目的 探讨四妙丸联合硫酸羟氯喹治疗湿热痹阻型类风湿性关节炎的临床疗效。方法 选取2022年1月—2025年1月新疆维吾尔自治区人民医院收治的湿热痹阻型类风湿性关节炎患者110例。按照随机单双数法均分为对照组和治疗组，各55例。对照组患者给予硫酸羟氯喹片口服治疗，0.2 g/次，2次/d。治疗组患者在对照组的基础上，给予四妙丸口服治疗，6 g/次，2次/d。两组患者疗程均为12周。观察两组临床疗效，比较两组患者治疗前后中医证候积分、类风湿性关节炎简化疾病活动指数（SDAI）、健康评价调查表（HAQ）评分、关节压痛数（TJC）、关节肿胀数（SJC）、视觉模拟疼痛（VAS）评分以及红细胞沉降率（ESR）、类风湿因子（RF）、抗环瓜氨酸肽（CCP）抗体、C反应蛋白（CRP）、白细胞介素-6（IL-6）水平。结果 治疗组总有效率94.55%，要显著高于对照组总有效率78.18%（P＜0.05）。治疗后，两组患者中医证候积分、SDAI评分、TJC、SJC、HAQ评分和VAS评分均显著降低（P＜0.05），且治疗组要明显优于对照组（P＜0.05）。治疗后，两组患者ESR、RF、抗CCP抗体、CRP、IL-6水平均显著降低（P＜0.05），且治疗组要明显优于对照组（P＜0.05）。结论 四妙丸联合硫酸羟氯喹治疗湿热痹阻型类风湿性关节炎患者临床疗效良好，能够减轻患者疼痛症状和体征，降低关节炎症反应，提高患者生活质量。

Objective To investigate the clinical efficacy of Simiao Pills combined with hydroxychloroquine sulfate in treatment of damp-heat obstruction type rheumatoid arthritis. Methods A total of 110 patients with damp-heat obstruction type rheumatoid arthritis admitted to the People’s Hospital of Xinjiang Uygur Autonomous Region from January 2022 to January 2025 were selected. According to the random odd-even number method, they were evenly divided into control group and treatment group, with 55 cases in each group. Patients in control group were po administered with Hydroxychloroquine Sulfate Tablets, 0.2 g each time, twice daily. Patients in treatment group were po administered with Simiao Pills on basis of control group, 6 g each time, twice daily. The treatment course for both groups of patients was 12 weeks. The clinical efficacy of two groups was observed, and TCM syndrome score, SDAI score, HAQ scores, number of joint tenderness (TJC), number of joint swelling (SJC), VAS scores, ESR, RF, anti-CCP antibody, CRP, and IL-6 of two groups of patients before and after treatment were compared. Results The total effective rate of the treatment group was 94.55%, which was significantly higher than that of the control group (78.18%, P < 0.05). After treatment, the TCM syndrome scores, SDAI scores, TJC, SJC, HAQ scores, and VAS scores of both groups were significantly decreased (P < 0.05), and the treatment group was significantly better than control group (P < 0.05). After treatment, the levels of ESR, RF, anti-CCP antibody, CRP, and IL-6 in both groups were significantly decreased (P < 0.05), and the treatment group was significantly better than those in control group (P < 0.05). Conclusion Simiao Pills combined with hydroxychloroquine sulfate has good clinical efficacy in treatment of damp-heat obstruction type rheumatoid arthritis, and can alleviate patients’ pain symptoms and signs, reduce joint inflammatory responses, which can improve patients’ life quality.

R977

新疆维吾尔自治区自然科学基金资助项目（2024D01C97）；新疆维吾尔自治区人民医院院级课题（20240247）