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Literature Analysis of Clinical Application and Adverse Drug Reaction/Event of Lianhua Qingwen Capsule PENG Li-li, LI Lan, SHEN Lu, LI Xing-ling Chinese Journal of Pharmacovigilance    2015, 12 (12): 753-755.   Abstract （9022）      PDF（pc） （642KB）（2225）       Knowledge map    Save ObjectiveTo investigate and analyze the literatures on clinical application and ADR/ADE induced by Lianhua Qingwen Capsule to provide reference for its rational use in clinic. MethodsThe literatures for ADR/ADE of Lianhua Qingwen Capsule were retrieved in the databases of CNKI、Wangfang data for the last 10 years, which were screened out and analyzed by evidence-based medicine method and bibliometric statistical method. ResultsThirty-eight literatures were included and toltal 122 adverse drug reaction cases were collected. Most drug adverse reactions occurred after first use, primarily involved gastrointestinal system(73.9%), skin and its appendaes (9.6%), including nausea, vomiting, abdominal distention, diarrhea, skin rashes, itching, etc. ConclusionWe should reinforce the clinical application of Lianhua Qingwen Capsule, standardize and improve the drug package inserts, promote the rational use of drug and guarantee the safety of patients. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Pharmocovigilance and Difference with the ADR Monitoring in China WANG Dan, PENG Li-li, LIU Cui-li, LIU Jia, WANG Tao, DONG Duo Chinese Journal of Pharmacovigilance    2017, 14 (3): 150-152.   Abstract （2431）      PDF（pc） （3574KB）（659）       Knowledge map    Save Objective To explore the application of pharmacovigilance in China. Methods The concept of parmocovigilance and the differences between pharmacovigilance and ADR Monitoring were disserted. Results There is a gap between ADR monitoring and pharmacovigilance in the aspect of object, scope and method. However, ADR monitoring is in keeping with international pharmacovigilance theoretically and is developing towards it. Conclusion Pharmacovigilancecan provide growth space for development of ADR monitoring in china. Reference | Related Articles | Metrics | Comments（0）

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Present Situation and Prospect of Antiviral Treatments for COVID-19 TIAN Di, WANG Lin, GE Ziruo, CUI Shuping, CHEN Zhihai Chinese Journal of Pharmacovigilance    2020, 17 (3): 129-135.   DOI: 10.19803/j.1672-8629.2020.03.01 Abstract （2352）      PDF（pc） （1004KB）（1305）       Knowledge map    Save In December 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei Province. In January 2020, a new type of coronavirus (2019-nCoV) was isolated. With the outbreak of COVID-19, the number of severe, critical and death cases is increasing gradually. In the diagnosis and treatment program of our country, the oral administration of lopinavir/ritonavir and the atomization of α-interferon were used, and ribavirin, chloroquine phosphate and abidol can also be used for antiviral treatment.The plasma of convalescent patients can be used for the treatment of severe and critical patients. Recently, a United States report that the first case of 2019-nCoV infection confirmed patient have been significantly improved after treatment with remdesivir. Fabiravir is also considered to have potential efficacy. Antiviral treatment is the key to the treatment of severe and critical diseases. In this paper, the present situation and prospect of selective antiviral treatments for COVID-19 is reviewed. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Ketoacidosis Induced by Dapagliflozin Tablets YUAN Menghu, QIAN Fengdan Chinese Journal of Pharmacovigilance    2020, 17 (3): 157-160.   DOI: 10.19803/j.1672-8629.2020.03.06 Abstract （2212）      PDF（pc） （781KB）（3108）       Knowledge map    Save Objective To explore the safety of dapagliflozin tablets in clinical application. Methods This article summarizes two cases which have been diagnosed with ketoacidosis after using dapagliflozin tablets from Shanghai General Hospital in November 2018. In addition, relevant literatures at home and abroad are reviewed. Results The two diabetic patients began to show symptoms of tolerance, nausea and vomiting without obvious inducement on the 6th and 1st day after taking dapagliflozin tablets respectively. On the 7th and 6th day after taking the tablets, they were diagnosed with ketoacidosis through laboratory examination. Their symptoms improved after drug withdrawal, fluid rehydration, low-dose insulin intravenous drip, electrolyte correction and other treatments. Conclusion Dapagliflozin tablets may cause ketoacidosis. Medical personnel should pay attention and use carefully in high-risk groups. Reference | Related Articles | Metrics | Comments（0）

