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Risk factors of adverse drug reaction from non-steroidal anti-inflammatory drugs in Shanghai patients with arthropathy

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Acta Pharmacologica Sinica 2004年第3期25卷 103-111页

作者： Wen SHI2,Yong-ming WANG,Shao-li LI3,Min YAN3,Duan Li,Bin-yan CHEN,Neng-neng CHENG Department of Pharmacology,School of Pharmacy,Fudan University,Shanghai 200032 The Center for drug Reevaluation and 3 The Center for adverse drug reaction Monitoring,State Food and drug Administration,Beijing 100061,China Department of Pharmacology School of Pharmacy Fudan University The Center for drug Reevaluation and The Center for adverse drug reaction Monitoring State Food and Drug Administration Beijing 100061 China

AIM: The study was to screen the possible risk factors of adverse drug reaction (ADR) induced by non-steroidal anti-inflammatory drugs (NSAIDs) in Shanghai patients with arthropathy. METHODS: The subjects were ran- domly selected from a database of outpatients with arthropathy from 9 main hospitals in Shanghai. A door to door retrospective epidemiological survey was used to collect demographic information about the patients, both indi- vidual and familial. This included data on their medical histories, lifestyle and dietary habits, history of smoking and alcohol consumption, history of drug therapy, quality of life (QOL) prior to NSAIDs intake, history of NSAIDs therapy and its ADR events, etc. Descriptive statistical methods and univariate analysis were also used to identify possible risk factors for ADRs induced by NSAIDs. RESULTS: Of the 1002 patients surveyed, the average length of NSAIDs intake was 2 years. ADR incidence from different NSAIDs was high, in a range from 46.7 %-66.2 %. In general, the candidate risk factors for ADRs were different for each NSAID. Each of the candidate risk factors were defined and studied in order to evaluate its role in the determination of ADRs from NSAIDs. “Family history of ADRs caused by NSAIDs” was found to be a significant risk factor for the four commonly used NSAIDs: meloxicam, diclofenac, nimesulide, and nabumetone. CONCLUSION: A retrospective epidemiological survey was useful in detecting the risk factors for ADRs caused by NSAIDs. The study found that different NSAIDs might have different risk factors and that there is no single risk factor universally applicable to all NSAIDs.

关键词： non-steroidal anti-inflammatory drugs adverse drug reaction risk factors retrospective studies quality of life

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A review on the Pharmacology and adverse drug reaction of Chaihu Herbal Injection

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Asian Toxicology Research 2020年第1期2卷 42-47页

作者： Cui-Hong Zhu Xiao-Yan Wang Dan Chen Jia-Wen Zhao Xue Yang Tianjin Cancer Hospital Airport Hospital No.99East Fifth AvenueDongli DistrictTianjin 300308China Tianjin Medical University General Hospital No.154Anshan RoadHeping DistrictTianjin 300052China

The Chaihu herbal injection was the first herbal injection to be developed and used in China,which has been used in clinic for more than 70 *** injection is widely used to treat fever caused by influenza or common cold and ***,there is an ongoing debate about the safety of the clinical use of Chaihu herbal injection in view of the large number of adverse drug reaction reports and literature in *** May 29,2018,the China Food and drug Administration issued a notice requiring to revise the instruction manual of Chaihu herbal injection,list"prohibit for children"under the taboo item,and add the warning"adverse reactions of this product include anaphylactic shock".The purpose of this review is to provide updated,comprehensive information on the pharmacology and adverse drug reaction of Chaihu herbal injection based on scientific literatures in the past few decades.

关键词： Chaihu herbal injection Radix Bupleuri Chaihu Toxicology adverse drug reaction Pharmacology

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Analysis and Enlightenment of Big Data Platform for adverse drug reaction Supervision in China and the United States

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Asian Journal of Social Pharmacy 2023年第3期18卷 213-220页

作者： Chang Senhao Chang Yingnan Gong Jingran Chen Yuwen School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China Research Institute of drug Regulatory Science Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to deepen the reform of medical and health *** A comparative analysis was made on China’s big data for regulatory science after studying the development process,operation mode,practical significance and characteristics of the big data platform for FDA regulatory science,which would help China to establish a perfect big *** and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United *** is necessary to build data platforms in line with China’s national conditions through efforts in law,talents,standards,and other aspects.

