Top Read

Published in last 1 year |

In last 2 years |

In last 3 years |

All

Please wait a minute...


For Selected: Download Citations EndNote Ris BibTeX Toggle Thumbnails

Select

Research Advances in the Pathogenesis of Cytokine Release Syndrome Induced by CAR-T Cell Therapy REN Yuke, JIANG Hua, LI Lulu, LI Shuangxing, HUO Guitao, YANG Yanwei, ZHANG Di, HUANG Ying, GENG Xingchao, LIN Zhi, QU Zhe Chinese Journal of Pharmacovigilance    2025, 22 (7): 735-741.   DOI: 10.19803/j.1672-8629.20250258 Abstract （1501）      PDF（pc） （1222KB）（448）       Knowledge map    Save Objective To investigate the mechanisms, grading, and management strategies of cytokine release syndrome (CRS) in chimeric antigen receptor T-cell (CAR-T) therapy in order to enhance the safety and efficacy of CAR-T cell therapy. Methods By reviewing studies currently available, the pathogenesis of CRS was analyzed, involving the key cytokines and signaling pathways before the grading criteria for and clinical approaches to CRS were summarized. Results CRS, a common adverse reaction in CAR-T therapy, involved the activation of cytokines (e.g., IL-6, IL-1, IFN-γ) and signaling pathways (e.g., JAK-STAT, NF-κB). Grading systems that guided clinical interventions were available, but targeted therapies required more optimization. Conclusion A better understanding of CRS mechanisms will facilitate the development of novel targeted drugs while improving the safety/efficacy of CAR-T therapy. Reference | Related Articles | Metrics | Comments（0）

Select

Pharmacodynamic Evaluation of CAR-T Cell Products Based on Deep Learning Convolutional Neural Network Recognition REN Yuke, QU Zhe, LAI Zixuan, ZHANG Di, ZHAO Yongtian, YANG Yanwei, LI Shuangxing, HUO Guitao, ZHOU Xiaobing, LIN Zhi, GENG Xingchao Chinese Journal of Pharmacovigilance    2025, 22 (7): 742-748.   DOI: 10.19803/j.1672-8629.20250257 Abstract （1270）      PDF（pc） （2157KB）（236）       Knowledge map    Save Objective To establish an auxiliary diagnostic model for mouse liver lymphoma using deep learning (DL) technology in order to improve the accuracy and consistency of pathological diagnosis and facilitate the research and development of cell therapy products. Methods A total of 102 hepatic lymphoma tissues and 41 normal liver tissues were collected from mice used in chimeric antigen receptor (CAR) T-cell therapeutic and toxicological studies. After the tissues were scanned into digital slides, semi-automated data annotation was performed. To enhance the accuracy of annotation, all data underwent preprocessing (tissue extraction and artifact removal) and was randomly divided into training, validation, and test sets at a ratio of 8∶1∶1. Five convolutional neural networks-FCN, LR-ASPP, DeepLabv3+, U-Net, and DenseNet-were applied to identify tumor and non-tumor regions. The tumor prediction images based on slice images were compared, and the performance of the constructed algorithm models was evaluated using precision, recall, and the F1-score. Results The precision, recall, and F1-score of the DenseNet, DeepLabv3+, and FCN algorithms were all close to or exceeded 95%. Among them, the DenseNet algorithm model performed best in the test set, with an overall precision of 0.989 4, a recall of 0.990 6, and an F1- score of 0.990 0. Conclusion The DenseNet algorithm model established in this study has a good prospect of application in auxiliary diagnosis of mouse liver lymphoma, which can effectively improve the accuracy and consistency of assessment of tumor occurrence in studies on the efficacy and toxicology of CAR-T cell therapy products. Reference | Related Articles | Metrics | Comments（0）

Select

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 （1221）      PDF（pc） （1785KB）（972）       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）

Select

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 （1104）      PDF（pc） （2253KB）（411）       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）

Select

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 （1029）      PDF（pc） （1375KB）（1334）       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）

Select

Quality Control and Test Methods of Human Induced Pluripotent Stem Cells YANG Yifan, YANG Yanwei, ZHANG Di, XIE Yin, ZHANG Yong, CHEN Xulin, GAO Sutao, GENG Xingchao, QU Zhe Chinese Journal of Pharmacovigilance    2025, 22 (7): 728-734.   DOI: 10.19803/j.1672-8629.20250265 Abstract （988）      PDF（pc） （1227KB）（225）       Knowledge map    Save Objective To explore the challenges to clinical translation of human induced pluripotent stem cell (hiPSC) therapies and define the quality control requirements in order to provide references to regulation of related products. Methods Based on literature review, the current R&D of hiPSC therapies was outlined and technical hurdles in each stage of production were identified. Quality control standards were summarized out of recent guidelines. Results While hiPSC-based therapies promised wide applications, no clinical-grade product had been approved for marketing. The major obstacles arose from technical challenges encountered in the complicated process of production. Quality control and product characterization were critical to the development and commercialization of these products. Despite the lack of a uniform standard, there was consensus regarding critical quality attributes of hiPSC-derived cell therapies. Conclusion A uniform quality control standard is essential to overcome translational barriers. Keen insights into each element of quality control during the process of production will facilitate the assessment of safety/efficacy of hiPSC-derived products, thus accelerating clinical translation and regulatory approval. Reference | Related Articles | Metrics | Comments（0）

