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Progress in Clinical and Pharmacological Research of Angong Niuhuang Pills BAI Xue, CHEN Yafei, TANG Tian, LIU Zhejun, WANG Guoyu, TAN Tianyang Chinese Journal of Pharmacovigilance    2025, 22 (3): 349-356.   DOI: 10.19803/j.1672-8629.20240592 Abstract （1508）      PDF（pc） （1259KB）（4912）       Knowledge map    Save Objective To evaluate the clinical efficacy of Angong Niuhuang pills in the past three years and explore their pharmacological mechanisms in order to provide a reference for subsequent research. Methods By analyzing the latest data on clinical research, the therapeutic effects of Angong Niuhuang pills against such diseases as cerebral hemorrhage, cerebral infarction, craniocerebral injury, heatstroke, sepsis, viral encephalitis and pneumonia were summerized. Additionally, current pharmacological research was reviewed to analyze the mechanisms of action of Angong Niuhuang pills. Results The study found that Angong Niuhuang pills were highly effective in treating the aforementioned diseases. Pharmacological research suggested that they worked through multiple mechanisms, including anti-inflammation, antioxidation, anti-apoptosis, regulation of autophagy and mitochondrial dysfunction, inhibition of pyroptosis and ferroptosis, and regulation of metabolic products and gut microbiota. Conclusion This study has evaluated the clinical efficacy and pharmacological mechanism of Angong Niuhuang pills in the treatment of various diseases and confirmed their therapeutic effect and multi-target characteristics, providing data for subsequent research and clinical applications. Reference | Related Articles | Metrics | Comments（0）

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Risk Signal Mining and Experimental Observations of Febuxostat Cardiotoxicity WANG Xue, DING Xueli, LU Chengjin, CHEN Siying, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian Chinese Journal of Pharmacovigilance    2024, 21 (11): 1201-1208.   DOI: 10.19803/j.1672-8629.20240393 Abstract （1498）      PDF（pc） （2112KB）（446）       Knowledge map    Save Objective To evaluate the US spontaneous reporting system of cardiac adverse events of febuxostat, analyze the risks and provide data for safe use of uric acid-lowering drugs. Methods Based on the FAERS database reports of cardiac adverse events of febuxostat from Q1 2004 to Q3 2021, the risk signals were evaluated. In a rat model of hyperuricemia, high dose (7.2 mg·kg-1) and low dose (3.6 mg·kg-1) groups of febuxostat were set up to observe the uric acid level, related cardiac indexes and histopathology in biochemical tests. Results A total of 5 001 adverse reaction reports and 15 989 adverse reactions were retrieved from the FAERS database for febuxostat, and 992 of the adverse reactions with cardiac relevance had 18 cardiac risk signals. Febuxostat cardiotoxicity was more common in males and usually occurred among those over 65. In animal experiments, a significant reduction in uric acid levels was observed in rats administered with febuxostat in a hyperuricemic state, indicating a good uric acid-lowering effect. Such cardiac indicators as AST, CK and cTn-I increased, while LDH and CK-MB levels decreased. MASSON staining showed that the febuxostat groups appeared to have different degrees of fibrosis, with pronounced blue collagen deposition. Conclusion In the clinical use of febuxostat for the treatment of hyperuricemia, cardiac risks ought to be considered to ensure rational use of febuxostat in different clinical populations. Reference | Related Articles | Metrics | Comments（0）

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Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei Chinese Journal of Pharmacovigilance    2024, 21 (11): 1280-1283.   DOI: 10.19803/j.1672-8629.20240471 Abstract （1104）      PDF（pc） （1223KB）（1020）       Knowledge map    Save Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China. Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV) jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted. Results READUS-PV included 14 items concerning the title, introduction, methods, results, discussion, declaration and abstracts. Conclusion In actual drug safety signal detection research, READUS-PV can be consulted to improve research quality. Reference | Related Articles | Metrics | Comments（0）

