Husby G, Holme I, Rugstad H E, Herland O B, Giercksky K E
Clin Rheumatol. 1986 Jan;5(1):84-91. doi: 10.1007/BF02030974.
A multicentre, double-blind study of unprecedented size was conducted to compare the safety and efficacy of piroxicam and naproxen in the treatment of osteoarthritis. The study comprised 2,035 patients and a treatment period of 12 weeks. The dosage was 20 mg piroxicam and 750 mg naproxen daily with the option to reduce to 10 and 500 mg, respectively, at week 4 or 8. No major difference between the drugs was observed with regard to overall incidence of adverse events. The frequency of serious adverse events was about 1% for both drugs. A statistically significant decline of adverse events with age was found in both sexes. Piroxicam was significantly superior to naproxen for pain at rest and pain on movement at 12 weeks and degree of restriction in daily activity at 4 weeks. A significantly increasing beneficial effect was observed with both drugs between 4 and 12 weeks of treatment. The comparable safety observed for the two drugs is in contrast to perceptions based on spontaneous reports to official monitoring systems.
一项规模空前的多中心双盲研究开展，以比较吡罗昔康和萘普生治疗骨关节炎的安全性和有效性。该研究纳入2035名患者，治疗期为12周。剂量为每日20毫克吡罗昔康和750毫克萘普生，在第4周或第8周可分别减至10毫克和500毫克。在不良事件的总体发生率方面，未观察到两种药物之间存在重大差异。两种药物的严重不良事件发生率约为1%。在两性中均发现不良事件随年龄有统计学意义的下降。在12周时，吡罗昔康在静息痛、运动痛以及4周时的日常活动受限程度方面显著优于萘普生。在治疗的4至12周期间，两种药物均观察到有益效果显著增加。两种药物观察到的可比安全性与基于向官方监测系统的自发报告形成的认知相反。
