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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 （1810）      PDF（pc） （1259KB）（11624）       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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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 （1678）      PDF（pc） （2112KB）（468）       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 （1561）      PDF（pc） （1350KB）（788）       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 （1521）      PDF（pc） （1222KB）（461）       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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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 （1364）      PDF（pc） （3599KB）（318）       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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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 Abstract （1327）      PDF（pc） （1584KB）（831）       Knowledge map    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. Reference | Related Articles | Metrics | Comments（0）

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Pharmacodynamic Evaluation of CAR-T Cell Products Based on Deep Learning Convolutional Neural Network Recognition REN Yuke, QU Zhe, LAI Zixuan, ZHANG Di, ZHAO Yongtian, YANG Yanwei, LI Shuangxing, HUO Guitao, ZHOU Xiaobing, LIN Zhi, GENG Xingchao Chinese Journal of Pharmacovigilance    2025, 22 (7): 742-748.   DOI: 10.19803/j.1672-8629.20250257 Abstract （1273）      PDF（pc） （2157KB）（238）       Knowledge map    Save Objective To establish an auxiliary diagnostic model for mouse liver lymphoma using deep learning (DL) technology in order to improve the accuracy and consistency of pathological diagnosis and facilitate the research and development of cell therapy products. Methods A total of 102 hepatic lymphoma tissues and 41 normal liver tissues were collected from mice used in chimeric antigen receptor (CAR) T-cell therapeutic and toxicological studies. After the tissues were scanned into digital slides, semi-automated data annotation was performed. To enhance the accuracy of annotation, all data underwent preprocessing (tissue extraction and artifact removal) and was randomly divided into training, validation, and test sets at a ratio of 8∶1∶1. Five convolutional neural networks-FCN, LR-ASPP, DeepLabv3+, U-Net, and DenseNet-were applied to identify tumor and non-tumor regions. The tumor prediction images based on slice images were compared, and the performance of the constructed algorithm models was evaluated using precision, recall, and the F1-score. Results The precision, recall, and F1-score of the DenseNet, DeepLabv3+, and FCN algorithms were all close to or exceeded 95%. Among them, the DenseNet algorithm model performed best in the test set, with an overall precision of 0.989 4, a recall of 0.990 6, and an F1- score of 0.990 0. Conclusion The DenseNet algorithm model established in this study has a good prospect of application in auxiliary diagnosis of mouse liver lymphoma, which can effectively improve the accuracy and consistency of assessment of tumor occurrence in studies on the efficacy and toxicology of CAR-T cell therapy products. Reference | Related Articles | Metrics | Comments（0）

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Traditional Chinese medicine for prevention and treatment of adriamycin cardiotoxicity and an empirical study of evidence elements LIU Yadi, ZHANG Xiaomeng, CAI Haili, CHEN Siying, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (7): 759-764.   DOI: 10.19803/j.1672-8629.20240294 Abstract （1241）      PDF（pc） （1666KB）（381）       Knowledge map    Save Objective To validify the evidence of adriamycin cardiotoxicity via animal experiments based on the analysis of TCM medications used for the prevention and treatment of adriamycin cardiotoxicity in order to provide data for related treatment. Methods Literature related to the prevention and treatment of anthracycline cardiotoxicity with TCM and published between the inception to March 1st, 2024 was searched for from some databases to analyze the pattern of medications and to establish a rat model of anthracycline cardiotoxicity via injection with doxorubicin at 3.5 mg•kg-1. Results A total of 104 Chinese herbal medicines, such as Astragalus, Glycyrrhiza glabra, Maitong, Ginseng, Radix et Rhizoma Ginseng, Radix et Rhizoma Ginseng, and Salviae Miltiorrhizae, were included. The efficacy of these drugs was determined as tonifying deficiency, activating blood circulation, removing blood stasis, clearing heat, eliminating phlegm, and expelling dampness. Anthracycline cardiotoxic rats showed dirty fur, hair loss, loose stools, stasis of blood, depression, lethargy, decrease in anal temperatures, and dark tongue color. The serum contents of antidiuretic hormone, aldosterone, and antithrombin Ⅲ were significantly decreased while the content of D-dimer was significantly increased. Conclusion The development of drugs for prevention and treatment of anthracycline cardiotoxicity should involve tonifying the deficiency, stimulating blood circulation, eliminating stasis, expelling dampness and resolving turbidity. Reference | Related Articles | Metrics | Comments（0）

