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Isoorientin from Gentiana dahurica Fisch. Flower regulates COPD-related airway inflammation via MAPK pathway: an in vitro study of mechanisms Song Wenxuan, Zhou Shuhong, Zhang Wenxue, Wang Ning, Guo Qi, Ma Ao, Wang Minjie, Yi Letai Chinese Journal of Pharmacovigilance    2026, 23 (10): 1115-1122.   DOI: 10.19803/j.1672-8629.20260697 Abstract （1265）      PDF（pc） （2101KB）（64）       Knowledge map    Save Objective To explore the role of ISO, an active component of Gentiana dahurica Fisch. Flower in attenuating airway inflammation related to chronic obstructive pulmonary disease (COPD) and the molecular mechanism. Methods ISO, gentiopicroside and loganic acid in Gentiana dahurica Fisch. Flower were quantified via LC-MS/MS. Lipopolysa-ccharide (LPS, 5 μg·mL-1) was used to establish an in-vitro COPD-related inflammatory model in BEAS-2B human bronchial epithelial cells. CCK-8 assay was performed to screen the safe ISO dosage and evaluate its effect of cytoprotection. RT-qPCR was adopted to detect mRNA levels of inflammatory mediators. Transcriptome sequencing was employed to screen differentially expressed genes and key enriched pathways. RT-qPCR and Western blot were used to measure the expression levels of core MAPK-related genes and proteins. Molecular docking was conducted to predict the binding affinity between isoorientin and target proteins. Results ISO was the leading active component of Gentiana dahurica Fisch. Flower. The safe intervention condition of ISO was 5 μmol•L⁻¹ and 12 hours of intervention. Compared with the control group, LPS markedly reduced cell viability (P<0.001) while 5 μmol·L-1 ISO restored cell viability in the model group (P<0.01). The mRNA levels of IL-6, IL-1β, IL-8, TNF-α, MMP-9 and CXCL5 were significantly elevated in LPS-treated cells (P<0.001), and ISO markedly suppressed these up-regulated transcripts (P<0.01, P<0.001). Transcriptome enrichment identified the MAPK pathway as a major anti-inflammatory target. LPS up-regulated EREG, MAPK8 (JNK1) and FOS at the mRNA level (P<0.01, P<0.001), increased EREG, c-Fos protein abundance and elevated the p-JNK/JNK ratio (P<0.01), but ISO reversed these alterations and restrained excessive MAPK activation (P<0.01, P<0.001). Molecular docking suggested that binding energies between ISO and EREG, JNK1 and c-Fos were all less than -5 kcal·mol-1, suggesting favorable binding potentials. Conclusion ISO derived from Gentiana dahurica Fisch. Flower may inhibit aberrant MAPK signaling, reduce pro-inflammatory mediator release and alleviate LPS-provoked airway inflammatory injury related to COPD by interacting with key MAPK-related proteins. Reference | Related Articles | Metrics | Comments（0）

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Risk Factors for Liver Injury Induced by Anaplastic Lymphoma Kinase Inhibitors DENG Qingqing, YAO Qingqing, HU Tao, YANG Jiale, BIAN Yicong, MIAO Liyan Chinese Journal of Pharmacovigilance    2026, 23 (2): 162-166.   DOI: 10.19803/j.1672-8629.20250760 Abstract （1223）      PDF（pc） （1273KB）（144）       Knowledge map    Save Objective To investigate the clinical characteristics of and risk factors for liver injury induced by anaplastic lymphoma kinase (ALK) inhibitors in patients with non-small cell lung cancer (NSCLC). Methods The clinical data of NSCLC patients treated with ALK inhibitors at the First Affiliated Hospital of Soochow University between January 2019 and July 2024 was collected. Patients were divided into a liver injury group and a non-liver injury group based on the occurrence of liver injury. Demographics, disease diagnosis, baseline biochemical indicators of livers, and other clinical data were compared between the two groups. Univariate and multivariate logistic regression analyses were used to identify risk factors for liver injury. Results A total of 75 NSCLC patients treated with ALK inhibitors were included in this study, with an overall incidence of liver injury of 42.7% (32/75). There were no significant differences in clinical characteristics such as demographic information, lung cancer stage, or baseline biochemical indicators of the liver between the two groups. Logistic regression analysis revealed that pre-existing diseases [P=0.047, hypertension P=0.006, 95%CI (1.691, 21.312)] and concomitant medications [P=0.008, concomitant use of proton pump inhibitors P=0.022, 95%CI (1.274, 23.761)] might be independent risk factors for ALK inhibitor-induced liver injury. Conclusion The results of this study suggest that the risk of liver injury in NSCLC patients receiving ALK inhibitor treatment is potentially associated with comorbid underlying diseases such as hypertension, or concurrent use of drugs like proton pump inhibitors during treatment. For such patients, close monitoring of liver function is essential in clinical practice to ensure the safe and rational use of ALK inhibitors. Reference | Related Articles | Metrics | Comments（0）

