摘要
目的：比较研究尼美舒利（Ｎｉｍ）和萘普生（Ｎａｐ）治疗类风湿关节炎的疗效和安全性。方法：试验设计为随机、对照、平行性和多中心的比较研究。试验组病例数为１７１例，其中双盲试验６０例，单盲试验１１１例，每次ｐｏＮｉｍ１００ｍｇ·，ｂｉｄ，疗程２周，累积用药４周者７８例，１２周者５０例；对照组病例数为１１２例，其中双盲试验６１例，单盲试验５１例，每次ｐｏＮａｐ２５０ｍｇ·，ｂｉｄ，疗程２周，累积用药４周者６２例，１２周者５１例。结果：２，４，８周时Ｎｉｍ的总有效率分别为６３６１％，６７９５％和９８００％，Ｎａｐ的总有效率分别为５３５７％，５９６８％和７６４７％。两药均能显著改善患者的症状和体征，降低血沉、Ｃ反应蛋白水平。经安全性评价：Ｎｉｍ和Ｎａｐ的耐受性相似，２，４，１２周时Ｎｉｍ的不良反应发生率分别为２７４９％，３０７７％，２８００％；Ｎａｐ的不良反应发生率分别为３２１４％，３５４８％，４３１３％。结论：Ｎｉｍ治疗类风湿关节炎的疗效在２，４周时与Ｎａｐ相近，在１２周时好于Ｎａｐ；Ｎｉｍ的不良反应发生率稍低于Ｎｉｍ。
OBJECTIVE:To evaluate the efficacy and safety of nimesulide and naproxen in the treatment of patients with rheumatoid arthritis. METHODS:Randomized, double or single blind, controlled and multi centre clinical trial of nimesulide versus naproxen was performed. One hundred and seventy one patients were given po with nimesulide 100 mg twice daily for 2 weeks and another 112 patients were given po with naproxen 250 mg twice daily for 2 weeks. There are 78 patients treated for 4 weeks and 50 patients for 12 weeks in the nimesulide group and 62 patients treated for 4 weeks and 51 patients for 12 weeks in the naproxen group. RESULTS:Nimesulide and naproxen could improve the symptoms and signs of rheumatoid arthritis, decrease ESR and C reactive protein levels. The total efficacy rates of nemesulide were 63 16%,67 95% and 98 00% after 2, 4 and 12 week treatment respectively. The total efficacy rates of naproxen were 53 57%, 59 68% and 76 47% after 2,4 and 12 week treatment, respectively. The incidences of adverse effects of nimesulide were 27 49%,30 77% and 28 00% after 2,4 and 12 week treatment. The incidences of adverse effects of naproxen were 32 14%,35 48% and 43 13% after 2, 4 and 12 week treatment. Their adverse effects were mild in intensity and predominant in the gastrointestinal tract. CONCLUSION:Nimesulide has a similar efficacy rates with naproxen in the treatment of rheumatoid arthritis for 2 and 4 weeks, but its efficacy rate is more highly significant than that of naproxen after 12 week treatment. The tolerance of nimesulide is better, but there is no significant difference campared with naproxen.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1998年第12期752-755,共4页
Chinese Pharmaceutical Journal
关键词
尼美舒利
类风湿性关节炎
疗效
安全性
nimesulide, naproxen, rheumatoid, arthritis, random, control
