尼美舒利治疗类风湿关节炎的临床研究

Clinical study of nimesulide in the treatment of rheumatoid arthritis

目的 研究新型非甾体类抗炎药尼美舒利治疗类风湿关节炎 (rheumatoidarthritis,RA)的疗效及安全性。方法 在全国范围内组织了开放性、多中心临床试验 ,采用随机试验方法 ,研究了尼美舒利对 6 4 6例RA病人的疗效、耐受性及不良反应。尼美舒利口服 1 0 0mg ,1d 2次 ,疗程为 4wk ,其中30 2例病人连用 8wk。结果 4wk时治疗 6 4 6例RA病人的总有效率为 84 2 1 % ,8wk时治疗 30 2例病人的总有效率为94 70 %。 4wk时 6 4 6例中不良反应发生率为 1 7 4 9% ,其中 ,2例为重度不良反应 ,1 4例为中度不良反应 ,其余为轻度。 8wk时 30 2例中不良反应发生率为 1 8 5 4 % ,其中 7例为中度不良反应 ,余为轻度。结论 尼美舒利治疗RA疗效明显且安全性较好。

AIM To evaluate the efficacy and safety of nimesulide in the treatment of rheumatoid arthritis(RA). METHODS An open and multi centre clinical trial in the whole country was performed to study the efficacy and safety of nimesulide on 646 RA patients. These patients were given orally with nimesulide 100 mg twice a day for 4 weeks, of whom 302 were picked out and given nimesulide for another 4 weeks. RESULTS The total efficacy rates of nimesulide were 84 21% after 4 week treatment and 94 70% after 8 week treatment. In the 646 cases, the incidence of adverse reaction of nimesulide was 17 49% after 4 week treatment. Severe adverse reaction occurred in 2 cases.14 had mild adverse reaction and the rest had slight adverse reation. After 8 weeks, the incidence of adverse reaction in the 302 cases was 18 54%, among including, 7 mild and 47 slight case of adverse reaction. CONCLUSION Nimesulide exhibited remarkable efficacy and safety in the treatment of RA.