目的 探讨七味通痹口服液联合甲氨蝶呤治疗类风湿关节炎的疗效观察及其对血清疼痛介质和炎症因子的影响。方法 选取2019年5月—2020年11月海南省中医院收治的84例类风湿关节炎患者作为研究对象，按照治疗方法将84例患者分为对照组和观察组，每组各42例。对照组口服甲氨蝶呤片，10 mg/次，1次/周。观察组在对照组基础上口服七味通痹口服液，10 mL/次，3次/d。两组连续治疗3个月。观察两组患者的临床疗效，比较两组治疗前后的关节压痛数、肿胀数、晨僵持续时间，同时比较两组视觉模拟评分法（VAS）、血清前列腺素E₂（PGE₂）、血浆P物质（SP）、白细胞介素-17（IL-17）、抗链球菌溶血素O（ASO）、类风湿因子（RF）、C反应蛋白（CRP）和血沉（ESR）水平。结果 治疗后，观察组总有效率为85.71%，显著高于对照组的66.67%，两组间对比差异有统计学意义（P<0.05）。两组治疗后的压痛数、肿胀数、晨僵持续时间、疼痛程度评分显著降低（P<0.05）；治疗后，观察组的压痛数、肿胀数、晨僵持续时间、疼痛程度评分显著低于对照组，差异有统计学意义（P<0.05）。两组治疗后的PGE₂、SP、IL-17水平显著降低（P<0.05）；治疗后，观察组的PGE₂、SP、IL-17水平显著低于对照组，差异有统计学意义（P<0.05）。两组治疗后的ASO、RF、CRP、ESR水平显著降低（P<0.05）；治疗后，观察组的ASO、RF、CRP、ESR水平显著低于对照组，差异有统计学意义（P<0.05）。结论 七味通痹口服液联合甲氨蝶呤可提高类风湿关节炎的疗效，降低患者血清疼痛介质和炎症因子的水平，进一步减轻临床症状体征，具有一定临床研究价值。

Objective To investigate the efficacy of Qiwei Tongbi Oral Liquid combined with methotrexate in treatment of rheumatoid arthritis, and its effect on serum pain mediators and inflammatory factors. Methods A total of 84 patients with rheumatoid arthritis admitted to Hainan Hospital of Traditional Chinese Medicine from May 2019 to November 2020 were selected as the research subjects. According to the treatment methods, 84 patients were divided into control group and observation group, with 42 cases in each group. Patients in the control group were po administered with Methotrexate Tablets, 10 mg/time, once a week. Patients in the observation group were po administered with Qiwei Tongbi Oral Liquid, 10 mL/time, three times daily. The two groups were treated for 3 months. The clinical efficacy of two groups was observed. The number of joint tenderness, swelling, and duration of morning stiffness before and after treatment were compared between two groups. The levels of VAS score, serum levels of PGE 2, SP, IL-17, ASO, RF, CRP, and ESR were compared between two groups. Results After treatment, the total effective rate of the observation group was 85.71%, significantly higher than 66.67% of the control group, and the difference between the two groups was statistically significant (P < 0.05). After treatment, the number of tenderness, swelling, the duration of morning stiffness, and the degree of pain in two groups were significantly decreased (P < 0.05). After treatment, the number of tenderness, swelling, the duration of morning stiffness, and the degree of pain in the observation group were significantly lower than those in the control group, with statistical significance (P < 0.05). After treatment, the levels of PGE₂, SP, and IL-17 in two groups were significantly decreased (P < 0.05). After treatment, the levels of PGE₂, SP, and IL-17 in the observation group were significantly lower than those in the control group, with statistical significance (P < 0.05). After treatment, the levels of ASO, RF, CRP, and ESR in two groups were significantly decreased (P < 0.05). After treatment, the levels of ASO, RF, CRP, and ESR in the observation group were significantly lower than those in the control group, with statistical significance (P < 0.05). Conclusion Qiwei Tongbi Oral Liquid combined with methotrexate can improve the efficacy of rheumatoid arthritis, reduce the level of serum pain mediators and inflammatory factors, and further reduce clinical symptoms and signs, which has certain clinical research value.

河南省医学科技公关计划项目（LHGJ20190363）