Lewis D, Capell H A
Clin Rheumatol. 1984 Mar;3 Suppl 1:83-96. doi: 10.1007/BF03342626.
The therapeutic and toxic effects of the orally absorbed gold compound auranofin have been compared with placebo and parenterally administered sodium aurothiomalate (GST) in 90 patients with active rheumatoid arthritis over one year. At the end of this period 57% of patients on auranofin, 73% on GST and 0% on placebo remained on therapy. Toxicity caused discontinuation of therapy in 10% of patients on auranofin, 20% on GST and 7% on placebo. Lack of response to therapy led to withdrawal of 20% on auranofin, 0% on GST and 90% on placebo. Multiple clinical and biochemical assessments were performed during this study. Analysing them separately, and in the case of 6 of them grouped together in a disease activity index, the same trend is apparent throughout, namely that placebo has no effect on active inflammatory rheumatoid arthritis, and that both gold drugs are beneficial. GST has an earlier effect and tends to produce a greater change but after one year there was no significant difference between the 2 gold drugs for any parameter assessed. Gold levels in plasma or erythrocytes did not predict or correlate with either the development of toxicity or clinical efficacy. This study has demonstrated the second-line potential of auranofin which seems to be effective at gold concentrations in the blood below those observed with GST therapy. Toxicity limits the use of gold salts in RA. If the reduced incidence of adverse reaction with auranofin observed in this study is substantiated in larger numbers over prolonged periods, the use of gold at an earlier stage of disease may be facilitated.
在一项为期一年的研究中,对90例活动性类风湿关节炎患者口服吸收的金化合物金诺芬的治疗效果和毒性作用,与安慰剂及胃肠外给药的硫代苹果酸金钠(GST)进行了比较。在这一阶段结束时,服用金诺芬的患者中有57%、服用GST的患者中有73%、服用安慰剂的患者中有0%仍在接受治疗。毒性导致服用金诺芬的患者中有10%、服用GST的患者中有20%、服用安慰剂的患者中有7%停止治疗。对治疗无反应导致服用金诺芬的患者中有20%、服用GST的患者中有0%、服用安慰剂的患者中有90%退出治疗。在这项研究中进行了多次临床和生化评估。分别分析这些评估结果,其中6项合并在一个疾病活动指数中,整个过程呈现相同的趋势,即安慰剂对活动性炎性类风湿关节炎无作用,两种金制剂均有益。GST起效较早,且往往产生更大的变化,但一年后,两种金制剂在任何评估参数上均无显著差异。血浆或红细胞中的金水平不能预测毒性的发生或与临床疗效相关。这项研究证明了金诺芬作为二线药物的潜力,其似乎在血液中的金浓度低于GST治疗时所观察到的浓度时仍有效。毒性限制了金盐在类风湿关节炎中的应用。如果本研究中观察到的金诺芬不良反应发生率降低在更长时间内的大量研究中得到证实,可能会促进在疾病早期使用金制剂。