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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 （3057）      PDF（pc） （1413KB）（199）       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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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 （2593）      PDF（pc） （1366KB）（263）       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 （2446）      PDF（pc） （3192KB）（855）       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 （2349）      PDF（pc） （1355KB）（1068）       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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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 （1937）      PDF（pc） （1259KB）（12913）       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 （1928）      PDF（pc） （2217KB）（882）       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 （1927）      PDF（pc） （1295KB）（210）       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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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 （1868）      PDF（pc） （1309KB）（673）       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 （1811）      PDF（pc） （1284KB）（903）       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 （1807）      PDF（pc） （1862KB）（415）       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 （1788）      PDF（pc） （1870KB）（185）       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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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 （1763）      PDF（pc） （2583KB）（420）       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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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 （1757）      PDF（pc） （3891KB）（157）       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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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 （1725）      PDF（pc） （2112KB）（490）       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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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 Abstract （1607）      PDF（pc） （1350KB）（827）       Knowledge map    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. 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 （1586）      PDF（pc） （1222KB）（518）       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）

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Research Progress in Drug-Related Liver Injury in the Treatment of Autoimmune Diseases SUN Xiaorui, ZHAO Ning, ZHANG Luyong, JIANG Zhenzhou, WANG Xinzhi Chinese Journal of Pharmacovigilance    2025, 22 (5): 523-527.   DOI: 10.19803/j.1672-8629.20250035 Abstract （1535）      PDF（pc） （1224KB）（617）       Knowledge map    Save Objective To explore the pathogenesis of drug-induced liver injury in the treatment of autoimmune diseases, and to provide references for rational clinical use. Methods CNKI, Wanfang Data, PubMed and other databases were searched for literature on the mechanisms of drug-induced liver injury associated with drugs used in the treatment of autoimmune diseases, including methylprednisolone, methotrexate, infliximab, and adalimumab. The search focused on two categories: traditional drugs, as well as biologics and small molecule inhibitors. Results The mechanisms of liver injury caused by different classes of autoimmune disease drugs varied. However, most of these drugs led to an increase in one or more liver cell enzymes. For some drugs, the underlying mechanism of drug-induced liver injury remained unclear. Conclusion The incidence of drug-induced liver injury associated with drugs used to treat autoimmune diseases is closely linked to the characteristics of the drugs and the individual differences between patients. Clinical follow-up should be ensured, and liver function should be monitored. Reference | Related Articles | Metrics | Comments（0）

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Roles of Hepatocellular NF-κB Signaling Pathway in Triptolide-Induced Indirect Liver Injury TANG Qianhui, ZHU Ying, ZHANG Haoran, ZHANG Luyong, JIANG Zhenzhou Chinese Journal of Pharmacovigilance    2025, 22 (2): 128-138.   DOI: 10.19803/j.1672-8629.20240855 Abstract （1521）      PDF（pc） （5603KB）（1113）       Knowledge map    Save Objective To investigate the role of hepatocellular nuclear factor-κB (NF-κB) signaling pathway in increasing hepatic sensitivity to lipopolysaccharide (LPS) mediated and drug-induced indirect liver injury caused by triptolide (TP). Methods In the in vivo experiment, female C57BL / 6N mice were randomly divided into the control group (Con), TP sequential LPS group (TP+LPS), and LPS sequential TP group (LPS+TP). Six hours after coadministration of TP and LPS, blood biochemistry, liver weight coefficient and hematoxylin eosin staining (HE) were detected to assess liver injury. Polymerase chain reaction (PCR) was used to detect the levels of inflammatory factors and genes related to anti-apoptosis. The expressions of apoptosis / anti-apoptosis related proteins were detected by Western Blot (WB) and immunohistochemistry (IHC), and the enzyme activity of apoptosis related proteins was also measured. Two hours after administration of LPS, the protein expressions of NF-κB inhibitory protein α (IκBα) and p65 were detected by WB. The translocation of p65 from the cytoplasm to the nucleus was observed by IHC. Changes in the levels of anti-apoptosis related genes were determined by PCR. In the in vitro experiment, the LDH content, enzyme activity of apoptosis related proteins, and levels of apoptosis / anti-apoptosis related proteins were detected after coadministration of TP and TNF-α. After administration of TP, changes in degradation of IκBα protein induced by TNF-α were determined by WB, and translocation of p65 was observed via immunofluorescence (IF). Phorbol 12-myristate 13-acetate (PMA) was selected to activate NF-κB signaling pathway in AML12 cells. The enzyme activity of apoptosis related proteins, protein levels of apoptosis / anti-apoptosis related proteins, and the content of LDH were measured to evaluate the changes caused by PMA pre-administration. Results Compared with the Con group, mice in the (TP+LPS) group showed a significant increase in aminotransferase levels, liver weight coefficient, and inflammatory factors, with significant pathological changes in the liver. However, there were no significant changes in the (LPS+TP) group compared with the Con group. The enzyme activity of caspase-8, expressions of apoptosis-related proteins, and IHC positive regions of cleaved caspase-3 increased significantly in the liver tissue of the (TP+LPS) group, and the expression of the anti-apoptotic protein FLIP showed a significant reduction, while the above-mentioned indexes were not significantly changed in the (LPS+TP) group. Pre-administration of TP significantly inhibited LPS-induced degradation of IκBα and p65 entry into the nucleus, and downregulated the expressions of anti-apoptosis related genes. In AML12 cells in in vitro, after coadministration of TP and TNF-α at a non-toxic concentration, the release of LDH and the expressions of apoptosis related proteins were significantly increased while the expressions of anti-apoptotic proteins were significantly decreased. TNF-α induced degradation of IκBα and the entry of p65 into the nucleus were significantly inhibited by TP. After pre-activation of the NF-κB signaling pathway in AML12 cells by administration of PMA, the expressions of apoptosis-related proteins, the enzyme activity of caspase-8 and the release of LDH were significantly decreased, while the expression of anti-apoptotic proteins was significantly increased. Conclusion NF-κB signaling pathway can make a big difference to the liver injury resulting from different sequential administrations of TP and LPS. TP can impair hepatocytes' ability to withstand the stimulation of exogenous pathogens and apoptosis signaling by inhibiting NF-κB activation, triggering a significant increase in apoptosis among hepatocytes, ultimately leading to the development of indirect drug-induced liver injury. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1399）      PDF（pc） （3599KB）（352）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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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 Abstract （1388）      PDF（pc） （1975KB）（195）       Knowledge map    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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）