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目的评价化瘀通痹方联合甲氨蝶呤(methotrexate,MTX)治疗难治性类风湿关节炎(refractory rheuamtoid arthritis,RRA)的疗效和安全性。方法 167例RRA患者,按治疗方法不同分为治疗组(73例,采用化瘀通痹方联合MTX治疗)和对照组[94例,采用来氟米特(leflunomide,LEF)联合MTX治疗]。比较两组治疗前、治疗12、24周临床症状、体征、类风湿因子(rheumatoid factor,RF)、C反应蛋白(C-reactive protein,CRP)、血沉(erythrocyte sedimentation rate,ESR)、疾病活动指数(disease activity score 28,DAS28)、安全性指标等变化,评估疗效和安全性。结果治疗12、24周,治疗组总有效率分别为为82.2%(60/73),78.1%(57/73);对照组总有效率分别为79.8%(75/94),75.5%(71/94);两组比较,差异均无统计学意义(χ~2=0.15,χ~2=0.15,P>0.05);与治疗12周比较,对照组治疗24周总有效率差异有统计学意义(φ~2=0.49,P<0.05)。两组治疗12、24周症状、体征,RF,CRP,ESR及DAS28均较治疗前有明显改善(P<0.01),与对照组比较,治疗12周治疗组改善程度差异无统计学意义(P>0.05),治疗24周,在晨僵时间、关节压痛数、关节肿胀数、患者总体评分、RF、CRP、DAS28方面差异有统计学意义(P<0.05)。治疗组不良反应少于对照组(P<0.01)。结论化瘀通痹方联合MTX治疗RRA疗效与LEF(10 mg/天)联合MTX疗效相当,但中西药结合治疗较单纯西药治疗RRA疗效更稳定、不良反应更少。
Objective To evaluate the efficacy and safety of Huayu Tongbi Decoction combined with methotrexate (MTX) in the treatment of refractory rheumatoid arthritis (RRA). Methods One hundred and sixty-seven patients with RRA were divided into treatment group (73 cases treated with Huayu Tongbi prescription combined with MTX) and control group (94 cases treated with leflunomide and MTX). The clinical symptoms, signs, rheumatoid factor (RF), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), disease activity index (disease activity score 28, DAS28), safety indicators and other changes to assess the efficacy and safety. Results The total effective rates in the treatment group were 82.2% (60/73) and 78.1% (57/73), respectively. The total effective rates in the control group were 79.8% (75/94) and 75.5% (71/71), respectively / 94). There was no significant difference between the two groups (χ ~ 2 = 0.15, χ ~ 2 = 0.15, P> 0.05). Compared with the 12-week treatment, the total effective rate of the control group at 24 weeks of treatment was statistically significant Significance (φ ~ 2 = 0.49, P <0.05). The symptoms, signs, RF, CRP, ESR and DAS28 at 12 and 24 weeks after treatment in both groups were significantly improved compared with before treatment (P <0.01). There was no significant difference in the improvement rate between the two groups > 0.05). After treatment for 24 weeks, there were significant differences in morning stiffness time, joint tenderness, swollen joint number, total score of patients, RF, CRP and DAS28 (P <0.05). Adverse reactions in the treatment group were less than those in the control group (P <0.01). Conclusion The efficacy of Huayu Tongbi Decoction combined with MTX in the treatment of RRA is comparable to that of LEF (10 mg / day) combined with MTX. However, the combination of Chinese and western medicine is more stable and has fewer side effects than the western medicine alone.