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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 （2428）      PDF（pc） （3192KB）（821）       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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Effect of Yiye Anti-Influenza Capsules on Pneumonia Induced by Human Coronavirus 229E Infection in Mice WANG Xinwei, PENG Yifeng, SUN Jing, JI Zuen, BAO Lei, LUO Henglei, GENG Zihan, ZHANG Hujuan, LI Shuran, ZHANG Jingsheng, GUO Shanshan, CUI Xiaolan, ZHAO Ronghua Chinese Journal of Pharmacovigilance    2025, 22 (8): 851-855.   DOI: 10.19803/j.1672-8629.20250010 Abstract （1791）      PDF（pc） （1862KB）（399）       Knowledge map    Save Objective To investigate the therapeutic effect of Yiye anti-influenza capsules (YYKLG) against pneumonia in mice infected with human coronavirus 229E (HCoV-229E). Methods A mouse model of pneumonia was established via intranasal infection with HCoV-229E. The mice were randomly divided into seven groups, including high-dose, medium-dose, and low-dose YYKLG groups (0.70 , 0.35 and 0.18 g·kg-1·d-1, respectively). The effects of YYKLG at three doses on the lung index, viral load, pulmonary bronchioles and pathological changes of lung tissues in mice were assessed. Results The lung index of mice in the high and medium dose groups of YYKLG decreased significantly, so did the viral load of lung tissues in the three dose groups. Compared with the model control group, YYKLG reduced the pathological damage to lung bronchioles and lung tissues to varied extents, and the degree of pathological damage in the high and middle dose groups was significantly different from that of the model control group. Conclusion YYKLG can improve the symptoms of pneumonia in model mice infected with the HCoV-229E virus. This study is expected to provide a reference for the treatment of respiratory diseases with traditional Chinese medicine. Reference | Related Articles | Metrics | Comments（0）

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Impacts of Shuangshenling Granules on a Cadmium-Induced Chronic Renal Failure Model of Mice XIE Rui, SUN Qiyue, LI Yanying, ZHANG Jingsheng, ZHAO Ronghua, GUO Shanshan, GENG Zihan, BAO Lei, GAO Shuangrong, CUI Xiaolan, XIE Dan, SUN Jing Chinese Journal of Pharmacovigilance    2025, 22 (8): 856-862.   DOI: 10.19803/j.1672-8629.20241036 Abstract （1329）      PDF（pc） （1702KB）（293）       Knowledge map    Save Objective To study the effect of Shuangshenling granules on a chronic renal failure model of mice induced by cadmium poisoning in order to provide data for clinical applications. Methods The mice were randomly divided into six groups based on body mass, with 20 mice in each group: normal control group, model control group, Shenshuaining granule positive control group, and three Shuangshenling granule dosage groups (9.0, 4.5, 2.2 g·kg-1·d-1). Except the normal control group, each group was injected intraperitoneally with 2 mg·kg-1·d-1 anhydrous cadmium chloride solution for 30 days to establish a chronic renal failure model, and received respective drugs via gavage administration for 45 days at the same time. On days 15 and 45, the retro-orbital blood was collected while enzyme-linked immunosorbent assay (ELISA) was used to measure the content of serum creatinine (Cr) and blood urea nitrogen (BUN). The 24-hour urine samples were collected to measure the content of totalprotein (TP). The bilateral kidneys of the mice were excised after the experiment before hematoxylin-eosin (HE) staining was adopted to examine the histopathological changes of renal tissues. Results Compared with the normal control group, the model group showed a significant increase in serum Cr, BUN and TP on days15 and 45 (P<0.01), and the 24-hour urine significantly increased on day 15 but significantly decreased on day 45. Compared with the model control group, the three Shuangshenling granule dosage groups showed significantly decreased contents of serum Cr and BUN (P<0.01), improved renal function, and regulated urine outputs on days 15 and 45 (P<0.01, P<0.05). On day 15, the content of TP in the three Shuangshenling granule dosage groups significantly decreased, and the same effect was observed in Shuangshenling granule high and medium dosage groups on day 45(P<0.01, P<0.05). In the three dosage groups, such histopathological changes induced by cadmium chloride were mitigated as glomerular enlargement, proliferation of glomerular mesangial cells, renal interstitial congestion, and swelling of renal convoluted tubules. Conclusion Shuangshenling granules have a significant therapeutic effect on chronic renal failure induced by cadmium poisoning in mice. 