国产来氟米特治疗类风湿关节炎的随机双盲对照试验  

A Randomized, Double-blind Controlled Trial of Indigenous Leflunomide in the Treatment of Rheumatoid Arthritis

作　　者：姜林娣[1] 陈慧勇[1] 於强[1] 王臻[1] 

机构地区：[1]复旦大学附属中山医院,上海200032

出　　处：《中国循证医学杂志》2005年第10期743-746,785,共5页Chinese Journal of Evidence-based Medicine

摘　　要：目的与进口来氟米特(商品名:爱若华,美国欣凯公司产品)相比较,观察国产来氟米特(leflunomide,LFM)治疗活动期类风湿关节炎(类风关)的疗效和不良反应。方法采用随机、双盲双模拟、阳性药物平行对照研究方法,将56例活动期类风关患者随机分为两组,分别服用受试药和对应模拟片各2片,疗程24周,并比较其疗效。结果与治疗前比较,治疗12周时,除血沉外,两组在各个主要指标方面均较各自治疗前明显改善(P<0.05);治疗24周后,两组在血沉、C反应蛋白等指标上与治疗前比较,差异无统计学意义,其它各主要指标均较治疗前明显改善(P<0.05)。两组间各项主要指标改善值在治疗12周和24周时差异均无统计学意义(P>0.05)。按国内综合评价指标分析,治疗12周时,爱若华组改善率为37.0%,国产来氟米特组为64.0%,两组间差异有统计学意义(P<0.05);治疗24周时,爱若华组为81.5%,国产来氟米特组为77.3%,两组在改善率方面的差异无统计学意义(P>0.05)。此外,两组不良事件发生率的差异也无统计学意义。结论国产来氟米特与爱若华比较具有相似的疗效和安全性。Objective To assess effectiveness and safety in rheumatoid arthritis （RA） patients treated with the indigenous leflunomide in comparison with Airohua produced by Cinkate Corp. Methods A double blind and double dummy randomized controlled trial was conducted in the outpatient clinic of rheumatology. Fifty-six Chinese RA patients were divided into two groups who received either indigenous Leflunomide or Airohua of 20 mg daily and the two matching placebo tablets of Airohua or indigenous Leflunomide with the constant dose of Oxaprozin （0.4 g, qd） in the first 6 weeks. Clinical and laboratory data were collected every 6 weeks during 24 weeks of follow-up. Results This study showed that the patients of both groups significantly improved on main variables except erythrocyte sedimentation rate （EXR） at the 12th week . The variables such as ESR, and the level of c-reaction protein in both groups at 24th week showed no statistical difference compared with those at the baseline. There were also no statistical difference in the clinical characteristics and laboratory findings between the two groups at the 12th week and 24th week （P 〉0. 05）. The effcacy of Airohua（37% ） was lower than that of indigenous Leflunomide（ 64% ） at the 12th week （P 〈0. 05 ） and slightly better than indigenous Leflunomide group at the 24 week （81.5% vs 77.3% , （ P 〉0. 05）. The administration of Airohua and indigenous leflunomide presented a similar pattern and frequency of adverse events. Serious adverse events such as interstitial pneumonitis, pulmonary infiltration, and liver impairment etc. were not reported in either group. Conclusions The study shows that the indigenous Leflunomide has a superior therapeutic effect. Its efficacy and safety are similar to Airohua in the treatment of acfive RA patients in China.

关 键 词：类风湿关节炎 来氟米特 随机双盲对照试验 

分 类 号：R593.22[医药卫生—内科学]