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来氟米特治疗类风湿关节炎双盲试验 被引量:24

Leflunomide in treating rheumatoid arthritis: a double blind study
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摘要 目的 :比较来氟米特和甲氨蝶呤治疗类风湿关节炎的疗效及安全性。方法 :80例类风湿关节炎病人、随机分配入 2组 ,各组 4 0例。 2组病人于试验前 1wk停用原有非甾体抗炎药 ,服用奥沙普秦(oxaprozin)每晚 2片。第 1组服抗炎 1号 ,每日 2片 ;抗炎 3号 ,每周 1次 ,每次 6片。第 2组服抗炎 2号 ,每日 2片 ;抗炎 4号每周 1次 ,每次 6片。 4~ 6wk后 2组停用奥沙普秦 ,其余服药至 2 4wk后揭盲。结果 :来氟米特组总有效率 93 % ,显效 85% ,甲氨蝶呤组分别为 93 %和 83 % ,P >0 .0 5。不良反应 :来氟米特组 9例占 2 3% ,甲氨蝶呤组 17例占4 3 %。结论 :来氟米特疗效与甲氨蝶呤相似 。 AIM: To compare the therapeutic efficacy of leflunomide and methotrexate in treating rheumatoid arthritis. METHODS: Eighty patients with rheumatoid arthritis were randomly divided into two groups with each group having 40 patients. Group one (M 8, F 32; age 46 a± s 11 a; disease history 63 mo±48 mo) was treated with anti inflammation sub group No.1 and No.3. Group two (M 6, F 34; 44 a±9 a; disease history 45 mo±45 mo) was treated with sub group No.2 and No.4. One week before the initiate of the study, the originally used non steroid anti inflammation drugs were stopped for all two groups patients and each patient took 2 tablets of oxaprozin po qn. At the beginning of the study the patients received 2 tablets of anti inflammation drugs No.1 daily and 6 tables of No.3 weekly in 1st group, and 2 tablets of anti inflammation drugs No.2 daily and 6 tablets of No.4 weekly in 2nd group respectively. RESULTS: In the leflunomide group, the total effect rate was 93 % and the remarkable improvement rate was 85 %. In the methotrexate group, the total effect rate was also 93 % and the remarkable effect rate was 83 %, P > 0.05. Nine patients (23 %) in leflunomide group had adverse reaction as mainly skin itch, nettle like rash, decrease of leukocytes, liver malfunction and others. Seventeen parients (43 %) in methotrexate group had adverse reaction as mainly responses of digestive tract, liver enzyme elevation, decrease of leukocytes, trichomadesis, manoxenia, and others. CONCLUSION: Leflunomide has similar therapeutic efficacy to methotrexate. However, it has relatively less toxicity.
机构地区 上海光华医院
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2001年第2期94-97,共4页 Chinese Journal of New Drugs and Clinical Remedies
关键词 类风湿性关节炎 药物疗法 来氟米特 治疗 leflunmide methotrexate rheumatoid arthritis double blind method
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  • 1蒋明,风湿病学,1995年,908页
  • 2劳志英,新药与临床,1993年,12卷,205页
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