目的 探讨通络开痹片与洛索洛芬钠凝胶贴膏联合治疗膝骨关节炎的临床疗效。方法 选取2025年1—12月武汉市中医医院收治的膝骨关节炎患者共80例，采用随机数字表法将收治的80例膝骨关节炎患者分为对照组和治疗组，每组各40例。对照组给予洛索洛芬钠凝胶贴膏，1次/d。治疗组在对照组治疗基础上口服通络开痹片，3片/次，1次/d。两组均连续治疗8周。观察两组临床疗效，比较两组西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、国际膝关节文献委员会主观膝关节评估表（IKDC）评分、炎症因子水平。结果 治疗过程中，治疗组总有效率（95.00%）显著高于对照组（67.50%，P＜0.05）。治疗后，两组WOMAC量表中疼痛、僵硬、日常活动难度及总评分均较同组治疗前显著降低，IKDC量表评分升高（P＜0.05）；治疗后治疗组患者疼痛、僵硬、日常活动难度及总评分均低于对照组，IKDC量表评分高于对照组（P＜0.05）。治疗后，两组血清白细胞介素-6（IL-6）、白细胞介素-1β（IL-1β）、肿瘤坏死因子-α（TNF-α）水平均显著降低（P＜0.05）；治疗后，相较于对照组，治疗组血清IL-6、IL-1β及TNF-α更低（P＜0.05）。结论 通络开痹片与洛索洛芬钠凝胶贴膏联合治疗膝骨关节炎患者临床疗效更高，且利于缓解患者关节肿痛、僵硬等临床症状，修复关节功能，抑制炎症反应，且安全性尚可，值得临床推广应用。

Objective To explore the therapeutic effect of Tongluo Kaibi Tablets combined with loxoprofen sodium in treatment of knee osteoarthritis. Methods A total of 80 patients with knee osteoarthritis admitted to Wuhan Hospital of Traditional Chinese Medicine from January 2025 to December were selected. Using the random number table method, the 80 patients with knee osteoarthritis admitted were divided into control group and treatment group, with 40 cases in each group. Patients in control group were given Loxoprofen Sodium Cataplasms once daily. Patients in treatment group took Tongluo Kaibi Tablets, 3 tablets/time, once daily. Both groups were treated continuously for 8 weeks. The clinical efficacy of two groups was observed, and scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the International Knee Documentation Committee Subjective Knee Assessment Form (IKDC), and the levels of inflammatory factors in two groups were compared. Results During the treatment process, the total effective rate of treatment group (95.00%) was significantly higher than that of control group (67.50%, P < 0.05). After treatment, the scores of pain, stiffness, difficulty in daily activities and the total score in WOMAC scale of both groups were significantly lower than those before treatment in same group, but score in IKDC scale increased (P< 0.05). After treatment, score of pain, stiffness, difficulty in daily activities and total score of patients in treatment group were lower than those in control group, and the score in IKDC scale was higher than that of control group (P < 0.05). After treatment, the levels of serum interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α) in both groups were significantly lower (P < 0.05). After treatment, compared with control group, the serum IL-6, IL-1β, and TNF-α levels in treatment group were lower (P < 0.05). Conclusion The combined treatment of Tongluo Kaibi Tablets and Loxoprofen Sodium Cataplasms for patients with knee osteoarthritis has a higher clinical efficacy. It is beneficial for alleviating the clinical symptoms such as joint swelling, pain and stiffness of the patients, restoring joint function, inhibiting inflammatory reactions, and has acceptable safety. Therefore, it is worthy of clinical promotion and application.

R982

湖北省中医药管理局中医药科研项目（ZY2023Z011）