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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 Abstract （3090）      PDF（pc） （1413KB）（207）       Knowledge map    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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions GAO Yunjuan, ZHAO Xu, BAI Tiankai, BAI Zhaofang, WANG Jiabo, SONG Haibo, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 1-5.   DOI: 10.19803/j.1672-8629.20230772 Abstract （2758）      PDF（pc） （1327KB）（1540）       Knowledge map    Save Objective To explore how to quickly discover and accurately identify drug safety risks from a vast number of adverse reaction reports from domestic and foreign Chinese and Western medicines. The aim is also to make scientific and effective predictions and control measures for these risks. Methods Drug-induced liver injury data was taken as an example, and the process of discovering, evaluating, confirming, and controlling risks associated with drugs were discussed. Results A preliminary exploration was conducted, leading to the establishment of an integrated strategy and method system for “large-scale adverse reaction monitoring and discovery - multi-model recognition and analysis- disease-symptom-toxicology verification.” This system has been successfully applied in identifying and analyzing drug-induced liver injury. Conclusion This strategy offers a fresh perspective for the continuous development and innovation of drug safety evaluation. It also provides technical support for ensuring public safety in medication and promoting the healthy development of the Chinese and Western medicine industry. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （2650）      PDF（pc） （1366KB）（272）       Knowledge map    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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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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 Abstract （2461）      PDF（pc） （3192KB）（894）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Research Progress in Triptolide-Induced Live Injury TANG Qianhui, ZHANG Haoran, ZHANG Luyong, JIANG Zhenzhou Chinese Journal of Pharmacovigilance    2025, 22 (2): 121-127.   DOI: 10.19803/j.1672-8629.20230658 Abstract （2406）      PDF（pc） （1355KB）（1133）       Knowledge map    Save Objective To summarize the research progress in the hepatotoxicity mechanism of triptolide and shed light on the mechanism of drug-induced liver injury caused by triptolide. Methods Based on literature research, the mechanism of drug induced liver injury caused by triptolide was summarized in terms of direct toxicity and indirect toxicity. Results The hepatotoxic mechanism of triptolide involved oxidative stress, mitochondrial damage, metabolic abnormalities, activation of NKT cells, imbalance between T helper cells and regulatory T cells, and increased liver sensitivity to inflammatory stimuli. Conclusion The hepatotoxicity mechanism of triptolide is complex, as there are a wide range of targets for direct toxicity. In addition, the indirect toxicity is highly concealed and complex. The elucidation of mechanisms of hepatotoxicity caused by triptolide provides a reference for enhancing the efficacy and reducing the toxicity of Tripterygium wilfordii Hook.f. and its preparations as well as for clinical safety and rational drug use. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （2098）      PDF（pc） （1550KB）（1359）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring GUO Longxin, GAO Yunjuan, WU Chengzhao, LONG Minjuan, ZHU Shengkai, SONG Haibo, ZHAO Xu, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 15-19.   DOI: 10.19803/j.1672-8629.20230779 Abstract （2033）      PDF（pc） （1290KB）（535）       Knowledge map    Save Objective To explore the method of discovering signals of hepatotoxicity risk in traditional Chinese medicine (TCM) based on national adverse reaction monitoring big data, preliminarily screen risky varieties, and analyze the susceptible factors of liver damage based on the “ Trielement Injury Hypothesis ” theory. Methods Retrospective analysis of adverse drug reaction (ADR) reports related to TCM-induced drug-induced liver injury (DILI) collected between 2012 and 2016. Identify suspicious TCM varieties and predict the susceptible factors for liver damage in these varieties. Results A total of 1 901 ADR reports（1 719 patients) of TCM-induced DILI were collected, and 237 suspicious TCM varieties were newly discovered. Traditional Chinese medicine used for anti-tumor purposes had the highest incidence of DILI. The oral route of administration accounted for the largest proportion (71.70%), with a median latency period of 13.00 days, and the majority of cases had a latency period of 0 to 7 days (34.46%). Analysis based on the “ Trielement Injury Hypothesis ”theory revealed that the TCM varieties suspected of causing DILI were related to the body’s state, the drugs themselves, and the medication environment. Conclusion Discovery of a series of TCM risk signals requires further confirmation of the risk and analysis of the causal mechanisms. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （2011）      PDF（pc） （1259KB）（13093）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Effects of Triptolide on Secretion of Steroid Hormone in Primary Adrenocortical Cells WANG Hongli, DU Juan, CAO Mengqi, ZHANG Luyong, JIANG Zhenzhou, HUANG Xin Chinese Journal of Pharmacovigilance    2025, 22 (2): 139-146.   DOI: 10.19803/j.1672-8629.20230660 Abstract （1947）      PDF（pc） （2217KB）（1054）       Knowledge map    Save Objective To establish a method for the extraction and verification of primary rat adrenocortical cells and to investigate the effect of triptolide on primary rat adrenocortical cells and the mechanism. Methods Primary adrenocortical cells were isolated and cultured in culture plates, their serum dependence and steroid hormone secretion function were verified, the toxicity of triptolide on primary adrenocortical cells and the effect of age on toxicity sensitivity to triptolide were investigated, and the mechanism was explored via PCR and WB experiments. Results The primary rat adrenocortical cells were serum-dependent and could secrete steroid hormone after 72 h in vitro. The toxicity sensitivity of triptolide was influenced by week age. Triptolide dose-dependently inhibited steroid hormone secretion and inhibited HSD3B2 gene and protein expressions. Conclusion The primary adrenocortical cells of female Wistar rats can serve as a good model to study the effect of drugs on adrenal steroid hormone secretion, whose inhibition by triptolide in primary adrenocortical cells is associated with decreased gene and protein expressions of HSD3B2. Reference | Related Articles | Metrics | Comments（0）

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Research Progress in Adaptive Response of Hepatocytes in Intrinsic Drug-Induced Liver Injury CHEN Qingyu, JIANG Zhenzhou, ZHANG Luyong Chinese Journal of Pharmacovigilance    2025, 22 (5): 532-538.   DOI: 10.19803/j.1672-8629.20250021 Abstract （1947）      PDF（pc） （1295KB）（221）       Knowledge map    Save Objective To summarize the research progress in the adaptive response of hepatocytes against intrinsic drug-induced liver injury so as to provide a safe medication regimen for drugs with potential hepatotoxicity. Methods By searching databases for related literature published as of January 10, 2025, the mechanism by which adaptive response of hepatocytes helped alleviate intrinsic drug-induced liver injury was studied in terms of drug metabolism, mitochondrial stress response and hepatocyte proliferation. Results Drug-induced liver injury coincided with the activation of adaptive response that was believed to maintain liver homeostasis and mitigate intrinsic drug-induced liver injury by increasing detoxification metabolism, reducing toxic metabolism, promoting mitophagia, enhancing the antioxidant system, promoting hepatocyte proliferation, and regulating functional gene expressions in surviving hepatocytes. Conclusion The mechanism of adaptive response is complex and plays an important role in endogenous protection against intrinsic drug-induced liver injury. The study of adaptive response can provide a clinically safe and rational regimen for potentially hepatotoxic drugs and facilitate the treatment and prevention of intrinsic drug-induced liver injury. Reference | Related Articles | Metrics | Comments（0）

