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金诺芬与青霉胺:类风湿关节炎患者安全性和疗效的一年对比研究,随后是金诺芬的两年开放性评估。

Auranofin and D-penicillamine: a one year comparative study of safety and efficacy in patients with rheumatoid arthritis followed by a two year open assessment of auranofin.

作者信息

Franchimont P, Hauwaert C, Vanschoubroek K

出版信息

Clin Rheumatol. 1984 Mar;3 Suppl 1:75-82. doi: 10.1007/BF03342625.

Abstract

Forty-six patients with classical or definite rheumatoid arthritis participated in a prospective clinical trial comparing auranofin 6 mg/day (26 patients) with D-penicillamine 500 mg/day (20 patients) during one year. NSAIDs were also given throughout the study period. After the first year, patients receiving auranofin with a satisfactory response continued for a further two years with a reduced dose of 3 mg/day. However the 6 mg dose could be reinstituted in patients showing deterioration after dose reduction. This paper only discusses the long-term treatment with auranofin. Seven out of 26 patients did not complete the one year treatment period; three because they did not return to follow-up, one because of inefficacy, and 3 because of untoward events. During the second year 5 more patients discontinued treatment, one because he was lost to follow-up, two because of inefficacy, one because of untoward events and another one because of a surgical procedure of the left knee. Two more patients discontinued auranofin treatment during the third year, one because of a flare up of his disease activity, and one because of a rash. Statistically significant improvements in the number of tender joints, activity and articular indices, duration of morning stiffness, pain score and ESR were observed at each time analysed. Statistically significant reductions in the number of swollen joints were seen throughout the first two years of treatment. Increases in grip strength were statistically significant at 6, 24 and 30 months. A statistically significant reduction was seen after 6 months of treatment in serum IgA and IgM concentrations.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

46例典型或确诊类风湿关节炎患者参与了一项前瞻性临床试验,该试验比较了一年中每日服用6毫克金诺芬(26例患者)与每日服用500毫克青霉胺(20例患者)的疗效。在整个研究期间还给予了非甾体抗炎药。第一年结束后,对金诺芬治疗反应良好的患者继续服用两年,剂量减至每日3毫克。然而,在剂量减少后病情恶化的患者可恢复至6毫克的剂量。本文仅讨论金诺芬的长期治疗。26例患者中有7例未完成一年的治疗期;3例是因为未返回接受随访,1例是因为无效,3例是因为出现不良事件。在第二年,又有5例患者停止治疗,1例是因为失去随访,2例是因为无效,1例是因为出现不良事件,另1例是因为左膝进行了手术。在第三年,又有2例患者停止金诺芬治疗,1例是因为疾病活动突然加剧,1例是因为出现皮疹。在每次分析时,观察到压痛关节数、活动度和关节指数、晨僵持续时间、疼痛评分和血沉均有统计学意义的改善。在治疗的前两年,肿胀关节数有统计学意义的减少。握力在6个月、24个月和30个月时增加有统计学意义。治疗6个月后,血清IgA和IgM浓度有统计学意义的降低。(摘要截短至250字)

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An European open multicentre trial with auranofin in rheumatoid arthritis.
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