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 （1240）      PDF（pc） （1785KB）（1036）       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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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 （1133）      PDF（pc） （1375KB）（1482）       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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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 （1121）      PDF（pc） （2253KB）（446）       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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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 （977）      PDF（pc） （1267KB）（1851）       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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Advances in Research of Mesenchymal Stem Cell-Derived Exosomes BAI Zhijie, GAO Yue Chinese Journal of Pharmacovigilance    2026, 23 (1): 1-6.   DOI: 10.19803/j.1672-8629.20250908 Abstract （843）      PDF（pc） （1319KB）（478）       Knowledge map    Save Objective To explore the current research, core mechanisms, opportunities, and challenges related to mesenchymal stem cell-derived exosomes in disease treatment, and to provide references for their subsequent clinical translation. Methods PubMed was searched for related literature by using mesenchymal stem cell and exosome as key words. Articles published within the past ten years and those published earlier were included to summarize the research findings and applications associated with the discovery, components and functional mechanisms of mesenchymal stem cell-derived exosomes. Challenges facing the clinical translation of mesenchymal stem cell-derived exosomes were discussed. Results Exosomes were the crucial mediator of functions of mesenchymal stem cells and could be potentially used for the treatment of diseases. Exosomes enjoyed advantages over mesenchymal stem cells in quality control and safety assessment due to their simpler structure and lower immunogenicity. In addition, mesenchymal stem cell-derived exosomes were nanoscale in size, making it possible for them to cross the blood-brain barrier. These exosomes promised to be a sphere of study that was capable of easy translation. Conclusion Mesenchymal stem cell-derived exosomes are one of the hot spots for regenerative medicine and rapid progress is being made in basic research and clinical translation. There is evidence that exosomes are lower in immunogenicity, stronger in tissue penetration and higher in targeting potential compared with mesenchymal stem cell therapies, which makes mesenchymal stem cell-derived exosomes superior to traditional stem cell therapies. The cell-free therapy strategy generated herein can possibly provide a new line of thought for research into stem cell therapies. Reference | Related Articles | Metrics | Comments（0）

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Pharmacovigilance for Radioprotective Drugs LONG Huan, WANG Kaixin, YANG Yueqi, AN Minghui, LIANG Yuwei, LIU Hongran, GAO Xu, ZHANG Li, DING Jiaxin, GONG Jian Chinese Journal of Pharmacovigilance    2026, 23 (3): 355-360.   DOI: 10.19803/j.1672-8629.20250771 Abstract （765）      PDF（pc） （1321KB）（684）       Knowledge map    Save Objective To analyze the challenges facing pharmacovigilance related to radioprotective drugs and propose optimization strategies so as to promote safe and rational clinical use of drugs. Methods Through literature review, radioprotective drugs and the identified representative agents were categorized. Major problems with pharmacovigilance were summarized while corresponding countermeasures were proposed. Results Radioprotective drugs were classified into three major categories: radioprotective agents, radiation mitigators, and radiotherapeutic agents. Five major challenges were identified: inadequate regulatory frameworks, insufficient research on pharmacology and toxicology, the lack of real-world data, difficulties in detecting adverse reactions, and imperfect data collection and sharing mechanisms. Conclusion A multidimensional approach is required to enhance the pharmacovigilance system for radioprotective drugs by strengthening regulatory frameworks, broadening nonclinical and clinical research, establishing real-world data platforms, developing intelligent risk identification tools, and promoting data sharing and international collaboration to ensure medication safety and efficacy. Reference | 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 （762）      PDF（pc） （1473KB）（599）       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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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 （695）      PDF（pc） （812KB）（303）       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 （552）      PDF（pc） （713KB）（946）       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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One Case of Agranulocytosis Caused by Zoledronic Acid Injection FANG Wei, WANG Huanping, ZHU Hongxia Chinese Journal of Pharmacovigilance    2026, 23 (4): 467-469.   