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Study of VigiBase Database of Uppsala Monitoring Centre ZHANG Wei, WEI Fuqian, YANG Yue Chinese Journal of Pharmacovigilance    2020, 17 (10): 676-680.   DOI: 10.19803/j.1672-8629.2020.10.06 Abstract （1875）      PDF（pc） （1616KB）（1111）       Knowledge map    Save Objective To study the structure, tools and functions of VigiBase, a database managed by the Uppsala Monitoring Centre (UMC), and to provide reference for improving the database of adverse drug reactions (ADRs) in China. Methods The structure and functions of VigiBase were analyzed by consulting literature and searching VigiBase. Results VigiBase was the largest database of individual case safety reports (ICSRs) in the world. UMC evaluated the quality of ICSRs via VigiGrade, inspected the duplicate reports via VigiMatch, detected drug safety signals via VigiRank, and also provided VigiLyze, VigiFlow, VigiAccess and other tools for member states to manage ICSRs and retrieve data from VigiBase. Conclusion The assessment of report quality and drug safety signal detection need to be improved in China. Reference | Related Articles | Metrics | Comments（0）

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Research Progress of Pharmacological Activity and Toxicity of 5-Hydroxymethylfurfural LI En-can, HE Jiu-ming, JIN Hong-tao, LIN Ni Chinese Journal of Pharmacovigilance    2018, 15 (4): 210-215.   Abstract （1775）      PDF（pc） （711KB）（524）       Knowledge map    Save Objective To understand and summarize the recent progress in the pharmacology and toxicology research of 5-hydroxymethylfurfural(5-HMF). Methods The author listed the common pharmacological effects and toxicity of 5-HMF, and collected and analyzed the existing research data which showed the research direction of 5-HMF at the present stage, then emphasized the necessity of 5-HMF content detection and limited control. Results 5-HMF has both pharmacological activity and toxicity, and is widely present in food and medicine, and ultimately whether it is harmful to the human body or not depends on the route of exposure, the dose and frequency of exposure, therefore, people should pay more attention to the toxicity of 5-HMF. Conclusion The safety evaluation of 5-HMF may provide guidance for the quality control and safe application of 5-HMF-containing foods and drugs. Reference | Related Articles | Metrics | Comments（0）

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Implementation of Pharmacovigilance System in Drug Administration Law and Application of ICH E2 Guideline YANG Yue Chinese Journal of Pharmacovigilance    2020, 17 (2): 65-71.   DOI: 10.19803/j.1672-8629.2020.02.01 Abstract （1753）      PDF（pc） （1079KB）（1684）       Knowledge map    Save This paper is intended to analyze the difference in adverse reaction reporting and monitoring systems between the previous Drug Administration Law and the pharmacovigilance system specified in the newly revised Drug Administration Law. Starting with the meaning of pharmacovigilance and combined with the macro background of acceleration of new drug authorization since the reform of drug review and approval in China, this paper points out that the pharmacovigilance system can be compared to the braking mechanism for new drug review to enter the “expressway”. Combined with the transformation and application of ICH E2 series guidelines, this paper makes recommendations for the implementation of pharmacovigilance requirements according to the revised Drug Administration Law, such as changing notions about the monitoring and reporting of drugs, improving the efficiency and ability of signal detection, carrying out cumulative risk benefit evaluation, and exploring the requirements of risk management plans suited to China. Reference | Related Articles | Metrics | Comments（0）

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Thoughts on Drug Regulatory Science in the New Era MAO Zhenbin, WANG Ying, WANG Siming Chinese Journal of Pharmacovigilance    2020, 17 (4): 193-197.   DOI: 10.19803/j.1672-8629.2020.04.01 Abstract （1708）      PDF（pc） （1048KB）（1313）       Knowledge map    Save This paper describes the course of development and significance of regulatory science, and attempts in-depth thinking about the application of drug regulatory science in China in the new era. We discussed the birth and beginning of regulatory science, the development and achievement of drug regulatory science, the essence and characteristic of regulatory science, the effect and duty of regulatory science. Through the study of the strategies and implementation method path, this paper specifies the direction in which the regulatory science systems for Traditional Chinese medicine and modern pharmaceuticals of the world level are to be established. Reference | Related Articles | Metrics | Comments（0）