关键词： adverse drug reaction regulatory science big data platform US FDA life cycle

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Effects of Modern Preparation Technology for Chinese Patent Medicine on adverse drug reaction and the Related Strategies

Effects of Modern Preparation Technology for Chinese Patent ...

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第十四届全国中药和天然药物学术研讨会

作者： Jin Gao Peng Lu Huiqing Dai Hui Cao Zhaohua Peng Qiang Shang Livzon Pharmaceutical Group Co. Ltd National Engineering Research Center for Modernization of Traditional Chinese Medicine China Academy of Chinese Medical Sciences

This article briefly introduces the main factors of adverse reactions caused by Chinese patent medicine,including drug toxicity,confusable species,improper processing,inappropriate drug dosage,incorrect compatibility and individual difference of *** searching the literature,the article summarizes different techniques used in TCM preparation industry,analyses the effects of modern preparation technology on drug safety and adverse *** with traditional process,modern preparation technology may change chemical composition of TCM preparation,drug dosage,drug formulation,drug delivery and add processing impurity,which can make passive effect on drug *** article also proposes effective solutions for drug safety and appeals that we should strengthen research on basic chemical constituents of TCM,toxicology of TCM,correlation between preparation process and clinical application,establish quality control system of pharmaceutical excipient to improve its safety,and emphasizes significance of enterprises in adverse reactions monitoring system.

关键词： Chinese patent medicine adverse drug reaction preparation technology

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Analysis of Innovations in Monitoring adverse drug reaction and Application

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Asian Journal of Social Pharmacy 2024年第4期19卷 319-326页

作者： Gong Jingyu Tian Lijuan School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To systematically study foreign adverse drug reaction monitoring technologies and applications to extract valuable experience,and provide reference for promoting its application in *** Literature research,comparative research and other methods were used to investigate foreign adverse drug reaction(ADR)monitoring technologies and applications such as passive reporting systems,active monitoring systems,electronic health records and real-world data,and analyze the problems in the application of the above technologies in *** and Conclusion At present,China is relatively mature in the application of ADR passive reporting system,but there are some problems in the application of ADR active monitoring system,electronic health records and real-world *** the future,we should improve the application of adverse drug reaction active monitoring system,establish close cooperation with universities,research institutes and other institutions to improve the evaluation of adverse drug ***,we should promote the construction of the Chinese medical language processing system and strengthen the understanding of real-world *** will improve the level of monitoring adverse drug reactions in China and promote rational drug use.

关键词： adverse drug reaction active monitoring technical system real-world data

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Predicting disruptions to drug pharmacokinetics and the risk of adverse drug reactions in nonalcoholic steatohepatitis patients

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Acta Pharmaceutica Sinica B 2023年第1期13卷 1-28页

作者： Solène Marie Kayla L.Frost Raymond K.Hau Lucy Martinez-Guerrero Jailyn M.Izu Cassandra M.Myers Stephen H.Wright Nathan J.Cherrington College of Pharmacy Department of Pharmacology&ToxicologyUniversity of ArizonaTucsonAZ 85721USA College of Medicine Department of PhysiologyUniversity of ArizonaTucsonAZ 85724USA