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148 Case of Drug-Induced Liver Adverse Reactions TUO Kangxiu, YANG Chengli, LI Ming, JIANG Man Chinese Journal of Pharmacovigilance    2025, 22 (10): 1154-1158.   DOI: 10.19803/j.1672-8629.20250482 Abstract （1912）      PDF（pc） （713KB）（1070）       Knowledge map    Save Objective To investigate the characteristics of drug-induced liver injury and provide references for related medications and prevention. Methods The case reports of drug-induced liver adverse reactions submitted to the National Adverse Drug Reaction Monitoring System by the Affiliated Hospital of Guizhou Medical University in 2021-2024 were collected and analyzed. Results A total of 148 cases of drug-induced liver adverse reactions were collected. Using the RUCAM scale, 109 cases were scored 6 to 8, and 39 cases 3 to 5. Among the 59 cases of liver injury whose detection indicators met the classification criteria, hepatocyte injury was the dominating type (44 cases), followed by the cholestatic type (10 cases) and the mixed type (5 cases). There were 55 grade Ⅰ cases and 4 grade Ⅱ cases. The top three drug categories responsible for live injury were antineoplastic drugs (41.58%), anti-infective drugs (36.63%) and drugs for the cardiovascular system (13.86%). The time from drug administration to the first detection of abnormal liver biochemical indicators was 2 to 15 days. Clinically, hepatoprotective drugs were used by 137 patients (92.57%) with drug-induced liver adverse reactions, 129 of whom provided detailed reports on their usage of hepatoprotective drugs. The types of hepatoprotective agents used ranged from 1 to 3 types: 73 cases (56.59%) took one type of hepatoprotective agent, 43 cases (33.33%) received two types of hepatoprotective agents, and 13 cases (10.08%) were given three types of hepatoprotective agents. Conclusion A wide range of drugs can cause drug-induced liver adverse reactions, with those causing hepatocellular injury as the dominating type. In clinical practice, high-risk drugs for liver injury should be monitored more rigorously. When formulating liver-protecting treatment plans, clinicians are advised to weigh the advantages and disadvantages of combined medications. Reference | Related Articles | Metrics | Comments（0）

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Big Data Analysis of Liver Adverse Reactions Monitoring of Chinese and Western Medicines Based on Age Correction and Risk Warning for Dermatologic Drugs LONG Minjuan, ZHAO Xu, GUO Longxin, CAI Yuhan, LIN Li, ZHU Shengkai, LIU Wenlong, SONG Haibo, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2025, 22 (3): 271-275.   DOI: 10.19803/j.1672-8629.20240720 Abstract （1904）      PDF（pc） （1309KB）（742）       Knowledge map    Save Objective To explore the relationship between age and the risk of drug-induced liver injury (DILI), and to study the impact of age on the risk of adverse reactions induced by Chinese and Western medicines. Methods Reports about adverse drug reactions related to DILI were retrospectively analyzed, and the number of ADR reports was adjusted demographically based on the data of a census. The way in which the risk of DILI changed with age, the usage of categorized drugs and the characteristics of drugs of special varieties were analyzed. Results After age correction, the incidence of liver injury was found to increase with the age of users of traditional Chinese medicines and Western medicines in particular. Analysis by drug category showed that the risk of DILI increased with age, except for Western medicines used for the nervous system, traditional Chinese medicines and Western medicines for skin diseases. DILI due to traditional Chinese medicines for dermatologic diseases caused a larger number of serious adverse reactions than Western medicines. The underlying diseases of patients were mostly vitiligo, psoriasis and alopecia. Preparations involving Dictamni cortex, Polygonum multiflorum, Psoralea corylifolia were high-risk drugs. Conclusion The risk of DILI is positively correlated with age for most drugs. The risk posed by drugs for DILI and by traditional Chinese medicines for skin diseases deserves more attention so as to prevent the occurrence of serious adverse reactions. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress in Liver Injury Caused by Drugs Commonly Used during Pregnancy CAO Weiping, ZHANG Shichao, NI Xia, XIE Bing, WANG Xinzhi, XING Mengtao Chinese Journal of Pharmacovigilance    2025, 22 (5): 528-531.   