小剂量来氟米特治疗类风湿关节炎的临床研究  

Small dose of leflunomide for rheumatoid arthritis

作　　者：王军[1,2] 祖比亚[1,2] 杨俊生[1,2] 覃学勇[1,2] 尹琦[1,2] 廖明[1,2] 

机构地区：[1]南方医科大学附属柳州医院 [2]柳州铁路中心医院肾内科,广西柳州545007

出　　处：《现代生物医学进展》2011年第6期1145-1148,共4页Progress in Modern Biomedicine

基　　金：广西卫生厅自筹经费课题(Z2010135)

摘　　要：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。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,respectively,were-9.7 and-8.3 for tender joint count（p0.05）;-7.6 and-6.7 for swollen joint count（p0.05）;-1.1 and-1.0 for physician global assessment（p0.05）;-1.1 and-1.1 for patients global assessment（p0.05）;the improved HAQ scores and C-reactive protein in leflunomide group were higher when comared with those of controlled group,while the ACR response in the two groups were comparable.The adverse events for patients received low-dose leflunomide were slightly except for two drug-related hypertension.Conclusion：Low-dose leflunomide used in the study were efficacious for active rheumatoid arthritis treatment compared with sulphasalazine,and it was well tolerated.

关 键 词：来氟米特 类风湿关节炎 小剂量 临床研究 

分 类 号：R593.22[医药卫生—内科学] R969[医药卫生—临床医学]