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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 （893）      PDF（pc） （1223KB）（914）       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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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 （814）      PDF（pc） （1259KB）（1469）       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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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 （751）      PDF（pc） （1427KB）（426）       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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Risk Signal Mining of Adverse Events Related to Levothyroxine Sodium Tablets Based on FAERS CHEN Chongze, ZHOU Tianyu, SUN Siman, GUO Shushu, JIN Hongtao Chinese Journal of Pharmacovigilance    2024, 21 (12): 1425-1431.   DOI: 10.19803/j.1672-8629.20240036 Abstract （710）      PDF（pc） （1426KB）（531）       Knowledge map    Save Objective To analyze the adverse drug events (ADE) caused by levothyroxine sodium tablets to provide a reference for rational and safe clinical use. Methods The U. S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) was searched to retrieve the ADE data on the primarily suspected drug collected from the first quarter of 2015 to the second quarter of 2023. The reporting odds ratio (ROR)、proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCNPP) and multi-item gamma poisson shrinker (MGPS) methods were used to screen for effective signals of ADEs of drugs. Results A total of 271 356 ADEs related to levothyroxine tablets as the primary suspect were reported. Most of the people involved were women (198 219, 73.05%) and the patients ranged from 18 to 85 in age (62.46%). A total of 5 991 adverse events of levothyroxine sodium tablets were mined, 3 371 signals were obtained after excluding non-drug adverse event signals, and 20 organ systems were found to be involved. Fatigue (22 511 items), nausea (17 591 items), diarrhea (16 400 items), headache (15 043 items) and dyspnea (12 866 items)were the top five ADEs reported.Analysis showed that neonatal gangrene (ROR=267.57, IC025=4.66), bronchiolithiasis (ROR=187.30, IC025=267.57), homophonic association (ROR=107.03, IC025=267.57), increased trans-triiodothyronine (ROR=89.19, IC025=4.42), and decreased free thyroxine indexes (ROR=80.27, IC025=4.38）were the top five ADEs in terms of intensities of signals. Based on secondary screening, the top three PTs related to the neonatal risk signal intensity were neonatal gangrene, neonatal intestinal dilation, and neonatal thyrotoxicosis. The top three PTs regarding the stone risk signal intensity were bronchial stones, cerebral stones, and staghorn stones. A total of 146 signals that were not recorded in the instructions were found, which were mostly manifested in various examinations, gastrointestinal system diseases, infections and invasive diseases, nervous system diseases, benign and malignant tumors of unknown nature. Conclusion Levothyroxine sodium tablets can potentially cause such ADRs as calculuses, infections and secondary tumors in patients with hypothyroidism. Clinical multidisciplinary follow-up is recommended for patients taking levothyroxine sodium tablets. Reference | Related Articles | Metrics | Comments（0）

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Methods for Assessment of MAH Compliance with GVP LIU Ying, XIONG Shunyu, XIONG Huiyu, CAI Fei, XU Mengdan, WANG Qing, REN Wei, XU Yan Chinese Journal of Pharmacovigilance    2025, 22 (3): 282-285.   DOI: 10.19803/j.1672-8629.20240394 Abstract （693）      PDF（pc） （1207KB）（785）       Knowledge map    Save Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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A National Pharmacovigilance Management System in a New Era YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao Chinese Journal of Pharmacovigilance    2025, 22 (3): 276-281.   DOI: 10.19803/j.1672-8629.20240861 Abstract （636）      PDF（pc） （1478KB）（1152）       Knowledge map    Save Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry. 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 （609）      PDF（pc） （1246KB）（957）       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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Research Progress in Uric Acid-Lowering Drugs YAN Caiying, QIN Linying, XU Yaoqing, WANG Xinge, CHAI Nannan, CHEN Long Chinese Journal of Pharmacovigilance    2025, 22 (5): 592-595.   