Bird H A, Clarke A K, Fowler P D, Little S, Podgorski M R, Steiner J
Clinical Pharmacology Unit, Royal Bath Hospital, Harrogate, UK.
Clin Rheumatol. 1989 Dec;8(4):453-60. doi: 10.1007/BF02032096.
Fifty-eight patients, aged 48-87 years, with impaired renal function and mean initial creatinine clearance of 52.1 mls/min were recruited to a 12-week open study of tenoxicam 20 mg/day for osteoarthrosis or rheumatoid arthritis. Renal function was measured before and after a brief run-in period when patients discontinued all nonsteroidal anti-inflammatory drugs, taking paracetamol alone, prior to monthly monitoring thereafter. Fifty-four % of patients completed the study, the others being withdrawn from lack of efficacy (17%), adverse events (24%) or both (5%). During the run-in period the mean creatinine clearance of 28 patients completing the trial improved to 64.7 mls/min and then dropped to 57.9 mls/min during the course of 12 weeks treatment with tenoxicam. Serial analysis of haematological and biochemical safety parameters showed no drug-induced change of significance. Twenty-three% of patients felt worse and 45% better at the end of treatment. Seventeen patients withdrew because of adverse events. These were normally gastrointestinal and always unrelated to further deterioration in renal function. Tenoxicam, 20 mg/day, can be given safely for a period of at least three months in patients with mild or moderate renal impairment.
58名年龄在48至87岁之间、肾功能受损且平均初始肌酐清除率为52.1毫升/分钟的患者被纳入一项为期12周的开放性研究，该研究使用每天20毫克的替诺昔康治疗骨关节炎或类风湿性关节炎。在短暂的导入期前后测量肾功能，在此期间患者停用所有非甾体抗炎药，仅服用扑热息痛，此后每月进行监测。54%的患者完成了研究，其他患者因缺乏疗效（17%）、出现不良事件（24%）或两者皆有（5%）而退出。在导入期，完成试验的28名患者的平均肌酐清除率提高到64.7毫升/分钟，然后在使用替诺昔康治疗的12周期间降至57.9毫升/分钟。对血液学和生化安全参数的系列分析显示，没有药物引起的显著变化。23%的患者在治疗结束时感觉更糟，45%的患者感觉更好。17名患者因不良事件退出。这些不良事件通常是胃肠道方面的，且总是与肾功能的进一步恶化无关。对于轻度或中度肾功能损害的患者，每天20毫克的替诺昔康可以安全服用至少三个月。
