来氟米特与甲氨蝶呤治疗银屑病关节炎关节病变的临床研究

目的 评价来氟米特、甲氨蝶呤及甲氨蝶呤与来氟米特联用治疗银屑病关节炎(PsA)关节病变的疗效与安全性.方法 2个中心的开放性临床对照研究.选确诊的PsA患者,接受甲氨蝶呤(甲氨蝶呤组)、来氟米特(来氟米特组)、甲氨蝶呤+来氟米特(联合治疗组)中的任意一种治疗方案,治疗24周.以PsA疗效标准(PsARC)为主要疗效指标,修改的美国风湿病学会疗效标准提高20%(ACR20)为次要疗效指标,对关节病变进行评估,并分析具体评价指标[包括压痛关节数、肿胀关节数、疼痛视觉模拟评分、患者总体评价(PGA)、医生总体评价、健康评估问卷(HAQ)]的变化.结果 治疗24周时甲氨蝶呤组、来氟米特组、联合治疗组达到PsARC的比例分别为75.0%、68.8%、83.3%,达到ACR20的比例分别为66.7%、50.0%、83.3%.24周后3组患者压痛关节数、肿胀关节数、疼痛视觉模拟评分、PGA、医生总体评价、HAQ均显著低于基线水平(P<0.05).联合治疗组在疼痛视觉模拟评分、HAQ、ESR的改善程度显著高于来氟米特组,甲氨蝶呤组在疼痛视觉模拟评分、PGA、HAQ、ESR的改善程度亦显著高于来氟米特组.甲氨蝶呤、来氟米特、联合治疗组不良反应发生率分别为38.5%、38.9%、35.0%,无严重不良事件发生.结论 甲氨蝶呤与来氟米特联合治疗与单用药物治疗对PsA的关节病变均具有良好的疗效和安全性.

A clinical study of leflunomide and methotrexate therapy in psoriatic arthritis

Objective 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). Methods 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 Rheumatolngy (ACR20) response. Results 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. Conclusion Low dose MTX + LEF regimen showed similar good efficacy and safety profde for PsA patients.