Haibel H, Brandt H C, Song I H, Brandt A, Listing J, Rudwaleit M, Sieper J
Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
Ann Rheum Dis. 2007 Mar;66(3):419-21. doi: 10.1136/ard.2006.054098. Epub 2006 Aug 10.
To examine the potential therapeutic effect of methotrexate 20 mg given weekly as subcutaneous injections to 20 patients with ankylosing spondylitis refractory to non-steroidal antirheumatic drugs.
20 patients with ankylosing spondylitis, a mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 5.6 (range 4-9.3) and predominantly axial manifestations were treated with weekly 15 mg methotrexate subcutaneously for 4 weeks, which was then increased to 20 mg subcutaneously for the next 12 weeks. Clinical outcome assessments included, among others, BASDAI score physical function, spinal mobility, patients' and physicians' global assessment (visual analogue scale), peripheral joint assessment, quality of life (Short Form 36) and C reactive protein. The primary end point of the study was a 20% improvement on the ASsessments in Ankylosing Spondylitis (ASAS 20) scale.
Using an intention-to-treat analysis, ASAS 20 was achieved in only 25% of patients. An ASAS 40 response was achieved in 10% of patients, and no patient reached an ASAS 70 response or the ASAS criteria for partial remission. For the mean BASDAI score, no change was observed between baseline and week 16 (baseline 5.6 v week 16, 5.6). No improvement was observed in any of the clinical parameters or C reactive protein, except a small but non-significant decrease in the number of swollen joints.
In this open study, methotrexate did not show any benefit for axial manifestations in patients with active ankylosing spondylitis beyond the expected placebo response.
探讨每周皮下注射20毫克甲氨蝶呤对20例非甾体类抗风湿药物治疗无效的强直性脊柱炎患者的潜在治疗效果。
20例强直性脊柱炎患者，平均巴斯强直性脊柱炎疾病活动指数（BASDAI）评分为5.6（范围4 - 9.3），主要为轴向表现，先每周皮下注射15毫克甲氨蝶呤，共4周，之后在接下来的12周内增加至每周皮下注射20毫克。临床结局评估包括BASDAI评分、身体功能、脊柱活动度、患者和医生的整体评估（视觉模拟量表）、外周关节评估、生活质量（简明健康状况调查量表36项）以及C反应蛋白。该研究的主要终点是强直性脊柱炎评估（ASAS 20）量表上改善20%。
采用意向性分析，仅25%的患者达到ASAS 20。10%的患者达到ASAS 40反应，且无患者达到ASAS 70反应或部分缓解的ASAS标准。对于平均BASDAI评分，在基线和第16周之间未观察到变化（基线5.6对第16周，5.6）。除肿胀关节数量有轻微但无统计学意义的减少外，在任何临床参数或C反应蛋白方面均未观察到改善。
在这项开放性研究中，对于活动性强直性脊柱炎患者的轴向表现，甲氨蝶呤并未显示出超出预期安慰剂反应的任何益处。
