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

A clinical study of leflunomide and methotrexate therapy in psoriatic arthritis

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。

Objective To evaluate the efficacy and safety profile of methotrexate （MTX）, lefluuomide （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 Rheumatology （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 profile for PsA patients.