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Traditional Chinese medicine for prevention and treatment of adriamycin cardiotoxicity and an empirical study of evidence elements LIU Yadi, ZHANG Xiaomeng, CAI Haili, CHEN Siying, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (7): 759-764.   DOI: 10.19803/j.1672-8629.20240294 Abstract （1086）      PDF（pc） （1666KB）（308）       Knowledge map    Save Objective To validify the evidence of adriamycin cardiotoxicity via animal experiments based on the analysis of TCM medications used for the prevention and treatment of adriamycin cardiotoxicity in order to provide data for related treatment. Methods Literature related to the prevention and treatment of anthracycline cardiotoxicity with TCM and published between the inception to March 1st, 2024 was searched for from some databases to analyze the pattern of medications and to establish a rat model of anthracycline cardiotoxicity via injection with doxorubicin at 3.5 mg•kg-1. Results A total of 104 Chinese herbal medicines, such as Astragalus, Glycyrrhiza glabra, Maitong, Ginseng, Radix et Rhizoma Ginseng, Radix et Rhizoma Ginseng, and Salviae Miltiorrhizae, were included. The efficacy of these drugs was determined as tonifying deficiency, activating blood circulation, removing blood stasis, clearing heat, eliminating phlegm, and expelling dampness. Anthracycline cardiotoxic rats showed dirty fur, hair loss, loose stools, stasis of blood, depression, lethargy, decrease in anal temperatures, and dark tongue color. The serum contents of antidiuretic hormone, aldosterone, and antithrombin Ⅲ were significantly decreased while the content of D-dimer was significantly increased. Conclusion The development of drugs for prevention and treatment of anthracycline cardiotoxicity should involve tonifying the deficiency, stimulating blood circulation, eliminating stasis, expelling dampness and resolving turbidity. Reference | Related Articles | Metrics | Comments（0）

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Methods for signal management using the global safety database VigiBase HJELMSTRÖM Peter, BOWRING Geoffrey, YUE Qun-Ying, NORÉN G. Niklas Chinese Journal of Pharmacovigilance    2024, 21 (7): 836-840.   DOI: 10.19803/j.1672-8629.20240373 Abstract （1080）      PDF（pc） （1584KB）（732）       Knowledge map    Save The WHO database of adverse event reports for medicines and vaccines, VigiBase, has been developed and maintained by UMC since 1978. VigiBase now holds over 39 million anonymised reports of suspected adverse effects of medicines and vaccines suffered by patients (as of June 2024). To support of members of the WHO Programme for International Drug Monitoring (WHO PIDM) in developing, implementing, and strengthening safety surveillance programmes, UMC has developed several systems, tools and methods to facilitate the use of VigiBase. This paper describes six such vigi Methods; vigiGrade, vigiMatch, vigiRank, vigiPoint, vigiGroup, vigiVec. VigiBase depends on unsolicited reporting of adverse drug effects and, regretfully, underreporting of adverse drug effects continues to be a major issue. Artificial intelligence methods for augmentation to increase efficiency, quality, and capability of case processing in the large databases such as VigiBase are evolving to meet the higher demands to manage the increasing volume of safety data. Continued development of existing and new methods to translate the information in the reports in VigiBase and other databases into valuable knowledge will be paramount for safer use of medicines and vaccines for patients in all countries globally. Reference | Related Articles | Metrics | Comments（0）