DOI: 10.19803/j.1672-8629.20250037 Abstract （1830）      PDF（pc） （1284KB）（924）       Knowledge map    Save Objective To provide an overview of the classification, mechanisms, diagnostic methods, and management of drug-induced liver injury(DILI) during pregnancy in order to ensure pharmacovigilance during pregnancy. Methods Such databases as PubMed, the Cochrane Library, the Web of Science, CNKI and CBM were searched for literature related to DILI during pregnancy. Results The incidence of DILI during pregnancy fluctuated. Liver injury was primarily divided into three types: direct, indirect or specific, with the last type dominating during pregnancy. DILI still relied on the diagnosis of exclusion, usually made only after other causes of hepatitis were ruled out. DILI during pregnancy was handled in the same way as in non-pregnant populations. The commonly used drugs that could cause DILI during pregnancy included antihypertensive drugs, anti-thyroid drugs, antiretroviral and anti-tuberculosis drugs as well as antibiotics. Conclusion Research reports on DILI during pregnancy are lacking. Moreover, most of the literature currently available is case reports. The incidence of this disease varies, diagnosis is difficult, and management is challenging. Pharmacovigilance during pregnancy has to be upgraded to ensure the safety of patients. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1822）      PDF（pc） （1862KB）（430）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1808）      PDF（pc） （1870KB）（199）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Dynamic Immunophenotyping of NK Cells in Triptolide-Induced Hepatotoxicity CHEN Runji, SUN Xiaorui, HUANG Xin, JIANG Zhenzhou, ZHANG Luyong, WANG Xinzhi, DING Jian Chinese Journal of Pharmacovigilance    2025, 22 (5): 517-522.   DOI: 10.19803/j.1672-8629.20250036 Abstract （1777）      PDF（pc） （3891KB）（174）       Knowledge map    Save Objective To explore the dynamic changes and roles of natural killer (NK) cells in the process of triptolide (TP)-induced liver injury. Methods Female C57BL/6 mice were divided into the control group, the 1, 3, 5, and 7 days of TP administration (600 μg·kg-1) groups, and groups treated with anti-NK1.1 antibody combined with TP for 1, 3, 5, and 7 days. At different time points, the blood of mice was collected and non-parenchymal cells in the liver were isolated for flow cytometry analysis of the temporal changes in NK cells, CD4⁺/CD8⁺ T cell subsets and cytokines (IFN-γ and IL-4). Results After TP treatment, the proportion of liver NK cells significantly increased at day 1 (P<0.05), while CD69⁺ NK cells kept increasing from day 3 to 7(P<0.05). NK cell depletion significantly reduced serum ALT levels (P<0.05) and inhibited IFN-γ production (P<0.05), shifting NK cell-derived cytokines toward a Th2 bias (reduced IFN-γ/IL-4 ratio, P<0.05). Additionally, TP induced a persistent increase in peripheral blood CD4⁺ T cells (days 1-7, P<0.05) and a selective decrease in CD8⁺ T cells (days 3-5, P<0.05), leading to an imbalanced CD4⁺/CD8⁺ ratio. Conclusion Hepatic NK cells can contribute to TP-induced liver injury. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1776）      PDF（pc） （2583KB）（444）       Knowledge map    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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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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 Abstract （1760）      PDF（pc） （2112KB）（513）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Risks of liver injury caused by Shiduqing preparations SHAO Bo, XU Lili, ZHU Lan, LIU Shuo, WAN Hao, HUANG Guangrui Chinese Journal of Pharmacovigilance    2024, 21 (6): 666-670.   DOI: 10.19803/j.1672-8629.20240137 Abstract （1724）      PDF（pc） （1363KB）（351）       Knowledge map    Save Objective To analyze the risks of liver injury posed by Shiduqing preparations and provide reference for proper clinical use. Methods Literature about adverse reactions related to Shiduqing preparations in China’s adverse drug reaction monitoring database (collected between 2004 and 2023) and domestic database (from inception to December 31, 2023) was sorted out and analyzed. Results The National Adverse Drug Reaction Monitoring System Database documented 24 cases of adverse reactions related to liver and gallbladder damage and involving Shiduqing preparations. No adverse reactions related to hepatobiliary damage were found in clinical studies. The adverse reactions mentioned in individual reports were drug induced liver disease and liver injury. Conclusion Clinicians should be alert to the risk of liver injury when Shiduqing preparations are used in clinic. The awareness of safe and proper medications should be raised, and medications monitored. At the same time, drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1628）      PDF（pc） （1222KB）（570）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）