尼美舒利随机对照治疗类风湿关节炎171例

 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63.61%，67.95%和98.00%，Nap的总有效率分别为53.87%，59.68%和76.47%。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27.49％，3.77%，28.00%；Nap的不良反应发生率分别为32.14%，35.48%，43.13%。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，但无显著性差别。

A randomized, controlled clinical trial of nimesulide in the treatment of 171 cases of rheumatoid anthritis

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 givenpo 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.