Zhang Gai-Lian, Huang Feng, Zhang Jiang-Lin, Li Xiao-Feng
Department of Rheumatology, Chinese PLA General Hospital, Beijing 100853, China.
Zhonghua Nei Ke Za Zhi. 2009 Jul;48(7):570-4.
To evaluate the efficacy and safety profile of methotrexate (MTX), leflunomide (LEF) and low-dose MTX and LEF (MTX + LEF) combined treatment for psoriatic arthritis (PsA).
This was a 24 weeks, two-center, open-labeled, controlled trial. All subjects fulfilled the moll and wright criteria for definite PsA. Subjects were given one of the 3 regimens, MTX, or LEF, or MTX + LEF. The primary end point was proportion of psoriatic arthritis response criteria (PsARC) response. The secondary end point was proportion of modified 20% improvement of American College of Rheumatology (ACR20) response.
At week 24, the percent of patients achieving PsARC in MTX, LEF and MTX + LEF group were 75.0%, 68.8%, 83.3% respectively, and the percent of patients achieving ACR20 were 66.7%, 50.0%, 83.3% respectively. At week 24, tender joint counts, swollen joint counts, patient's assessment of pain, patient's global assessment (PGA), physician's global assessment, health assessment questionnaire (HAQ) were significantly improved compared with base-line values (P < 0.05). At week 24, the improvement of patient's assessment of pain, HAQ, ESR were better in the MTX + LEF group compared with LEF group while the improvement of patient's assessment of pain, PGA, HAQ, ESR were better in the MTX group compared with LEF group (P < 0.05). The incidence of treatment related adverse events was 38.5%, 38.9% and 35% in MTX, LEF and MTX + LEF group respectively. There was no serious adverse reactions.
Low dose MTX + LEF regimen showed similar good efficacy and safety profile for PsA patients.
评估甲氨蝶呤（MTX）、来氟米特（LEF）及低剂量MTX与LEF联合治疗（MTX + LEF）对银屑病关节炎（PsA）的疗效及安全性。
这是一项为期24周的两中心、开放标签的对照试验。所有受试者均符合明确PsA的莫尔（Moll）和赖特（Wright）标准。受试者接受三种治疗方案之一，即MTX、LEF或MTX + LEF。主要终点为银屑病关节炎反应标准（PsARC）反应比例。次要终点为美国风湿病学会（ACR）20%改善标准（ACR20）反应比例。
在第24周时，MTX组、LEF组和MTX + LEF组达到PsARC的患者百分比分别为75.0%、68.8%、83.3%，达到ACR20的患者百分比分别为66.7%、50.0%、83.3%。在第24周时，与基线值相比，压痛关节计数、肿胀关节计数、患者疼痛评估、患者整体评估（PGA）、医生整体评估、健康评估问卷（HAQ）均有显著改善（P < 0.05）。在第24周时，MTX + LEF组患者疼痛评估、HAQ、血沉（ESR）的改善情况优于LEF组，而MTX组患者疼痛评估、PGA、HAQ、ESR的改善情况优于LEF组（P < 0.05）。MTX组、LEF组和MTX + LEF组治疗相关不良事件的发生率分别为38.5%、38.9%和35%。未出现严重不良反应。
低剂量MTX + LEF方案对PsA患者显示出相似的良好疗效及安全性。