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Treatment of Hypertensive Cardiac Hypertrophy with Siwei Tumuxiang Powder Based on Tissue Non-Targeted Metabolomics REN Zhongjie, WEI Minghui, YIN Dongjie, GUO Ying, LU Ziyu, YU Yang, GUO Yuting, ZHANG Xin, LIU Fangbing, ZHANG Jiaru, WANG Minjie, XUE Mingming Chinese Journal of Pharmacovigilance    2026, 23 (1): 42-49.   DOI: 10.19803/j.1672-8629.20250594 Abstract （1151）      PDF（pc） （2392KB）（382）       Knowledge map    Save Objective To investigate the mechanism through which Siwei Tumuxiang powder (STP) intervenes in hypertensive cardiac hypertrophy (HCH) in rats. Methods Forty Sprague-Dawley (SD) rats were randomly divided into four groups (n=10 each): the sham-operated (Sham) group, model (Mod) group, STP group (1.6 g·kg-1), and positive control captopril (CAP) group (0.015 g·kg-1). The last three groups underwent abdominal aortic coarctation (AAC) to induce HCH while the Sham group received abdominal aortic isolation without ligation. Concurrently, the STP and CAP groups were subjected to eight weeks of interventions with STP and CAP, whereas the Sham and Mod groups received 0.9% saline solution via gavage. After 8 weeks, cardiac function was assessed using echocardiography. Pathological changes in cardiac tissues were observed using hematoxylin-eosin (HE) and Masson staining. The mRNA expression levels of hypertrophy markers β-myosin heavy chain (β-MHC) and the myocardial fibrosis marker transforming growth factor-β (TGF-β) were measured using real-time quantitative polymerase chain reaction (RT-qPCR). Protein expression levels of β-MHC and TGF-β were determined by Western blot (WB). Additionally, metabolomic analysis was conducted. Results Compared to the Sham group, the ventricular wall thickened, cardiac function impaired, myocardial fibrosis and inflammatory infiltration became more pronounced, and mRNA and protein expression levels of β-MHC and TGF-β were elevated in the Mod group. In contrast, significant improvements in these indexes were observed in the STP group. Untargeted metabolomics identified 13 differential metabolites and implicated 14 pathways, including arachidonic acid metabolism and the tricarboxylic acid cycle (TCA). Conclusion STP exerts therapeutic effects against HCH and metabolic disorders through multi-target interventions, possibly by regulating energy metabolism and suppressing inflammatory responses. Reference | Related Articles | Metrics | Comments（0）

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Protective effects of Mongolian medicine Xiaohuixiang Sanwei Tang against myocardial ischemia-reperfusion injury in mice and the mechanisms Bai Lulu, Tian Jinman, Lu Jingkun, Zhang Zhongyue, Zhang Xiaoru, Song Xiaoxia, Tang Hao, Yu Lingze, Guo Na, Du Yulu, Wang Minjie Chinese Journal of Pharmacovigilance    2026, 23 (10): 1098-1107.   DOI: 10.19803/j.1672-8629.20260291 Abstract （1104）      PDF（pc） （3111KB）（73）       Knowledge map    Save Objective To investigate the protective effects of pretreatment with Mongolian medicine Xiaohuixiang Sanwei Tang (XHX) against myocardial ischemia-reperfusion injury (MIRI) in mice. Methods Seventy-two male C57BL/6J mice were evenly and randomly divided into six groups: a sham operation group (Sham), model group (Model), compound Danshen dripping Pill (CDDP, 0.11 g·kg-1) positive control group, and low-dose (XHX-L, 0.65 g·kg-1), medium-dose (XHX-M, 1.3 g·kg-1), and high-dose (XHX-H, 2.6 g·kg-1) XHX groups. An MIRI model was established by 30 minutes of ischemia followed by 24 hours of reperfusion. Cardiac function parameters were recorded, TTC staining was used to detect myocardial infarct size after 24 hours of MIRI, HE staining was performed to observe myocardial tissue structure and cell morphology, and Masson staining was conducted to evaluate myocardial fibrosis. Blood was taken from the heart before the serum was separated to detect the indexes of MIRI oxidative stress in each group. A hypoxia/reoxygenation (H/R) model of H9c2 cardiomyocytes was constructed, and the protective effects of XHX were confirmed at the cellular level by CCK-8 assay. Network pharmacology was used to predict the active components and potential targets of the drug, construct a protein-protein interaction (PPI) network, and perform GO functional annotation and KEGG pathway enrichment analysis on overlapping targets using databases. Myocardial tissue samples from the Sham, Model, and XHX-H groups were collected for transcriptome sequencing to identify and verify potential key targets. Results TTC staining showed that XHX reduced the infarct size in mice 24 hours after MIRI. ELISA and assay kit results suggested that XHX decreased the levels of creatine kinase-MB (CK-MB), lactate dehydrogenase (LDH), and malondialdehyde (MDA) while increasing superoxide dismutase (SOD) levels 24 hours after MIRI. HE staining revealed that XHX ameliorated myocardial pathological changes following MIRI. Masson staining indicated that XHX effectively reduced the degree of myocardial fibrosis in mice with MIRI. H9c2 cell experiments confirmed that interventions with the XHX-M group effectively alleviated H/R-induced cardiomyocyte injury and exerted a significant protective effect against cell viability. Transcriptome sequencing combined with network pharmacology analysis revealed that XHX could regulate the progression of myocardial ischemic disease through chemokines. Conclusion XHX pretreatment alleviates MIRI-induced damage, reduces myocardial infarct size and fibrosis, and protects the heart in mice following MIRI. