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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 （1323）      PDF（pc） （1259KB）（2922）       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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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 （857）      PDF（pc） （2553KB）（692）       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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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 （814）      PDF（pc） （1478KB）（1288）       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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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 （792）      PDF（pc） （1207KB）（838）       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 Progress in Uric Acid-Lowering Drugs YAN Caiying, QIN Linying, XU Yaoqing, WANG Xinge, CHAI Nannan, CHEN Long Chinese Journal of Pharmacovigilance    2025, 22 (5): 592-595.   DOI: 10.19803/j.1672-8629.20240857 Abstract （629）      PDF（pc） （1222KB）（193）       Knowledge map    Save Objective To explore the research progress in uric acid-lowering drugs so as to provide a reference for their clinical applications. Methods By accessing the official websites of the National Medical Products Administration, China National Knowledge Infrastructure (CNKI), Wanfang Database and PubMed, information was collected on the safety of uric acid-lowering drugs, including urate transporter 1 (URAT1) inhibitors, xanthine oxidase (XO) inhibitors and exogenous uricase, which were used in the treatment of chronic gout between April 1, 2014, and September 1, 2024. In addition, the key information on 27 uric acid-lowering drugs currently under development was analyzed using the Cortellis platform. Results The adverse reactions of URAT1 inhibitors mostly involved the digestive system, manifested as liver function abnormalities. The adverse reactions caused by XO inhibitors and exogenous uric acid oxidases primarily manifested themselves as skin and mucous membrane damage and blood system damage, such as immunogenic reactions and serious cardiovascular events. The targets of action for most of the currently-developed anti-gout drugs were URAT1 inhibitors, which increased the excretion of uric acid while reducing the incidence of gout. Conclusion Although three types of drugs are usually used for the treatment of chronic gout, the potential adverse reactions remain a concern. Future research and development of anti-gout drugs should focus on dual-target or new-target drugs with unique advantages in order to offer more options for the clinical treatment of patients. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress in Antiviral Targets and Active Ingredients of Traditional Chinese Medicine CUI Mengyao, LI Shuran, XIE Dan, YANG Xiaowei, LIU Xian, CUI Xiaolan, GENG Zihan, GUO Shanshan Chinese Journal of Pharmacovigilance    2025, 22 (5): 481-487.   DOI: 10.19803/j.1672-8629.20250099 Abstract （568）      PDF（pc） （1366KB）（194）       Knowledge map    Save Objective To elucidate the mechanisms of traditional Chinese medicine(TCM) that are characterized by multi-component, multi-target, and multi-pathway interactions, and identify bioactive components with antiviral, anti-inflammatory, and immunomodulatory properties in order to provide references for developing efficient and low-toxicity TCM formulations. Methods Modern techniques, including network pharmacology, molecular docking, high-throughput drug screening, integrative pharmacology, and structural biology, were reviewed to explore their applications in antiviral research on TCM. The binding capacity of TCM components to viral proteins and host targets, potential active ingredients in TCM formulations, and molecular pathways regulated by targets were summarized. Results TCM compounds such as flavonoids, alkaloids, glycosides, polysaccharides, and organic acids exhibited antiviral effects by directly targeting viral invasion/replication-related proteins or modulating host targets involved in immune responses and inflammatory pathways. Conclusion TCM can not only directly inhibit viral proliferation and kill viruses, but also suppress excessive immune reactions post-infection. Additionally, it enhances immunity through immunoregulation, offering indirect antiviral benefits. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress in Triptolide-Induced Live Injury TANG Qianhui, ZHANG Haoran, ZHANG Luyong, JIANG Zhenzhou Chinese Journal of Pharmacovigilance    2025, 22 (2): 121-127.   