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目的 :观察小剂量来氟米特和甲氨蝶呤联合应用治疗类风湿关节炎的疗效和安全性。方法 :64例类风湿关节炎病人随机分入 2组 ,各 32例。 2组病人于治疗前 1wk停用非甾体类抗炎镇痛药。试验开始时来氟米特 +甲氨蝶呤组 (Lef +MTX)给予来氟米特 2 0mg ,po ,qd +甲氨蝶呤 (MTX) 7.5mg po ,qw ,服 4wk后来氟米特 10mg ,po ,qd +MTX 7.5mg ,po ,qw ;MTX组服甲氨蝶呤 15mg ,po ,qw ,2组均以 2 4wk为一个疗程。治疗前、治疗后wk 12 ,2 4均做体检及实验室检查 ;治疗前后摄双手正位片。结果 :Lef +MTX组显效 88%( 2 8/32例 ) ,MTX组 38%( 12 /32例 )。Lef +MTX组不良反应 4例占 12 %,主要为皮疹、恶心 ;MTX组 14例占 4 3%,主要为恶心、呕吐、口腔溃疡、脱发、ALT升高、心悸、月经不调等。结论 :来氟米特与甲氨蝶呤联合治疗起效快、疗效佳、不良反应率低。
Objective: To observe the efficacy and safety of low-dose leflunomide combined with methotrexate in the treatment of rheumatoid arthritis. Methods: 64 cases of rheumatoid arthritis patients were randomly divided into two groups, each 32 cases. Two groups of patients discontinued non-steroidal anti-inflammatory analgesics 1wk prior to treatment. Leflunomide + methotrexate group (Lef + MTX) was given leflunomide 20 mg, po, qd + methotrexate (MTX) 7.5 mg po, qw at the beginning of the trial, leflunomide 10 mg , po, qd + MTX 7.5mg, po, qw; MTX group methotrexate 15mg, po, qw, 2 groups were 24wk for a course of treatment. Before treatment, after treatment wk 12, 24 are doing physical examination and laboratory tests; Results: In the Lef + MTX group, 88% (28/32) and 38% (12/32) patients in the MTX group were significantly improved. The adverse reaction in Lef + MTX group was 12%, mainly rash and nausea. In MTX group, 14 cases accounted for 43%, mainly nausea and vomiting, oral ulcer, alopecia, ALT, palpitations and irregular menstruation. Conclusion: Combination of leflunomide and methotrexate has rapid onset, good curative effect and low adverse reaction rate.