利妥昔单抗联合甲氨蝶呤在中重度类风湿关节炎中的临床应用

Clinical application of rituximab combined with methotrexate in the treatment of rheumatoid arthritis

目的评价利妥昔单抗(RTX)及甲氨蝶呤(MTX)在中重度类风湿性关节炎中联合应用的临床效果。方法将68例中重度类风湿性关节炎患者随机分为试验组及对照组,每组34例,分别给予RTX+MTX及安慰剂+MTX治疗,观察两组间类风湿性关节炎的临床及化验指标变化。结果治疗后1个月,试验组触痛关节数、晨僵时间、Barthel指数与对照组比较,差异有统计学意义(P<0.05)。治疗后3个月,试验组的肿胀关节数、触痛关节数、晨僵时间、DAS28评分及Barthel指数与对照组比较,差异有统计学意义(P<0.05或P<0.01)。治疗后1个月,试验组CRP、ESR、RF、IL-6低于对照组(P<0.05或P<0.01);治疗后3个月,试验组CRP、ESR、RF、IL-6低于对照组(P<0.01)。随访期内,试验组的并发症、过敏反应发生率高于对照组(P<0.05)。结论M TX联合应用RTX治疗中重度类风湿性关节炎可达到安全满意的临床效果。

Objective To evaluate the clinical efficacy of rituximab combined with methotrexate in the treatment of rheumatoid arthritis. Methods Sixty-eight patients diagnosed with moderate or severe rheumatoid arthritis were divided into experiment group（ n = 34） and control group（ n = 34） who accepted RTX ＋ MTX and placebo ＋MTX respectively. The clinical and laboratory indexes were observed. Results Compared with control group, the number of tender joint and time of morning stiffness in experiment group were lower at 1 month after treatment（ P〈0. 05）, and the Barthel index was higher（ P〈0. 05）. The number of swollen joint and tender joint, the time of morning stiffness and DAS28 score in experiment group were lower than those of control group at 3 months after treatment（ P〈0. 05 or P〈0. 01） with higher Barthel index（ P〈0. 05）. The levels of CRP（ C-reactive protein）,ESR（ erythrocyte sedimentation）,RF（ rheumatoid factor） and IL-6（ Interleukin 6） in experiment group were lower than those of control group at 1 month（ P〈0. 05 or P〈0. 01） and 3 months（ P〈0. 01） after treatment. The allergic rate in experiment group was higher than that of control group during follow-up period（ P〈0. 05）. Conclusion Rituximab combined with methotrexate is effective and safe with satisfactory result in the treatment of rheumatoid arthritis.