Giannini E H, Brewer E J, Person D A
Ann Rheum Dis. 1984 Apr;43(2):228-31. doi: 10.1136/ard.43.2.228.
During an uncontrolled, open-labelled, open-ended clinical trial of auranofin in children with juvenile rheumatoid arthritis (JRA) we obtained serial blood samples for the purpose of assessing gold content. Our objectives were (1) to observe the pattern of blood gold concentrations over a period of time in children undergoing long-term oral gold therapy, and (2) to observe the effect of changing dosage levels on blood gold concentrations. The initial dosage of auranofin was 0.1 mg/kg/day with allowable increases to 0.2 mg/kg/day. A concurrent nonsteroidal anti-inflammatory drug was allowed. Twenty-one patients were enrolled in the study, and we obtained 2 or more serial samples on 13 of the children. At a constant dosage of 0.1 mg/kg/day, steady state blood gold concentrations were attained in 11 to 13 weeks of therapy and, in the absence of a dosage change, remained remarkably constant through extended periods. The blood gold concentration was related to total daily dosage rather than to the cumulative amount of gold received. Increasing or decreasing the dose resulted in a direct effect on concentration. The clinical value of blood gold levels resulting from auranofin therapy in JRA will have to be established through double-blind controlled trials.
在一项针对青少年类风湿性关节炎(JRA)患儿的金诺芬开放性、非对照、无期限临床试验中,我们采集了系列血样以评估金含量。我们的目的是:(1)观察长期接受口服金治疗的患儿在一段时间内血中金浓度的变化模式;(2)观察改变剂量水平对血中金浓度的影响。金诺芬的初始剂量为0.1mg/kg/天,允许增至0.2mg/kg/天。允许同时使用一种非甾体抗炎药。21名患者参与了该研究,我们对其中13名患儿采集了2份或更多系列样本。在0.1mg/kg/天的恒定剂量下,治疗11至13周时达到血中金浓度稳态,并且在未改变剂量的情况下,长时间内血中金浓度保持相当稳定。血中金浓度与每日总剂量相关,而非与所摄入金的累积量相关。增加或减少剂量会直接影响浓度。金诺芬治疗JRA所产生的血中金水平的临床价值必须通过双盲对照试验来确定。