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Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health WANG Tao, SONG Haibo, WANG Qing, HOU Yongfang, LIU Hongliang, ZHANG Lin Chinese Journal of Pharmacovigilance    2024, 21 (8): 906-909.   DOI: 10.19803/j.1672-8629.20230518 Abstract （1054）      PDF（pc） （1244KB）（602）       Knowledge map    Save Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics. 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 （1052）      PDF（pc） （1785KB）（554）       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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Systematic Evaluation of Cardiotoxicity of Chinese Herbal Compounds for Breast Cancer Chemotherapy LIU Shujia, ZHANG Xiaomeng, CHEN Siying, CAI Haili, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (11): 1209-1215.   DOI: 10.19803/j.1672-8629.20240449 Abstract （1028）      PDF（pc） （2979KB）（285）       Knowledge map    Save Objective To evaluate the applicability and therapeutic effect of Chinese herbal compounds in preventing and treating chemotherapy-induced cardiotoxicity in breast cancer patients. Methods Data on randomized controlled trials (RCTs) of Chinese herbal compounds for chemotherapy-induced cardiotoxicity in breast cancer patients published in domestic and foreign databases was collected and sortde from establishment of the tibrary to April 1, 2024. Excel sheet was used to analyze the related medications while RevMan 5.4 software was adopted to perform Meta-analysis on RCTs that met the inclusion criteria. Results A total of 42 RCTs were included, involving 2 847 subjects. The experimental group was treated with Chinese herbal compounds plus conventional chemotherapy to combat chemotherapy-induced cardiotoxicity. Compared with the control group treated with chemotherapy drugs alone, the incidence of abnormal electrocardiograms was significantly reduced in the experimental group OR=0.23[95%CI (0.19, 0.28), P<0.000 01]. In addition, the left ventricular ejection fraction was increased with an MD of 9.02[95%CI (6.45, 11.60), P=0.000 1], but the expressions of creatine kinase isoenzyme and troponin I were reduced. Conclusion Chinese herbal compounds capable of replenishing qi and nourishing yin, promoting blood circulation and unblocking meridians have prominent advantages in preventing and treating the cardiotoxicity induced by chemotherapy drugs. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress of Epimedium in the Treatment of Male Infertility TANG Tian, TAN Tianyang, LIU Zhejun, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (11): 1238-1242.   DOI: 10.19803/j.1672-8629.20240638 Abstract （1000）      PDF（pc） （1246KB）（1023）       Knowledge map    Save Objective To assess the potential of Epimedium and its active components in the treatment of male infertility and to explore their prospects in traditional Chinese medicine therapy. Methods A systematic literature review was conducted to analyze the significant effects of Epimedium and its main active components on improving spermatogenesis, protecting the testicular microenvironment, regulating sex hormone levels, combating oxidative stress, and alleviating sexual dysfunction. Results Epimedium demonstrated the potential to protect germ cells by modulating key signaling pathways and improving apoptosis, and it also showed positive effects in improving sexual dysfunction. Conclusion The active components of Epimedium have significant potential in the treatment of male infertility. Future research should further verify their clinical efficacy to promote their application in the field of male reproductive health. Reference | Related Articles | Metrics | Comments（0）

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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 （985）      PDF（pc） （2253KB）（247）       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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Cardiotoxicity of Euodia rutaecarpa(Juss.) Benth. Based on Network Pharmacology and Untargeted Metabolomics YIN Xiaoyang, ZHANG Xiaomeng, LIU Zeyu, LIU Yadi, WANG Yu, LIN Zhijian, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (11): 1216-1223.   DOI: 10.19803/j.1672-8629.20240472 Abstract （980）      PDF（pc） （2597KB）（284）       Knowledge map    Save Objective To explore the potential mechanisms of cardiotoxicity of Euodia rutaecarpa, a long-used traditional Chinese medicine, in order to contribute to clinical safety and risk prevention. Methods Network pharmacology was employed to analyze the target pathways of Euodia rutaecarpa that acted on the heart. In combination with untargeted metabolomics, the impact of Euodia rutaecarpa on cardiac metabolic pathways was investigated in order to find out about the potential mechanisms of cardiotoxicity. Results Network pharmacology identified 51 intersecting targets between Euodia rutaecarpa and cardiotoxicity, such as TNF, IL-6, IL-1β, TP53, and CASP3. These targets were involved in key signaling pathways such as the Advanced Glycation End Products-Receptor (AGE-RAGE) and Mitogen-Activated Protein Kinase (MAPK) pathways. Metabolomics analysis revealed metabolic pathways, including purine metabolism, biosynthesis of valine, leucine, and isoleucine, and the citric acid (TCA) cycle. The combination of network pharmacology and untargeted metabolomics suggested that the cardiotoxicity of Euodia rutaecarpa was related to myocardial energy metabolism, potentially via the disruption of the intracellular TCA cycle, purine metabolism, and protein synthesis and degradation. Conclusion The cardiotoxicity of Euodia rutaecarpa is closely related to its impact on myocardial energy metabolism and exhibits bidirectional effects on the heart. Clinicians should be cautious regarding dosage and symptoms while attaching importance to drug monitoring. Reference | Related Articles | Metrics | Comments（0）

