来氟米特和甲氨蝶呤联合用药治疗类风湿关节炎的疗效

Effects of leflunomide combined with methotrexate in treatment of rheumatoid arthritis

目的 :比较来氟米特和甲氨蝶呤联合用药与来氟米特单独用药的疗效和不良反应。方法 :试验为 2 4wk的开放对照试验 ,共 6 0例 ,活动性类风湿关节炎病人分为 2组。试验组 30例给来氟米特10mg ,po ,qd ,甲氨蝶呤 7.5mg ,po ,qw ;对照组 30例给来氟米特 2 0mg ,po ,qd ;用药前 3d ,2组来氟米特均给予负荷剂量 5 0mg·d- 1。评价休息痛、晨僵、握力、关节压痛数、关节肿胀数、生活能力、病人评价、医生评价、血沉、C 反应蛋白、类风湿因子等指标。结果 :用药 12 ,2 4wk ,2组主要疗效指标的改善差异无显著意义 ,P >0 .0 5。 2wk时 ,试验组按美国风湿病学会 (ACR)有效率为 89% ,显著高于对照组 (6 1% ) ,P <0 .0 5 ;12 ,2 4wk时试验组ACR有效率分别为 89%和 93% ,对照组为 86 %和 89% ,P>0 .0 5。试验组和对照组的不良反应发生率为2 7% (8/ 30 )和 2 0 % (6 / 30 ) ,P >0 .0 5。结论 :联合用药起效较单用来氟米特快 ,12wk后疗效与单用来氟米特相近 。

AIM: To compare the efficacy and adverse reaction of leflunomide (Lef) plus methotrexate (MTX) (Group Lef+MTX) and Lef alone (Group Lef) in the treatment of active rheumatoid arthritis (RA). METHODS: It was an open controlled trial for 24 wk. Sixty patients with active RA were divided into two groups. Thirty patients of the control group (M 11,F 19; age(46±s10) a) administrated Lef 20 mg,po,qd. The other thirty patients of the experiment group (M 8,F 22; age (49±13) a), received Lef 10 mg,po,qd and MTX 7.5 mg po,qw as well. The status of patients have no significant difference between the two groups when they enrolled the trial. At the first 3 d, the dose of Lef for all patients was 50 mg·d -1. The indexes of the effeciency assessment included rest pain, morning stiffness, gripping strength, count of joint tenderness (TJC), count of joint swollen (SJC), activities of daily living, patient's assessment, physician's assessment, ESR, C-reactive protein (CRP), RF. RESULTS: No significant differences were found in efficiency assessment indexes between the two groups after 12 wk and 24 wk treatment. The efficacy rate of group Lef+MTX was 89 %, higher than that of group Lef (61 %) after 2 wk treatment, P<0.05. It reached 89 %, 93 % respectively after 12 and 24 wk for group Lef+MTX and 86 %, 89 % for group Lef and there were no significant difference between the two groups again, P>0.05. The rate of adverse reaction was 27 %(8/30) in group Lef+MTX and 20 % (6/30) in group Lef and no significant differences were found, P>0.05. CONCLUSION: Lef combined with MTX in the treatment of rheumatoid arthritis asserted their efficacy more quickly than Lef alone. The efficacy was similar between the two groups after 12 wk. The rate of adverse reaction was a little higher in Lef and MTX combined therapy than in Lef alone.