尼美舒利和萘普生治疗类风湿关节炎的临床研究

目的 :比较研究尼美舒利和萘普生治疗类风湿关节炎的疗效和安全性。方法 :为随机、双盲、平行的比较研究。共完成病例 6 0例 ,尼美舒利和萘普生各 30例。口服尼美舒利 10 0mg每天两次 ;萘普生 2 5 0mg每天两次 ,疗程 4周 ,连用 2个疗程。结果 :4周、8周时尼美舒利总有效率为 5 6 78% ,6 0 71% ;萘普生为 6 0 71% ,6 4 2 9% ,两药均能显著改善患者的症状和体征 ,降低血沉与C -反应蛋白。安全性评价 :两药耐受性无明显差异 ,但不良反应发生率 :尼美舒利 13 33 % ;萘普生 2 6 6 7% ;不良反应主要为消化道症状及皮疹 ,水肿等。尼美舒利不良反应轻 ,一般不予处理或仅给对症处理 ,不需停药 ;萘普生有 2例因不良反应而停药 (皮疹 ,胃痛各 1例 )。结论 :尼美舒利治疗类风湿关节炎疗效与萘普生相近 ,但不良反应发生率较低且症状较轻

A double- blind, controlled clinical study of nimesulide and naproxen in the treatment of rheumatoid arthritis

Objective:To evaluate the efficacy and safety of nimesulide and naproxen in the treatment of patients with rheumatoid arthritis.Methods:Double-blind,randomized,controlled clinical trial of nimesulide versus naproxen was performed.Sixty patients (30 pairs) were given po with nimesulide 100 mg twice daily or naproxen 250 mg twice daily for 8 weeks.Results:Nimesulide and naproxen could improve the symptoms and signs of rheumatoid arthritis,decrease ESR and C-reactive protein levels.The total efficacy retes of nimesulide were 56 78%,60 71%;and the naproxen were 60 71%,64 29% after 4 and 8 weeks treatment,respectively.The incedence of adverse effects of nimesulide were 13.33%;and the naproxen were 26.67%.Main adverse effects were symptoms of gastrointestinal tract,edema and rashes.The adverse effects of nimesulide were mild and none ceased treatment.Tow cases with naproxen were ceased treatment for severe adverse effect (the one was stomache-ache and nausea,other was severe rashes).Conclusion:Nimesulide has a similar efficacy rates with naproxen in the treatment of rheumatoid arthritis.The tolerance of nimesulide is better,because its adverse effects were lower and milder than naproxen.