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Progress in construction and evaluation of a drug-induced cardiotoxicity model CAI Haili, ZHANG Xiaomeng, LIU Yadi, LIU Shujia, GAO Fujun, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (7): 765-770.   DOI: 10.19803/j.1672-8629.20240345 Abstract （968）      PDF（pc） （2255KB）（332）       Knowledge map    Save Objective To find out about the establishment and applications of animal models for drug-induced cardiotoxicity, and to provide data for the prevention and treatment of drug-induced cardiotoxicity. Methods Literature research was conducted using “cardiotoxicity” as the key term. Related literature on applications of drug-induced cardiotoxicity models published since 2015 was selected from the CNKI and Web of Science Core Collection databases. Literature about experimental research on applications of animal models for drug-induced cardiotoxicity was screened based on the inclusion criteria. Analysis software Citespace 6.3 R1 (64-bit) Basic as well as Excel was used to visualize the selected literature. Results A total of 731 articles were included. The model animals used in studies of drug-induced cardiotoxicity were mostly rats, mice and zebrafish while the modeling agents were chiefly adriamycin, aconitine and bupivacaine. The toxicity mechanism involved oxidative stress and apoptosis. Most studies used such multi-category indicators as general indicators, histopathological indicators, and cardiac function test indicators for comprehensive evaluation. The applications were also relatively concentrated, and there were great differences in the criteria for evaluating drug-induced cardiotoxicity models. Conclusion Research on drug-induced cardiotoxicity models remains promising, which can facilitate systematic development of Traditional Chinese Medicine for the prevention and treatment of drug-induced cardiotoxicity. Reference | Related Articles | Metrics | Comments（0）

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Advancements in Treating Ischemic Stroke with Chinese Medicine Compounds Formulae LIU Wenjie, GAO Yuanyuan, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (12): 1382-1387.   DOI: 10.19803/j.1672-8629.20240654 Abstract （948）      PDF（pc） （1427KB）（470）       Knowledge map    Save Objective To examine findings related to the applications of TCM compound formulae in the management of ischemic stroke, and to offer data for subsequent clinical and experimental investigations. Methods By searching China Knowledge Network and PubMed for articles published from the inception to October 20, 2024, TCM compound formulae were summarized and evaluated. Results Clinical investigations indicated that TCM compound formulae, including Buyang Huanwu Tang, Xinglou Chengqi Tang, and Taohong Siwu Tang, exhibited substantial therapeutic efficacy in patients with ischemic stroke. Conclusion TCM compound formulae possess considerable benefits in the management of ischemic stroke. However, investigations are comparatively limited, and there is a lack of clinical studies and large-scale trials. Multi-sample and high-quality clinical studies are lacking. Reference | Related Articles | Metrics | Comments（0）

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Risk Analysis and Mechanism Discussion of Cardiovascular, Hepatic, or Nephrotoxicity Induced by Tripterygium Wilfordii CHEN Lijuan, ZHANG Xiaomeng, GAO Fujun, LIU Zeyu, WANG Yu, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (11): 1224-1231.   DOI: 10.19803/j.1672-8629.20240498 Abstract （933）      PDF（pc） （2212KB）（241）       Knowledge map    Save Objective To analyze the characteristics and potential mechanisms of adverse drug reactions/events (ADR/ADE) in the heart, liver, or kidney caused by Tripterygium wilfordii (Leigongteng), with the aim of providing reference for the rational use of medicine in clinical practice. Methods The ADR/ADE in the heart, liver, or kidneys caused by Leigongteng were collected retrospectively from the China National Knowledge Infrastructure (CNKI) from constrac tion to 1, Jan 2024. By using Apriori association analysis and decision tree CART algorithm, the influencing factors that caused by Leigonteng to the heart, liver, or kidneys damage were conducted. After collectting the compounds contained in Leigongteng and the action targets of the heart, liver, or kidneys based on the Traditional Chinese Medicine Systems Pharmacology Analysis Platform and GeneCards database, using network pharmacology to analyze the intrinsic mechanisms of Leigongteng’s multi-organ toxicity. Results A total of 50 cases ADR/ADE involved the heart, liver, or kidneys damage were collected, among which 20 cases involved two or more systems-organs. There was a strong correlation between the toxicity to the heart, liver, or kidneys and the dosage and duration of medication, and there was also a certain association with the patient’s original diseases. 51 compounds from Leigongteng and 153 effective action targets were screened out. Through the use of Venn diagrams, 987 common targets of toxicity to the heart, liver, and kidneys were identified. Protein-protein interaction network and Gene Ontology functional analysis revealed that TP53-mediated apoptosis, AKT1 and STAT3-mediated inflammatory responses may be associated with the multi-organ toxicity of Leigongteng to the heart, liver, and kidneys. Conclusion The multi-organ toxicity caused by Leigongteng has intrinsic correlations that require further in-depth research, and clinical prevention necessitates strict control over the dosage and duration of medication use. Reference | Related Articles | Metrics | Comments（0）

