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目的 探讨甲氨蝶呤联合小剂量激素与大活络胶囊对早期类风湿性关节炎患者临床疗效及其对血清学指标的影响.方法 选取2014年12月至2017年1月于大连大学附属新华医院治疗的早期类风湿性关节炎患者166例为研究对象,按照不同的治疗方法分为观察组和对照组,每组83例.对照组患者给予甲氨蝶呤片联合小剂量激素口服治疗,观察组在对照组治疗的基础上给予大活络胶囊口服治疗,比较两组患者的临床疗效及血清学指标.结果 观察组患者的总有效率为97.59％,高于对照组的90.36％,差异有统计学意义(P<0.05);治疗后两组患者的血清学指标均显著优于治疗前,差异均有统计学意义(均P<0.05),且观察组各指标均优于对照组,差异均有统计学意义(均P<0.05).治疗后,观察组患者的症状缓解程度优于对照组,差异有统计学意义(P<0.05).结论 甲氨蝶呤与小剂量激素联合大活络胶囊治疗早期类风湿性关节炎的疗效显著,安全性高.“,”Objective To investigate the clinical efficacy of methotrexate combined with low-dose hormones and Dahuoluo Capsules (大活洛胶囊) and its effects on serological indexes in the treatment of early rheumatoid arthritis. Methods A total of 166 patients with early rheumatoid arthritis who were treated in Xinhua Hospital Affiliated to Dalian University from December 2014 to January 2017 were enrolled. The patients were divided into the observation group and the control group according to different treatment methods, with 83 patients in each group. Patients in the control group were treated with methotrexate tablets and low-dose hormones orally. The observation group was given oral administration of Dahuoluo Capsules on the basis of the control group, and the clinical efficacy and serological indexes were observed. Results The total effective rate was 97.59％ in the observation group and 90.36％ in the control group. The observation group was superior to the control group (P<0.05). After treatment, the serological indexes of the two groups were significantly improved than those before treatment (P<0.05), and the indexes of the observation group were better than those of the control group, and the difference was statistically significant (P<0.05). The improvement of symptoms of the observation group was better than that of the control group, and the difference was statistically significant (P<0.05). Conclusion In the treatment of early rheumatoid arthritis, methotrexate combined with low-dose hormones and Dahuoluo Capsules has significant clinical efficacy and high safety.