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Research Progress on Toxicity of Pyrrolizidine Alkaloids SUN Xiaoxiang, XIANG E, QIU Shuaikai, WANG Hui, GUO Yu Chinese Journal of Pharmacovigilance    2019, 16 (2): 76-80.   Abstract （1667）      PDF（pc） （672KB）（249）       Knowledge map    Save Pyrrolizidine alkaloids (PAs) are a group of natural components which widely distributed in plants all over the world. Some of them have anti-tumor and anti-bacterial effects. However, most PAs exert multiple toxicities after metabolic activation, while toxicities of pyrrolizidine alkaloid N-oxides (PANO) have been reported in recent years. They attack multiple organs, induce carcinomas and cause developmental toxicity. This review updated the research on mechanism and effect of PAs toxicity as well as detoxification during recent years. Reference | Related Articles | Metrics | Comments（0）

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Annual report of national adverse drug reaction monitoring (2022) Chinese Journal of Pharmacovigilance    2023, 20 (6): 712-719.   DOI: 10.19803/j.1672-8629.20230168 Abstract （1657）      PDF（pc） （3455KB）（1266）       Knowledge map    Save Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public. Related Articles | Metrics | Comments（0）

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One Case of Severe Skin Damage Induced by Combination of Doxorubicin Hydrochloride Liposome Injection and Paclitaxel for Injection (albumin-binding) ZHOU Xiangzhen, LI Jingtai, REN Shaolin, ZHANG Chunping, ZHANG Tianhua Chinese Journal of Pharmacovigilance    2021, 18 (3): 280-283.   DOI: 10.19803/j.1672-8629.2021.03.16 Abstract （1653）      PDF（pc） （853KB）（474）       Knowledge map    Save Objective To remind clinicians to pay close attention to medication safety when doxorubicin liposomes and paclitaxel (albumin-bound type) are used in combination. Methods One case of a 43-year-old female patient with grade 3 hand-foot syndrome and grade 2 intertrigo-like eruption after combined use of doxorubicin liposome and paclitaxel (albumin-bound type) was analyzed. Literature about the clinical manifestations, pathogenesis and prevention of skin toxicity caused by the above two drugs was reviewed. Results The patient's hand-foot syndrome was probably caused by doxorubicin liposomes, and the intertrigo-like eruption by the combined use of doxorubicin liposomes and paclitaxel (albumin-bound). After such symptomatic interventions as dose reduction, delayed chemotherapy and traditional Chinese medicine, the patient' s skin symptoms were gradually relieved. Conclusion The combined use of doxorubicin liposomes and paclitaxel (albumin-bound type) may cause serious skin toxicity and impact the quality of life of patients, which deserves the attention of clinicians. Patients should be better informed of the related risk and take precautions. Reference | Related Articles | Metrics | Comments（0）

