Bird H A, Hill J, Sitton N G, Dixon J S, Wright V
Clinical Pharmacology Unit, Royal Bath Hospital, Harrogate, UK.
Rheumatol Int. 1988;8(2):55-9. doi: 10.1007/BF00271835.
Etretinate (Tigason; Roche), which is effective in the treatment of psoriatic arthritis has immunomodulating activity in vivo. We have therefore assessed this drug in an open clinical and biochemical assessment of 24 weeks duration in rheumatoid arthritis. The treatment dose was 1.0 mg/kg/day for the first 4 weeks reducing to 0.5 mg/kg/day thereafter. There was a modest clinical improvement though this only reached statistical significance for joint circumference at 12 and 16 weeks (P less than 0.05). Biochemical improvement only reached levels of statistical significance for IgM at week 16 (P less than 0.01). Eight out of 15 patients had discontinued the drug because of side-effects by week 12 and only three out of 15 patients showed individual improvement by week 24. Some biochemical parameters (ESR) worsened. These results suggest only modest clinical efficacy and use of the drug in rheumatoid arthritis is likely to be curtailed by unacceptable side-effects. The improvement in biochemical variables that occurs when the drug is used in psoriatic arthritis does not occur in rheumatoid arthritis.
依曲替酯(银屑灵;罗氏公司生产)对银屑病关节炎有效,在体内具有免疫调节活性。因此,我们对类风湿关节炎患者进行了一项为期24周的开放临床和生化评估,以评估该药物。治疗剂量为前4周1.0毫克/千克/天,之后减至0.5毫克/千克/天。临床有一定程度的改善,但仅在第12周和第16周时关节周长的改善达到统计学显著性(P小于0.05)。生化指标的改善仅在第16周时IgM达到统计学显著水平(P小于0.01)。到第12周时,15名患者中有8名因副作用停药,到第24周时,15名患者中只有3名有个体改善。一些生化参数(血沉)恶化。这些结果表明临床疗效有限,该药物在类风湿关节炎中的应用可能会因不可接受的副作用而受限。该药物用于银屑病关节炎时出现的生化指标改善在类风湿关节炎中并未出现。