Ejstrup L, Knudsen J V, Petersen L
Department of Rheumatology, Skive Hospital, Roche, Denmark.
Scand J Rheumatol Suppl. 1989;80:48-53. doi: 10.3109/03009748909103712.
A double-blind multicentre study was conducted to compare the efficacy and safety of tenoxicam and ketoprofen in the treatment of osteoarthritis (OA). The study comprised 307 patients and the treatment period was 12 weeks. One-hundred and fifty-five patients received 20 mg tenoxicam once-daily and 152 patients received 100 mg ketoprofen b.i.d. Seventy-seven patients were prematurely withdrawn; 32 patients in the tenoxicam group and 45 in the ketoprofen group (p less than 0.05). There were only small insignificant differences in the efficacy parameters with the exception that significantly more patients in the tenoxicam group took paracetamol tablets during treatment. Adverse events developed in 29.0% of the patients on tenoxicam and in 47.3% of the patients on ketoprofen, this difference was statistically significant (p less than 0.05). The adverse events were predominantly from the gastrointestinal tract and the central nervous system. No serious side-effects occurred and the laboratory parameters showed no clinically relevant changes. The investigator's overall impression of treatment showed no significant difference between groups. Excellent or good results were judged in 55.2% of the patients on tenoxicam and in 62.1% on ketoprofen (p greater than 0.05). Tenoxicam appears to have a reasonable balance between efficacy and side-effects in the treatment of OA.
进行了一项双盲多中心研究，以比较替诺昔康和酮洛芬治疗骨关节炎（OA）的疗效和安全性。该研究包括307名患者，治疗期为12周。155名患者每日一次接受20mg替诺昔康治疗，152名患者每日两次接受100mg酮洛芬治疗。77名患者提前退出研究；替诺昔康组32名，酮洛芬组45名（p<0.05）。除了替诺昔康组在治疗期间服用对乙酰氨基酚片的患者明显更多外，疗效参数方面只有微小的无显著差异。替诺昔康组29.0%的患者出现不良事件，酮洛芬组47.3%的患者出现不良事件，这种差异具有统计学意义（p<0.05）。不良事件主要来自胃肠道和中枢神经系统。未发生严重副作用，实验室参数也未显示出临床相关变化。研究者对治疗的总体印象显示两组之间无显著差异。替诺昔康组55.2%的患者和酮洛芬组62.1%的患者被判定为治疗效果优秀或良好（p>0.05）。在OA治疗中，替诺昔康在疗效和副作用之间似乎具有合理的平衡。
