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金诺芬治疗青少年类风湿性关节炎:五年开放标签扩展试验的结果

Auranofin therapy for juvenile rheumatoid arthritis: results of the five-year open label extension trial.

作者信息

Giannini E H, Barron K S, Spencer C H, Person D A, Baum J, Bernstein B H, Kredich D W, Jacobs J C, Zemel L S, Gibbas D

机构信息

Division of Rheumatology, Children's Hospital Medical Center, Cincinnati, OH 45229.

出版信息

J Rheumatol. 1991 Aug;18(8):1240-2.

PMID:1941832
Abstract

Eighty-eight children with juvenile rheumatoid arthritis (JRA) who completed a double blind, randomized placebo controlled trial of oral gold were entered into an open label extension phase during which they received auranofin (AF) at a dosage of 0.15-0.2 mg/kg/day (9 mg/day maximum). Eleven (12.5%) patients completed 5 years of AF therapy; 77 (87.5%) did not. Fifteen (17%) of the 88 were in disease remission at the final visit. Mean duration of therapy for those who discontinued was 646 days. Parental/patient decision and insufficient therapeutic effect were the 2 most frequent reasons for early termination, followed by adverse effects. Though relatively well tolerated, AF provides adequate longterm management for only a small percentage of patients with JRA.

摘要

88名完成口服金制剂双盲随机安慰剂对照试验的幼年类风湿性关节炎(JRA)患儿进入开放标签延长期,在此期间他们接受金诺芬(AF)治疗,剂量为0.15 - 0.2毫克/千克/天(最大9毫克/天)。11名(12.5%)患者完成了5年的AF治疗;77名(87.5%)未完成。88名患者中有15名(17%)在最后一次随访时疾病缓解。停药患者的平均治疗持续时间为646天。家长/患者的决定和治疗效果不佳是早期终止治疗的两个最常见原因,其次是不良反应。尽管AF耐受性相对较好,但仅能为一小部分JRA患者提供充分的长期治疗。

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