目的 探讨艾拉莫德片联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎的临床疗效。方法 选取2015年4月-2016年4月在邢台市人民医院进行治疗的类风湿关节炎患者96例为研究对象，根据入院先后将患者分为对照组和治疗组，每组各48例。对照组皮下注射注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白，25 mg/次，2次/周。治疗组在对照组基础上口服艾拉莫德片，25 mg/次，2次/d。两组患者均连续治疗12周。观察两组的临床疗效，比较两组的关节症状、类风湿关节炎患者病情评价（DAS-28）评分、健康评估问卷（HAQ）评分和血清学指标。结果 治疗后，对照组和治疗组的总有效率分别为79.17%、93.75%，两组比较差异有统计学意义（P<0.05）。治疗后，两组关节疼痛数、关节压痛数、关节肿胀数和晨僵时间均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标明显低于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，两组DAS-28评分、HAQ评分均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标明显低于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组血清肿瘤坏死因子-α（TNF-α）、白细胞介素-1β（IL-1β）、白细胞介素-37（IL-37）、类风湿因子（RF）和血沉（ESR）水平均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标明显低于对照组，两组比较差异具有统计学意义（P<0.05）。结论 艾拉莫德片联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎具有较好的临床疗效，可改善患者临床症状，降低机体炎症反应，改善患者生活质量，具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Iguratimod Tablets combined with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection in treatment of rheumatoid arthritis. Methods Patients (96 cases) with rheumatoid arthritis in Xingtai People's Hospital from April 2015 to April 2016 were randomly divided into control and treatment groups, and each group had 48 cases. Patients in the control group were subcutaneous injection administered with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection, 25 mg/time, twice weekly. Patients in the treatment group were po administered with Iguratimod Tablets on the basis of the control group, 25 mg/time, twice daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical efficacies were evaluated, and joint symptoms, DAS-28 scores, HAQ scores, and serological indexes in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 79.17% and 93.75%, respectively, and there was difference between two groups (P<0.05). After treatment, joint pain count, tender joint counts, joint swelling count, and morning stiffness time in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, DAS-28 scores and HAQ scores in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of TNF-α, IL-1β, IL-37, RF, and ESR in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Iguratimod Tablets combined with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection has clinical curative effect in treatment of rheumatoid arthritis, can improve clinical symptoms, decrease the body inflammatory reaction, and improve the quality of life, which has a certain clinical application value.

河北省医学科学研究重点课题计划项目（20171464）