The liver plays a central role in the pharmacokinetics of drugs through drug metabolizing enzymes and ***-alcoholic steatohepatitis(NASH)causes disease-specific alterations to the absorption,distribution,metabolism,and excretion(ADME)processes,including a decrease in protein expression of basolateral uptake transporters,an increase in efflux transporters,and modifications to enzyme *** can result in increased drug exposure and adverse drug reactions(ADRs).Our goal was to predict drugs that pose increased risks for ADRs in NASH *** research identified 71 drugs with reported ADRs in patients with liver disease,mainly non-alcoholic fatty liver disease(NAFLD),54 of which are known substrates of transporters and/or metabolizing *** NASH is the progressive form of NAFLD but is most frequently undiagnosed,we identified other drugs at risk based on NASH-specific alterations to ADME ***,we present another list of 71 drugs at risk of pharmacokinetic disruption in NASH,based on their transport and/or metabolism *** encompasses drugs from various pharmacological classes for which ADRs may occur when used in NASH patients,especially when eliminated through multiple pathways altered by the ***,these results may inform clinicians regarding the selection of drugs for use in NASH patients.

关键词： Non-alcoholic steatohepatitis Hepatic elimination Transporter Enzyme Pharmacokinetics drug-drug interaction Liver adverse drug reaction

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The dopaminergic system and Alzheimer's disease

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Neural Regeneration Research 2025年第9期20卷 2495-2512页

作者： Yuhan Zhang Yuan Liang Yixue Gu International Medical College Chongqing Medical UniversityChongqingChina College of Pharmacy Chongqing Medical UniversityChongqingChina Department of Neurology The First Affiliated Hospital of Chongqing Medical UniversityChongqing Key Laboratory of NeurologyChongqingChina

Alzheimer's disease is a common neurodegenerative disorder in older *** its prevalence,its pathogenesis remains unclea *** addition to the most widely accepted causes,which in clude excessive amyloid-beta aggregation,tau hyperphosphorylation,and deficiency of the neurotransmitter acetylcholine,numerous studies have shown that the dopaminergic system is also closely associated with the occurrence and development of this *** is a crucial catecholaminergic neurotransmitter in the human ***-associated treatments,such as drugs that target dopamine receptor D and dopamine analogs,can improve cognitive function and alleviate psychiatric symptoms as well as ameliorate other clinical *** r,therapeutics targeting the dopaminergic system are associated with various adverse reactions,such as addiction and exacerbation of cognitive *** review summarizes the role of the dopaminergic system in the pathology of Alzheimer's disease,focusing on currently available dopamine-based therapies for this disorder and the common side effects associated with dopamine-related *** aim of this review is to provide insights into the potential connections between the dopaminergic system and Alzheimer's disease,thus helping to clarify the mechanisms underlying the condition and exploring more effective therapeutic options.

关键词： adverse drug reaction Alzheimer's disease catecholamine dopamine receptor dopamine receptor heterodimers dopaminergic system neurodegenerative disease neurotransmitter signaling pathways traditional Chinese medicine treatment

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Why Don’t We Adequately Identify and Manage adverse drug reactions despite Having the Needed Information?

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Health 2024年第2期16卷 148-159页

作者： Mark J. Kupersmith Karl Kieburtz Department of Neurology Ophthalmology and Neurosurgery Icahn School of Medicine at Mount Sinai New York NY USA SafeTherapeutics LLC New York NY USA Clintrex Research Corporation Sarasota FL USA

Importance/Objective: adverse drug reactions (ADRs) are unavoidable, but recognizing and addressing ADRs early can improve wellness and prevent permanent injury. We suggest that available medical information and digital/electronic methods could be used to manage this major healthcare problem for individual patients in real time. Methods: We searched the available digital applications and three literature databases using the medical subject heading terms, adverse drug reaction reporting systems or management, filtered by clinical trial or systemic reviews, to detect publications with data about ADR identification and management approaches. We reviewed the reports that had abstract or summary data or proposed or implemented methods or systems with potential to identify or manage ADRs in clinical settings. Results: The vast majority of the 481 reports used retrospectively collected data for groups of patients or were limited to surveying one population group or class of medication. The reports showed potential and definite associations of ADRs for specific drugs and problems, mostly, but not exclusively, for patients in hospitals and nursing homes. No reports described complete methods to collect comprehensive data on ADRs for individual patients in a healthcare system. The digital applications have ADR information, but all are too cumbersome or incomplete for use in active clinical settings. Several studies suggested that providing information about potential ADRs to clinicians can reduce these problems. Conclusion and Relevance: Although investigators and government agencies agree with the need, there is no comprehensive ADR management program in current use. Informing the patient’s healthcare practitioners of potential ADRs at the point of service has the potential for reduction of these complications, which should improve healthcare and reduce unneeded costs.

