Alexander S J
Arch Intern Med. 1975 Nov;135(11):1429-35.
A total of 42 patients participated in three controlled clinical trials, each of different design, to demonstrate the efficacy and safety of naproxen in the treatment of rheumatodi arthritis. First, a double-blind comparison of aspirin and naproxen was made in 24 patients. As judged by objective and subjective measurements of disease activity, naproxen was at least as effective as aspirin and the incidence of severity of side effects were less with naproxen than with aspirin. Second, the safety and efficacy of naproxen administration was followed in 42 patients for up to two years. Third, the continued efficacy of naproxen during these two years was tested by interspersing a short period of double-blind placebo administration for some patients. The observations made in this clinical study suggest that naproxen is an effective and well-tolerated drug in the long-term treatment of rheumatoid arthritis.
共有42名患者参与了三项对照临床试验，每项试验设计不同，目的是证明萘普生治疗类风湿性关节炎的有效性和安全性。首先，对24名患者进行了阿司匹林和萘普生的双盲比较。根据疾病活动的客观和主观测量判断，萘普生至少与阿司匹林一样有效，且萘普生副作用的严重程度发生率低于阿司匹林。其次，对42名患者进行了长达两年的萘普生给药安全性和有效性跟踪。第三，通过对部分患者穿插短期双盲安慰剂给药，测试了萘普生在这两年期间的持续疗效。这项临床研究中的观察结果表明，萘普生在类风湿性关节炎的长期治疗中是一种有效且耐受性良好的药物。
