Methotrexate vs. ciclosporin in psoriasis:: effectiveness, quality of life and safety.: A randomized controlled trial
Methotrexate vs. ciclosporin in psoriasis:: effectiveness, quality of life and safety.: A randomized controlled trial
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DOI：
10.1111/j.1365-2133.2007.08284.x
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发表时间：
2008-01-01
影响因子：
10.3
通讯作者：
Bergbrant, I-M.
中科院分区：
文献类型：
--
作者：
Flytstrom, I.;Stenberg, B.;Bergbrant, I-M.
背景当这项研究开始时，没有以前的研究比较甲氨蝶呤和环孢素为中度至重度斑块状psoriasis.Objectives比较甲氨蝶呤和环孢素治疗的有效性，生活质量和副作用的背景下，反映正常的临床practice.Methods 84例中度至重度斑块状psoriasis随机治疗甲氨蝶呤或环孢素12周。主要结局是银屑病面积和严重程度指数（PASI）。次要结局是生活质量，通过皮肤病生活质量指数（DLQI）和36项简明健康调查表（SF-36）测量。采用视觉模拟评分法（VAS）对患者进行评估。结果68例患者开始治疗并纳入分析。环孢素组治疗开始前脱落率较高。12周时，甲氨蝶呤组PASI较基线的平均变化为58%，环孢素组为72%，表明环孢素比甲氨蝶呤更有效。环孢素组的VAS评分改善更高。甲氨蝶呤组在SF-36的身体功能子量表中显示出更大的改善。结论甲氨蝶呤或环孢素治疗慢性斑块状银屑病可有效控制病情，提高生活质量，不良反应可耐受。记录了治疗组之间有效性的统计学显著差异，表明环孢素在短期内比甲氨蝶呤更有效。
Background When this study was initiated, no previous studies comparing methotrexate and ciclosporin for moderate to severe plaque psoriasis had been performed.Objectives To compare the effectiveness, quality of life and side-effects of methotrexate and ciclosporin treatments in a context reflecting normal clinical practice.Methods Eighty-four patients with moderate to severe plaque psoriasis were randomized to treatment with methotrexate or ciclosporin for 12 weeks. The primary outcome was the Psoriasis Area and Severity Index (PASI). The secondary outcome was quality of life, measured by the Dermatology Life Quality Index (DLQI) and the 36-item Short Form Health Survey (SF-36). A visual analogue scale (VAS) was used for patients' assessment.Results Sixty-eight patients started treatment and were included in the analysis. Dropout before initiation of treatment was higher in the ciclosporin group. Mean PASI change from baseline at 12 weeks was 58% in the methotrexate group and 72% in the ciclosporin group, showing ciclosporin to be more effective than methotrexate. Improvement of the VAS score was higher in the ciclosporin group. The methotrexate group showed a greater improvement in the subscale Physical Functioning of the SF-36. No significant difference between the groups was found for DLQI.Conclusions Treatment with methotrexate or ciclosporin for chronic plaque psoriasis brings satisfactory disease control, improved quality of life and tolerable side-effects. A statistically significant difference in effectiveness between treatment groups was recorded, showing ciclosporin to be more effective than methotrexate in a short-term perspective.