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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 （784）      PDF（pc） （1223KB）（784）       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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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 （640）      PDF（pc） （1350KB）（681）       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 （619）      PDF（pc） （1207KB）（623）       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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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 （592）      PDF（pc） （1244KB）（370）       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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Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data SUN Yixin, NIE Xiaolu, WANG Xiaoling, GUO Peng Chinese Journal of Pharmacovigilance    2024, 21 (8): 892-899.   DOI: 10.19803/j.1672-8629.20240376 Abstract （587）      PDF（pc） （1301KB）（545）       Knowledge map    Save Objective s To compare and analyze the active post-marketing safety surveillance practices based on real-world data (RWD) worldwide, in order to provide the reference for establishing an effective and feasible nationwide active surveillance system in China. Methods The literature on active surveillance systems around the world were searched and reviewed. The framework synthesis was used to determine the analytical framework, coding and mapping the information related to organizational structure, data characteristics, and operation mechanism. The similarities and differences of the active surveillance model were summarized. Results A total of 12 systems/organizations that conduct active surveillance based on RWD were included in this study, 9 of which are located in Europe and the United States, and in Asia. There are two Chinese systems, the China Hospital Pharmacovigilance System (CHPS) and the Adverse Drug Event Active Surveillance and Assessment System-Ⅱ (ADE-ASAS-Ⅱ). After integrating the information, the active monitoring model was summarized in six dimensions: (i) The organizational model was divided into three categories, including the government (with academia and pharmaceutical companies) led consortium, the direct government management, and the academic alliance consultation; (ii) The data integration and sharing model included the common data model, the common study protocol, and the centralized database; (iii) The data collection model could be divided into two forms: automatic collection from databases, and manual collection for target populations or specialized studies; (iv) The data management model included anonymizing, structuring and standardizing processes; (v) The data storage and transmission model can be categorized into the distributed data networks and the central database storage; (vi) Correspondingly, the data analysis model was divided into two categories: distributed computing and centralized analysis. Conclusion At present, the pattern of active surveillance for drug safety based on RWD are relatively mature in developed countries. While learning from those advanced experiences, we should also explore the active surveillance in line with the actual situation of China, to protect the medication safety of patients. Reference | 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 （582）      PDF（pc） （1426KB）（310）       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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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 （542）      PDF（pc） （1478KB）（789）       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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Chinese Journal of Pharmacovigilance    2024, 21 (12): 0-0.   Abstract （526）      PDF（pc） （443KB）（483）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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One case of severe constipation caused by dapagliflozin LU Jing, YU Shanshan, TONG Fei, LIN Zhuohui, SONG Luyao Chinese Journal of Pharmacovigilance    2024, 21 (9): 1071-1074.   DOI: 10.19803/j.1672-8629.20240167 Abstract （504）      PDF（pc） （1269KB）（327）       Knowledge map    Save Objective To remind health care professionals to be more alert to the risk of severe constipation associated with dapagliflozin and to provide reference for safe use of this drug. Methods The clinical process of treating a patient who developed severe constipation after taking dapagliflozin tablets was analyzed. Based on related literature, the possible mechanisms and treatment regimens of severe constipation caused by sodium-glucose cotransporter 2 inhibitors (SGLT-2i) were studied. Results One patient developed severe constipation after taking dapagliflozin. After discontinuation of the drug, the patient's constipation improved. However, upon re-administration of dapagliflozin, the patient relapsed into constipation. Immediately after drug withdrawal and treatment with laxatives to moisten the intestines, the patient's conditions improved. The causal relationship of adverse reactions was defined as “definite”, so the severe constipation of this patient was considered to have been caused by dapagliflozin. Conclusion Constipation poses a significant threat to patients' quality of life and may potentially precipitate cardiovascular events. Therefore, it is imperative to enhance clinicians' awareness and pharmacological surveillance regarding the adverse effects of constipation associated with dapagliflozin and SGLT-2i. Reference | Related Articles | Metrics | Comments（0）

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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 （499）      PDF（pc） （1259KB）（885）       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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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 （465）      PDF（pc） （1427KB）（419）       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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Chinese Journal of Pharmacovigilance    2025, 22 (3): 0-0.   Abstract （444）      PDF（pc） （501KB）（154）       Knowledge map    Save 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 （436）      PDF（pc） （2112KB）（377）       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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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 （426）      PDF（pc） （1355KB）（504）       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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Challenges to the current development of fixed-dose antitumor drug combinations JIANG Haiyan, ZHOU Tianyu, FAN Xiaoyu, LI Wanfang, BAO Jie, JIN Hongtao Chinese Journal of Pharmacovigilance    2024, 21 (9): 961-966.   DOI: 10.19803/j.1672-8629.20240274 Abstract （420）      PDF（pc） （1492KB）（595）       Knowledge map    Save Objective To summarize the characteristics of fixed-dose combinations in the development of antitumor drugs so as to provide references for the development of related combinations. Methods By searching for relevant literature from domestic and overseas databases, the marketed fixed-dose antitumor drug combinations and combination therapies approved by the US FDA in the past three years were analyzed. Results The marketed fixed-dose antitumor drug combinations could significantly improve the therapeutic effects of drugs, improve patient compliance and reduce drug toxicity through multi-target synergistic effects or by improving drug delivery routes. Conclusion Fixed-dose antitumor drug combinations enjoy significant advantages in clinic but still face many challenges in the course of development. In the future, artificial intelligence can provide strong technical support and innovation incentives for the development of drugs. Reference | Related Articles | Metrics | Comments（0）