DOI: 10.19803/j.1672-8629.20230658 Abstract （565）      PDF（pc） （1355KB）（639）       Knowledge map    Save Objective To summarize the research progress in the hepatotoxicity mechanism of triptolide and shed light on the mechanism of drug-induced liver injury caused by triptolide. Methods Based on literature research, the mechanism of drug induced liver injury caused by triptolide was summarized in terms of direct toxicity and indirect toxicity. Results The hepatotoxic mechanism of triptolide involved oxidative stress, mitochondrial damage, metabolic abnormalities, activation of NKT cells, imbalance between T helper cells and regulatory T cells, and increased liver sensitivity to inflammatory stimuli. Conclusion The hepatotoxicity mechanism of triptolide is complex, as there are a wide range of targets for direct toxicity. In addition, the indirect toxicity is highly concealed and complex. The elucidation of mechanisms of hepatotoxicity caused by triptolide provides a reference for enhancing the efficacy and reducing the toxicity of Tripterygium wilfordii Hook.f. and its preparations as well as for clinical safety and rational drug use. Reference | Related Articles | Metrics | Comments（0）

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Key Technologies for Quality Control of Oligonucleotide Drugs LIU Bo, YUAN Yanan, WANG Yue, CHENG Shuqian, LU Zhiguo, FAN Huihong, SUN Huimin Chinese Journal of Pharmacovigilance    2025, 22 (1): 1-9.   DOI: 10.19803/j.1672-8629.20240806 Abstract （534）      PDF（pc） （2006KB）（630）       Knowledge map    Save Objective To review the basic data and quality control methods of oligonucleotide drugs in order to provide a reference for quality control of oligonucleotide drugs. Methods By searching related literature and databases at home and abroad, the methods of analysis of related substances, structural characterization, and quantification of oligonucleotides were summarized. Results There were three types of oligonucleotide drugs that had been listed: antisense oligonucleotide, small interfering RNA, and aptamer. Their domestic quality control guidelines mainly referred to foreign guidelines. Ion-pair reverse phase chromatography, ion exchange chromatography, and mass spectrometry were commonly used for quality control of oligonucleotide drugs. Other analysis techniques had their own advantages. Conclusion Significant progress has been made in quality control of oligonucleotide drugs. However, China lacks specific guidelines. Furthermore, there are several problems with the current oligonucleotide drug analysis techniques. To offer strong technical support for quality control of oligonucleotide drugs, research and the development of novel techniques are required. Reference | Related Articles | Metrics | Comments（0）

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Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines ZHU Lan, SHAO Bo, ZHU Yan, DAI Jie, ZHONG Shiqi Chinese Journal of Pharmacovigilance    2025, 22 (2): 188-192.   DOI: 10.19803/j.1672-8629.20240621 Abstract （528）      PDF（pc） （1297KB）（1316）       Knowledge map    Save Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines. Methods To analyze the guidelines and requirements for the updating of information on adverse reactions, contraindications, precautions and warnings information in the labels of Chinese traditional patent medicines, and to make suggestions based on working experience. Results For some historical reasons, safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines. Conclusion Revision of labeling and updating of safety information is one of the risk management measures, after solving the problem of missing safety information, there is still a need for continuous monitoring of adverse reactions, post-marketing research to identify drug risks, and to control the risks by revising labels and other measures. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (3): 0-0.   Abstract （479）      PDF（pc） （501KB）（180）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Patent Medicines for Preventing Myelosuppression in Adjuvant Treatment of Malignant Tumors: a Systematic Review and Network Meta-Analysis WANG Han, WANG Cunxuan, LYU Xuehaiyue, ZHANG Lining, SUO Yusi, GU Zhi'en, WANG Ping, JIN Xuejing Chinese Journal of Pharmacovigilance    2025, 22 (2): 169-176.   