小剂量来氟米特治疗类风湿关节炎的临床研究

目的:前瞻性观察小剂量来氟米特治疗类风湿关节炎(RA)的临床疗效。方法:32例类风湿关节炎病例随机进入治疗组及对照组。治疗方案治疗组采用小剂量来氟米特(略去负荷剂量,每日剂量10mg维持),对照组使用柳氮磺胺吡啶治疗,1.5-2.0g/日。观察期6个月,观察指标为主要疗效指标:肿胀、压痛关节数、患者及医师对疾病状况总体评价;次要疗效指标疼痛视觉模拟评分、晨僵时间、美国风湿病学会疗效评价指标(ACR20、50)、健康评价问卷(HAQ)、C反应蛋白。结果:治疗6个月后,主要疗效指标压痛、肿胀关节数改善及医师总体评价,来氟米特均优于柳氮磺胺吡啶(p<0.05)。在次要疗效指标方面,来氟米特组HAQ评分及C反应蛋白改善优于柳氮磺胺吡啶组(p<0.05),两组在关节晨僵改善无明显差异。达到ACR20标准的病例,来氟米特组占56.3%,柳氮磺胺吡啶组占57.1%(p>0.05);达到ACR50标准分别为37.5%、35.7%(p>0.05)。研究中,来氟米特组胃肠道反应轻微,有2例出现血压升高。结论:小剂量来氟米特治疗类风湿关节炎治疗活动性类风湿关节炎,与柳氮磺胺吡啶疗效相当,耐受性好。

Small dose of leflunomide for rheumatoid arthritis

Objectives:To prospectively study the efficiency of low-dose leflunomide in active rheumatoid arthritis with sulphasalazine.Methods:thirty-two subjects with active rheumatoid arthritis were randomized assigned to low dose leflunomide(omitting loading dose,maintenance dose10mg/day) or sulphasalazine for six months.The primary end-points were tender and swollen joint counts and global physician and patients assessments.Results:After six months,the mean changes in the low-dose leflunomide and sulphasalazine,re...