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Research progress of sustained and controlled release preparations of Chinese medicine SUN Li, XIE Bin, XU Yanqin Chinese Journal of Pharmacovigilance    2024, 21 (8): 949-954.   DOI: 10.19803/j.1672-8629.20240249 Abstract （411）      PDF（pc） （1293KB）（896）       Knowledge map    Save Objective To summarize the research progress on the slow and controlled release preparations of traditional Chinese medicine, and provide a basis for understanding the preparation process, prescription and quality evaluation of slow and controlled release preparations of traditional Chinese medicine. Methods Through literature search,the advantages and disadvantages, preparation process, and quality evaluation system was summarized from different new types of sustained and controlled release formulations. Results The new types of sustained and controlled release formulations involve solid lipid nanoparticles sustained and controlled release formulations, oral osmotic pump sustained and controlled release formulations, gastric retention delivery sustained and controlled release formulations, bioadhesive microspheres, and solid dispersions, and the preparation process uses multiple screening methods to arrive at the optimal process, and the quality evaluation methods for the sustained and controlled release formulations of traditional Chinese medicines include in vitro release studies, in vivo release, and in vitro and in vivo correlation studies. Conclusion The research on slow and controlled release preparations of traditional Chinese medicine mainly focuses on the single component of traditional Chinese medicine, traditional Chinese medicine extracts or active parts, and combination of several single components of traditional Chinese medicine, and the quality evaluation system mainly includes in vivo release, in vitro release and in vitro and in vivo correlation studies, which can provide reference basis for the future development of slow and controlled release preparations of traditional Chinese medicine. Reference | 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 （407）      PDF（pc） （1222KB）（117）       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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Chinese Journal of Pharmacovigilance    2025, 22 (2): 0-0.   Abstract （400）      PDF（pc） （480KB）（418）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Applications of “Target Fishing” Technique in Pharmacological Research of Traditional Chinese Medicine CHEN Siyi, SHENG Lisong, SUN Rong Chinese Journal of Pharmacovigilance    2024, 21 (12): 1321-1328.   DOI: 10.19803/j.1672-8629.20240700 Abstract （400）      PDF（pc） （1661KB）（336）       Knowledge map    Save Objective To review the recent applications of “target fishing” technique in the fields of Traditional Chinese Medicine (TCM) in recent years in order to contribute to overcoming the bottleneck of TCM modernization caused by the complexity of TCM components and the uncertainty of target components. Methods Literature on “target fishing” techniques in the field of TCM in the past 15 years was searched. Research methods involved in the commonly used “target fishing” techniques were summarized. The strengths and weaknesses of these techniques in revealing the action or toxicity targets of TCM components were analyzed. Results “Target fishing” techniques applied in the field of TCM were mostly based on “affinity fishing”, which was often used in conjunction with liquid chromatography, mass spectrometry and other technologies for direct target research of TCM potent or toxic components on the basis of a clear mechanism of affinity fishing and toxicity. It was difficult to apply this technique to small molecules with close conformational relationships or to perform rapid and unbiased protein target identification for complex TCM systems. The interpretation of TCM theories in existing studies remained weak, and there was a lack of in-depth integration with TCM theories in subsequent validation studies or in-depth excavation. Conclusion The “target fishing” technique offers novel insights and methodologies for elucidating the molecular-level mechanisms of TCM action. This study proposes a research strategy for investigating the effects and toxicity of TCM, which should be thoroughly explored within the framework of TCM theories and substantiated from comprehensive system-level perspectives. The“target fishing” technique provides references for integrated evaluation of the “effect-toxicity” of TCM. Reference | Related Articles | Metrics | Comments（0）

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One case of severe systemic rash caused by atorvastatin calcium tablets LI Fang, LONG Xiuying, BAI Na, WEI Jingxia Chinese Journal of Pharmacovigilance    2024, 21 (8): 939-942.   DOI: 10.19803/j.1672-8629.20240094 Abstract （396）      PDF（pc） （1234KB）（914）       Knowledge map    Save Objective To analyze the clinical characteristics and potential allergenic mechanisms of atorvastatin induced severe generalized rash in patients with chronic diseases, providing a warning for future polypharmacy and reference for early clinical management. Methods A retrospective study was conducted on a patient with cerebral infarction who developed a generalized rash after polypharmacy (amlodipine, aspirin, atorvastatin, urinary kallidinogenase and edaravone dexborneol) was conducted. The rash worsened even after discontinuing urinary kallidinogenase and edaravone dexborneol and switching aspirin to clopidogrel. The rash subsided only after discontinuing all medications except for antiallergic drugs. When clopidogrel and amlodipine were reintroduced, the rash did not recur. The Naranjo score and literature review were used to analyze the potential allergenic drug. Results Based on the clinical presentation of the rash and its relationship with the timing of medication, combined with the Naranjo score of 5 for atorvastatin, it is very likely that atorvastatin is the drug causing the patient’s rash. Conclusions Clinicians should be aware that atorvastatin can cause severe generalized rash in chronic diseases patients a few days after administration during polypharmacy. Reference | Related Articles | Metrics | Comments（0）