Heydendael Vera M R, Spuls Phyllis I, Opmeer Brent C, de Borgie Corianne A J M, Reitsma Johannes B, Goldschmidt Wouter F M, Bossuyt Patrick M M, Bos Jan D, de Rie Menno A
Department of Dermatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
N Engl J Med. 2003 Aug 14;349(7):658-65. doi: 10.1056/NEJMoa021359.
Methotrexate and cyclosporine are well-known systemic therapies for moderate-to-severe chronic plaque psoriasis. We conducted a randomized, controlled trial comparing methotrexate and cyclosporine in terms of effectiveness, side effects, and the quality of life.
A total of 88 patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either methotrexate (44 patients; initial dose, 15 mg per week) or cyclosporine (44 patients; initial dose, 3 mg per kilogram of body weight per day) and were followed for another 36 weeks. The primary outcome was the difference between groups in the psoriasis area-and-severity index after 16 weeks of treatment, after adjustment for base-line values; scores were determined in a blinded fashion by trained observers.
Two patients were excluded from the analysis after randomization because they were found to be ineligible, and one patient withdrew his consent. Twelve patients in the methotrexate group had to discontinue treatment because of reversible elevations in liver-enzyme levels, and 1 patient in the cyclosporine group had to do so because of an elevation in the bilirubin level, but all 13 were included in the analysis. After 16 weeks of treatment, the mean (+/-SE) score for the psoriasis area-and-severity index decreased from 13.4+/-3.6 at base line to 5.0+/-0.7 among 43 patients treated with methotrexate, whereas the score decreased from 14.0+/-6.6 to 3.8+/-0.5 among 42 patients treated with cyclosporine. After adjustment for base-line values, the mean absolute difference in values at 16 weeks was 1.3 (95 percent confidence interval, -0.2 to 2.8; P=0.09). The physician's global assessment of the extent of psoriasis, the time to and the rates of remission, and the quality of life were similar in the two groups.
No significant differences in efficacy were found between methotrexate and cyclosporine for the treatment of moderate-to-severe psoriasis.
甲氨蝶呤和环孢素是治疗中度至重度慢性斑块状银屑病的知名全身疗法。我们进行了一项随机对照试验，比较甲氨蝶呤和环孢素在疗效、副作用及生活质量方面的差异。
总共88例中度至重度银屑病患者被随机分配，分别接受甲氨蝶呤（44例患者；初始剂量为每周15 mg）或环孢素（44例患者；初始剂量为每日每千克体重3 mg）治疗16周，并随访另外36周。主要结局是治疗16周后，经基线值校正的两组银屑病面积和严重程度指数的差异；评分由经过培训的观察者以盲法确定。
随机分组后，2例患者因不符合入选标准被排除在分析之外，1例患者撤回同意书。甲氨蝶呤组有12例患者因肝酶水平可逆性升高而不得不停止治疗，环孢素组有1例患者因胆红素水平升高而不得不停止治疗，但所有这13例患者均纳入分析。治疗16周后，43例接受甲氨蝶呤治疗的患者的银屑病面积和严重程度指数的平均（±SE）评分从基线时的13.4±3.6降至5.0±0.7，而42例接受环孢素治疗的患者的该评分从14.0±6.6降至3.8±0.5。经基线值校正后，16周时两组的平均绝对差值为1.3（95%置信区间为-0.2至2.8；P = 0.09）。两组在医生对银屑病严重程度的整体评估、缓解时间和缓解率以及生活质量方面相似。
在治疗中度至重度银屑病方面，未发现甲氨蝶呤和环孢素在疗效上有显著差异。
