【摘要】 目的与方法:为了验证尼美舒利的临床疗效和安全性,采用随机双盲对照和开放共三组的Ⅱ期临床试验方案进行研究,对照药为萘普生(naproxen,NAP),观察骨性关节炎(osteoarthritis,OA),病人96例。结果:经4周治疗,尼美舒力对照组总有效率为93.3％(26/27),显效率为78.7％(21/27);萘普生总有效率为91.7％(22/24),显效率为58.3％(14/24);尼美舒利开放组总有效率为93.8％(30/32),显效率为78.1％(25/32),三组疗效接近,P>0.05,均无显著性差异。尼美舒利对照组的药物不良反应发生率为10％(3/30);萘普生的药物不良反应发生率为20％(6/30);尼美舒利开放组药物不良反应发生率为11％(4/36),P>0.05,均无显著性差异,但尼美舒利没有一例重度药物不良反应,而萘普生重度不良反应占16.7％,P<0.05,差异显著。结论:尼美舒利治疗骨性关节炎疗效明显,与萘普生的疗效相近,但药物不良反应发生率明显轻于萘普生。更多还原

【Abstract】 Nimesulide is a new type of non - steroid anti - inflammatory drug(NSAID). To verify the clinical efficacy and safety of the drug. We engaged in a phase 2 clinical trial which was a double - blind and randomly with an open - labeled Nimesulide group. The comparative drug was naproxen(NAP). The subjects included 96 patients with os-teoarthritis( OA). The result showed that, after 4 - week treatment, the total effective rate was 93.3% in group( Ga), 91.7% in NAP group(Gb), and 93.8% in open-labeled Nimesulide group (Gc), respectively. The efficacy was the same in the three groups (P>0.05). The rate of side effect was 10% , 20% and 11% in Ga. Gb. and Gc, respectively (P>0.05) .But the rate of serious side effect was higher (16.7% ) in Gb than Ga (P<0.05). We concluded that the efficacy of nimesulide was the same as NAP, but the rate of serious side effect was lower of nimesulide than that of NAP.更多还原