DOI: 10.19803/j.1672-8629.20240857 Abstract （547）      PDF（pc） （1222KB）（148）       Knowledge map    Save Objective To explore the research progress in uric acid-lowering drugs so as to provide a reference for their clinical applications. Methods By accessing the official websites of the National Medical Products Administration, China National Knowledge Infrastructure (CNKI), Wanfang Database and PubMed, information was collected on the safety of uric acid-lowering drugs, including urate transporter 1 (URAT1) inhibitors, xanthine oxidase (XO) inhibitors and exogenous uricase, which were used in the treatment of chronic gout between April 1, 2014, and September 1, 2024. In addition, the key information on 27 uric acid-lowering drugs currently under development was analyzed using the Cortellis platform. Results The adverse reactions of URAT1 inhibitors mostly involved the digestive system, manifested as liver function abnormalities. The adverse reactions caused by XO inhibitors and exogenous uric acid oxidases primarily manifested themselves as skin and mucous membrane damage and blood system damage, such as immunogenic reactions and serious cardiovascular events. The targets of action for most of the currently-developed anti-gout drugs were URAT1 inhibitors, which increased the excretion of uric acid while reducing the incidence of gout. Conclusion Although three types of drugs are usually used for the treatment of chronic gout, the potential adverse reactions remain a concern. Future research and development of anti-gout drugs should focus on dual-target or new-target drugs with unique advantages in order to offer more options for the clinical treatment of patients. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (12): 0-0.   Abstract （535）      PDF（pc） （443KB）（488）       Knowledge map    Save 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 （501）      PDF（pc） （1305KB）（266）       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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Identification of Druggable Targets for Intervertebral Disc Degeneration Based on Multi-Omics Data-Driven Mendelian Randomization and Prediction of Traditional Chinese Medicine Interventions GUO Dongqi, WANG Hao, BAI Xin, BAI Jianqi, SU Hongmei, ZHANG Jingru, GUO Xiaofei, ZHAO Xiaoqi, WANG Min, WANG Yuan, ZHANG Ping Chinese Journal of Pharmacovigilance    2025, 22 (3): 241-248.   DOI: 10.19803/j.1672-8629.20240899 Abstract （497）      PDF（pc） （2553KB）（655）       Knowledge map    Save Objective To identify druggable targets for the treatment of intervertebral disc degeneration (IDD), evaluate their safety, and to predict the traditional Chinese medicines (TCMs) that can regulate these druggable targets for IDD. Methods Data on expression quantitative trait loci of druggable genes was retrieved from the eQTLGen Consortium as exposures, while data on IDD genome-wide association study was downloaded from the GWAS Catalog to serve as outcomes for Mendelian randomization analysis intended to identify potential IDD therapeutic targets. Enrichment analyses were conducted on druggable genes related to IDD. The data on protein quantitative trait loci of druggable genes related to IDD was retrieved from the FinnGen database to validate the efficacy of these genes. A phenome-wide association study (PheWAS) via the PheWAS Portal was conducted to assess drug safety. The BATMAN-TCM 2.0 and ETCM 2.0 platforms were used to mine TCM components and analyze medication patterns. Potential lead compounds were identified through molecular docking of targets and TCM components on the CB-Dock 2 platform. Results 35 TCMs, including Corydalis yanhusuo W. T. Wang., Morinda officinalis How., and Artemisia argyi Lévl. et Vant., were found to treat IDD by regulating three druggable targets-ZP3, RRM2B, and CCL4, through their 20 active components. Gene expression MR indicated that 248 druggable genes were causally related to IDD, and enrichment analyses showed that these genes were associated with cytokine activities and cellular senescence. Protein MR validated six of these genes as druggable targets for IDD. PheWAS revealed no significant adverse effects associated with the aforementioned druggable targets. Molecular docking results showed good binding activity between the TCM components and the druggable targets, with the best binding energy of -10.2 kcal·mol-1. Conclusion Such genes as ZP3, RRM2B, and CCL4 are potential therapeutic targets for IDD with good safety profiles. TCMs like Morinda officinalis How., Corydalis yanhusuo W. T. Wang., and Artemisia argyi Lévl. et Vant. can treat IDD through these druggable targets, and their active components, such as Xanthosine, are potential compounds for new drug development. 