Shi Wen, Wang Yong-ming, Li Shao-li, Yan Min, Li Duan, Chen Bin-yan, Cheng Neng-neng
Department of Pharmacology, School of Pharmacy, Fudan University, Shanghai 200032, China.
Acta Pharmacol Sin. 2004 Mar;25(3):357-65.
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.
The subjects were randomly 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 individual 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.
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.
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.
本研究旨在筛查上海关节病患者中由非甾体抗炎药(NSAIDs)引起的药物不良反应(ADR)的可能风险因素。
研究对象从上海9家主要医院的关节病门诊数据库中随机选取。采用上门回顾性流行病学调查收集患者的人口统计学信息,包括个人和家族信息。这包括他们的病史、生活方式和饮食习惯、吸烟和饮酒史、药物治疗史、服用NSAIDs前的生活质量(QOL)、NSAIDs治疗史及其ADR事件等。还采用描述性统计方法和单因素分析来确定NSAIDs引起ADR的可能风险因素。
在1002名接受调查的患者中,NSAIDs的平均服用时长为2年。不同NSAIDs的ADR发生率较高,在46.7%-66.2%的范围内。一般来说,每种NSAIDs的ADR候选风险因素各不相同。对每个候选风险因素进行定义和研究,以评估其在确定NSAIDs引起的ADR中的作用。发现“NSAIDs引起的ADR家族史”是四种常用NSAIDs(美洛昔康、双氯芬酸、尼美舒利和萘丁美酮)的显著风险因素。
回顾性流行病学调查有助于检测NSAIDs引起的ADR的风险因素。研究发现,不同的NSAIDs可能有不同的风险因素,且不存在适用于所有NSAIDs的单一风险因素。