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目的 对 II期随机对照临床试验中应用来氟米特 (L EF)和甲氨喋呤 (MTX)治疗的类风湿关节炎 (RA)患者的生命质量和临床疗效比较 ,旨在科学地评价 L EF在治疗 RA中的作用。方法 5 0例活动性 RA病人按 1:1随机分入 L EF组(2 4例 )和 MTX组 (2 6例 ) ,分别服用 L EF2 0 mg/天 +安慰剂 (C)和 MTX15 m g/每周 +安慰剂 (B) 3个月。所有病人测定临床指标 ,并完成类风湿关节炎生命质量量表 [1 ] 和抑郁自评量表 (SDS)。结果 L EF组病人主要生理指标除握力外均有明显改善 ,在统计学上均有意义 (P <0 .0 0 1) ,与 MTX组相比无明显差别 . L EF组显效率为 83.33% ,MTX组为 73.0 8%。 L EF组副反应发生率 8.3% ,较 MTX组低且轻微。 L EF组生命质量分均和 MTX组相近 ,统计学上无明显差别。 L EF组 35 %病人有抑郁临床表现 ,MTX组为 5 0 % (P =0 .2 3)。结论 L EF治疗 RA病人 ,其疗效及生命质量和情绪抑郁改善方面与 MTX相似 ,且副反应更轻微。
Objective To compare the quality of life and clinical efficacy of rheumatoid arthritis (RA) patients treated with leflunomide (L EF) and methotrexate (MTX) in a phase II randomized controlled clinical trial aimed at scientifically evaluating the effects of L The role of EF in the treatment of RA. Methods Fifty patients with active RA were randomized into L EF group (24 cases) and MTX group (26 cases) randomly by 1: 1 dose of L EF2 0 mg / day + placebo (C) and MTX 15 mg / Weekly + Placebo (B) 3 months. All patients were measured for clinical indicators and completed the Rheumatoid Arthritis Quality of Life Scale [1] and the Depression Scale for Self Assessment Scale (SDS). Results The main physiological indexes of patients with LEF were significantly improved except for grip strength, which were statistically significant (P <0.01), there was no significant difference compared with MTX group.The effective rate of L EF was 83.33% , MTX group was 73.0 8%. The incidence of side effects in the EF group was 8.3%, lower and lower than that in the MTX group. The quality of life scores of L EF group were similar to those of MTX group, with no statistically significant difference. 35% of patients in the LEF group had clinical manifestations of depression, compared with 50% in the MTX group (P = .023). Conclusions L EF treatment of patients with RA, its efficacy and quality of life and emotional depression improved with MTX similar side effects and more minor.