Arendt-Racine E C, Atkinson M H, Decoteau W E, Flatt V L, Varady J
Clin Pharmacol Ther. 1978 Feb;23(2):233-40. doi: 10.1002/cpt1978232233.
The comparative efficacy and safety of naproxen and ibuprofen were studied in 64 patients with rheumatoid arthritis. A new trial design with three aspirin periods interspersed during the study was used. By passing a smooth curve through the values obtained for the various measures of disease activity during the aspirin periods, one could calculate the difference between what would have been expected on aspirin therapy and what was found during therapy with the two trial drugs. These differences, or "incremental values," allowed each patient's variations to be analyzed individually, thus eliminating the necessity of assuming that a patient's disease was constant. Napoxen and ibuprofen were comparable in efficacy to each other and to aspirin, but both drugs caused significantly less severe side effects than aspirin. Although analysis of the incremental values showed essentially the same results as a standard analysis of the raw data with only a modest increase in sensitivity in this particular study, the novel trial design may prove useful in future drug studies in patients with rheumatoid arthritis and other chronic but fluctuating diseases.
在64例类风湿性关节炎患者中研究了萘普生和布洛芬的疗效及安全性对比。本研究采用了一种新的试验设计，即在研究期间穿插三个使用阿司匹林的阶段。通过一条平滑曲线连接阿司匹林阶段所获得的各种疾病活动度测量值，可以计算出在阿司匹林治疗预期效果与两种试验药物治疗期间实际结果之间的差异。这些差异，即“增量值”，能够对每位患者的变化进行单独分析，从而无需假定患者的病情是恒定不变的。萘普生和布洛芬在疗效上彼此相当，且与阿司匹林相当，但两种药物所引起的副作用均明显不如阿司匹林严重。虽然对增量值的分析与对原始数据的标准分析显示的结果基本相同，只是在本特定研究中敏感性略有提高，但这种新颖的试验设计可能在未来针对类风湿性关节炎及其他慢性但病情波动疾病患者的药物研究中证明是有用的。