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 （490）      PDF（pc） （2112KB）（386）       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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Research Progress on Models of Ischemic Stroke LIU Zhejun, TANG Tian, TAN Tianyang, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (12): 1393-1397.   DOI: 10.19803/j.1672-8629.20240637 Abstract （484）      PDF（pc） （1476KB）（201）       Knowledge map    Save Objective To find out more about the disease mechanism of ischemic stroke, evaluate the therapeutic efficacy and predict prognosis. Methods The latest progress in clinical models, pharmacological models (including in vivo and in vitro models), and other emerging models related to ischemic stroke research was summarized. Results Clinical models were mostly used for risk prediction, prognosis assessment, and treatment decision support. Pharmacological models played a crucial role in mechanism exploration and drug screening. Emerging computer models and multi-omics models offered new perspectives for personalized treatments and precision medicine. Conclusion Despite significant advancements in ischemic stroke research, these models are still facing challenges related to clinical relevance, model integration, and translational applications. Future research should try to work on the accuracy and generalizability of models, strengthen multidisciplinary collaboration, and promote the translation of basic research into clinical practices in order to improve diagnosis, treatments, and quality of life for patients with ischemic stroke. 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 （478）      PDF（pc） （1355KB）（567）       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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Chinese Journal of Pharmacovigilance    2025, 22 (3): 0-0.   Abstract （465）      PDF（pc） （501KB）（172）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Research Progress on Traditional Chinese Medicine Compound Formulae against Hemorrhagic Stroke LIU Zhejun, TANG Tian, TAN Tianyang, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (12): 1405-1410.   DOI: 10.19803/j.1672-8629.20240636 Abstract （463）      PDF（pc） （1368KB）（397）       Knowledge map    Save Objective To explore the research progress in clinical efficacy and mechanisms of action of traditional Chinese medicine compound formulae in the treatment of hemorrhagic stroke in recent years, and to find out more about the potential applications of traditional Chinese medicine compound formulae. Methods Literature related to TCM compound formulae against hemorrhagic stroke that was published from inception to August 2024 was searched for in National Knowledge Infrastructure (CNKI) databases, while related research progress was summarized. Results Clinical studies showed that such TCM compound formulae as Yisui Poxue formula and decoctions for invigorating blood and removing blood stasis could do much to improve the neurological function of patients, reduce cerebral edema, facilitate recovery and improve the quality of life. Studies on the mechanisms suggested that TCM compound formulae could exert such pharmacological effects as protection of neurons, improvement of microcirculation, reduction of inflammatory response, attenuation of oxidative stress, inhibition of apoptosis, pyroptosis and ferroptosis in multi-target and multi-pathway ways. Conclusion With in-depth research, TCM compound formulae are expected to play a greater role in the comprehensive treatment of hemorrhagic stroke and provide patients with more individualized and precise treatment options, but most of the current studies are small-sample observational studies with limited evidence. More high-quality clinical studies are needed in the future to validate the efficacy of TCM compound formulae in the treatment of hemorrhagic stroke. Reference | Related Articles | Metrics | Comments（0）

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Introduction and Quality Factors of Peucedanum Praeruptorum Dunn LI Yaolei, JIN Hongyu, WEI Feng, MA Shuangcheng Chinese Journal of Pharmacovigilance    2024, 21 (11): 1315-1320.   