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目的:探讨桂枝芍药知母汤联合甲氨蝶呤(MTX)和柳氮磺吡啶(SSZ)治疗难治性类风湿关节炎(RA)的疗效和安全性。方法:选择符合纳入标准患者81例,随机分为治疗组和对照组,治疗组40例给予桂枝芍药知母汤、MTX和SSZ治疗,对照组41例给予MTX和SSZ治疗,疗程均为12周。采用美国风湿病学会(ACR)推荐的RA疾病活动评价核心指标对两组治疗前后进行评估。结果:治疗后2组病情活动主要指标评分均有显著降低,治疗前后比较,差异均有非常显著性意义(P<0.01),治疗组评分降低优于对照组,差异有显著性意义(P<0.05)。治疗组达到ACR20,ACR50,ACR90疗效标准的分别为:37.5%,32.5%,20%,总有效率90%;对照组达到ACR20,ACR50,ACR90疗效标准的分别为:46.34%,19.51%,4.88%,总有效率70.73%。结论:桂枝芍药知母汤联合MTX和SSZ治疗难治性RA疗效明显优于MTX联合SSZ的疗效,且具有较好的安全性。
Objective: To investigate the efficacy and safety of Guizhi Shaoyao Zhimu Decoction combined with methotrexate (MTX) and sulfasalazine (SSZ) in the treatment of refractory rheumatoid arthritis (RA). Methods: Eighty-one patients were enrolled and divided into treatment group and control group randomly. 40 cases in the treatment group were treated with Guizhi Shaoyao Zhimu Decoction, MTX and SSZ, and 41 cases in the control group were treated with MTX and SSZ week. The assessment of pre- and post-treatment of both groups was performed using core indicators of RA disease activity evaluation recommended by the American College of Rheumatology (ACR). Results: After treatment, the scores of major indexes of disease activity in both groups were significantly decreased. There was significant difference between the two groups before and after treatment (P <0.01), and the score of the treatment group was lower than that of the control group (P < 0.05). The therapeutic effect of ACR20, ACR50 and ACR90 in the treatment group were 37.5%, 32.5% and 20% respectively, and the total effective rate was 90%. In the control group, the therapeutic effect of ACR20, ACR50 and ACR90 were 46.34%, 19.51% and 4.88 %, The total effective rate 70.73%. Conclusion: Guizhi Shaoyao Zhimu Decoction combined with MTX and SSZ treatment of refractory RA curative effect is superior to MTX combined with SSZ, and has good safety.