DOI: 10.19803/j.1672-8629.20240803 Abstract （470）      PDF（pc） （1515KB）（627）       Knowledge map    Save Objective To conduct a network Meta-analysis of eight Chinese patent medicines (CPMs) that are commonly used in clinical practice, have a large market share, and are relatively affordable for patients in order to assess their protective effects against myelosuppression in adjuvant radiotherapy and chemotherapy for malignant tumors. Methods CNKI, Wanfang Database, Chinese Science and Technology Journal Database, SinoMed, Cochrane Library, PubMed, and Embase were searched for related literature published from inception to April 9, 2024. Randomized controlled trials (RCTs) in which CPMs were used to prevent myelosuppression during radiotherapy in patients with solid tumors were enrolled. Two researchers independently screened the literature, retrieved the data, and evaluated the quality of the literature using the risk of bias assessment tool. Stata software was used for network Meta-analysis. Results The number of RCTs included was 48 involving a total of 4 204 patients and eight CPMs, namely, Diyu Shengbai tablets, Qijiao Shengbai capsules, compound E Jiao Jiang, compound Zaofan pills, Zhenqi Fuzheng granules (capsule and punch), Shengxuebao mixture, Shenqi Shiyiwei granules and Shiyiwei Shenqi capsules. The results showed that Diyu Shengbai tablets, Qijiao Shengbai capsules, and Fufang Zaofan pills could reduce the incidence of myelosuppression while compound E Jiao Jiang, Diyu Shengbai tablets, and Zhenqi Fuzheng granules could reduce the incidence of leukopenia. Conclusion CPMs of the “buqi shengxue” category can reduce the incidence of myelosuppression and leukopenia during adjuvant treatment of malignant tumors, among which Shenqi Shiyiwei granules, Zhenqi Fuzheng granules (capsule and punch), and compound E Jiao Jiang have the better protective effect against myelosuppression. Reference | Related Articles | Metrics | Comments（0）

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Research Progress in the Treatment of Advanced Non-Small Cell Lung Cancer with Aumonertinib YANG Shengxi, XU Juntong, TU Wenlian Chinese Journal of Pharmacovigilance    2025, 22 (2): 235-240.   DOI: 10.19803/j.1672-8629.20240491 Abstract （456）      PDF（pc） （1290KB）（506）       Knowledge map    Save Objective To investigate the clinical efficacy of aumonertinib as the third representative epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKIs) in patients with advanced epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). Methods The clinical efficacy of aumonertinib against advanced NSCLC with classical EGFR mutation, advanced NSCLC with T790M drug-resistant mutation, and advanced NSCLC with rare EGFR mutation as well as the research progress in combined treatment with aumonertinib to delay the occurrence of drug resistance were reviewed. Results In real-world studies, aumonertinib extended the median progression-free survival (mPFS) to 20 months in NSCLC patients with classical EGFR mutations and to 15 months in NSCLC patients with T790M resistance mutations. Aumonertinib also showed good efficacy in NSCLC patients with rare mutations. The combination therapy with aumonertinib could effectively slow down the occurrence of drug resistance. Conclusion Aumonertinib has a marked clinical effect on patients with advanced NSCLC, which can effectively improve the survival time and prognosis of patients. Reference | Related Articles | Metrics | Comments（0）

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Considerations for Revision of Safety Information in the Post-Marketing Instructions of Chemical Drugs WANG Chunting, CHEN Yafei Chinese Journal of Pharmacovigilance    2025, 22 (7): 776-779.   DOI: 10.19803/j.1672-8629.20250211 Abstract （448）      PDF（pc） （574KB）（455）       Knowledge map    Save Objective To lay out the considerations for post-marketing revision of safety information in the instructions of chemical drugs, and provide a reference for drug marketing authorization holders and regulatory agencies. Methods Based on experiences related to revision of safety information in package inserts for chemical drugs, the priorities for collecting and analyzing safety information in package inserts were described, and the key points for writing the revised information related to warnings, adverse reactions, contraindications and precautions were summarized. Results and Conclusion Safety information needs to be revised all the time to dynamically reflect the risk-benefit balance of chemical drugs. Regulatory agencies should specify the working procedures and key points of the post-marketing revision of package inserts for chemical drugs while marketing authorization holders should promptly and proactively fulfill their responsibility of revising the safety information in drug instructions after marketing to ensure the safety of drugs. Reference | Related Articles | Metrics | Comments（0）

