沙利度胺联合来氟米特与甲氨蝶呤治疗类风湿关节炎的疗效观察

目的比较沙利度胺联合来氟米特(LEF)及甲氨蝶呤(MTX)与来氟米特(LEF)及甲氨蝶呤(MTX)治疗重度疾病活动度类风湿关节炎的疗效和不良反应。方法将80例DAS>5.1类风湿关节炎患者按随机数字表法分为2组:试验组40例,口服沙利度胺50mg,每日1次,LEF20mg,每日1次,MTX10mg,每周1次;对照组40例:口服LEF20mg,每日1次,MTX10mg,每周1次;观察评价关节肿胀压痛数,采用目视10cm模拟标尺法(VAS)由患者评估病情的整体变化程度,血沉(ESR),类风湿因子(RF)等指标,同时监测患者肝肾功、血尿常规。结果在疗程第8周、12周、24周、48周,试验组患者关节肿胀压痛数、患者VAS评分及血沉改善与对照组比较,差异有显著性;DAS28评分比较发现,试验组患者达到低疾病活动度比例高于对照组,差异有统计学意义(P<0.05)。结论沙利度胺联合来氟米特及甲氨蝶呤治疗重度疾病活动度类风湿关节炎疗效优于来氟米特与甲氨蝶呤两药联合。

Objective To compare the efficacy and safety of leflunomide（LEF） and methotrexate（MTX） combined with thalidomide versus of LEF plus MTX in the treatment of DAS5.1 rheumatoid arthritis.Methods 80 patients were randomizedly divided into two groups,each one with 40 patients.The experiment group administrated thalidomide 50 mg po.qd,LEF 20mg po.qd,and MTX 10mg po.qw for 48 weeks,the control group received LEF 20mg po.qd,and MTX 10mg po.qw for 48 weeks.The indexes of efficiency assessment included count of joint tenderness,count of joint swollen,patient＇s global assessment with visual analogue scal,erythrocyte sedimentation rate（ESR）,adverse events were registered at the same time.Results After 8 weeks treatment,significant differences has existed（P0.05）between the two group,more people in the experiment group ameliorated,achieved DAS283.2,which suggests that efficacy of experiment group is better than the control one.No significant difference exists in adverse events between the two groups.Conclusion The efficacy of LEF and MTX combined with thalidomide in the treatment of rheumatoid arthritis is much better than LEF plus MTX.