目的 探讨尪痹胶囊联合来氟米特治疗湿热阻络型类风湿关节炎患者的临床疗效。方法 选取2022年4月—2025年3月河北北方学院附属第一医院收治的150例湿热阻络型类风湿关节炎患者，采用随机数字表法分为对照组（75例）和治疗组（75例）。对照组给予来氟米特片，治疗组在对照组基础上口服尪痹胶囊。比较两组治疗4、12周后Th17细胞、Treg细胞占CD4⁺T细胞比例及Th17/Treg比值，血清炎性因子水平，关节功能指标，炎症标志物及中医证候积分变化。结果 治疗后，治疗组总有效率为90.67%，显著高于对照组的70.67%（P＜0.05）。治疗4、12周后，两组Th17细胞比例、Th17/Treg比值及血清肿瘤坏死因子-α（TNF-α）、巨噬细胞集落刺激因子（GM-CSF）、白细胞介素-17（IL-17）水平均比治疗前显著降低，而Treg细胞比例及血清白细胞介素-10（IL-10）、转化生长因子-β1（TGF-β1）水平显著升高（P＜0.05），且治疗组上述指标改善幅度显著优于同期对照组（P＜0.05）。治疗12周后，两组红细胞沉降率（ESR）、C反应蛋白（CRP）、类风湿因子（RF）水平，28个关节疾病活动度评分（DAS28）、视觉模拟评分（VAS）、压痛关节数、肿胀关节数及中医证候各项积分均显著降低（P＜0.05），且治疗组这些指标均显著低于对照组（P＜0.05）。结论 尪痹胶囊联合来氟米特可通过调节湿热阻络型类风湿关节炎患者Th17/Treg细胞平衡，下调促炎因子表达、上调抗炎因子水平，减轻关节炎症反应，改善关节功能及中医证候。

Objective To investigate the effects of Wangbi Capsules combined with leflunomide in treatment of damp-heat Obstructing meridians rheumatoid arthritis. Methods A total of 150 patients with rheumatoid arthritis of damp-heat obstruction collateral syndrome admitted to the First Affiliated Hospital of Hebei North University from April 2022 to March 2025 were enrolled and divided into control group (75 cases) and treatment group (75 cases) using a random number table method. The control group received conventional treatment with Leflunomide Tablets, and the treatment group was additionally given oral Wangbi Capsules on the basis of the control regimen. The proportions of Th17 cells, Treg cells in CD4⁺ T cells, Th17/Treg ratio, serum inflammatory factor levels, joint function indicators, inflammatory markers and TCM syndrome scores were compared between the two groups at 4 and 12 weeks of treatment. Results After treatment, the total clinical effective rate of the treatment group was 90.67%, which was significantly higher than 70.67% of the control group (P < 0.05). At 4 and 12 weeks after treatment, the proportion of Th17 cells, Th17/Treg ratio, and serum levels of tumor necrosis factor-α (TNF-α), granulocyte-macrophage colony-stimulating factor (GM-CSF), and interleukin-17 (IL-17) in both groups were significantly decreased compared with baseline, while the proportion of Treg cells and serum levels of interleukin-10 (IL-10) and transforming growth factor-β1 (TGF-β1) were significantly increased (P < 0.05). The improvement of the above indicators in the treatment group was significantly better than that in the control group at the same time points (P < 0.05). At 12 weeks after treatment, the levels of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), 28-joint disease activity score (DAS28), visual analogue scale (VAS), number of tender joints, swollen joints and TCM syndrome scores in both groups were significantly decreased (P < 0.05), and all these indicators in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion Wangbi Capsules combined with leflunomide can regulate Th17/Treg cell balance in patients with rheumatoid arthritis of damp-heat obstruction collateral syndrome, down-regulate pro-inflammatory factors and up-regulate anti-inflammatory factors, alleviate joint inflammation, improve joint function and TCM syndromes, with favorable safety.

R982

河北省中医药管理局科研计划项目（2024320）