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Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health WANG Tao, SONG Haibo, WANG Qing, HOU Yongfang, LIU Hongliang, ZHANG Lin Chinese Journal of Pharmacovigilance    2024, 21 (8): 906-909.   DOI: 10.19803/j.1672-8629.20230518 Abstract （1241）      PDF（pc） （1244KB）（1500）       Knowledge map    Save Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics. Reference | Related Articles | Metrics | Comments（0）

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Doxorubicin-Induced Cardiotoxicity Related to Regulation of Mitochondrial-Associated Membranes by PDK4 SHI Yanlei, ZHANG Bing, WANG Yu, XU Zhuoxin, TIAN Min, MENG Min, SA Rina Chinese Journal of Pharmacovigilance    2025, 22 (8): 863-868.   DOI: 10.19803/j.1672-8629.20250272 Abstract （1232）      PDF（pc） （1785KB）（1008）       Knowledge map    Save Objective To analyze the molecular mechanism through which PDK4 regulates Mitochondria-Associated Membranes(MAMs) and explore its potential association with anthracycline-induced cardiotoxicity in order to provide data for developing cardioprotective strategies. Methods By reviewing recent literature, the role of PDK4 in MAMs and its potential involvement in anthracycline-induced cardiotoxicity was explored. Results There were complicated interactions between PDK4, MAMs, and anthracycline-induced cardiotoxicity, primarily manifested as energy metabolism disorders, oxidative stress, apoptosis, and calcium homeostasis imbalance. These interactions played a significant role in the progression of anthracycline-induced cardiotoxicity. Conclusion Overexpression of PDK4 can, above all, disrupt calcium homeostasis mediated by MAMs, leading to mitochondrial calcium overload and consequently exacerbating anthracycline-induced cardiotoxicity. This study can offer novel insights and help identify potential therapeutic targets for developing protective strategies against anthracycline-associated cardiotoxicity. Reference | Related Articles | Metrics | Comments（0）

