目的 探讨祛风止痛胶囊联合重组人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2020年1月—2020年12月天津中医药大学第一附属医院风湿免疫科收治的109例类风湿关节炎患者，按照随机数字法分为对照组（n=54）和治疗组（n=55）。对照组患者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；治疗组在对照组的基础上口服祛风止痛胶囊，6粒/次，2次/d。1个月为1个疗程，两组患者连续治疗2个疗程。观察两组临床疗效，比较两组症状改善情况，血清炎症因子、实验室指标和不良反应情况。结果 治疗后，治疗组总有效率94.55%显著高于对照组的81.48%（P<0.05）。治疗后，两组患者关节肿胀数目、关节压痛数目、DAS28评分和VAS评分均显著降低（P<0.05）；治疗后，治疗组临床症状改善情况优于对照组（P<0.05）。治疗后，两组肿瘤坏死因子α（TNF-α）、环氧合酶-2（COX-2）、白细胞介素-β（IL-1β）、白细胞介素-6（IL-6）和C反应蛋白（CRP）水平显著降低（P<0.05）；治疗后，治疗组血清炎症因子水平明显低于对照组（P<0.05）。治疗后，两组患者红细胞沉降率（ESR）、类风湿因子（RF）、补体C3和C4水平均显著降低（P<0.05）；治疗后，治疗组ESR、RF、C3、C4水平明显低于对照组（P<0.05）。结论 祛风止痛胶囊联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎临床疗效显著，可有效改善患者的反应症状，降低相关炎性因子水平，并减少不良反应的发生，值得临床推广。

Objective To investigate the efficacy of Qufeng Zhitong Capsules combined with recombinant human tumor necrosis factor receptor-antibody fusion protein type Ⅱ in treatment of rheumatoid arthritis. Methods A total of 109 patients with rheumatoid arthritis who were admitted to the department of rheumatology of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from January 2020 to December 2020 were selected and divided into control group (n=54) and treatment group (n=55) according to random number method. Patients in the control group were sc administered with Recombinant Human Tumor Necrosis Factor Receptor-antibody Fusion Protein Type Ⅱ for injection, 25 mg/time, twice weekly. Patients in the treatment group were po administered with Qufeng Zhitong Capsules on the basis of the control group, 6 grains/time, twice daily. One month was one course of treatment, and the two groups were treated for two courses of treatment continuously. The clinical efficacy of the two groups was observed, and the improvement of symptoms, serum inflammatory factors, laboratory indicators and adverse reactions were compared between the two groups. Results After treatment, the total effective rate in the treatment group was 94.55% significantly higher than that in the control group (81.48%) (P < 0.05). After treatment, the number of joint swelling, number of joint tenderness, DAS28 score, and VAS score in two groups were significantly decreased (P < 0.05). After treatment, the improvement of clinical symptoms in the treatment group was better than that in the control group (P < 0.05). After treatment, the levels of tumor necrosis factor (TNF-α), cyclooxygenase-2 (COX-2), interleukin-β (1L-1β), interleukin-6 (1L-6), and C-reactive protein (CRP) in two groups were significantly decreased (P < 0.05). After treatment, the levels of serum inflammatory factors in treatment group were significantly lower than those in control group (P < 0.05). After treatment, erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), complement C3 and C4 levels in two groups were significantly decreased (P < 0.05). After treatment, the levels of ESR, RF, C3, and C4 in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion Qufeng Zhitong Capsules combined with recombinant human tumor necrosis factor receptor-antibody fusion protein type Ⅱ has a significant clinical effect in treatment of rheumatoid arthritis, and can effectively improve the reaction symptoms of patients, reduce the level of related inflammatory factors and the occurrence of adverse reactions, which is worthy of clinical promotion.

R977

天津市科技计划项目（15ZXLCSY00020）