DOI: 10.19803/j.1672-8629.20241010 Abstract （552）      PDF（pc） （1193KB）（134）       Knowledge map    Save Objective To investigate a rare adverse reaction caused by zoledronic acid injection and provide a reference for safe and rational drug use in clinical practice. Methods The process of diagnosing and treating one case of agranulocytosis induced by zoledronic acid injection was analyzed. The clinical manifestations, risk factors, and prevention strategies related to this adverse reaction were summarized based on both domestic and foreign literature. Results After the administration of zoledronic acid injection, the patient developed persistent fever accompanied by sore throat. Three days later, a blood routine examination pointed to agranulocytosis. Following treatment with granulocyte colony-stimulating factors, the granulocyte count returned to normal while the associated symptoms, including fever and sore throat, were mitigated. Conclusion When zoledronic acid injection is used clinically, clinicians should be vigilant to the occurrence of agranulocytosis and ensure quick identification and treatment. Reference | Related Articles | Metrics | Comments（0）

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Adverse Drug Reactions and Medications among 213 Pediatric Inpatients ZHAO Jie, XU Juan, LI Xinghua Chinese Journal of Pharmacovigilance    2025, 22 (11): 1282-1286.   DOI: 10.19803/j.1672-8629.20250288 Abstract （498）      PDF（pc） （1417KB）（307）       Knowledge map    Save Objective To analyze the adverse drug reactions (ADR) among and medications for hospitalized pediatric patients so as to provide references for rational drug use. Methods A retrospective analysis was conducted of ADR reports involving inpatients treated at a tertiary children's hospital between April 1, 2024 and March 31, 2025. The association between medications and ADR was studied, and the severity of ADR was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Among the 213 patients involved, 110 were male and 103 were female. There were 10 cases (4.70%) aged 1 or younger, 36 cases (16.90%) ages 1 to 3, 68 cases (31.92%) ages 4 to 6, 91 cases (42.72%) ages 7 to 12 and 8 cases (3.76%) aged 12 to 17. The most common type of drug involved was anti-infective drugs, the dominating route of administration was intravenous injection (79.73%), and the most vulnerable organ was the skin and its accessories (59.73%), with rash as the primary clinical manifestation. Severe adverse reactions occurred in 45 cases (21.13%), and the top three drugs involved were cefotaxime sodium for injection (5 cases), erythromycin lactobionate for injection (4 cases), and chloral hydrate enema solution (3 cases). One case of new drug adverse reactions was reported. Conclusion ADR among pediatric patients are mostly adverse reactions that are caused by anti-infective drugs and manifest as skin damage. Severe allergic reactions caused by non-anti-infective drugs (such as chloral hydrate and turmeric oil) in children deserve more attention. Self-medication by parents is an important risk factor for ADR in children. Clinicians should try to ensure safe medications among children under 12. Reference | Related Articles | Metrics | Comments（0）

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Bleeding Risk and Interactions of Warfarin Combined with Traditional Chinese Medicine ZHAO Ziyi, LU Chengjin, ZHANG Xiaomeng, HUANG Huaijuan, ZHANG Bing Chinese Journal of Pharmacovigilance    2025, 22 (11): 1217-1222.   