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Active Constituents of Mongolian Medicinal Gentiana dahurica Fisch. Flower Ameliorate Chronic Obstructive Pulmonary Disease in Mice through NF-κB Signaling Pathway ZHANG Wenxue, WANG Ning, GUO Qi, SONG Wenxuan, CHEN Xingyu, MA Ao, WANG Minjie, YI Letai Chinese Journal of Pharmacovigilance    2026, 23 (1): 34-41.   DOI: 10.19803/j.1672-8629.20250783 Abstract （1099）      PDF（pc） （2393KB）（136）       Knowledge map    Save Objective To investigate the protective effects and underlying mechanisms of active constituents-caffeic acid and quercetin-from Gentiana dahurica flower against lung injury in a mouse model of chronic obstructive pulmonary disease (COPD) induced by cigarette smoke exposure combined with lipopolysaccharide (LPS). Methods A COPD mouse model was established by combining cigarette smoke exposure with intranasal LPS administration. Sixty male C57BL/6J mice were randomly assigned to five groups (n=12): control group, model group, dexamethasone group (2 mg·kg⁻¹), caffeic acid group (15 mg·kg⁻¹), and quercetin group (10 mg·kg⁻¹). Except the control group, all the mice were exposed to cigarette smoke using a semi-automatic exposure system for 16 weeks. Drug administration by gavage started at week 5 and continued for 12 weeks. Low-dose LPS was intranasally instilled once weekly. Body weight, lung function, histopathological changes, inflammatory mediator expressions, and NF-κB pathway-related protein levels were recorded. Molecular docking analysis was conducted to evaluate the binding affinity of caffeic acid and quercetin to key NF-κB signaling proteins. Results Compared with the control group, COPD model mice exhibited suppressed body weight gain, impaired lung function, pronounced inflammatory lung injury, and significantly elevated mRNA levels of inflammatory cytokines as well as increased expressions of NF-κB p65 and IκBα proteins (P<0.05). Treatment with caffeic acid or quercetin markedly improved body weight and lung function, alleviated pathological damage to the lung, and significantly reduced inflammatory cytokine expressions and NF-κB pathway-related protein levels compared with the model group (P<0.05). Molecular docking results demonstrated stable binding of both caffeic acid and quercetin to key proteins of the NF-κB signaling pathway. Conclusion Caffeic acid and quercetin, the major active constituents of Gentiana dahurica flower, can effectively ameliorate lung dysfunction, pathological injury, and inflammatory responses in COPD mice, potentially by inhibiting NF-κB signaling pathway activation. Reference | Related Articles | Metrics | Comments（0）

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Periplocin-Induced Hepatotoxicity in Zebrafish via Inhibition of the HNF4α-CYP Axis:a Combination of CYP Inhibitors and Transcriptomics LIU Yuxin, SHENG Yuhan, YU Weijie, CHENG Yunzhe, LI Jiaqi, SUN Yan, ZHAO Chongjun Chinese Journal of Pharmacovigilance    2026, 23 (4): 398-404.   DOI: 10.19803/j.1672-8629.20260018 Abstract （1049）      PDF（pc） （2914KB）（197）       Knowledge map    Save Objective To elucidate the underlying mechanisms of periplocin-induced hepatotoxicity using a zebrafish model, combined with cytochrome P450 (CYP) inhibitor interventions and transcriptomics. Methods Zebrafish larvae at 4 days post-fertilization (4 dpf) were used as the experimental model. Hepatotoxicity was evaluated by analyzing liver phenotypes in transgenic zebrafish and performing hematoxylin-eosin (H&E) staining following combined exposure to periplocin and CYP inhibitors. Subsequently, transcriptome sequencing and real-time quantitative PCR (RT-qPCR) were employed to uncover and validate the molecular mechanisms. Results Periplocin exposure caused a dose-dependent decrease in liver fluorescence intensity and induced pathological damage, including hepatocyte vacuolization and disordered arrangement. Notably, co-treatment with CYP inhibitors exacerbated these toxic effects, suggesting that the hepatotoxicity of periplocin was closely associated with its metabolic clearance. Transcriptomic analysis revealed significant alterations in the hepatic gene transcription profile, characterized primarily by the suppression of pathways related to CYP-mediated xenobiotic metabolism, lipid metabolism, and bile acid synthesis. RT-qPCR confirmed the significant downregulation of the key transcription factor hnf4a and its downstream phaseⅠmetabolic enzymes (cyp3a65, cyp2p6), phaseⅡmetabolic enzyme (gstp1), as well as the lipid metabolism regulator pparab and the bile acid regulator cyp8b1 (P<0.05). Conclusion Periplocin can induce severe liver injury by suppressing the expression of the upstream core transcription factor-hepatocyte nuclear factor 4α (HNF4α). This suppression triggers a transcriptional inhibition cascade affecting downstream CYP detoxification systems and the PPARα lipid metabolism pathway, leading to disrupted hepatic homeostasis, diminished detoxification capacity, and metabolic disorders. 