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Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei Chinese Journal of Pharmacovigilance    2024, 21 (11): 1280-1283.   DOI: 10.19803/j.1672-8629.20240471 Abstract （1223）      PDF（pc） （1223KB）（1338）       Knowledge map    Save Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China. Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV) jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted. Results READUS-PV included 14 items concerning the title, introduction, methods, results, discussion, declaration and abstracts. Conclusion In actual drug safety signal detection research, READUS-PV can be consulted to improve research quality. Reference | 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 （1178）      PDF（pc） （3192KB）（803）       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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Systematic Evaluation of Cardiotoxicity of Chinese Herbal Compounds for Breast Cancer Chemotherapy LIU Shujia, ZHANG Xiaomeng, CHEN Siying, CAI Haili, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (11): 1209-1215.   DOI: 10.19803/j.1672-8629.20240449 Abstract （1146）      PDF（pc） （2979KB）（519）       Knowledge map    Save Objective To evaluate the applicability and therapeutic effect of Chinese herbal compounds in preventing and treating chemotherapy-induced cardiotoxicity in breast cancer patients. Methods Data on randomized controlled trials (RCTs) of Chinese herbal compounds for chemotherapy-induced cardiotoxicity in breast cancer patients published in domestic and foreign databases was collected and sortde from establishment of the tibrary to April 1, 2024. Excel sheet was used to analyze the related medications while RevMan 5.4 software was adopted to perform Meta-analysis on RCTs that met the inclusion criteria. Results A total of 42 RCTs were included, involving 2 847 subjects. The experimental group was treated with Chinese herbal compounds plus conventional chemotherapy to combat chemotherapy-induced cardiotoxicity. Compared with the control group treated with chemotherapy drugs alone, the incidence of abnormal electrocardiograms was significantly reduced in the experimental group OR=0.23[95%CI (0.19, 0.28), P<0.000 01]. In addition, the left ventricular ejection fraction was increased with an MD of 9.02[95%CI (6.45, 11.60), P=0.000 1], but the expressions of creatine kinase isoenzyme and troponin I were reduced. Conclusion Chinese herbal compounds capable of replenishing qi and nourishing yin, promoting blood circulation and unblocking meridians have prominent advantages in preventing and treating the cardiotoxicity induced by chemotherapy drugs. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Advancements in Treating Ischemic Stroke with Chinese Medicine Compounds Formulae LIU Wenjie, GAO Yuanyuan, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (12): 1382-1387.   DOI: 10.19803/j.1672-8629.20240654 Abstract （1119）      PDF（pc） （1427KB）（529）       Knowledge map    Save Objective To examine findings related to the applications of TCM compound formulae in the management of ischemic stroke, and to offer data for subsequent clinical and experimental investigations. Methods By searching China Knowledge Network and PubMed for articles published from the inception to October 20, 2024, TCM compound formulae were summarized and evaluated. Results Clinical investigations indicated that TCM compound formulae, including Buyang Huanwu Tang, Xinglou Chengqi Tang, and Taohong Siwu Tang, exhibited substantial therapeutic efficacy in patients with ischemic stroke. Conclusion TCM compound formulae possess considerable benefits in the management of ischemic stroke. However, investigations are comparatively limited, and there is a lack of clinical studies and large-scale trials. Multi-sample and high-quality clinical studies are lacking. Reference | Related Articles | Metrics | Comments（0）

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Research Progress on Wuzi Yanzong Pill in the Treatment of Oligoasthenospermia TAN Tianyang, TANG Tian, LIU Zhejun, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (11): 1232-1237.   DOI: 10.19803/j.1672-8629.20240635 Abstract （1117）      PDF（pc） （1305KB）（1089）       Knowledge map    Save Objective Oligoasthenospermia (OA) is a prevalent cause of male infertility, significantly impairing fertility and life quality. The traditional Chinese medicine formula, Wuzi Yanzong Pill, has demonstrated promising efficacy in treating this condition. This article explores the clinical efficacy and mechanism of action of Wuzhi Yanzong Pill in the treatment of oligoasthenozoospermia. Methods This article reviews the latest research progress on the treatment of oligoasthenozoospermia with Wuzhi Yanzong Pill in the past three years, encompassing its clinical effectiveness, mechanisms of action, and pharmacological investigations. Result Studies have shown that Wuzi Yanzong Pill enhances sperm quality and quantity through various targets and pathways. It is primarily achieved by reducing oxidative stress and cellular apoptosis, regulating endocrine functions, protecting the blood-testis barrier, and boosting mitochondrial function. Additionally, the pill is found to influence gut microbiota and affect gene expression. Clinical research supports the therapeutic benefits of Wuzi Yanzong Pill in individuals with oligoasthenospermia and examines its synergistic use with other treatments. Conclusion Wuzhi Yanzong Pill has shown good clinical efficacy in the treatment of oligoasthenozoospermia. However, more comprehensive research is needed to fully understand its mechanisms and refine its clinical application strategies. Reference | Related Articles | Metrics | Comments（0）