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Research on the Differences and Correlation Between‘Serious’ and ‘Severe’ Adverse Drug Reactions/Events YUAN Li, YANG Yue Chinese Journal of Pharmacovigilance    2016, 13 (8): 484-488.   Abstract （1646）      PDF（pc） （1045KB）（3376）       Knowledge map    Save Objective To ravel out the concept,connotation and significance of ‘serious’ and ‘severe’ adverse drug reactions (ADRs) /adverse events (AEs), clear out the differences and correlation between the two concepts, and lay a foundation for accurate use in the actual work. Methods Literature research and comparative analysis were introduced to compare and summarize the differences and relationship between the concepts and connotation. Results ‘Serious’ ADR/AE is based on outcome, it is a guidance in determining responsibility in drug safety monitoring, ‘severe’ adverse drug reaction/event is a class of ADR/ADE marked as ‘severe’. Conclusion ‘Serious’ and ‘severe’ ADRs/AEs are not the same and often confused in use, the former is more likely a concept of administration, and the latter is more likely a technical concept. The existence of the two plays a different role, it should be paid attention when use. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2020, 17 (1): 63-64.   DOI: 10.19803/j.1672-8629.2020.01.08 Abstract （1597）      PDF（pc） （824KB）（821）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong Chinese Journal of Pharmacovigilance    2021, 18 (10): 965-968.   DOI: 10.19803/j.1672-8629.2021.10.15 Abstract （1451）      PDF（pc） （1215KB）（185）       Knowledge map    Save Objective To search the database of the US Food and Drug Administration public data open project (OpenFDA) for adverse drug reactions (ADR) of PCSK9 inhibitors evolocumab and alirocumab, and to compare and analyze the related ADR so as to provide reference for clinical rational use. Methods Using the API module in the interactive chart section of the ADR endpoint in OpenFDA database, the data on ADR reports of evolocumab and alirocumab harvested between January 1, 2004 and January 18, 2021 was retrieved. Results The number of ADR reports of evolocumab and alirocumab was 71 676 and 8 006, respectively. ADR reports of evolocumab mostly came from doctors, consumers and non-health professionals, compared with consumers, non-health professionals and other health professionals for alirocumab. Most of the ADR occurred in the United States. Female patients outnumbered male ones. Adults and the elderly made up the majority of the patients. The main indications for the drug were cardiovascular diseases. The dominating ADR related to elouzumab was pain at the injection site, and myalgia for alirocumab. The outcomes of most of these patients were unknown. Conclusion In the process of using evolocumab and alirocumab clinically, clinicians should be alert to the related ADR so as to promote the rational use of drugs. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Current Abuse among Drug Abusers in China SUN Jun, YU Dandan, LI Ming, WU Chen, LIU Pengcheng, WANG Jiayu Chinese Journal of Pharmacovigilance    2020, 17 (1): 37-44.   DOI: 10.19803/j.1672-8629.2020.01.08 Abstract （1436）      PDF（pc） （1256KB）（1313）       Knowledge map    Save Objective To seek the basic information and behavioral characteristics of drug abusers in order to provide data for the follow-up study on the characteristics of abusers/users of compound tramadol. Methods A descriptive statistical analysis was conducted on the basis of a self-designed questionnaire that sampled such factors as social demographic characteristics, the living environment and abuse behaviors of drug abusers in compulsory isolated treatment centers. Results Most of the drug abusers were male, poorly-educated and unemployed. Heroin and methamphetamine were the main drugs of abuse. Curiosity, seduction by peers and euphoria-seeking were largely responsible for abuse. Conclusion Firstly, we should pay attention to the characteristics of drug abusers, establish mechanisms of preventive education at grassroots levels, and intensify publicity on rational use of drugs. Secondly, we should focus on main drugs of abuse such as methamphetamine and heroin. Thirdly, we should make Methods of detoxification more accessible, such as opening methadone clinics, in an effort to help drug abusers to get detoxified properly. Reference | Related Articles | Metrics | Comments（0）

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Review of Adverse Drug Reaction Reports Causality Assessment Methods WEI Jing, WANG Yu-xin Chinese Journal of Pharmacovigilance    2011, 8 (10): 600-602.   Abstract （1414）      PDF（pc） （470KB）（1585）       Knowledge map    Save ADR causality assessment method is an important tool in the process of pharmacovigilance. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. The methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods(Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. Different causality categories are adopted in each method, and the categories are assessed using different criteria. In conclusion, there is still no method universally accepted for causality assessment of ADRs. Reference | Related Articles | Metrics | Comments（0）

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Use of WHOART and MedDRA in Adverse Reaction Monitoring WU Gui-zhi, TIAN Chun-hua, WANG Dan, FENG Hong-yun, CHEN Yi-xin Chinese Journal of Pharmacovigilance    2010, 7 (2): 81-85.   Abstract （1403）      PDF（pc） （492KB）（795）       Knowledge map    Save World Health Organization Adverse Reaction Terminology(WHOART) and Medical Dictionary for Regu-latory Activities(MedDRA) developed by International Conference on Harmonisation are most often used terminology to classify and code adverse reaction terms in post-marketing safety surveillance and drug adverse reaction monitoring. This article introduced term definitions, rules and conventions, hierarchy structure, characteristics, the applications in coding and data analysis of WHOART and MedDRA. On the basis of analyzing the strongpoint and shortcoming of WHOART and MedDRA terminology now in use, the current status of WHOART and potential use of MedDRA in China are discussed. Related Articles | Metrics | Comments（0）