Select

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 （945）      PDF（pc） （1267KB）（1735）       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）

Select

Research Progress in Integration Sites for Cellular and Gene Therapy Products QI Yujie, WANG Xin, ZHANG Jiahui, MA Enlong, GENG Xingchao Chinese Journal of Pharmacovigilance    2025, 22 (7): 721-727.   DOI: 10.19803/j.1672-8629.20250151 Abstract （835）      PDF（pc） （803KB）（240）       Knowledge map    Save Objective To elaborate the insertional integration mechanisms of retroviral and recombinant adeno-associated viral (rAAV) vectors, and review assessment Methods of integrated toxicity and analytic approaches to integration sites in order to call attention to the safety of cellular and gene therapy (CGT) products. Methods CNKI, PubMed and other databases were searched for literature related to integration sites of different vector types in general and toxicity mechanisms and investigational Methods in particular. Results Retroviral vectors were characterized by high-frequency random integration. The integrated toxicity was assessed using in vitro immortalization assay (IVIM), modified IVIM, or the transcript detection method. rAAV vectors were capable of low-frequency targeted integration, and the integrated toxicity was assessed using a neonatal mouse model of methylmalonic acidemia, where circulating cell-free nucleic acid was a more suitable characterization specimen. Besides, advantages and limitations of analytic techniques for integration sites, including WGS, LM-PCR, LAM-PCR, nr LAM-PCR, MGS-PCR, ITR-seq and AAV-seq, were compared. Conclusion Viral vectors are the primary gene delivery tool for the making of CGT products. The analysis of integration sites of vectors is crucial for ensuring product safety and preventing adverse drug reactions. Reference | Related Articles | Metrics | Comments（0）

Select

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 （742）      PDF（pc） （1473KB）（565）       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）

Select

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 （724）      PDF（pc） （1321KB）（627）       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）

Select

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 （720）      PDF（pc） （1319KB）（444）       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）

Select

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 （661）      PDF（pc） （812KB）（297）       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）

Select

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 （630）      PDF（pc） （574KB）（851）       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）

Select

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 （535）      PDF（pc） （713KB）（913）       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）

Select

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 （478）      PDF（pc） （1417KB）（306）       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）

Select

Chinese Journal of Pharmacovigilance    2025, 22 (10): 0-0.   Abstract （473）      PDF（pc） （504KB）（322）       Knowledge map    Save Related Articles | Metrics | Comments（0）

Select

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 （457）      PDF（pc） （1403KB）（137）       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）

Select

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 （456）      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）

Select

Research Progress in Pharmacological Actions, Mechanisms, Structural Modifications and Targeted Formulations of Ribavirin XIE Rui, GENG Zihan, BAO Lei, ZHAO Ronghua, LI Shuran, SUN Qiyue, WANG Xinwei, ZHANG Jingsheng, CUI Xiaolan, GUO Shanshan, SUN Jing Chinese Journal of Pharmacovigilance    2025, 22 (8): 950-955.   DOI: 10.19803/j.1672-8629.20250199 Abstract （452）      PDF（pc） （1289KB）（626）       Knowledge map    Save Objective To explore the pharmacological actions, mechanisms, structural modifications and targeted formulations of ribavirin (RBV) in order to provide references for the pharmacological research and clinical applications of RBV. Methods Related literature on RBV that was published as of May 2, 2025 was retrieved from such databases as China National Knowledge Infrastructure, National Science and Technology Library of China, and PubMed before the pharmacological actions, mechanisms, structural modifications and targeted drug delivery systems of RBV were summarized. Results The pharmacological effects of RBV were mostly antiviral and antitumor. Most of the structural modifications of RBV involved glycosyl modifications and base modifications. The research and development of nanosized formulations among the targeted formulations of RBV were intensified. The drug delivery systems of RBV based on nanoparticles could significantly reduce the dosage administered and enhance the drug’s targetability. The vesicles and liposomes of RBV exhibited distinct targeting properties and effectively reduced the incidence of adverse reactions. In addition, RBV could be innovatively conjugated with hemoglobin and bile acids. The conjugates not only possessed targeting properties, but also could reduce toxicity or side effects. Besides the conjugation strategy, RBV could also combine with polyanionic macromolecules to form complexes with more pronounced antiviral effects. Conclusion Thanks to precise targeted delivery, RBV can act more effectively on lesion sites, reduce the drug dosage, and thereby lower the incidence of adverse reactions. Innovative drug delivery systems and combination strategies that enhance therapeutic efficacy while reducing adverse effects promise wide applications of RBV. Reference | Related Articles | Metrics | Comments（0）

Select

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 （450）      PDF（pc） （1270KB）（732）       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）