c-Met and observe its ability to kill ovarian cancer cells. Methods The expression of c-Met in three ovarian cancer cell lines was detected by real-time fluorescence quantitative polymerase chain reaction and Western blotting. The c-Met was knocked down by transfection, and cell proliferation was detected by cell counting kit-8 (CCK-8) and cell cloning. Cell invasion and cell scratch were used to detect cell invasion and migration ability. The cell cycle, apoptosis and the positive rate of lentivirus infected cells were detected by flow cytometry. CCK-8 was used to detect the proliferation of CAR-T cells stimulated by target cells. Lactate dehydrogenase assay was used to detect the killing rate of cells while the release of interferon-γ (IFN-γ) and interleukin-2 (IL-2) was detected by enzyme-linked immunosorbent assay. A subcutaneous xenograft model of nude mice was established before T, CAR-T, c-Met CAR-T, c-Met/CD47 CAR-T effector cell groups were injected. The tumor weight was measured. Hematoxylin-eosin staining and immunohistochemistry were used to study the therapeutic effect of CAR-T cells against ovarian cancer. Results The expression of c-Met in SKOV3 cell line was high. Compared with the control group, the cell proliferation, invasion, migration ability of the c-Met knockdown group decreased while the apoptosis rate increased. G1 and S phase decreased while G2 phase increased. Flow cytometry showed that the infection efficiency of CAR-T, c-Met CAR-T and c-Met/CD47 CAR-T cells was 97.42%, 97.39% and 97.35%, respectively. CCK-8 assay indicated that the proliferation potential of c-Met/CD47 CAR-T cells to target cells was significantly enhanced. LDH assay suggested that the killing rate of c-Met/CD47 CAR-T cells to target cells was significantly increased. ELISA showed that SKOV3 induced c-Met/CD47 CAR-T cells to release more IFN-γ and IL-2. The weight of transplanted tumor in the c-Met/CD47 CAR-T cell group was lighter than in T, CAR-T and c-Met CAR-T cell groups when SKOV3 cells were injected subcutaneously. HE results showed that there was no physiological structure damage in the tissues and organs of each cell treatment group. Conclusion c-Met/CD47 can be used as a molecular target for CAR-T cell therapy for ovarian cancer, which can target and recognize ovarian cancer cells with higher c-Met expression. The stronger the killing ability, the better the proliferation ability and cytokine release level.
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    Therapeutic Effect of Shufeng Jiedu Capsules against Respiratory Syncytial Virus-Infected Pneumonia by Regulating AIM2 Inflammasome Pathway
    BAO Lei, GENG Zihan, CUI Xiaolan
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 495-500.   DOI: 10.19803/j.1672-8629.20250043
    Abstract1379)      PDF(pc) (1975KB)(187)       Save
    Objective To study the possible mechanism and pathway of action through which Shufeng Jiedu capsules combat respiratory syncytial virus (RSV). Methods Sixty BALB/c mice were randomly divided into the normal control group, model control group, ribavirin positive control group, and high, medium and low dose groups of Shufeng Jiedu capsules, with 10 mice in each. All these groups were infected with RSV by nasal drops to establish pneumonia models except the normal control group. Four hours after infection, the drug was administered for four consecutive days, once a day by gavage. On the fifth day of the experiment, the mice were killed, the lung index was calculated, and lung tissues were taken for RT-PCR to detect the mRNA expressions of such genes as absent in melanoma 2 (AIM2), apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC), cysteine-aspartic protease 1 (Caspase-1), interleukin 18 (IL-18), and interleukin 1 beta (IL-1β). The expression levels of corresponding proteins were analyzed by Western Blot. Results Compared with the normal control group, the lung indexes of mice in the model control group were significantly increased (P<0.01), suggesting that RSV infection caused severe lung inflammation. Compared with the model control group, the lung indexes in all the other groups of Shufeng Jiedu capsules were significantly reduced, especially in the medium and high dose groups (P<0.01). Results of RT-PCR and Western Blot showed that the expressions of AIM2, ASC, pro-caspase-1, cleaved-caspase-1, pro-IL-18, cleaved-IL-18, pro-IL-1β and cleaved-IL-1β (P<0.05, P<0.01) were significantly reduced in the high dose group. Conclusion Shufeng Jiedu capsules can significantly inhibit lung inflammation caused by RSV infection and mitigate the damage to lung tissues by regulating the AIM2 inflammasome pathway.