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 （953）      PDF（pc） （1319KB）（584）       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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Research progress in Mongolian medicine formulas for hypertensive cardiac injury Guo Yuting, Wei Minghui, Guo Ying, Dong Na, Xue Mingming Chinese Journal of Pharmacovigilance    2026, 23 (7): 753-756.   DOI: 10.19803/j.1672-8629.20260482 Abstract （926）      PDF（pc） （1298KB）（149）       Knowledge map    Save Objective To summarize the current research on Mongolian medicine formulas for hypertensive cardiac injury and provide insights into the mechanisms of Mongolian medicine and future development of drugs with reference to related studies on traditional Chinese medicine. Methods Recent literature on hypertensive cardiac injury and Mongolian medicine formulas was reviewed. Representative Mongolian medicine formulas and related TCM evidence were analyzed in general and key pathological processes in particular, including cardiac hypertrophy, ventricular remodeling, myocardial fibrosis, inflammation, oxidative stress, and metabolic abnormalities. Results Hypertensive cardiac injury involved multiple pathological processes, such as cardiomyocyte hypertrophy, cardiac remodeling, abnormal fibrotic signaling, and metabolic disorders. Current studies suggested that representative Mongolian medicine formulas, such as Anshen Buxin Liuwei pills, Nutmeg-5, and Siwei Tumuxiang powder, might be effective at cardiomyocyte protection, cardiac remodeling, hypertensive myocardial hypertrophy, and metabolic regulation. These formulas might exert cardioprotective effects through anti-oxidative, anti-apoptotic, calcium homeostasis-regulating, mitochondrial protective, and metabolic network-modulating mechanisms. In comparison, studies on TCM formulas and their active components against hypertensive cardiac injury were more full-fledged and might provide useful references for mechanistic studies of Mongolian medicine formulas. Conclusion Mongolian medicine formulas can be potentially used in interventions with hypertensive cardiac injury. However, current evidence remains limited by insufficient direct studies, unclear pharmacodynamic material bases, inadequate validation of core targets, and a lack of high-quality clinical data. More effort should be devoted to multi-omics-based functional validation and high-quality clinical research to shed light on their pharmacodynamic basis and mechanisms of action. 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 （922）      PDF（pc） （1321KB）（855）       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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Protective Effects of Mongolian Medicines Saurile, Zhenbao Pills and Zandan-3 against Cerebral Ischemia-Reperfusion Injury in Mice: a Comparative Study SONG Xiaoxia, YANG Yan, ZHOU Shuhong, ZHAO Xiangdong, ZHANG Zhongyue, ZHANG Xiaoru, GAO Qian, WANG Minjie Chinese Journal of Pharmacovigilance    2026, 23 (1): 26-33.   DOI: 10.19803/j.1672-8629.20250355 Abstract （921）      PDF（pc） （2466KB）（430）       Knowledge map    Save Objective To compare the protective effects of three classic Mongolian medicinal formulas—Saurile, Zhenbao pills, and Zandan-3 decoction—against cerebral ischemia-reperfusion injury in mice, and to identify the optimal formula for subsequent mechanistic investigations. Methods A total of 120 C57BL/6J mice were randomly divided into six groups: sham-operated group, model group, nimodi-pine group (46.8 mg·kg-1), Saurile group (338 mg·kg-1), Zhenbao pill group (780 mg·kg-1), and Zandan-3 decoction group (1 950 mg·kg-1), with 20 mice in each group. The treatment groups were administered with respective formulas via gavage for 10 days, while the sham-operated and model groups received an equivalent volume of saline. A transient middle cerebral artery occlusion model was established using the filament method, involving 1.5 hours of ischemia followed by 24 hours of reperfusion. The sham-operated group underwent the surgical procedure without filament insertion. After 24 hours of reperfusion, brain tissues were harvested for TTC staining to assess the ischemic area, HE and Nissl staining were used to observe pathological changes, and behavioral scoring was recorded. Serum samples were collected to measure levels of SOD, MDA, and LDH. The protective effects of Saurile, Zhenbao pills, and Zandan-3 decoction against cerebral ischemia-reperfusion injury were compared, and network pharmacology was employed to predict the targets of Saurile. Results Compared to the