关键词： adverse drug reaction Medication Side Effect Identification Medication Complication Medication Safety

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Anlotinib-induced sick sinus syndrome:Two case reports

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World Journal of Clinical Cases 2025年第6期13卷 30-34页

作者： Cheng-Feng Fu Li-Fen Yang Lei Tian Song Deng Qi Zhang Biao Yao Department of Oncology Tongren People’s HospitalTongren 554300Guizhou ProvinceChina Department of Oncology Guizhou Provincial People’s HospitalGuiyang 550000Guizhou ProvinceChina

BACKGROUND This manuscript describes the first known cases of sick sinus syndrome(SSS)associated with the use of anlotinib in non-small cell lung cancer patients,highlighting the need for increased vigilance and cardiac *** SUMMARY Two patients with non-small cell lung cancer developed SSS after 15 months and 5 months of anlotinib treatment,respectively,presenting with syncope and *** confirmed SSS,and different treatment approaches were taken for each *** patient received a dual-chamber permanent pacemaker,while the other discontinued the medication and experienced symptom *** Anlotinib can induce SSS,suggesting that cardiac monitoring is crucial during anlotinib *** management strategies are necessary for affected individuals.

关键词： Lung cancer Anlotinib Sick sinus syndrome Cardiac pacemaker adverse drug reaction Case report

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Intensive care drug therapy and its potential adverse effects on blood pressure and heart rate in critically ill children

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World Journal of Pediatrics 2023年第9期19卷 902-911页

作者： Lisa Marie Kiesel Astrid Bertsche Wieland Kiess Manuela Siekmeyer Thilo Bertsche Martina Patrizia Neininger drug Safety Center and Clinical Pharmacy Institute of PharmacyMedical FacultyLeipzig UniversityBruederstr.3204103 LeipzigGermany Division of Neuropediatrics University Hospital for Children and AdolescentsFleischmannstr.817475 GreifswaldGermany Department of Women and Child Health Hospital for Children and Adolescents and Center for Pediatric ResearchUniversity Hospital of LeipzigLiebigstr.20a04103 LeipzigGermany

Background Owing to complex treatment,critically ill children may experience alterations in their vital *** investigated whether such hemodynamic alterations were temporally and causally related to drug *** In a university pediatric intensive care unit,we retrospectively analyzed hemodynamic alterations defined as values exceeding the limits set for heart rate(HR)and blood pressure(BP).For causality assessment,we used the World Health Organization–Uppsala Monitoring Center(WHO–UMC)system,which categorizes the probability of causality as“certain,”“probable,”“possible,”and“unlikely.”Results Of 315 analyzed patients with 43,200 drug prescriptions,59.7%experienced at least one hemodynamic alteration;39.0%were affected by increased HR,19.0%by decreased HR,18.1%by increased BP,and 16.2%by decreased *** to drug information databases,83.9%of administered drugs potentially lead to hemodynamic ***,88.3%of the observed hemodynamic alterations had a temporal relation to the administration of drugs;in 80.2%,more than one drug was *** on the WHO–UMC system,a drug was rated as a“probable”causing factor for only 1.4%of hemodynamic *** the remaining alterations,the probability ratings were lower because of multiple potential causes,e.g.,several *** Critically ill children were frequently affected by hemodynamic *** administration of drugs with potentially adverse effects on hemodynamic parameters is often temporally related to hemodynamic *** alterations are often multifactorial,e.g.,due to administering multiple drugs in rapid succession;thus,the influence of individual drugs cannot easily be captured with the WHO–UMC system.

关键词： adverse drug reaction drug therapy Hemodynamic monitoring Multifactorial causality Pediatric intensive care unit

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