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Trend Analysis of Ten-year Annual Reports on Adverse Drug Reaction Monitoring WANG Dan, REN Jingtian, DONG Duo, PENG Lili, LIU Wei Chinese Journal of Pharmacovigilance    2020, 17 (5): 276-283.   DOI: 10.19803/j.1672-8629.2020.05.05 Abstract （1396）      PDF（pc） （1576KB）（914）       Knowledge map    Save ObjectiveTo analyze the pattern of change of ADR monitoring data in China over the past ten years so as to point out some issues worthy of attention. Methods The data in the annual report on ADR monitoring issued by the state drug regulatory agencies from 2009 to 2018 was analyzed, the trend of change explored and the reasons were analyzed. Results The number and quality of ADR reports in China have been improved rapidly in the past decade, the coverage of monitoring networks has been expanding, and the ability of risk identification and control has been enhanced. However, there are still some problems worthy of attention and the need for improvement. Conclusion Drug regulatory agencies and ADR monitoring centers should conduct in-depth research based on the risk highlighted by the monitoring data and on the experience accumulated over the years, shift priorities and work hard to improve the level of monitoring. Reference | Related Articles | Metrics | Comments（0）

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Literature Analysis of 30 Adverse Drug Reaction/Event Cases Induced by Xingnaojing Injection ZOU Zhen-lei, YANG Le, GUO Xiao-xin Chinese Journal of Pharmacovigilance    2014, 11 (11): 683-686.   Abstract （1370）      PDF（pc） （890KB）（376）       Knowledge map    Save Objective To analyze the causes and characteristics of the adverse drug reaction/event (ADR/ADE) cases induced by Xingnaojing injection provide references for clinical rational drug use. Methods 30 ADR/ADE cases induced by Xingnaojing injection were analyzed retrospectively. Results The middle-aged and the old patients accounted for 56.67%. The use of Xingnaojing injection in 43.33% cases is beyond the indications of the drug instructions. The dosage of Xingnaojing injection in 13.33% cases is more than the dosage of the drug instructions. 70.00% of ADR/ADE occurred within 30 minutes after administration. The ADR/ADE can occur in the first time medication or continuous administration process. 33.33% of the patients had combined medication. The ADR/ADE involved six systems-organs. Systemic damage in which allergic reactions and anaphylactic shock is majority accounted for 60.00%. Conclusion Clinicians should pay attention to allergies of patients. The instruction should be adhered to. The combined medication should be cautious. The monitoring of adverse drug reactions should been strengthened. The drug manufacturing enterprise should strengthen the quality control and drug safety research, and improve the drug instructions of Xingnaojing injection. Reference | Related Articles | Metrics | Comments（0）

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Methods for Quality Evaluation of Individual Case Reports of Adverse Drug Reactions in China CHEN Liye, AN Lianyu, SHI Ping, WANG Shuling Chinese Journal of Pharmacovigilance    2020, 17 (3): 148-153.   DOI: 10.19803/j.1672-8629.2020.03.04 Abstract （1360）      PDF（pc） （1099KB）（1027）       Knowledge map    Save Objective To seek a long-term method for evaluating the quality of individual case reports of adverse drug reactions so as to evaluate case reports more accurately. Methods By analyzing literature, looking at current evaluation methods at home and abroad, and consulting experts, the weight of indicators was determined. AHP was used to establish the quality evaluation system of individual case reports on ADRs. Results This evaluation system was well-designed as evidenced by the evaluation of 40 ADR reports from a big A hospital. Conclusion The evaluation system of individual ADR cases based on characteristics of multiplication calculation is scientific and well-grounded, which can facilitate the dynamic management of the content of ADR reports and improve the efficiency of evaluation. Reference | Related Articles | Metrics | Comments（0）