Williams H J, Ward J R, Egger M J, Reading J C, Samuelson C O, Altz-Smith M, Willkens R W, Solsky M A, Hayes S P, Furst D
Clin Rheumatol. 1984 Mar;3 Suppl 1:39-50. doi: 10.1007/BF03342621.
Two hundred eight patients were studied in a prospective, controlled, double-blind multicenter trial comparing auranofin (AUR), gold sodium thiomalate (GST), and placebo. One hundred sixty-one patients completed at least 20 weeks of therapy. Response to a variety of measures of efficacy was generally modest for both gold treatment groups although improvement was continuing in both groups at the end of the study. There was statistically significant improvement with both gold preparations compared to placebo for the number of tender joints, the joint tenderness score, and physician assessment of disease severity. GST was also significantly better than placebo for the joint swelling score. GST demonstrated more improvement in patients with anemia and thrombocytosis compared to the other treatment groups and both gold preparations were superior to placebo in improvement of an elevated erythrocyte sedimentation rate. Twenty-seven percent of patients on GST were withdrawn from the study for adverse drug reaction with rash and stomatitis being the predominant cause. Only 6% of patients on AUR were withdrawn for untoward drug effect. The time of onset of the adverse reactions is discussed. The two gold preparations were similar in efficacy although AUR was better tolerated.
在一项前瞻性、对照、双盲多中心试验中，对208例患者进行了研究，比较了金诺芬（AUR）、硫代苹果酸金钠（GST）和安慰剂。161例患者完成了至少20周的治疗。尽管在研究结束时两个金治疗组仍在持续改善，但两个金治疗组对各种疗效指标的反应总体较为一般。与安慰剂相比，两种金制剂在压痛关节数、关节压痛评分和医生对疾病严重程度的评估方面均有统计学意义的改善。GST在关节肿胀评分方面也显著优于安慰剂。与其他治疗组相比，GST在贫血和血小板增多症患者中显示出更多改善，且两种金制剂在改善红细胞沉降率升高方面均优于安慰剂。27%接受GST治疗的患者因药物不良反应退出研究，皮疹和口腔炎是主要原因。接受AUR治疗的患者中只有6%因药物不良反应退出。讨论了不良反应的发生时间。两种金制剂疗效相似，但AUR耐受性更好。