sham-operated group, there was a significant increase in the infarct area based on TTC staining, a markedly reduced neurobehavioral score (P<0.001), evident infarct lesions as evidenced by HE staining, and pronounced neuronal damage after Nissl staining in the model group (P<0.001). Serum levels of SOD, MDA, and LDH were significantly decreased (P<0.001). Compared with the model group, the nimodipine, Saurile, Zhenbao Pill, and Zandan-3 Decoction groups showed a significant decrease in the infarct area according to TTC staining (P<0.05), an increased neurobehavioral score (P<0.05), a decrease in lesions based on HE and Nissl staining (P<0.05), and higher serum levels of SOD, MDA, and LDH (P<0.05). Saurile proved to be the most effective, followed by Zhenbao pills and Zandan-3 decoction. Conclusion This study has found that, compared to the model group, the classic Mongolian medicinal formulas Saurile, Zhenbao pills, and Zandan-3 decoction can significantly ameliorate cerebral ischemia-reperfusion injury in mice. Saurile delivers the best effect, potentially by regulating the MAPK signaling pathway and inhibiting inflammatory responses. However, the specific active components and precise mechanisms require more study. Reference | Related Articles | Metrics | Comments（0）

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Mechanisms of action of Siwei Tumuxiang powder against hypertensive myocardial hypertrophy in rats based on transcriptomics Wei Minghui, Liu Fangbing, Li Xiangming, Li Jianying, Zhang Jiaru, Yin Dongjie, Ren Zhongjie, Guo Ying, Wang Minjie, Xue Mingming Chinese Journal of Pharmacovigilance    2026, 23 (7): 767-774.   DOI: 10.19803/j.1672-8629.20250886 Abstract （870）      PDF（pc） （2219KB）（169）       Knowledge map    Save Objective To investigate the mechanism by which Siwei Tumuxiang powder ameliorates hypertensive myocardial hypertrophy so as to provide a reference for clinical treatment. Methods A rat model of myocardial hypertrophy was established via abdominal aortic ligation. Transcriptomics technology and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) were used. Eighteen Sprague-Dawley (SD) rats were randomly divided into three groups: the sham-operated group (Sham), the model group (Mod), and the Siwei Tumuxiang powder administration group (STP, 1.6 g·kg-1·d-1), with six rats in each. A model of hypertensive myocardial hypertrophy was constructed via abdominal aortic coarctation in the Mod and STP groups. The STP group was given STP solution by gavage at a dose of 1.6 g·kg-1·d-1, while the Sham and Mod groups received an equal volume of normal saline by gavage. After 8 weeks of feeding, echocardiography was used to evaluate the cardiac function of each group. Heart tissue sections were stained with HE and Masson to observe the pathological changes in the structure of myocardial tissue and the degree of myocardial fibrosis. Western blot was used to detect the expressions of hypertrophy-related proteins. Based on network pharmacology simulation, a component-target network map was constructed and pathway enrichment analysis was conducted to predict the potential biological pathways of Siwei Tumuxiang powder against hypertensive myocardial hypertrophy. RNA-Seq was used for sequencing to analyze the differentially expressed genes, which were subjected to GO and KEGG enrichment analysis. The expressions of target genes were verified by qPCR. Results Echocardiography showed that the AWT and PWT of the STP group were significantly reduced, while EF and FS were significantly increased. HE and Masson staining suggested that Siwei Tumuxiang powder could mitigate the disordered arrangement of myocardial cells, cell hypertrophy, inflammatory infiltration, and the appearance of obvious fibrotic areas around myocardial vessels and in myocardial tissue spaces. Western blot showed that the expressions of hypertrophy-related protein ANP and fibrosis-related protein COL-1 were inhibited. The results of network pharmacology indicated that the 150 main components in Siwei Tumuxiang powder might exert therapeutic effects against hypertensive myocardial hypertrophy through 124 potential core targets. RNA-Seq identified 1 168 differentially expressed genes between the Sham group and the Mod group, and another 47 between the Mod group and the STP group. There were 22 feedback expressed genes in the intersection, among which 3 differentially expressed genes were related to hypertensive myocardial hypertrophy: Hamp, Ndrg1, and Gfpt2. RT-qPCR showed that Siwei Tumuxiang powder could reverse the expressions of Hamp, Ndrg1, and Gfpt2 genes in the heart tissue of model rats of hypertensive myocardial hypertrophy. Conclusions iwei Tumuxiang powder can retard the occurrence and development of hypertensive myocardial hypertrophy by regulating Hamp, Ndrg1, and Gfpt2 genes through complement and coagulation cascade, PPAR signaling pathway, and cholesterol metabolism pathways. 