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Preventive Strategies for Anthracycline-Induced Cardiotoxicity Using Traditional Chinese Medicine via Ferroptosis Regulation CAI Haili, ZHANG Xiaomeng, LIU Yadi, CHEN Lijuan, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2025, 22 (8): 876-882.   DOI: 10.19803/j.1672-8629.20250310 Abstract （1106）      PDF（pc） （2253KB）（426）       Knowledge map    Save Objective To investigate the role of the hyperuricemia-ferroptosis pathway in anthracycline-induced cardiotoxicity and evaluate the effects of intervention of chicory (Cichorium intybus L.) extract, a traditional Chinese medicine. Methods A doxorubicin (DOX)-induced cardiotoxicity model was established using zebrafish larvae at 3 days post-fertilization (dpf). The larvae were divided into seven groups: control, DOX alone (10 μmol·L-1), hyperuricemia (100 μmol·L-1) + DOX(10 μmol·L-1), allopurinol (136 μg·mL-1) + DOX(10 μmol·L-1), hyperuricemia(100 μmol·L-1) + DOX(10 μmol·L-1) +ferroptosis inhibitor Fer-1 (1 μmol·L-1), and hyperuricemia(100 μmol·L-1) + DOX(10 μmol·L-1) + chicory extract (low/high dose: 500/1 000 μg·mL-1). Survival rate, heart rate, and cardiac morphological parameters (SV-BA distance and pericardial edema) were recorded. Results Hyperuricemia significantly exacerbated DOX-induced cardiotoxicity, which was manifested as increased heart rate, extended SV-BA distance, and aggravated pericardial edema (P<0.05 or P<0.01). Both Fer-1 and chicory extract markedly ameliorated cardiac injury (P<0.01), especially in the high-dose chicory group. Conclusion Hyperuricemia may aggravate anthracycline cardiotoxicity by activating ferroptosis, while the chicory extract exerts cardioprotective effects. Monitoring ferroptosis-related biomarkers could help establish an early warning system and provide novel strategies for clinical prevention and treatment. Reference | Related Articles | Metrics | Comments（0）

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Research Progress of Epimedium in the Treatment of Male Infertility TANG Tian, TAN Tianyang, LIU Zhejun, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (11): 1238-1242.   DOI: 10.19803/j.1672-8629.20240638 Abstract （1104）      PDF（pc） （1246KB）（2143）       Knowledge map    Save Objective To assess the potential of Epimedium and its active components in the treatment of male infertility and to explore their prospects in traditional Chinese medicine therapy. Methods A systematic literature review was conducted to analyze the significant effects of Epimedium and its main active components on improving spermatogenesis, protecting the testicular microenvironment, regulating sex hormone levels, combating oxidative stress, and alleviating sexual dysfunction. Results Epimedium demonstrated the potential to protect germ cells by modulating key signaling pathways and improving apoptosis, and it also showed positive effects in improving sexual dysfunction. Conclusion The active components of Epimedium have significant potential in the treatment of male infertility. Future research should further verify their clinical efficacy to promote their application in the field of male reproductive health. Reference | Related Articles | Metrics | Comments（0）

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Progress in construction and evaluation of a drug-induced cardiotoxicity model CAI Haili, ZHANG Xiaomeng, LIU Yadi, LIU Shujia, GAO Fujun, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (7): 765-770.   DOI: 10.19803/j.1672-8629.20240345 Abstract （1092）      PDF（pc） （2255KB）（933）       Knowledge map    Save Objective To find out about the establishment and applications of animal models for drug-induced cardiotoxicity, and to provide data for the prevention and treatment of drug-induced cardiotoxicity. Methods Literature research was conducted using “cardiotoxicity” as the key term. Related literature on applications of drug-induced cardiotoxicity models published since 2015 was selected from the CNKI and Web of Science Core Collection databases. Literature about experimental research on applications of animal models for drug-induced cardiotoxicity was screened based on the inclusion criteria. Analysis software Citespace 6.3 R1 (64-bit) Basic as well as Excel was used to visualize the selected literature. Results A total of 731 articles were included. The model animals used in studies of drug-induced cardiotoxicity were mostly rats, mice and zebrafish while the modeling agents were chiefly adriamycin, aconitine and bupivacaine. The toxicity mechanism involved oxidative stress and apoptosis. Most studies used such multi-category indicators as general indicators, histopathological indicators, and cardiac function test indicators for comprehensive evaluation. The applications were also relatively concentrated, and there were great differences in the criteria for evaluating drug-induced cardiotoxicity models. Conclusion Research on drug-induced cardiotoxicity models remains promising, which can facilitate systematic development of Traditional Chinese Medicine for the prevention and treatment of drug-induced cardiotoxicity. Reference | Related Articles | Metrics | Comments（0）

