Hull R G, Morgan S H, Parke A L, Childs L, Goldman M, Hughes G R
Int J Clin Pharmacol Res. 1984;4(6):395-401.
Auranofin, an orally active gold preparation, was compared with sodium aurothiomalate in a double-blind trial in patients with rheumatoid arthritis fulfilling the ARA criteria, who had been stabilized on sodium aurothiomalate for at least six months. Twenty-four patients have so far been entered in the trial, of whom fourteen have been randomly allocated to receive auranofin and ten to receive sodium aurothiomalate. After initial stabilization, patients receive either auranofin 6 mg daily and placebo injection, or sodium aurothiomalate 50 mg monthly and placebo tablets. Five patients have completed one year on auranofin. The remaining nine patients were withdrawn because of loss of efficacy (two), side-effects, (five), loss of efficacy and side-effects (one) and default (one). Four patients have completed one year's treatment with sodium aurothiomalate. Of the remaining six patients, two were withdrawn because of side-effects, three because of poor disease control and one because of side-effects and poor disease control. Diarrhoea occurred in eight patients receiving auranofin. Rashes occurred in both groups but otherwise there were no serious side-effects. The efficacy of both drugs appeared similar, there being no significant differences in morning stiffness, fatiguability, visual analogue pain score, grip strength and articular index. There were also no significant differences in laboratory parameters of efficacy. Auranofin appears to control disease activity in rheumatoid arthritis but diarrhoea is a frequent side-effect.
金诺芬是一种口服有效的金制剂，在一项双盲试验中，将其与硫代苹果酸金钠进行了比较。试验对象为符合美国风湿病学会（ARA）标准的类风湿关节炎患者，这些患者已使用硫代苹果酸金钠稳定治疗至少六个月。到目前为止，已有24名患者进入该试验，其中14名被随机分配接受金诺芬治疗，10名接受硫代苹果酸金钠治疗。在初始稳定期后，患者要么每日服用6毫克金诺芬并注射安慰剂，要么每月注射50毫克硫代苹果酸金钠并服用安慰剂片。5名患者已完成一年的金诺芬治疗。其余9名患者因疗效丧失（2例）、副作用（5例）、疗效丧失和副作用（1例）以及未按规定治疗（1例）而退出。4名患者已完成一年的硫代苹果酸金钠治疗。其余6名患者中，2名因副作用退出，3名因疾病控制不佳退出，1名因副作用和疾病控制不佳退出。8名接受金诺芬治疗的患者出现腹泻。两组均出现皮疹，但除此之外没有严重的副作用。两种药物的疗效似乎相似，在晨僵、疲劳感、视觉模拟疼痛评分、握力和关节指数方面没有显著差异。在疗效的实验室参数方面也没有显著差异。金诺芬似乎可以控制类风湿关节炎的疾病活动，但腹泻是一种常见的副作用。
