Wober W, Rahlfs V W, Büchl N, Grässle A, Macciocchi A
Institute for Clinical Research of MIM, Munich, Germany.
Int J Clin Pract. 1998 Apr-May;52(3):169-75.
The efficacy and tolerability of nimesulide, a non-steroidal anti-inflammatory drug (NSAID) 100 mg twice daily were compared with diclofenac 75 mg b.i.d. in short term treatment of acute shoulder (acute subdeltoid bursitis and bicipital tendinitis) in adult patients. In this double-blind (double-dummy), randomised, parallel group study over two weeks, 122 patients were included. The Mann-Whitney statistics revealed therapeutic equivalence of both treatments with a slight superiority for nimesulide. The tolerability of nimesulide, judged by investigators and patients and analysed statistically, was superior to that of diclofenac. Thus, the benefit-risk relationship was better for the test drug than for the reference drug.
在成年患者急性肩部疾病(急性肩峰下滑囊炎和肱二头肌肌腱炎)的短期治疗中,对每日两次服用100毫克非甾体抗炎药(NSAID)尼美舒利与每日两次服用75毫克双氯芬酸的疗效和耐受性进行了比较。在这项为期两周的双盲(双模拟)、随机、平行组研究中,纳入了122名患者。曼-惠特尼统计显示两种治疗具有治疗等效性,尼美舒利略具优势。经研究者和患者判断并进行统计学分析,尼美舒利的耐受性优于双氯芬酸。因此,试验药物的效益风险比优于参比药物。