摘要
目的 :研究来氟米特对类风湿关节炎病人的疗效及不良反应。方法 :15 0名病人随机分配进入试验组和对照组 ,2组各 75例。试验组服用来氟米特 2 0mg ,qd ,甲氨蝶呤 (MTX)空白片 6片 ,1次·wk- 1;对照组服用来氟米特空白片 2片 ,qd ,MTX片 15mg ,1次·wk- 1。疗程 2 4wk ,试验开始前 4～6wk可同时使用奥沙普秦。结果 :试验组 12 ,2 4wk有效率分别为 79%和 90 % ,显效率分别为4 4 %和 80 % ,对照组 12 ,2 4wk有效率分别为83%和 84 % ,显效率分别为 4 9%和 72 %。 2组临床疗效差别无显著意义 (P >0 .0 5 )。试验组不良反应发生率 17% ,明显低于对照组 32 % (P <0 .0 5 )。结论 :经 2 4wk治疗 ,来氟米特对类风关的疗效与MTX相近 ,不良反应轻 。
AIM: To assess efficacy and adverse reaction of leflunomide for rheumatoid arthritis in comparing with methotrexate (MTX). METHODS: One hundred and fifty patients were randomly assigned to receive leflunomide or MTX. Patients in leflunomide group were administered with leflunomide at 20 mg once daily and placebo of MTX at 6 tablets once weekly; those in MTX group took MTX at 15 mg once weekly and placebo of leflunomide at 2 tablets once daily. The therapeutic course was 24 wk. At the first 4-6 wk, oxaprozin could be used. RESULTS: The effective rates at 12 wk and 24 wk were 79 % and 90 % in leflunomide group respectively, 83 % and 84 % in MTX group respectively; the remarkably effective rates at 12 wk and 24 wk were 44 % and 80 % in leflunomide group respectively; 49 % and 72 % in MTX group respectively. No statistical differences on efficacy were demonstrated between two groups (P>0.05). Leflunomide-related adverse reactions were observed: gastrointestinal symptoms, alopecia, skin rash and elevation of ALT etc, most of them were mild or moderate. The incidence of adverse reactions was 17 %, significantly lower than that in MTX group (32 %) (P<0.05) and the severity was milder than that of MTX. CONCLUSION: Leflunomide is proved to be effective and well tolerated in the treatment of rheumatoid arthritis with less adverse reactions than MTX.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2002年第6期325-328,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
来氟米特
治疗
类风湿关节炎
Ⅱ期
临床试验
leflunomide
oxaprozin
methotrexate
clinical trials, phaseⅡ
arthritis, rheumatoid
