【摘要】 目的评价2种来氟米特治疗类风湿关节炎(RA)的有效性和安全性。方法采用多中心、随机、双盲、阳性药物平行对照试验设计,患者分试验组和对照组,均口服来氟米特20mg,qd,疗程24wk。对照组118例,试验组119例,观察指标包括休息痛、晨僵、28个关节肿胀关节数及指数、28个关节压痛关节数及指数、健康状况问卷、患者及医师对疾病总体状况的评价。以美国风湿病学会类风湿关节炎20%改善标准(ACR20)作为主要有效性评价标准,观察2组疗效和不良反应。结果试验组和对照组的ACR20分别为68.9%和69.5%,2组无显著差异(P>0.05)。2组ACR20差值的95%可信区间为-12.95%～19.88%,其下限高于-15%。不良反应发生率分别为:试验组51.3%,对照组44.9%,2组无显著差异(P>0.05)。结论2种来氟米特均是治疗类风湿关节炎的有效药物,疗效和安全性相当。更多还原

【Abstract】 AIM To evaluate the efficacy and safety of domestic leflunomide in rheumatoid arthritis (RA).METHODS A multicenter,double-blind,and randomized controlled trial in 240 patients with RA was conducted.Patients were divided into trial group (n=120) and control group (n=120),and were treated with leflunomide,20 mg,qd,for 24 wk.Assessments included pain VAS,morning stiffness,28-joint count for tenderness and swelling,health assessment questionnaire,and the global assessments about disease activity of patients and physicians.Efficacy was assessed using the American College of Rheumatology criteria for 20% improvement (ACR20),and clinical and laboratory adverse reactions of the drugs were observed in both groups.RESULTS ACR20 in the trial group and the control group was 68.9% and 69.5% (P > 0.05),respectively.95% CI for the differences in ACR20 between the two groups was-12.95% to 19.88%,and the lower limit was above-15%.The incidence of adverse reactions was 51.3% (61 /119) and 44.9% (53 /118) in the trial group and the control group,respectively.There was no significant difference between the two groups (P > 0.05) CONCLUSION Both of the leflunomide are effective and safe in RA.更多还原