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

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 

作者机构：Department of Pharmacology School of Pharmacy Fudan University 上海 200032 The Center for Drug Reevaluation and The Center for Adverse Drug Reaction Monitoring State Food and Drug Administration 北京 100061 

出 版 物：《Acta Pharmacologica Sinica》 (中国药理学报(英文版))

年 卷 期：2004年第25卷第3期

页      面：103-111页

核心收录：

学科分类：1002[医学-临床医学] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

基　　金：The project was supported by The Center for Drug Reevalua-tion and The Center for Adverse Drug Reaction MonitoringState Food and Drug Administration China. Grant No BK-PJ-0301 

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

摘      要：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.