Brenol J C, Chahade W, De Freitas G G, De Pádua P M, Rachid A, Samara A, Seda H, Ximenes A C
Scand J Rheumatol Suppl. 1986;63:37-45.
An open, noncomparative study at 8 rheumatology centers in Brazil assessed the efficacy and safety of auranofin (AF) when given for up to 24 months. The study enrolled 80 patients with classic or definite rheumatoid arthritis (RA); disease was severe in 20 (25%), moderate in 55 (69%), and mild in 5 (6%). Patients received auranofin, 3 mg twice daily, and varying doses of anti-inflammatory drugs (aspirin, nonsteroidal anti-inflammatory drugs, and corticosteroids). Sixty patients (75%) completed the full 24 months of therapy. No patients were withdrawn from therapy because of insufficient therapeutic effect. There was statistically significant improvement (p less than 0.001) in 9 clinical parameters of disease activity, evident as early as 3 months after beginning AF therapy, increasing steadily over 12 months, and remaining at improved levels for another 12 months. Improvements in some parameters were particularly striking. By 24 months, assessment of well-being had increased by 150%, intensity of pain had decreased by 66%, and duration of morning stiffness had decreased by 78%. The average daily dose of anti-inflammatory drugs also decreased over time. The safety profile of AF was similar to that found in comparable trials. Ten patients (12.5%) were withdrawn because of adverse events: 6 for diarrhea (7.5%), 2 for proteinuria (2.5%), and 1 each for pruritus and anemia (1.25%). Adverse events occurred in 24 of 80 patients; some reported more than one adverse event. The most common adverse events were loose stools (20 patients) or diarrhea (11 patients).(ABSTRACT TRUNCATED AT 250 WORDS)
巴西8个风湿病中心开展的一项开放性、非对照研究评估了金诺芬（AF）使用长达24个月时的疗效和安全性。该研究纳入了80例典型或确诊类风湿关节炎（RA）患者；其中20例（25%）病情严重，55例（69%）病情中等，5例（6%）病情轻微。患者接受每日两次、每次3 mg的金诺芬治疗，并使用不同剂量的抗炎药（阿司匹林、非甾体抗炎药和皮质类固醇）。60例患者（75%）完成了24个月的完整治疗。没有患者因治疗效果不佳而退出治疗。疾病活动的9项临床参数有统计学意义的改善（p<0.001），早在开始AF治疗3个月后就很明显，在12个月内稳步增加，并在接下来的12个月保持改善水平。一些参数的改善尤为显著。到24个月时，健康评估增加了150%，疼痛强度降低了66%，晨僵持续时间降低了78%。抗炎药的平均日剂量也随时间减少。AF的安全性与类似试验中的情况相似。10例患者（12.5%）因不良事件退出：6例因腹泻（占7.5%），2例因蛋白尿（占2.5%），1例因瘙痒和贫血（各占1.25%）。80例患者中有24例发生不良事件；一些患者报告不止一种不良事件。最常见的不良事件是大便溏稀（20例患者）或腹泻（11例患者）。（摘要截断于250字）