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A National Pharmacovigilance Management System in a New Era YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao Chinese Journal of Pharmacovigilance    2025, 22 (3): 276-281.   DOI: 10.19803/j.1672-8629.20240861 Abstract （926）      PDF（pc） （1478KB）（1472）       Knowledge map    Save Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry. Reference | Related Articles | Metrics | Comments（0）

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Identification of Druggable Targets for Intervertebral Disc Degeneration Based on Multi-Omics Data-Driven Mendelian Randomization and Prediction of Traditional Chinese Medicine Interventions GUO Dongqi, WANG Hao, BAI Xin, BAI Jianqi, SU Hongmei, ZHANG Jingru, GUO Xiaofei, ZHAO Xiaoqi, WANG Min, WANG Yuan, ZHANG Ping Chinese Journal of Pharmacovigilance    2025, 22 (3): 241-248.   DOI: 10.19803/j.1672-8629.20240899 Abstract （920）      PDF（pc） （2553KB）（729）       Knowledge map    Save Objective To identify druggable targets for the treatment of intervertebral disc degeneration (IDD), evaluate their safety, and to predict the traditional Chinese medicines (TCMs) that can regulate these druggable targets for IDD. Methods Data on expression quantitative trait loci of druggable genes was retrieved from the eQTLGen Consortium as exposures, while data on IDD genome-wide association study was downloaded from the GWAS Catalog to serve as outcomes for Mendelian randomization analysis intended to identify potential IDD therapeutic targets. Enrichment analyses were conducted on druggable genes related to IDD. The data on protein quantitative trait loci of druggable genes related to IDD was retrieved from the FinnGen database to validate the efficacy of these genes. A phenome-wide association study (PheWAS) via the PheWAS Portal was conducted to assess drug safety. The BATMAN-TCM 2.0 and ETCM 2.0 platforms were used to mine TCM components and analyze medication patterns. Potential lead compounds were identified through molecular docking of targets and TCM components on the CB-Dock 2 platform. Results 35 TCMs, including Corydalis yanhusuo W. T. Wang., Morinda officinalis How., and Artemisia argyi Lévl. et Vant., were found to treat IDD by regulating three druggable targets-ZP3, RRM2B, and CCL4, through their 20 active components. Gene expression MR indicated that 248 druggable genes were causally related to IDD, and enrichment analyses showed that these genes were associated with cytokine activities and cellular senescence. Protein MR validated six of these genes as druggable targets for IDD. PheWAS revealed no significant adverse effects associated with the aforementioned druggable targets. Molecular docking results showed good binding activity between the TCM components and the druggable targets, with the best binding energy of -10.2 kcal·mol-1. Conclusion Such genes as ZP3, RRM2B, and CCL4 are potential therapeutic targets for IDD with good safety profiles. TCMs like Morinda officinalis How., Corydalis yanhusuo W. T. Wang., and Artemisia argyi Lévl. et Vant. can treat IDD through these druggable targets, and their active components, such as Xanthosine, are potential compounds for new drug development. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Risk Signal Mining of Adverse Events Related to Levothyroxine Sodium Tablets Based on FAERS CHEN Chongze, ZHOU Tianyu, SUN Siman, GUO Shushu, JIN Hongtao Chinese Journal of Pharmacovigilance    2024, 21 (12): 1425-1431.   DOI: 10.19803/j.1672-8629.20240036 Abstract （892）      PDF（pc） （1426KB）（580）       Knowledge map    Save Objective To analyze the adverse drug events (ADE) caused by levothyroxine sodium tablets to provide a reference for rational and safe clinical use. Methods The U. S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) was searched to retrieve the ADE data on the primarily suspected drug collected from the first quarter of 2015 to the second quarter of 2023. The reporting odds ratio (ROR)、proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCNPP) and multi-item gamma poisson shrinker (MGPS) methods were used to screen for effective signals of ADEs of drugs. Results A total of 271 356 ADEs related to levothyroxine tablets as the primary suspect were reported. Most of the people involved were women (198 219, 73.05%) and the patients ranged from 18 to 85 in age (62.46%). A total of 5 991 adverse events of levothyroxine sodium tablets were mined, 3 371 signals were obtained after excluding non-drug adverse event signals, and 20 organ systems were found to be involved. Fatigue (22 511 items), nausea (17 591 items), diarrhea (16 400 items), headache (15 043 items) and dyspnea (12 866 items)were the top five ADEs reported.Analysis showed that neonatal gangrene (ROR=267.57, IC025=4.66), bronchiolithiasis (ROR=187.30, IC025=267.57), homophonic association (ROR=107.03, IC025=267.57), increased trans-triiodothyronine (ROR=89.19, IC025=4.42), and decreased free thyroxine indexes (ROR=80.27, IC025=4.38）were the top five ADEs in terms of intensities of signals. Based on secondary screening, the top three PTs related to the neonatal risk signal intensity were neonatal gangrene, neonatal intestinal dilation, and neonatal thyrotoxicosis. The top three PTs regarding the stone risk signal intensity were bronchial stones, cerebral stones, and staghorn stones. A total of 146 signals that were not recorded in the instructions were found, which were mostly manifested in various examinations, gastrointestinal system diseases, infections and invasive diseases, nervous system diseases, benign and malignant tumors of unknown nature. Conclusion Levothyroxine sodium tablets can potentially cause such ADRs as calculuses, infections and secondary tumors in patients with hypothyroidism. Clinical multidisciplinary follow-up is recommended for patients taking levothyroxine sodium tablets. Reference | Related Articles | Metrics | Comments（0）

