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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 （1491）      PDF（pc） （1259KB）（4753）       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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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 （1050）      PDF（pc） （1785KB）（543）       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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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 （979）      PDF（pc） （2253KB）（243）       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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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 （919）      PDF（pc） （1478KB）（1459）       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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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 （915）      PDF（pc） （2553KB）（724）       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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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 （868）      PDF（pc） （1207KB）（915）       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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Revision of the Provisions for Adverse Drug Reactions Reporting and Monitoring TIAN Chunhua Chinese Journal of Pharmacovigilance    2025, 22 (11): 1253-1257.   DOI: 10.19803/j.1672-8629.20250657 Abstract （697）      PDF（pc） （1267KB）（603）       Knowledge map    Save Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development. 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 （694）      PDF（pc） （1222KB）（216）       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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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 （665）      PDF（pc） （1366KB）（223）       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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Modeling for Prediction of Cardiotoxicity of Chinese Herbal Medicines CHEN Siying, DING Xueli, LIU Shujia, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian Chinese Journal of Pharmacovigilance    2025, 22 (8): 869-875.   DOI: 10.19803/j.1672-8629.20250236 Abstract （614）      PDF（pc） （1473KB）（205）       Knowledge map    Save Objective To establish a prediction model for cardiotoxicity of Chinese herbal medicines (CHMs) in order to provide data for safety evaluation and rational clinical use of CHMs. Methods Active ingredients with potential cardiac risks were identified from the FDA Adverse Event Reporting System (FAERS) database by using the proportional imbalance method. The data was randomly divided into a training set and a validation set. The Random Forest (RF), Decision Tree (DT), K-Nearest Neighbors(KNN), and Extreme Gradient Boosting (XGBoost) were used for modeling and internal verification. The performance of the model was evaluated using such criteria as the area under the curve (AUC), accuracy, and precision. Active ingredients of CHMs with cardiotoxicity were retrieved from literature that was published from the inception to January 1, 2025. CHMs with possible cardiac risks were retrieved from the spontaneous reporting system database. The Traditional Chinese Medicine Systems Pharmacology (TCMSP) database was searched for the active ingredients. The constructed model was externally validated via these tests. Results The model with the best predictability was the KNN. The AUC was 0.684 for the training set and 0.718 for the validation set. Twenty-five chemical ingredients of CHMs with cardiotoxicity were selected based on literature while eleven suspected cardiotoxic CHMs were selected from the spontaneous reporting system database. After external validation, eighteen chemical ingredients and ten CHMs were predicted to have cardiac risks. Conclusion The overall prediction of the model is 80% accurate, so it can be used for predicting cardiotoxicity of chemical ingredients in CHMs. Reference | Related Articles | Metrics | Comments（0）

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Considerations for Revision of Safety Information in the Post-Marketing Instructions of Chemical Drugs WANG Chunting, CHEN Yafei Chinese Journal of Pharmacovigilance    2025, 22 (7): 776-779.   DOI: 10.19803/j.1672-8629.20250211 Abstract （539）      PDF（pc） （574KB）（496）       Knowledge map    Save Objective To lay out the considerations for post-marketing revision of safety information in the instructions of chemical drugs, and provide a reference for drug marketing authorization holders and regulatory agencies. Methods Based on experiences related to revision of safety information in package inserts for chemical drugs, the priorities for collecting and analyzing safety information in package inserts were described, and the key points for writing the revised information related to warnings, adverse reactions, contraindications and precautions were summarized. Results and Conclusion Safety information needs to be revised all the time to dynamically reflect the risk-benefit balance of chemical drugs. Regulatory agencies should specify the working procedures and key points of the post-marketing revision of package inserts for chemical drugs while marketing authorization holders should promptly and proactively fulfill their responsibility of revising the safety information in drug instructions after marketing to ensure the safety of drugs. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (3): 0-0.   Abstract （500）      PDF（pc） （501KB）（190）       Knowledge map    Save 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 （498）      PDF（pc） （1375KB）（291）       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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Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database ZHONG Ling, ZENG Huiyan, YUAN Xin, WANG Yingyan Chinese Journal of Pharmacovigilance    2025, 22 (3): 305-312.   DOI: 10.19803/j.1672-8629.20240753 Abstract （471）      PDF（pc） （1399KB）（662）       Knowledge map    Save Objective To mine and compare signals of post-marketing adverse events of liraglutide and semaglutide in order to provide references for safe and rational use. Methods Data on adverse events reported by the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2010 and March 31, 2024 was mined using the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, information component (IC) method, and the muti-item gamma poisson shrinker (MGPS) method. Positive signals and tumor related signals were screened out and compared. Results 175 positive signals related to liraglutide were mined, involving 20 systems organs class (SOC), compared with 231 for semaglutide, involving 21 SOC. The adverse events manifested themselves as gastrointestinal disorders, metabolism and nutrition disorders. In terms of tumors, thyroid and pancreatic related tumors were dominating and onset of symptoms in most of the cases was after 360 days. Liraglutide was more significantly correlated with such adverse events as thyroid tumors, pancreatic tumors, and pancreatitis while semaglutide was likely to cause adverse events related to eyes and the skin. Conclusion Liraglutide and semaglutide can cause similar adverse drug reactions, so clinicians are advised to opt for personalized medications while warnings about the possibility of pancreatic tumors should be given in related instructions. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (10): 0-0.   Abstract （459）      PDF（pc） （504KB）（281）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Adverse Reactions to Antihypertensive and Hypoglycaemic Drugs Based on Spontaneous Presentation Systems LIAO Mengfan, ZHONG Liling, XU Yan, LIU Ying, ZHANG Yexiang, CHEN Qingsong, LIU Xudong Chinese Journal of Pharmacovigilance    2025, 22 (3): 286-291.   DOI: 10.19803/j.1672-8629.20240675 Abstract （436）      PDF（pc） （1404KB）（349）       Knowledge map    Save Objective To analyze the reports of adverse drug reactions(ADR) caused by antihypertensive and hypoglycemic drugs so as to provide a reference for rational clinical use of drugs. Methods The ADR reports related to commonly-used antihypertensive and hypoglycemic drugs collected by the Guangdong ADR self-reporting system between September 1, 2020 and August 31, 2022 were analyzed, and the influential factors for the occurrence of severe ADR were identified. Results A total of 6 113 ADR reports involving 9 207 clinical cases were included. Females and middle-aged and elderly patients accounted for a large proportion. Mild ADR and severe ones accounted for 90.22% and 9.78% respectively. In addition, there were 844 new ADR (13.81%). ADR mostly involved the gastrointestinal system and the skin and its accessories or were systemic, with calcium channel blocker drugs and biguanides as the leading cause. ADR caused by different drugs varied. Most of these ADR occurred 2 to 7 days (29.45%) and 30 days (40.95%) after medication, and the majority of the patients improved (58.23%) or recovered (35.25%). Patients with two or more types of primary diseases, smoking history, and ADR induction time of over 7 days were at higher risk of severe ADR. Conclusion The ADR caused by commonly-used drugs for diabetes and hypertension vary, depending on age, gender, organs involved and types of drugs. It is recommended that clinicians take precautions, monitor and assess patients at critical time points after medication in order to detect potential ADR quickly to keep patients safe. Reference | Related Articles | Metrics | Comments（0）

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Research Progress in Drug-Induced Hypotension NI Wenqi, ZHU Feng, ZHOU Shuang, CUI Yimin Chinese Journal of Pharmacovigilance    2025, 22 (4): 475-480.   DOI: 10.19803/j.1672-8629.20240733 Abstract （417）      PDF（pc） （1310KB）（666）       Knowledge map    Save Objective To investigate the research progress in drug-induced hypotension and provide clinical references for its prevention. Methods The categories drugs of associated with increased hypotension risk and their mechanisms of action were analyzed, the impact of pharmacogenetic polymorphisms on hypotension risk were evaluated, and the current prevention and treatment strategies were summarized by reviewing literature and searching PharmGKB database. Results Over 250 types of drugs were identified that could induce hypotension, with cardiovascular drugs and neurological drugs as the primary high-risk categories. Drugs could induce hypotension through such mechanisms as vasodilation, cardiac suppression, and blood volume reduction. Pharmacogenetic polymorphisms could significantly influence drug metabolism and hypotensive risk. Effective prevention strategies included personalized medications, genetic testing-guided dosage adjustment, avoidance of inappropriate drug combinations, and symptomatic treatment. Conclusion Drug-induced hypotension requires increased clinical attention. Future research should prioritize the development of predictive models and targeted intervention protocols for high-risk populations. Reference | Related Articles | Metrics | Comments（0）