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 （790）      PDF（pc） （1502KB）（490）       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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Mongolian medicine Siwei Tumuxiang powder ameliorates pressure overload-induced cardiac hypertrophy by regulating metabolic networks Guo Ying, Guo Yuting, Yin Dongjie, Ren Zhongjie, Dong Na, Wei Minghui, Lu Ziyu, Li Xiangming, Wang Minjie, Xue Mingming Chinese Journal of Pharmacovigilance    2026, 23 (7): 757-766.   DOI: 10.19803/j.1672-8629.20260168 Abstract （741）      PDF（pc） （2284KB）（134）       Knowledge map    Save Objective To investigate the cardioprotective effects of the Mongolian medicine Siwei Tumuxiang powder (STP) against pressure overload-induced cardiac hypertrophy (POH) resulting from abdominal aortic constriction (AAC) in rats, and to explore its underlying mechanism using metabolomics. Methods Forty male Sprague-Dawley rats were randomly divided into four groups: sham-operated (Sham), model (Mod), STP (1.6 g·kg-1), and the positive control captopril (CAP) group (0.015 g·kg-1). Following AAC surgery, the rats received intragastric administration of the respective drug for four weeks. Cardiac function was recorded using echocardiography. Myocardial pathological changes were observed via Hematoxylin-Eosin and Masson staining. The expression levels of markers for cardiac hypertrophy and fibrosis were detected using RT-qPCR and Western blot. Untargeted metabolomics based on UPLC-Q-TOF/MS was employed in combination with weighted gene co-expression network analysis (WGCNA) to screen out key metabolites and pathways. Results Compared to the Mod group, STP inter-vention significantly reduced the anterior wall thickness (AWT) and posterior wall thickness (PWT), increased ejection fraction (EF) and fractional shortening (FS), thereby improving cardiac function in AAC rats. STP also mitigated myocardial cell edema, disordered fiber arrangement, and collagen deposition. Furthermore, STP downregulated the mRNA and protein expression levels of ANP, β-MHC, TGF-β, and Col-1. Metabolomics analysis identified five core metabolic modules closely associated with both the disease state and drug intervention, leading to the selection of 52 hub metabolites, 39 of which were closely correlated with the disease. KEGG pathway enrichment analysis revealed that these hub metabolites were primarily enriched in such pathways as riboflavin metabolism, caffeine metabolism, and linoleic acid metabolism. Conclusions TP exerts a significant protective effect against AAC-induced POH, which is closely associated with its ability to improve mitochondrial energy supply by regulating riboflavin metabolism, to maintain purine homeostasis by regulating caffeine metabolism, and to inhibit inflammation and fibrosis by inhibiting linoleic acid metabolism. This study highlights the multi-component, multi-target, and network-regulating properties of this Mongolian medicinal compound. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Evaluation of prescription similarity and safety for the revision of Mongolian medicine standards Lian Chaojie, Ren Jun, Hu Xiaoru, Dai Shengyun, Liu Jie, Wu Dongxue, Xiao Meng, Wu Zhihui, Zheng Jian, Wang Dong Chinese Journal of Pharmacovigilance    2026, 23 (10): 1144-1148.   DOI: 10.19803/j.1672-8629.20260319 Abstract （699）      PDF（pc） （1240KB）（65）       Knowledge map    Save Objective To determine the priorities during the revision of the ministerial Mongolian medicine standards by reviewing related literature from the perspectives of prescription similarity and pharmacovigilance. Methods One hundred and forty-four preparations included in the Drug Standards of the Ministry of Public Health of the People’s Republic of China (Mongolian Medicine Fascicle) were selected as the subjects before text analysis was conducted to retrieve and standardize information about these prescriptions. The Jaccard similarity coefficient between preparations was calculated to identify high-frequency and high-proportion medicinal ingredients, as well as highly similar prescription clusters. Meanwhile, the National Center for ADR Monitoring, the National Medical Products Administration website, and the CNKI database were searched for articles on adverse reactions and toxicity related to the relevant medicinal ingredients and preparations. Results The 144 preparations involved a total of 247 medicinal ingredients with a cumulative frequency of 1 446 occurrences. The top 27 ingredients, including Chebulae Fructus (Hezi), Aucklandiae Radix (Muxiang), and Carthami Flos (Honghua), accounted for 51.5% of the total frequency while the top 26 ingredients accounted for 50.58% of the total prescriptions. Notably, Aconiti Kusnezoffii Radix Cocta (Zhi Caowu) ranked only 21st in frequency, yet its proportion of prescriptions reached 1.70%, indicating a high cumulative risk of toxic constituents. Prescription similarity analysis revealed 15 groups of completely identical series varieties (31 preparations) with a Jaccard coefficient of 1, and 22 groups of highly similar prescription clusters (34 preparations) with a