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Regulation of cellular and gene therapies at home and abroad ZHAO Peipei, WEN Baoshu Chinese Journal of Pharmacovigilance    2024, 21 (9): 1019-1024.   DOI: 10.19803/j.1672-8629.20240160 Abstract （881）      PDF（pc） （1350KB）（744）       Knowledge map    Save Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry. Methods The ways in which cellular and gene therapy products were regulated in the US, Japan and Europe were compared by reviewing regulations and literature. The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development. Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States, Japan and Europe, China's regulatory system can be upgraded by means of innovative regulatory concepts, integration of review resources, more international exchanges and cooperation as well as intensified efforts. Reference | Related Articles | Metrics | Comments（0）

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Methods for Assessment of MAH Compliance with GVP LIU Ying, XIONG Shunyu, XIONG Huiyu, CAI Fei, XU Mengdan, WANG Qing, REN Wei, XU Yan Chinese Journal of Pharmacovigilance    2025, 22 (3): 282-285.   DOI: 10.19803/j.1672-8629.20240394 Abstract （878）      PDF（pc） （1207KB）（928）       Knowledge map    Save Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research on toxins, poisoning features and exploitation and utilization of Amanita CHEN Yuxin, LI Yao, GAO Haiyun, LI Hui, LIU Tianrui, YUAN Yuan Chinese Journal of Pharmacovigilance    2024, 21 (5): 496-501.   DOI: 10.19803/j.1672-8629.20240123 Abstract （878）      PDF（pc） （1410KB）（137）       Knowledge map    Save Objective To explore types of toxins, poisoning features and future utilization in the areas of medicine and biology, provide a new perspective for an objective understanding of Amanita safety, as well as references for further rational development and security applications of Amanita. Methods Based on the relevant literature in China and abroad, the present study of poisoning features, exploitation and utilization of toxins in Amanita were categorized, analyzed and summarized. Results Amanita mainly contains toxic components such as peptides, amino acids, and alkaloids, which are affected by the species, the application site and a variety of factors, resulting in a great difference in the composition and content. Main poisoning features of Amanita are gastrointestinal symptomsand acute liver and kidney injury. Meantime, these toxic components also have development and utilization value in the development of antibacterial, anti-tumor, anti-inflammatory and other drugs and play important roles in life science researches. Conclusion Amanita has important development value, toxic compositions types and mechanisms and safe dosages of Amanita are clarified to provide reference for the development and safe clinical utility. Reference | Related Articles | Metrics | Comments（0）