Meinicke J, Danneskiold-Samsøe B
Scand J Rheumatol Suppl. 1980;35:1-8. doi: 10.3109/03009748009101380.
A double-blind, cross-over trial compared the antiinflammatory and analgesic effects as well as tolerability of diclofenac sodium (Voltaren) and ibuprofen. Twenty-four outpatients with rheumatoid arthritis were included. A single-blind placebo period was inserted between the two active treatments. The daily dose of diclofenac sodium was 50 mg bid and that of ibuprofen 400 mg tid. The duration of each treatment period was 14 days. The efficacy was measured by the following criteria: Articular index (Lansbury), morning stiffness, fatigue, pain (measured on a visual analogue scale), consumption of rescue-analgesics, status of the arthritic condition, and patient preference. No significant differences were found between diclofenac sodium and ibuprofen, but regarding consumption of analgesic, global evaluation, rheumatic activity, and activity index, a slight trend towards a better effect of diclofenac sodium was found. The study had an adequate sensitivity as it could distinguish placebo from the active treatments for all parameters evaluated. No patient was withdrawn for unwanted effects. None of the laboratory data showed abnormalities of clinical relevance.
一项双盲交叉试验比较了双氯芬酸钠（扶他林）和布洛芬的抗炎、镇痛作用以及耐受性。纳入了24名类风湿性关节炎门诊患者。在两种活性治疗之间插入了一个单盲安慰剂期。双氯芬酸钠的日剂量为50毫克，每日两次，布洛芬的日剂量为400毫克，每日三次。每个治疗期持续14天。通过以下标准测量疗效：关节指数（兰斯伯里）、晨僵、疲劳、疼痛（采用视觉模拟评分法测量）、急救镇痛药的消耗量、关节炎病情状况以及患者偏好。双氯芬酸钠和布洛芬之间未发现显著差异，但在镇痛药消耗量、总体评估、风湿活动和活动指数方面，发现双氯芬酸钠有稍好疗效的轻微趋势。该研究具有足够的敏感性，因为对于所有评估参数，它都能区分安慰剂和活性治疗。没有患者因不良反应而退出。所有实验室数据均未显示具有临床相关性的异常。