coefficient≥0.5, forming multiple “formula clusters” that revolved around core medicinal ingredients. The search for literature on adverse reactions identified multiple reports about hepatotoxicity, nephrotoxicity, cardiotoxicity, and allergic reactions related to high-frequency ingredients such as Moschus (Shexiang), Aconiti Kusnezoffii Radix Cocta (Zhi Caowu), Gardeniae Fructus (Zhizi), and Carthami Flos (Honghua), and to highly similar preparations like Zhenbao pills and Zhenzhu Tongluo pills. Conclusion The ministerial Mongolian medicine prescriptions are strongly characterized by core ingredient clusters and formula cluster derivation. It is recommended that high-frequency and high-proportion medicinal ingredients involved in over 80% of the preparations be designated as the first-batch priority for revision of the standard, with identical series varieties and highly similar prescription clusters as the second-batch priority and packaged together for revision. Additionally, safety-related items indicated by the literature, such as limit tests for toxic constituents and monitoring of allergic reactions, should be incorporated into the efforts to improve the quality standard so as to establish a comprehensive research model that combines drug quality controllability with safety evaluation. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Hepatoprotective effects and underlying mechanisms of Ethanolic extract of Mongolian medicinal herb Scabiosa comosa on drug-induced liver injury in rats Chen Xingyu, Zhou Shuhong, Wang Lu, He Jianqi, Tian Jinman, Bao Fushun, Zhang Wenxue, Ma Ao, Bao Lili, Wang Minjie, Yi Letai Chinese Journal of Pharmacovigilance    2026, 23 (10): 1108-1114.   DOI: 10.19803/j.1672-8629.20260257 Abstract （674）      PDF（pc） （3185KB）（64）       Knowledge map    Save Objective To explore the pharmacodynamic material basis and potential mechanism of Mongolian medicine Scabiosa comosa Fisch. ex Roem. & Schult. ethanol extract against drug-induced liver injury (DILI). Methods After 8 weeks of preventive administration, an acute drug-induced liver injury model was established in C57BL/6 mice. Serum samples were collected to detect such liver function indicators as alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Liver tissues were subjected to hematoxylin-eosin (HE) pathological staining and transcriptome sequencing analysis. Network pharmacology was applied to screen potential targets of the ethanolic extract of Scabiosa comosa against acute drug-induced liver injury. The mRNA expression levels of candidate targets were verified to identify core targets, which were subjected to molecular docking with blood-absorbed components of the extract to screen core active ingredients. Results Serum liver function tests found that the activities of ALT and AST were significantly reduced in the medium-dose group of Scabiosa comosa ethanolic extract compared with the model group, with statistically significant differences (P<0.05). Pathological staining suggested that hepatic pathological damage was markedly mitigated in both low- and medium-dose extract groups. KEGG pathway enrichment and GO functional enrichment analyses of target gene sets from the transcriptome data revealed significant enrichment in biological processes and signaling pathways related to immune response. RT-qPCR results indicated that the expression levels of vascular cell adhesion molecule 1 (Vcam1), C-C motif chemokine ligand 2 (Ccl2) and androgen receptor (Ar) were significantly different between the model group and the medium-dose extract group (P<0.05). Molecular docking results showed favorable binding affinities between Vcam1 and luteolin, Ccl2 and isochlorogenic acid A, as well as Ar and chlorogenic acid, with binding energies all lower than -6 kcal·mol-1. Conclusion The active components in the ethanolic extract of Scabiosa comosa, including luteolin, isochlorogenic acid A and chlorogenic acid, could alleviate inflammatory response and ameliorate acute drug-induced liver injury by regulating downstream molecules (Vcam1, Ccl2) involved in the TNF signaling pathway. Reference | Supplementary Material | 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 （639）      PDF（pc） （1193KB）（171）       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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Comparison and Evaluation of Hepatotoxicity of Different Processed Samples of Paris polyphylla Based on a Zebrafish Model YU Weijie, LIU Yuxin, LIN Ruichao, LI Xiangri, ZHAO Chongjun Chinese Journal of Pharmacovigilance    2026, 23 (4): 390-397.   