Felix-Davies D D, Stewart A M, Wilkinson B R, Bateman J R, Delamere J P
Am J Med. 1983 Dec 30;75(6A):138-41. doi: 10.1016/0002-9343(83)90487-4.
The oral gold salt auranofin, 6 mg per day, was compared with oral d-penicillamine, 500 mg per day, in a single-blind trial in 40 patients suffering with definite or classic rheumatoid arthritis. The patients were randomly allocated into the two therapeutic regimens (19 patients auranofin; 21 patients d-penicillamine) and monitored at a minimum of four-week intervals during the first year of treatment. Significant diminution in rheumatoid disease activity, as assessed by numerous clinical and laboratory parameters, was observed in both the auranofin- and penicillamine-treated groups. No significant differences existed for these parameters between the two groups, either initially or at the end of the trial period. Ten patients were lost from the trial over the 52-week period. Three subjects were withdrawn from the auranofin-treated group (increasing severity of rheumatoid arthritis at four weeks; severe diarrhea at four weeks; probable drug-related erosive gastritis at 40 weeks). Seven subjects were permanently withdrawn from the penicillamine-treated group (four, skin rashes four to eight weeks; one, heavy proteinuria at 24 weeks; one, therapeutic failure at 32 weeks; one, compliance failure at eight weeks), and treatment was temporarily withheld in three further patients because of thrombocytopenia (two) and proteinuria (one). We conclude that both drugs are effective in rheumatoid arthritis and that the lesser toxicity with auranofin will make it a valuable addition to our therapeutic armamentarium.
在一项针对40例确诊或典型类风湿性关节炎患者的单盲试验中,对每日口服6毫克金盐硫代葡萄糖金与每日口服500毫克d-青霉胺进行了比较。患者被随机分配到两种治疗方案中(19例服用硫代葡萄糖金;21例服用d-青霉胺),并在治疗的第一年至少每四周进行一次监测。通过众多临床和实验室参数评估,在服用硫代葡萄糖金和青霉胺的两组患者中均观察到类风湿疾病活动度显著降低。在试验期开始时或结束时,两组之间这些参数均无显著差异。在52周的试验期内有10名患者退出试验。3名受试者从服用硫代葡萄糖金的治疗组中退出(4周时类风湿性关节炎病情加重;4周时严重腹泻;40周时可能与药物相关的糜烂性胃炎)。7名受试者从服用青霉胺的治疗组中永久退出(4名在4至8周出现皮疹;1名在24周出现重度蛋白尿;1名在32周治疗失败;1名在8周依从性差),另有3名患者因血小板减少(2名)和蛋白尿(1名)而暂时停止治疗。我们得出结论,两种药物对类风湿性关节炎均有效,且硫代葡萄糖金毒性较小,将成为我们治疗药物中的一种有价值的补充药物。