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WHODrug Global: a Validated, Regularly Updated and Standardised Drug Dictionary for Medicinal Information Coding STRESE Sara, LAGERLUND Olof, SHEN Ling, AHNFELT Emelie, YUE Qunying, FLADVAD Malin Chinese Journal of Pharmacovigilance    2025, 22 (10): 1194-1200.   DOI: 10.19803/j.1672-8629.20250092 Abstract （415）      PDF（pc） （812KB）（255）       Knowledge map    Save The WHODrug Global (WHODrug in short) medicinal information dictionary aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems in post-marketing surveillance, and thereby supporting the development and usage of effective and safe medications. WHODrug is a product provided by the Swedish foundation Uppsala Monitoring Centre (UMC). WHODrug contains individual product names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength, available in an English and a Chinese version. All related medications are linked using a structured WHODrug alphanumeric code, connecting product names and variations of the ingredient with the active moiety of the active ingredient s, including the International Nonproprietary Name (INN). Medications in WHODrug are classified using the ATC system and clustered into Standardised Drug Groupings, to allow for grouping of medications with one or more properties in common. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. Using WHODrug in clinical trials and post-marketing safety work enables the use of accurate standardised medication nomenclature and other information that supports easier global information exchange. The ISO standards for Identification of Medicinal Products (IDMP) global Pharmaceutical Product Identifier (PhPID) is currently being added to WHODrug Global. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is essential to keep the dictionary comprehensive, validated and constantly updated on a global scale. This article introduces the application of WHODrugin practice, its data structure and applications of the structure, as well as uses of other products within the product portfolio, with the aim of supporting the effective and safe development and use of drugs. Reference | Related Articles | Metrics | Comments（0）

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148 Case of Drug-Induced Liver Adverse Reactions TUO Kangxiu, YANG Chengli, LI Ming, JIANG Man Chinese Journal of Pharmacovigilance    2025, 22 (10): 1154-1158.   DOI: 10.19803/j.1672-8629.20250482 Abstract （411）      PDF（pc） （713KB）（288）       Knowledge map    Save Objective To investigate the characteristics of drug-induced liver injury and provide references for related medications and prevention. Methods The case reports of drug-induced liver adverse reactions submitted to the National Adverse Drug Reaction Monitoring System by the Affiliated Hospital of Guizhou Medical University in 2021-2024 were collected and analyzed. Results A total of 148 cases of drug-induced liver adverse reactions were collected. Using the RUCAM scale, 109 cases were scored 6 to 8, and 39 cases 3 to 5. Among the 59 cases of liver injury whose detection indicators met the classification criteria, hepatocyte injury was the dominating type (44 cases), followed by the cholestatic type (10 cases) and the mixed type (5 cases). There were 55 grade Ⅰ cases and 4 grade Ⅱ cases. The top three drug categories responsible for live injury were antineoplastic drugs (41.58%), anti-infective drugs (36.63%) and drugs for the cardiovascular system (13.86%). The time from drug administration to the first detection of abnormal liver biochemical indicators was 2 to 15 days. Clinically, hepatoprotective drugs were used by 137 patients (92.57%) with drug-induced liver adverse reactions, 129 of whom provided detailed reports on their usage of hepatoprotective drugs. The types of hepatoprotective agents used ranged from 1 to 3 types: 73 cases (56.59%) took one type of hepatoprotective agent, 43 cases (33.33%) received two types of hepatoprotective agents, and 13 cases (10.08%) were given three types of hepatoprotective agents. Conclusion A wide range of drugs can cause drug-induced liver adverse reactions, with those causing hepatocellular injury as the dominating type. In clinical practice, high-risk drugs for liver injury should be monitored more rigorously. When formulating liver-protecting treatment plans, clinicians are advised to weigh the advantages and disadvantages of combined medications. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (5): 0-0.   Abstract （402）      PDF（pc） （479KB）（405）       Knowledge map    Save Related Articles | Metrics | Comments（0）