DOI: 10.19803/j.1672-8629.20240255 Abstract （462）      PDF（pc） （1319KB）（334）       Knowledge map    Save Objective To describe the history of the medicinal use of Peucedanum Praeruptorum Dunn (PD), its chemical composition, efficacy, areas of production, market demands and quality control and to provide reference for its development, utilization and quality control. Methods Based on the reports available, the medicinal use of PD and its key chemical constituents were traced, and the traditional and modern pharmacology of PD was elaborated in terms of chemistry and pharmacology. The areas of production, chief planting areas, market demands and production of PD were analyzed. The current standard for PD and problems with the quality were discussed. Results PD had a long history of medicinal use and plenty of pharmacological activities, whose chemical components included simple coumarin, furan coumarin and pyranocoumarin. Zhejiang, Anhui and Jiangxi were important areas of production of PD. There was large-scale cultivation in Chongqing, Guizhou and elsewhere. The current market was dominated by domestic species and simulated wild products, and the wild resources were diminishing. The main reason for defects of the product was the presence of Praeruptorin B. Analysis of Praeruptorin A and Praeruptorin B suggested that environmental geography, extraction, and different morphologies made a huge difference to the quality of PD. Conclusion The basic profile and determinants of quality of PD have been explored. It is of great significance to promote the sustainable use and industrial development of the plant. 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 （462）      PDF（pc） （1366KB）（172）       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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Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines ZHU Lan, SHAO Bo, ZHU Yan, DAI Jie, ZHONG Shiqi Chinese Journal of Pharmacovigilance    2025, 22 (2): 188-192.   DOI: 10.19803/j.1672-8629.20240621 Abstract （457）      PDF（pc） （1297KB）（1275）       Knowledge map    Save Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines. Methods To analyze the guidelines and requirements for the updating of information on adverse reactions, contraindications, precautions and warnings information in the labels of Chinese traditional patent medicines, and to make suggestions based on working experience. Results For some historical reasons, safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines. Conclusion Revision of labeling and updating of safety information is one of the risk management measures, after solving the problem of missing safety information, there is still a need for continuous monitoring of adverse reactions, post-marketing research to identify drug risks, and to control the risks by revising labels and other measures. Reference | Related Articles | Metrics | Comments（0）

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Applications of “Target Fishing” Technique in Pharmacological Research of Traditional Chinese Medicine CHEN Siyi, SHENG Lisong, SUN Rong Chinese Journal of Pharmacovigilance    2024, 21 (12): 1321-1328.   DOI: 10.19803/j.1672-8629.20240700 Abstract （438）      PDF（pc） （1661KB）（386）       Knowledge map    Save Objective To review the recent applications of “target fishing” technique in the fields of Traditional Chinese Medicine (TCM) in recent years in order to contribute to overcoming the bottleneck of TCM modernization caused by the complexity of TCM components and the uncertainty of target components. Methods Literature on “target fishing” techniques in the field of TCM in the past 15 years was searched. Research methods involved in the commonly used “target fishing” techniques were summarized. The strengths and weaknesses of these techniques in revealing the action or toxicity targets of TCM components were analyzed. Results “Target fishing” techniques applied in the field of TCM were mostly based on “affinity fishing”, which was often used in conjunction with liquid chromatography, mass spectrometry and other technologies for direct target research of TCM potent or toxic components on the basis of a clear mechanism of affinity fishing and toxicity. It was difficult to apply this technique to small molecules with close conformational relationships or to perform rapid and unbiased protein target identification for complex TCM systems. The interpretation of TCM theories in existing studies remained weak, and there was a lack of in-depth integration with TCM theories in subsequent validation studies or in-depth excavation. Conclusion The “target fishing” technique offers novel insights and methodologies for elucidating the molecular-level mechanisms of TCM action. This study proposes a research strategy for investigating the effects and toxicity of TCM, which should be thoroughly explored within the framework of TCM theories and substantiated from comprehensive system-level perspectives. The“target fishing” technique provides references for integrated evaluation of the “effect-toxicity” of TCM. Reference | Related Articles | Metrics | Comments（0）