Suzuki Daisuke, Kimoto Osamu, Sawada Jin, Shimoyama Kumiko, Kawashima Masanori, Mukai Tomoyuki, Ohashi Hiroyuki, Yamamura Masahiro, Ogawa Noriyoshi
Department of Rheumatology, Hamamatsu University School of Medicine, Japan.
Nihon Rinsho Meneki Gakkai Kaishi. 2011;34(3):149-53. doi: 10.2177/jsci.34.149.
Background. MZB is a purine analog, and is used as a disease modifying anti-rheumatic drug (DMARD). We conducted an open label uncontrolled clinical trial to evaluate the efficacy and safety of combination therapy with methotrexate (MTX) and mizoribine (MZB). Methods. Thirty one RA patients (9 males, 22 females, 68±12 year-old) who fulfilled ACR criteria of RA and did not show sufficient clinical response to MTX were included. MZB (150 mg/day, once a day) were added to MTX. DAS28-CRP was measured at day 0 and 1, 3, 6, and 12 months after the treatment. Adverse events were recorded. Results. Overall DAS28-CRP was significantly decreased from 4.4±1.0 to 3.1±1.3 at 3 months (p<0.01), 2.7±0.68 at 6 months (p<0.01), 2.4±1.4 at 12 months (p<0.01). Seventeen patients (55%) achieved significant improvement of DAS28-CRP. Number of swollen joints of responders before the treatment was significantly fewer than that of non-responders. Improvement of DAS28-CRP was significantly different between the responders (0.91±0.74) and non-responders (0.18±0.66) at 1 month (p<0.01). Nine patients (29%) could achieve remission Four patients experienced adverse events. Conclusions. MTX and MZB combination therapy was effective and relatively safety.
背景。咪唑立宾是一种嘌呤类似物，用作改善病情抗风湿药（DMARD）。我们开展了一项开放标签非对照临床试验，以评估甲氨蝶呤（MTX）与咪唑立宾（MZB）联合治疗的疗效和安全性。方法。纳入31例符合类风湿关节炎（RA）美国风湿病学会（ACR）标准且对MTX临床反应不足的RA患者（9例男性，22例女性，年龄68±12岁）。在MTX基础上加用MZB（150mg/天，每日1次）。在治疗第0、1、3、6和12个月时测量28个关节疾病活动评分（DAS28）-C反应蛋白（CRP）。记录不良事件。结果。总体DAS28-CRP在3个月时从4.4±1.0显著降至3.1±1.3（p<0.01），6个月时为2.7±0.68（p<0.01），12个月时为2.4±1.4（p<0.01）。17例患者（55%）的DAS28-CRP显著改善。治疗前有反应者的肿胀关节数显著少于无反应者。在1个月时，有反应者（0.91±0.74）与无反应者（0.18±0.66）的DAS28-CRP改善情况有显著差异（p<0.01）。9例患者（29%）可实现缓解。4例患者发生不良事件。结论。MTX与MZB联合治疗有效且相对安全。