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Interpretations of Revised Guidelines for Bacterial Endotoxin Testing in Chinese Pharmacopoeia 2025 PEI Yusheng, GAO Hua, ZHU Ran, LIU Tao, CAI Tong Chinese Journal of Pharmacovigilance    2025, 22 (10): 1127-1131.   DOI: 10.19803/j.1672-8629.20250396 Abstract （1081）      PDF（pc） （1375KB）（1410）       Knowledge map    Save Objective To interpret the revised guidelines for bacterial endotoxin testing (9251) in Chinese Pharmacopoeia 2025 in order to help make the related testing more precise and feasible. Methods The modifications in the guidelines for bacterial endotoxin testing specified in Chinese Pharmacopoeia 2025 were analyzed. The background for the revision and implications were studied in depth. Results The major revisions included① specifications of endotoxin limits for ophthalmic medications; ②refined limit-setting requirements for raw materials, excipients, and packaging materials; ③ common interferents and ways of removal; ④ detailed descriptions of pretreatment methods for poorly soluble samples and packaging materials; ⑤ descriptions of low endotoxin recovery; ⑥ the specification of the recombinant factor C method as a complementary approach. Conclusion These revisions reflect better standards for pharmaceutical quality control in China and provide more practical technical guidance for professionals, which are of vital importance for quality control of pharmaceuticals. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Risk Analysis and Mechanism Discussion of Cardiovascular, Hepatic, or Nephrotoxicity Induced by Tripterygium Wilfordii CHEN Lijuan, ZHANG Xiaomeng, GAO Fujun, LIU Zeyu, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (11): 1224-1231.   DOI: 10.19803/j.1672-8629.20240498 Abstract （1070）      PDF（pc） （2212KB）（261）       Knowledge map    Save Objective To analyze the characteristics and potential mechanisms of adverse drug reactions/events (ADR/ADE) in the heart, liver, or kidney caused by Tripterygium wilfordii (Leigongteng), with the aim of providing reference for the rational use of medicine in clinical practice. Methods The ADR/ADE in the heart, liver, or kidneys caused by Leigongteng were collected retrospectively from the China National Knowledge Infrastructure (CNKI) from constrac tion to 1, Jan 2024. By using Apriori association analysis and decision tree CART algorithm, the influencing factors that caused by Leigonteng to the heart, liver, or kidneys damage were conducted. After collectting the compounds contained in Leigongteng and the action targets of the heart, liver, or kidneys based on the Traditional Chinese Medicine Systems Pharmacology Analysis Platform and GeneCards database, using network pharmacology to analyze the intrinsic mechanisms of Leigongteng’s multi-organ toxicity. Results A total of 50 cases ADR/ADE involved the heart, liver, or kidneys damage were collected, among which 20 cases involved two or more systems-organs. There was a strong correlation between the toxicity to the heart, liver, or kidneys and the dosage and duration of medication, and there was also a certain association with the patient’s original diseases. 51 compounds from Leigongteng and 153 effective action targets were screened out. Through the use of Venn diagrams, 987 common targets of toxicity to the heart, liver, and kidneys were identified. Protein-protein interaction network and Gene Ontology functional analysis revealed that TP53-mediated apoptosis, AKT1 and STAT3-mediated inflammatory responses may be associated with the multi-organ toxicity of Leigongteng to the heart, liver, and kidneys. Conclusion The multi-organ toxicity caused by Leigongteng has intrinsic correlations that require further in-depth research, and clinical prevention necessitates strict control over the dosage and duration of medication use. Reference | Related Articles | Metrics | Comments（0）