Lecomte J, Buyse H, Taymans J, Monti T
Centre de Médecine et de Traumatologie Sportive, Charleroi, Belgium.
Eur J Rheumatol Inflamm. 1994;14(4):29-32.
The clinical efficacy and the tolerability of nimesulide (100 mg bid) and naproxen sodium (550 mg bid) in the treatment of tendinitis and bursitis were evaluated in a multicentre double-blind study over a 14-day period. Two hundred and five patients were included in the study. Patients randomised to one of two parallel treatment groups. They were clinically examined at days 1, 7 and 14. Blood analysis was performed at day 1 and at the end of the treatment. The main efficacy criterion was the diminution of pain during active mobilisation measured using a visual analogue scale. The improvement of the scores was obvious and similar between the two groups. The secondary efficacy criteria (pain during motion against resistance, functional impairment and global assessment of efficacy) confirmed these favourable results and did not evidence any statistical difference between the two groups. The side effects observed were mainly gastrointestinal. Their frequency and intensity were slightly higher in the naproxen sodium group but without any statistically significant difference (28 complaints in 16 patients in the nimesulide group and 33 complaints in 22 patients in the naproxen group). There was no statistical difference between the two treated groups regarding the general clinical examination and the biological follow-up.
在一项为期14天的多中心双盲研究中,评估了尼美舒利(100毫克,每日两次)和萘普生钠(550毫克,每日两次)治疗肌腱炎和滑囊炎的临床疗效及耐受性。该研究纳入了205例患者。患者被随机分配至两个平行治疗组之一。在第1、7和14天进行临床检查。在第1天和治疗结束时进行血液分析。主要疗效标准是使用视觉模拟量表测量主动活动时疼痛的减轻程度。两组的评分改善情况明显且相似。次要疗效标准(抗阻力运动时的疼痛、功能障碍和疗效总体评估)证实了这些良好结果,且两组之间未显示出任何统计学差异。观察到的副作用主要为胃肠道方面的。其发生率和严重程度在萘普生钠组略高,但无任何统计学显著差异(尼美舒利组16例患者有28次不适,萘普生组22例患者有33次不适)。在一般临床检查和生物学随访方面,两个治疗组之间无统计学差异。