摘要
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.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2009年第7期570-574,共5页
Chinese Journal of Internal Medicine