DOI: 10.19803/j.1672-8629.20250658 Abstract （496）      PDF（pc） （1895KB）（199）       Knowledge map    Save Objective To investigate the bleeding risk associated with the concomitant use of warfarin and traditional Chinese medicine (TCM), and the underlying mechanisms for interactions in order to provide evidence for rational clinical co-administration. Methods Such databases as CNKI, Wanfang and Sinomed were searched for literature published between January 1, 2000 and June 30, 2025 to perform data mining on risk factors for warfarin-induced bleeding and the characteristics of TCM used in combination. Network pharmacology and molecular docking were employed to explore potential pharmacological interactions between warfarin and commonly co-administered TCM. Results Seventy-nine cases of warfarin-related bleeding were retrieved in the analysis. The concurrent use of TCM did not significantly increase the risk of bleeding during the initial phase of warfarin therapy (P>0.05). Data mining revealed frequent co-prescription patterns, particularly the herb pair SALVIA MILTIORRHIZA RADIX (Danshen) and OPHIOPOGONIS RADIX (Maidong), which were traditionally used to nourish yin and promote blood circulation. Pathway enrichment analysis indicated that these herbs and warfarin might work together to modulate key signaling pathways such as the PI3K-Akt pathway, lipid metabolism, and atherosclerosis. Molecular docking results demonstrated strong binding affinities between the active components of these herbs and critical targets including STAT3 and ESR1. Conclusion The study has offered evidence about clinical risks, patterns of medications, and interaction mechanisms that suggests warfarin can be used in combination with TCM under some conditions. However, enhanced pharmaceutical surveillance and more research on risk stratification are warranted to ensure patients' safety. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Safety Risks of Ranitidine Hydrochloride Injection Preparations WANG Chunting, ZHANG Ruifang, CHEN Yafei Chinese Journal of Pharmacovigilance    2026, 23 (2): 181-184.   DOI: 10.19803/j.1672-8629.20250814 Abstract （493）      PDF（pc） （1502KB）（197）       Knowledge map    Save Objective To analyze the safety risks of ranitidine hydrochloride injection preparations and provide a reference for safe medication. Methods Related data from the National Adverse Drug Reaction Monitoring Database (collected in 2004-2023), foreign databases (collected from inception to October 2025), domestic and foreign literature (published from inception to October 2025), and from drug inserts was compared while precautions against risks taken by drug regulators were analyzed. Results The number of reports about adverse reactions related to ranitidine hydrochloride injection preparations had trended upward since 2021. Patients ages 45 to 64 were a high-risk group. The dosage had to be adjusted for patients with renal insufficiency and patients with liver dysfunction had to use it with caution. Reports of serious reactions accounted for 12.63% of the total, with systemic diseases and reactions at the site of administration dominating. Reports about anaphylactic shock accounted for 10.86% of the total of reports on serious reactions. Rapid administration could induce serious adverse reactions like arrhythmia. Meanwhile, there were differences in information about safety between domestic and foreign drug inserts. Conclusion Marketing authorization holders of drugs should devote more effort to the monitoring of adverse reactions of the drug while offering guidance. Clinicians ought to take into consideration the patient’s age and liver and kidney function when giving prescriptions. The concentration and speed of administration should be under rigorous control to prevent serious adverse reactions such as anaphylactic shock. Reference | Related Articles | Metrics | Comments（0）

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Safety of Long-Term Oral Nucleos(t)ide Analogues Therapy for Chronic Hepatitis B ZHU Haomin, LI Yue, ZHANG Mengdie, GAO Lihong, WANG Jia, LI Xin, TAO Tiantian Chinese Journal of Pharmacovigilance    2025, 22 (11): 1315-1320.   DOI: 10.19803/j.1672-8629.20250189 Abstract （479）      PDF（pc） （1270KB）（898）       Knowledge map    Save Objective To explore the safety of long-term oral nucleos(t)ide analogues (NAs) in treating chronic hepatitis B (CHB) and to provide references for clinical practice. Methods By analyzing drug inserts, results of clinical trials, data on post-marketing surveillance and real-world cohort data, the risks of nephrotoxicity, bone toxicity, and dyslipidemia were compared between entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) and tenofovir amibufenamide (TMF). Results NAs were generally safe, but chronic use might lead to decreased renal function, hypophosphatemia and dyslipidemia. TAF and TMF caused significantly lower nephrotoxicity and bone toxicity than TDF, but were associated with a higher risk of hyperlipidemia. Conclusion NAs should be selected based on differences between individual patients. TAF/TMF is the first option for patients with renal insufficiency or at high risk of bone metabolism. For patients with cardiovascular risks or dyslipidemia, TAF/TMF should be used with caution. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (10): 0-0.   Abstract （479）      PDF（pc） （504KB）（322）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Research Advancements in Applications of Single-Cell Transcriptome Sequencing Technology in Mechanism Elucidation of Pharmacodynamics and Toxicity of Traditional Chinese Medicine NI Haoyu, ZHOU Lei, WANG Ningning, YANG Xingxin, ZHOU Wei, SHEN Pan, GAO Yue Chinese Journal of Pharmacovigilance    2025, 22 (9): 975-982.   DOI: 10.19803/j.1672-8629.20250374 Abstract （478）      PDF（pc） （1746KB）（1873）       Knowledge map    Save Objective To explore the applicability of single-cell RNA sequencing (scRNA-seq) technology in TCM research given the current challenges to precise characterization of the therapeutic efficacy and toxicological profiles of Traditional Chinese Medicine (TCM). Methods Recent research advances in utilizing scRNA-seq to investigate the efficacy and toxicity mechanisms of TCM were reviewed in general and related disease treatments and toxicity in particular. The functional positioning and key findings of scRNA-seq in various studies were also analyzed. Results A standardized research paradigm known as "component analysis-cellular localization-target screening-mechanism validation" was established to explore the efficacy and toxicity of TCM using scRNA-seq that could overcome the limitations of traditional organ-level observations and reveal the microscopic essence of TCM’s pharmacological and toxicological actions by enabling precise identification of cellular subpopulation-specific responses and dynamic gene expression changes. Based on these insights, we proposed a single-cell network pharmacological or toxicological strategy for systematic elucidation of mechanisms. Conclusion scRNA-seq has emerged as a pivotal methodology for deciphering what is underlying the pharmacology and toxicology of TCM. Research strategies in TCM using this technology can provide novel perspectives and references for advancing the modernization of TCM. Reference | Related Articles | Metrics | Comments（0）

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Methodological Validation of RQ-TRAP for Telomerase Activity Detection and Its Applications in Human Mesenchymal Stem Cells ZHANG Zhen, YU Xie'an, XU Chunqi, CHEN Ning, QIN Meirong, WANG Ping Chinese Journal of Pharmacovigilance    2026, 23 (2): 121-126.   DOI: 10.19803/j.1672-8629.20250916 Abstract （476）      PDF（pc） （1403KB）（142）       Knowledge map    Save Objective To validate the methodological performance of the real-time quantitative telomeric repeat amplification protocol (RQ-TRAP), including the specificity, accuracy, precision, linearity, amplification efficiency, and lower limit of quantification, and detect telomerase activity in human mesenchymal stem cells (hMSCs) using this method in order to assess the proliferative potential, senescence process, and potential tumorigenic risk of hMSCs. Methods Telomerase activity in hMSCs was detected using the RQ-TRAP method. hMSCs derived from human umbilical cords were cultured in MEM-α medium. Samples were prepared via cell lysis and extraction, and absolute quantification was performed on a real-time polymerase chain reaction system using TRAP reaction buffer. Methodological validation was conducted using TSR8 control templates to evaluate the specificity, accuracy (recovery rate), intermediate precision (RSD), linearity (R2 and amplification efficiency), and LLOQ (confidence interval of recovery). For hMSCs assessment, telomerase activity was calculated based on standard curve fitting and Ct values. Results Methodological validation results indicated a good specificity with no interference from heat-inactivated cell matrices. The 95% confidence interval (CI) for accuracy recovery ranged from 91.37% to 111.0% (meeting the standard of 75%-125%). The intermediate precision (RSD) was less than 25% for all samples. Linearity assessment showed an R2>0.99 with an amplification efficiency of 104.1% (within the 90%-110% range). The LLOQ was determined to be 0.2 TPG Units (recovery CI: 70%-130%). The telomerase activity in hMSCs was measured at 1.432 TPG per 10 000 cells and the amplification efficiency of the standard curve in this assay was 102.6%. Conclusion The RQ-TRAP method has proved to be reliable and sensitive, which can be used for quantitative detection of telomerase activity in hMSCs and for effective assessment of cell senescence and tumorigenic risks. This method fills the gap in standardized testing for hMSCs and supports safe applications of regenerative medicine. Reference | Related Articles | Metrics | Comments（0）