对乙酰氨基酚与非甾体抗炎药治疗骨关节炎的疗效和安全性的观察
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R684.3

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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资助项目(项目号BKPJ0301)


THE EFFICACY AND SAFETY OF ACETAMINOPHEN VERSUS NSAIDs IN OSTEOARTHRITIS TREATMENT
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    摘要:

    目的:比较对乙酰氨基酚、双氯芬酸钠、美洛昔康和布洛芬治疗骨关节炎的疗效和安全性。方法:采用多中心、随机、对照研究方法。每组30例。其中对乙酰氨基酚组口服1300mg,bid;双氯芬酸钠组口服25mg,tid;美洛昔康组口服7.5mg,qd;布洛芬组口服300mg,bid,共观察4周。结果:对乙酰氨基酚组的有效率为73.33%,双氯芬酸钠组为76.67%,美洛昔康组为76.67%,布洛芬组为70.00%,各组有效率无显著差异;4组患者的SF-36生活质量评分部分项目治疗前后有显著差异。各组不良反应发生率无显著差异,但实验室检查显示肝功能均有不同程度影响,以3种非甾体抗炎药尤为显著。结论:经4种药物治疗,骨关节炎患者的症状和生活质量均有改善,但4种药物对肝功能有一定的影响,临床长期运用要注意安全。

    Abstract:

    Objective: To compare the efficacy and safety of acetaminophen, diclofenac, meloxicam and ibuprofen in treating osteoarthritis(OA) patients. Methods: A multi center, randomized, case control study was adopted. Acetaminophen group(n=30) took 1300mg, bid; diclofenac group(n=30) 25mg tid; meloxicam group(n=30) 7.5mg qd and ibuprofen group (n=30) 300mg bid. The total course of treatment was 4 weeks. Results: The efficacy of acetaminophen, diclofenac, meloxicam and ibuprofen was 73.33%, 76.67%, 76.67% and 70.00% respectively and there is no significant difference ( P <0.05). The quality of life scores evaluated by SF 36 were significantly improved ( P <0.05). There is no significant difference in adverse drug reactions in 4 groups, but the liver function was affected, especially in 3 NSAIDs treating groups. Conclusion: The symptoms and quality of life scores were significantly improved in 4 groups. But all drugs affect the liver function, so attention should be paid to patients, with long term drug use.

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施文 王永铭 李端 李少丽 颜敏 程能能 陈斌艳.对乙酰氨基酚与非甾体抗炎药治疗骨关节炎的疗效和安全性的观察[J].中国疼痛医学杂志,2004,10(6):327~331

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