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上海骨关节疾病患者口服吲哚美辛不良反应危险因子筛选
引用本文:施文,王永铭,李绍丽,颜敏,程能能,陈斌艳,李端.上海骨关节疾病患者口服吲哚美辛不良反应危险因子筛选[J].中国药理学通报,2003,19(12):1416-1420.
作者姓名:施文  王永铭  李绍丽  颜敏  程能能  陈斌艳  李端
作者单位:1. 复旦大学药学院药理学教研室,上海,200032
2. 国家药品监督管理局药品审评中心和药物不良反应监测中心,北京,100061
基金项目:国家药品监督管理局药品审评中心和药物不良反应监测中心资助课题BK PJ 0 30 1
摘    要:目的 在上海骨关节疾病患者中筛选吲哚美辛引起不良反应的危险因素。方法 利用回顾性流行病学调查方法 ,调查服用吲哚美辛的骨关节疾病患者的一般情况、原发疾病、疾病家族史、服用非甾体抗炎药前生活质量评估、饮食习惯、生活方式、非甾体抗炎药服用情况和不良反应发生情况等 ,通过单因素和多因素分析从中筛选吲哚美辛不良反应发生的相关因素。结果 上海骨关节疾病患者中口服吲哚美辛的不良反应发生率为 48 1%。因子“合并药物治疗”(比值比 0 166,95%可信区间 0 0 3 7~ 0 74)、“饮酒史”(比值比 0 795,95%可信区间 0 675~ 0 93 7)、“来自于健康问题的何种程度的紧张或压力会影响你的生活” (比值比0 917,95%可信区间 0 848~ 0 992 )评分的降低分别使口服吲哚美辛不良反应发生的危险增高。而因子“与 6mon前比较 ,服用非甾体抗炎药前的健康状况如何” (比值比1 2 3 6,95%可信区间 1 0 2 2~ 1 496)评分的升高将使口服吲哚美辛不良反应发生的危险增高。结论 “合并药物治疗”、“饮酒史”、“与 6mon前比较 ,服用非甾体抗炎药前的健康状况如何”是吲哚美辛不良反应发生的危险因子

关 键 词:吲哚美辛  非甾体抗炎药  药物不良反应  危险因子  回顾性流行病学调查
文章编号:1001-1978(2003)12-1416-05
修稿时间:2003年7月11日

Risk factors for adverse drug reaction caused by indomethacin in shanghai patients with osteoathropathy
SHI Wen,WANG Yong-Ming,LI Shao-Li,YAN Min,CHENG Neng-Neng CHEN Bin-Yan,L i Duan.Risk factors for adverse drug reaction caused by indomethacin in shanghai patients with osteoathropathy[J].Chinese Pharmacological Bulletin,2003,19(12):1416-1420.
Authors:SHI Wen  WANG Yong-Ming  LI Shao-Li  YAN Min  CHENG Neng-Neng CHEN Bin-Yan  L i Duan
Abstract:AIM To investigate the risk factors for adver se drug reactions (ADRs) to indomethacin in Shanghai patients with osteoarthropathy. METHODS A retrospective epidemiological study was used to obtain patients' informati on including demographic, primary disease, family history of disease, quality of life, dietary habit, life style, the use of NSAIDs and the ADR history of NSAID s, etc. Univariate analysis and multivariate analysis were used to establish the relationship between these observational variabilities and the occurrence of AD Rs caused by indomethacin. RESULTS The ADR rate of indomethacin i n shanghai patients with arthro-ostearthropathy is about 48 1%. The study showed a decreased ris k for ADR occurrence with increased scoring of 3 factors, which were: ①“concom itant drug therapy”odds ratio (OR) 0 166, 95% confidence intervals (CI) 0 0 37 to 0 74,P<0 05]; ②“history of alcoholism” (OR 0 795, 95% CI 0 675 to 0 937, P<0 05); ③“whether physical heath and quality of life are inf luenced by external stress” (OR 0 917, 95% CI 0 848 to 0 992,P<0 05), r espectively. Meanwhile, there is an increased risk for ADR occurrence with an in creased scoring of the “compared to six months ago, how would you rate your hea lth in general now?”(OR 1 236, 95% CI 1 022 to 1 496, P<0 05). CONCLUSIONS “Concomitant drug therapy”, “history of alcoholism”, “wh ether physical heath and quality of life are influenced by external stress” and “compared to six months ago, how would you rate your health in general now?” are 4 risk factors of ADR caused by indomethacin intake.
Keywords:indomethacin  NSAIDs  adverse drug reaction  risk factors  retrospective epidemiogy
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