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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 （441）      PDF（pc） （1267KB）（420）       Knowledge map    Save Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (2): 0-0.   Abstract （430）      PDF（pc） （480KB）（484）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database ZHONG Ling, ZENG Huiyan, YUAN Xin, WANG Yingyan Chinese Journal of Pharmacovigilance    2025, 22 (3): 305-312.   DOI: 10.19803/j.1672-8629.20240753 Abstract （409）      PDF（pc） （1399KB）（626）       Knowledge map    Save Objective To mine and compare signals of post-marketing adverse events of liraglutide and semaglutide in order to provide references for safe and rational use. Methods Data on adverse events reported by the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2010 and March 31, 2024 was mined using the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, information component (IC) method, and the muti-item gamma poisson shrinker (MGPS) method. Positive signals and tumor related signals were screened out and compared. Results 175 positive signals related to liraglutide were mined, involving 20 systems organs class (SOC), compared with 231 for semaglutide, involving 21 SOC. The adverse events manifested themselves as gastrointestinal disorders, metabolism and nutrition disorders. In terms of tumors, thyroid and pancreatic related tumors were dominating and onset of symptoms in most of the cases was after 360 days. Liraglutide was more significantly correlated with such adverse events as thyroid tumors, pancreatic tumors, and pancreatitis while semaglutide was likely to cause adverse events related to eyes and the skin. Conclusion Liraglutide and semaglutide can cause similar adverse drug reactions, so clinicians are advised to opt for personalized medications while warnings about the possibility of pancreatic tumors should be given in related instructions. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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One Case of Thrombocytopenia and Leukopenia Induced by Teicolanin and Rebabapide KOU Jiejian, WANG Yangai Chinese Journal of Pharmacovigilance    2025, 22 (2): 227-230.   DOI: 10.19803/j.1672-8629.20240455 Abstract （405）      PDF（pc） （1245KB）（389）       Knowledge map    Save Objective To investigate the clinical characteristics and possible mechanism of thrombocytopenia and leukopenia induced by teicoplanin and rebamipide and provide a reference for safe clinical use. Methods One case of thrombocytopenia and leukopenia induced by teicoplanin and rebamipide was reported. Based on related literature, the mechanism of adverse reactions was analyzed. Results The patient experienced thrombocytopenia and leukopenia after using teicoplanin and rabamipide for 2 days respectively. Clinical pharmacists traced the patient's medications and consulted the drug instructions and related literature before they concluded that thrombocytopenia was related to teicolanin, and leukopenia to rebabapide. Therefore, they recommended that these two drugs be discontinued. Eight days and four days after discontinuation of teicoplanin and rebamipide, respecvtively, platelet transfusion was given and the platelet and white blood cell counts gradually returned to normal. Conclusion Clinicians are to be alert to the risk of such adverse reactions as thrombocytopenia and leukopenia caused by teicoplanin and rebamipide. In case of adverse reactions, related drugs should be discontinued promptly and symptomatic treatment should be given to ensure safe medication. Reference | Related Articles | Metrics | Comments（0）

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Advancements in Treatment of Brucellosis with Traditional Chinese Medicine LIANG Xiao, LI Li, XU Xiaolong, BAI Yinglu, YANG Yumei, ZHU Yong, LIU Qingquan Chinese Journal of Pharmacovigilance    2025, 22 (2): 231-234.   DOI: 10.19803/j.1672-8629.20240905 Abstract （398）      PDF（pc） （1346KB）（619）       Knowledge map    Save Objective To seek safer and more effective treatment options against brucellosis, which is an infectious zoonotic disease involving multiple organs and systems. Methods Literature related to the treatment of brucellosis with Traditional Chinese Medicine (TCM) in recent years was reviewed. Based on four diagnostic systems - etiological differentiation, six-meridian syndrome differentiation of treatise on febrile diseases, eight-line syndrome differentiation, and wei-qi-ying-xue differentiation, the medications and formula composition for brucellosis were categorized. Results and Conclusion The treatment of brucellosis is divided into acute and chronic phases, with medications involving the six-meridian syndrome differentiation and the wei-qi-ying-xue differentiation. TCM has shown good clinical effects. This study is expected to provide a reference for future research on and clinical medications for brucellosis with TCM. Reference | Related Articles | Metrics | Comments（0）