DOI: 10.19803/j.1672-8629.20250828 Abstract （586）      PDF（pc） （2256KB）（241）       Knowledge map    Save Objective To investigate the differences in hepatotoxicity between diverse prepared samples of Paris polyphylla in a zebrafish system and confirm the role of PolyphyllinⅠ(PPⅠ) in the overall hepatotoxicity of the herb so as to provide data for elucidating the toxic material basis of PPⅠ and its safe applications. Methods Methanol was used to extract Paris polyphylla medicinal materials while crude total saponins were obtained via n-Butanol extraction. More separation by column chromatography yielded the Paris extract without PolyphyllinⅠ(PE-PPⅠ). On this basis, a zebrafish model was used to evaluate the toxicity of different samples, involving the determination of lethal concentration 10% (LC10), observation of histopathological sections of livers, Nile Red staining, acridine orange staining, and fluorescence morphological analysis of livers. Meanwhile, the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were detected. Real-time quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of such genes as apoa2, cyp7a1, cyp27a1, hmgcs1, fabp4 and cd36. Results At specific mass concentrations, the methanol extract (ME), n-Butanol extract (NBE), and PE-PPⅠ of Paris polyphylla all induced liver injury in zebrafish, but there were significant differences in toxicity and pathology. In the high- and low-dose NBE groups, toxicity was relatively strong, characterized by extensive liver tissue damage that was accompanied by obvious hepatocyte apoptosis, compensatory enlargement of the liver size, and significant lipid metabolism disorders. In the ME group, focal hepatocyte damage with moderate lipid accumulation was observed. In the PE-PPⅠ group, only mild liver lesions occurred. RT-qPCR results indicated that the expression levels of core genes related to lipoprotein metabolism were significantly upregulated, the rate-limiting enzyme genes for bile acid synthesis were inhibited, the regulatory genes for cholesterol synthesis were upregulated, and that the key factors for fat transport trended upward. Conclusion PolyphyllinⅠ is one of the key active components responsible for the hepatotoxicity of Paris polyphylla, which may interfere with lipid metabolism pathways, leading to liver lipid accumulation, hepatocyte apoptosis, and structural damage to liver tissues. 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 （579）      PDF（pc） （1403KB）（250）       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）

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Global Trends and China’s Practices Related to Medical Device Vigilance Systems SONG Yana, ZHAO Yan, LI Dong, ZHAO Yifei, ZHENG Lijia, ZHI Rui, DENG Gang Chinese Journal of Pharmacovigilance    2026, 23 (3): 290-295.   DOI: 10.19803/j.1672-8629.20250930 Abstract （563）      PDF（pc） （1237KB）（949）       Knowledge map    Save Objective To analyze the developments of the medical device vigilance system so as to provide a reference and guidance for the establishment of such a system in China. Methods The developments of the medical device industry, post-market supervision of medical devices in developed countries, and the evolution of pharmacovigilance in China were traced. On this basis, the need to establish a vigilance system of medical devices in China was elaborated in combination with the progress in our pilot programs concerning adverse event monitoring and vigilance in medical device. Results and Conclusion Medical device vigilance is critical to risk management throughout the lifecycle of medical devices. Amid such vigilance, efforts should be made to accelerate the transition from oversight of adverse events to medical device vigilance, establish a new framework for related vigilance, and enforce proactive risk monitoring, precise analysis, and effective management of medical device products, which will boost product innovation and industrial upgrading. Reference | Related Articles | Metrics | Comments（0）

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Construction of an Indicator System for Evaluating Safety of Pediatric Medication LUO Qiang, DENG Bin, XIONG Huiyu, WANG Chunting, HUANG Yan, LIU Zuoren Chinese Journal of Pharmacovigilance    2026, 23 (3): 285-289.   DOI: 10.19803/j.1672-8629.20250768 Abstract （555）      PDF（pc） （1461KB）（1111）       Knowledge map    Save Objective To construct an indicator system for evaluating the safety of pediatric medication in order to contribute to children’s health. Methods A tentative framework was established via literature review and brainstorming. The Delphi method was used to analyze, screen, and refine the indicators. The Analytic Hierarchy Process (AHP) was applied to determine the weight of each indicator before the indicator system for evaluation of safety of pediatric medication was established. Results The final system comprised 3 first-level indicators, 10 second-level indicators, and 37 third-level indicators, with corresponding weights assigned to each indicator. Conclusion The significant weight of “inherent medication risks” underscores that the risk to pediatric medication lies in the drug itself. It is recommended that risks be managed throughout medication, pre-market research upgraded, and post-market surveillance enhanced. The constructed indicator system is well-grounded and can serve as a reference for evaluating the safety of pediatric medication. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）