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类风湿性关节炎患者服用双氯芬酸、萘丁美酮、美洛昔康、塞来昔布6mon生存质量的队列研究
引用本文:施文,王永铭,李少丽,颜敏,李端,陈斌艳,程能能. 类风湿性关节炎患者服用双氯芬酸、萘丁美酮、美洛昔康、塞来昔布6mon生存质量的队列研究[J]. 中国药理学通报, 2004, 20(6): 636-640
作者姓名:施文  王永铭  李少丽  颜敏  李端  陈斌艳  程能能
作者单位:1. 复旦大学药学院药理学教研室,上海,200032
2. 国家食品与药品监督管理局药品评价中心和药物不良反应监控中心,北京,100061
基金项目:国家食品药品监督管理局资助项目
摘    要:目的 对双氯芬酸、萘丁美酮、美洛昔康、塞来昔布治疗类风湿性关节炎 6mon前后患者生命质量进行评估。方法 采用回顾性和前瞻性队列研究相结合的方式 ,随机选择类风湿性关节炎新发病例 4 6 1名 ,其中双氯芬酸组 ,萘丁美酮组各 131名 ,美洛昔康组 14 4名 ,塞来昔布组 5 5例。观察时间 6mon。采用SF 36量表 (中文版 )对患者服药前后的健康相关生存质量进行评估 ,该评估包括躯体功能、躯体角色、肌体疼痛、总体健康状况、活力、社会功能、情绪角色和心理卫生 8个分量表。结果 按分量表进行分析 ,结果显示四组服药前后除“社会功能”的改变、以及塞来昔布组服药前后“躯体角色”的改变上无显著差异外 ,其他分量表各组服药前后均有显著差异。各分量表服药前后改变 4组间差异无显著性。按每个条目进行分析结果显示 ,双氯芬酸组在总体健康状况的改善 (条目 2 )、自我感觉身体疼痛改善程度 (条目7)以及SF 36量表总评分改善上优于塞来昔布组 (P均 <0 0 5 )。临床控制组生存质量改变优于其他 3组 ,显效组和好转组之间差异无显著性而且均优于无效组。结论 生存质量评分的改变与药物疗效呈正相关 ,SF 36量表 (中文版 )能用来评估非甾体抗炎药治疗前后生存质量的改变。按分量表进行分析四种NSAIDs前后患者生存质

关 键 词:非甾类  抗炎药  生存质量  SF-36中文量表  队列研究
文章编号:1001-1978(2004)06-0636-05
修稿时间:2004-01-03

Cohort study of quality of life (QOL) after 6 months of therapy by diclofenac,nabumetone,meloxicam or celecoxib in patients with rheumatoid arthritis
SHI Wen,WANG Yong-Ming,LI Shao-Li,YAN Min,LI Duan,CHEN Bin-Yan,CHENG Neng-Neng. Cohort study of quality of life (QOL) after 6 months of therapy by diclofenac,nabumetone,meloxicam or celecoxib in patients with rheumatoid arthritis[J]. Chinese Pharmacological Bulletin, 2004, 20(6): 636-640
Authors:SHI Wen  WANG Yong-Ming  LI Shao-Li  YAN Min  LI Duan  CHEN Bin-Yan  CHENG Neng-Neng
Affiliation:SHI Wen,WANG Yong-Ming,LI Shao-Li1,YAN Min1,LI Duan,CHEN Bin-Yan,CHENG Neng-Neng
Abstract:AIM To evaluate changes of QOL on patients with rheumatoid arthritis after six-month treatment of diclofenac, nabumetone, meloxicam and celecoxib respectively. METHODS With the combination of retrospective and prospective methods, the cohort study randomly enrolled 461 subjects with newly developed rheumatoid arthritis. The diclofenac group and nabumetone group each had 131 subjects, the meloxicam group had 144 subjects and celecoxib group had 55 subjects. The observation period was six months. SF-36 questionnaire was adopted to analyze changes in QOL-related variables including physical function, role physical, bodily pain, general health, vitality, social function, role emotional and mental health. RESULTS Except for "social function" and "role physical", where there were no significant differences in all four groups and the celecoxib group respectively, all other variables were improved significantly with the treatment of studied NSAIDs. Changes of considered variables were not statistically different across four groups. Analyzed by item, with six-month NSAID treatment, the diclofenac group made greater improvement than the celecoxib group in general health (Item 2), bodily pain (Item 7) and total SF-36 Questionnaire score. QOL improvement for those ranked as clinical control was significantly greater than the rest. Improvement was not statistically different between the marked improvement group and the improvement group, which both enjoyed greater improvement than the no effect group. CONCLUSION QOL improvement was discovered to be positively related to the drug's efficacy. SF-36 Questionnaire (Chinese version) is identified to be useful in the evaluation of QOL change. When analyzed by sub-questionnaire, patient's QOL all improved greatly with the treatment of studied four NSAIDs. Improvements were not substantially different across four groups. These were consistent with traditional efficacy evaluation results. Meanwhile, when analyzed by item, results of the study were somewhat different than those of traditional efficacy evaluation. The diclofenac group made greater improvement than the celecoxib group in general health, bodily pain and total SF-36 Questionnaire score.
Keywords:anti-inflammatory agents  non-steroidal agents  quality of life (QOL)  SF-36(Chinese version)  cohort study
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