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Retrospective Analysis of 763 Cases of Drug Eruptions CHENG Weineng, PAN Qiuna, YANG Jing, FENG Qiang, TANG Xiaomeng, LIANG Yue Chinese Journal of Pharmacovigilance    2025, 22 (1): 104-108.   DOI: 10.19803/j.1672-8629.20240320 Abstract （394）      PDF（pc） （1276KB）（295）       Knowledge map    Save Objective To analyze the incidence and clinical manifestations of drug eruptions and to provide a reference for safe clinical use of drugs. Methods The 763 cases of drug eruptions reported to the Adverse Drug Reaction Monitoring System by the hospital between 2019 and 2023 were analyzed in terms of the patients' gender, age, routes of administration, types of drugs, severity and treatments, respectively. Results There were 763 cases of drug eruptions, including 342 males (44.82%) and 421 females (55.18%). Suspected sensitizing medications involved antimicrobial agents in 310 cases, contrast agents in 160 cases, antitumor medications in 54 cases, Chinese patent medications in 47 cases, endocrine medications in 47 cases, and digestive system medications in 33 cases. The chief culprits among antibiotics were β-lactam antibiotics and quinolones. After the onset of drug eruptions, the suspected sensitizing medications were discontinued in 729 cases but continued in 34 cases. Among the 268 patients with drug eruptions who did not receive symptomatic treatment, the interval from occurrence to improvement for severe and mild drug eruptions was (1.93±1.22) days and (1.71±1.35) days, respectively. Four hundred and ninety-five cases received medications, involving antihistamines, glucocorticoids, calcium gluconate and glycerite lotion. Among them, loratadine was primarily used as the antihistamine, and dexamethasone was as the hormone drug. The time from occurrence to improvement of severe and mild drug eruptions was (2.40 ± 2.36) days and (1.80 ± 1.41) days, respectively. Among the symptomatically treated patients, 301 were treated with monotherapy alone, while 194 were treated with combination therapy. Conclusion There are differences in the incidence and severity of drug eruptions between different types of drugs. The decision to discontinue the drug and symptomatic management can be made according to the severity of drug eruptions. Monotherapy is the first option for the treatment of mild drug eruptions, and combination therapy can be determined based on changes in the patient's conditions. Reference | Related Articles | Metrics | Comments（0）

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Adverse Reactions to Antihypertensive and Hypoglycaemic Drugs Based on Spontaneous Presentation Systems LIAO Mengfan, ZHONG Liling, XU Yan, LIU Ying, ZHANG Yexiang, CHEN Qingsong, LIU Xudong Chinese Journal of Pharmacovigilance    2025, 22 (3): 286-291.   DOI: 10.19803/j.1672-8629.20240675 Abstract （392）      PDF（pc） （1404KB）（314）       Knowledge map    Save Objective To analyze the reports of adverse drug reactions(ADR) caused by antihypertensive and hypoglycemic drugs so as to provide a reference for rational clinical use of drugs. Methods The ADR reports related to commonly-used antihypertensive and hypoglycemic drugs collected by the Guangdong ADR self-reporting system between September 1, 2020 and August 31, 2022 were analyzed, and the influential factors for the occurrence of severe ADR were identified. Results A total of 6 113 ADR reports involving 9 207 clinical cases were included. Females and middle-aged and elderly patients accounted for a large proportion. Mild ADR and severe ones accounted for 90.22% and 9.78% respectively. In addition, there were 844 new ADR (13.81%). ADR mostly involved the gastrointestinal system and the skin and its accessories or were systemic, with calcium channel blocker drugs and biguanides as the leading cause. ADR caused by different drugs varied. Most of these ADR occurred 2 to 7 days (29.45%) and 30 days (40.95%) after medication, and the majority of the patients improved (58.23%) or recovered (35.25%). Patients with two or more types of primary diseases, smoking history, and ADR induction time of over 7 days were at higher risk of severe ADR. Conclusion The ADR caused by commonly-used drugs for diabetes and hypertension vary, depending on age, gender, organs involved and types of drugs. It is recommended that clinicians take precautions, monitor and assess patients at critical time points after medication in order to detect potential ADR quickly to keep patients safe. Reference | Related Articles | Metrics | Comments（0）