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为比较研究尼美舒利(NIM)和萘普生(NAP)治疗类风湿关节炎的疗效和安全性,将试验设计为随机、双盲、平行性和多中心的比较研究。试验组病例数为60例,每次口服尼美舒利100mg,每日二次,疗程2周,累积用药4周者28例;对照组病例数为61例,每次口服萘普生250mg,每日二次,疗程2周,累积用药4周者29例。结果表明,2、4周时尼美舒利的总有效率为53.33%,60.71%,萘普生的总有效率为47.54%、55.17%。两药均能改善患者的症状和体征。经安全性评价,尼美舒利和萘普生的耐受性相近,药物不良反应的发生以胃肠道系统为主。尼美舒利治疗类风湿关节炎的疗效与萘普生相近,两药的耐受性无明显差异。
To compare the efficacy and safety of nimesulide (NIM) and naproxen (NAP) in the treatment of rheumatoid arthritis, the trial was designed as a randomized, double-blind, parallel and multicenter comparative study. Test group, the number of cases was 60 cases, each oral nimesulide 100mg twice daily for 2 weeks, cumulative treatment of 4 weeks in 28 cases; control group, the number of cases was 61 cases, each oral naproxen 250mg, Two times a day, two weeks of treatment, cumulative medication for 4 weeks in 29 cases. The results showed that the total effective rate of nimesulide at 2 and 4 weeks was 53.33% and 60.71% respectively. The total effective rate of naproxen was 47.54% and 55.17% respectively. Both drugs can improve the patient’s symptoms and signs. The safety evaluation, nimesulide and naproxen are similar to the tolerance, the occurrence of adverse drug reactions to the gastrointestinal system. Nimesulide treatment of rheumatoid arthritis and naproxen efficacy similar to the two drugs no significant difference in tolerance.