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    Methods for signal management using the global safety database VigiBase
    HJELMSTRÖM Peter, BOWRING Geoffrey, YUE Qun-Ying, NORÉN G. Niklas
    Chinese Journal of Pharmacovigilance    2024, 21 (7): 836-840.   DOI: 10.19803/j.1672-8629.20240373
    Abstract1373)      PDF(pc) (1584KB)(860)       Save
    The WHO database of adverse event reports for medicines and vaccines, VigiBase, has been developed and maintained by UMC since 1978. VigiBase now holds over 39 million anonymised reports of suspected adverse effects of medicines and vaccines suffered by patients (as of June 2024). To support of members of the WHO Programme for International Drug Monitoring (WHO PIDM) in developing, implementing, and strengthening safety surveillance programmes, UMC has developed several systems, tools and methods to facilitate the use of VigiBase. This paper describes six such vigi Methods; vigiGrade, vigiMatch, vigiRank, vigiPoint, vigiGroup, vigiVec. VigiBase depends on unsolicited reporting of adverse drug effects and, regretfully, underreporting of adverse drug effects continues to be a major issue. Artificial intelligence methods for augmentation to increase efficiency, quality, and capability of case processing in the large databases such as VigiBase are evolving to meet the higher demands to manage the increasing volume of safety data. Continued development of existing and new methods to translate the information in the reports in VigiBase and other databases into valuable knowledge will be paramount for safer use of medicines and vaccines for patients in all countries globally.
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    TCM Medications for Pulmonary Nodules Based on Traditional Chinese Medicine Inheritance Assistance System
    LIU Lianlian, YU Huiyong, WANG Mingzhe, GUO Shanshan, LI Lei, GAO Yue, WEI Shixiang, KE Yinze, WANG Chengxiang
    Chinese Journal of Pharmacovigilance    2025, 22 (5): 513-516.   DOI: 10.19803/j.1672-8629.20241040
    Abstract1358)      PDF(pc) (1247KB)(1022)       Save
    Objective To conduct data mining analysis of prescriptions for outpatients with pulmonary nodules using the Traditional Chinese Medicine Inheritance Assistance System (V2.5) in order to find out more about what medications are likely used. Methods Clinically effective TCM prescriptions for the treatment of pulmonary nodules were collected and screened before being input into the system for statistical analysis of the frequency of medications, properties of traditional Chinese medicines, and commonly-used compound formulas. Results A total of 609 effective traditional Chinese medicine prescriptions were screened out, and 31 types of TCMs were used more than 100 times. The analysis of properties of traditional Chinese medicines showed that the clinic mostly used cold and bitter medicines in the prescriptions, and most of the drugs targeted the lung and spleen meridians. The analysis of medications suggested that the core prescription proved to be Erchen decoction. The analysis of association rules showed that Bulb of Thunberg Fritillary and Pinellia Ternata were dominating in the prescriptions. The analysis of new compound formulas showed that there were five new combinations. Conclusion The pathogenesis of pulmonary nodules is usually attributed to the imbalanced middle energizer and to the combination of positiveness, deficiency, and phlegmatic toxin. It is recommended that pulmonary nodules be treated by regulating the spleen and stomach, strengthening qi and clearing phlegmatic toxin.
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    Effect of Lutongning granulethe to trigeminal neuralgia induced by chronic constriction injury of the infraorbital nerve in rats
    LI Shuran, GUO Shanshan, GAO Suangrong, BAO Lei, GENG Zihan, ZHAO Ronghua, ZHANG Jingsheng, PANG Bo, ZHANG Yu, WANG Yaxin, XU Yingli, CAO Shan, HAN Bing, CUI Xiaolan, SUN Jing
    Chinese Journal of Pharmacovigilance    2024, 21 (3): 257-262.   DOI: 10.19803/j.1672-8629.20230591
    Abstract1339)      PDF(pc) (1832KB)(139)       Save
    Objective To investigate the therapeutic effect of Lutongning granules to rat with Trigeminal neuralgia, and provide reference materials for the clinical applications. Methods Trigeminal neuralgia was made by chronic constriction injury of infraorbital nerve in rats. Rats were randomly divided into normal group, sham group, model group, carbamazepine group, Lutongning high dose group (2.70 g crude drug·kg-1·d-1) and Lutongning low dose group (1.35 g crude drug·kg-1·d-1). Von Frey Brush brush was used to detect the mechanical pain threshold of rat whisker pad, biochemical method was used to detect the coagulation and hemostream function, HE staining was used to observe the microcirculation change of the infraorbital nerve after perfusion, western blot was used to detect the p38 and p-p38 expression in the trigeminal nerve. Results Lutongning granulethe increased the pain threshold in model rats (P<0.05, P<0.01), reduced the plasma viscosity (P<0.05, P<0.01) and the whole blood reduction viscosity in model rats (P<0.05, P<0.01), improved the flow ability in model rats, increased PT, APTT and TT levels in model rats (P<0.05, P<0.01), reduced FIB levels (P<0.01), improved the microcirculation on the infraorbital nerve in the model rats, reduced the p-p38 expression in the trigeminal nerve of model rats (P<0.01). Conclusion Lutongning granules have the effect of improving trigeminal neuralgia, which may be related to the function of promoting blood circulation and removing blood stasis.
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