Manthorpe R, Hørbov S, Sylvest J, Vinterberg H
Scand J Rheumatol. 1986;15(1):13-22. doi: 10.3109/03009748609092663.
Forty patients with definite or classical active rheumatoid arthritis were stratified by the minimization procedure to auranofin (6 mg/day) or penicillamine (go slow and low regime). This investigation is a prospective planned 3 year patient and 'doctor-open' as well as 'doctor-blind' clinical trial. This article describes the results after 12 months. Both drugs decreased disease activity and improved the functional capacity in a similar way. Two patients in the auranofin group and 5 in the penicillamine group stopped treatment due to major side effects. Four other patients in the auranofin group left treatment: 2 due to death from unrelated cause and 2 according to the Helsinki II Declaration. After one year a further patient in the auranofin group and 2 in the penicillamine group stopped treatment due to lack of clinical effect. Side effects due to auranofin were statistically more frequent distal in the gastrointestinal tract (loose stools/diarrhoea) than with penicillamine. In contrast, penicillamine produced significantly more side effects in the oral cavity (mainly taste disturbances) than auranofin. Other side effects were about equal in the two groups, but 2 cases of severe proteinuria and one with obstructive lung disease were observed in the penicillamine group. Only 3 patients did not complain of any untoward effect during the 12-month period. We conclude that on the basis of this one year investigation it is an open question whether one should select auranofin or penicillamine for the treatment of clinical active rheumatoid arthritis.
40例确诊或典型的活动性类风湿关节炎患者通过最小化程序被分层至金诺芬组（6毫克/天）或青霉胺组（缓慢递增和低剂量方案）。本研究是一项前瞻性计划的为期3年的患者、“医生开放”以及“医生盲法”的临床试验。本文描述了12个月后的结果。两种药物以相似的方式降低了疾病活动度并改善了功能能力。金诺芬组有2例患者和青霉胺组有5例患者因严重副作用停止治疗。金诺芬组另有4例患者停止治疗：2例因无关原因死亡，2例根据赫尔辛基宣言。1年后，金诺芬组又有1例患者和青霉胺组有2例患者因缺乏临床效果停止治疗。金诺芬引起的副作用在胃肠道远端（腹泻）在统计学上比青霉胺更频繁。相比之下，青霉胺在口腔产生的副作用（主要是味觉障碍）比金诺芬明显更多。两组的其他副作用大致相当，但青霉胺组观察到2例严重蛋白尿和1例阻塞性肺病。在12个月期间，只有3例患者未抱怨任何不良反应。我们得出结论，基于这一年的研究，对于临床活动性类风湿关节炎的治疗，选择金诺芬还是青霉胺仍是一个未决问题。
