目的 探讨关节克痹丸联合洛索洛芬钠凝胶贴膏治疗膝骨关节炎风寒湿痹证的临床疗效。方法 选取2023年3月—2025年3月南阳市中医院关节科收治的90例膝骨关节炎患者，按照随机数字表法分为对照组和治疗组，每组各45例。对照组患者给予洛索洛芬钠凝胶贴膏贴于膝关节患处，1贴/次，1次/d，使用12 h后撕掉，间歇12 h后再次使用。治疗组在对照组的基础上口服关节克痹丸，8丸/次，2次/d。两组均连续治疗6周。观察两组的临床疗效，比较两组中医症状积分、视觉模拟疼痛评分（VAS）、骨关节炎指数（WOMAC）评分、肿瘤坏死因子-α（TNF-α）、血清基质金属蛋白酶-3（MMP-3）、P物质（SP）、5-羟色胺（5-HT）水平。结果 治疗后，治疗组总有效率97.78%，显著高于对照组的82.22%（P＜0.05）。治疗后，两组膝关节冷痛积分、膝关节活动不利积分、膝关节僵硬积分、膝关节肿大积分均较前显著降低（P＜0.05）；治疗后，与对照组对比，治疗组膝关节冷痛积分、膝关节活动不利积分、膝关节僵硬积分、膝关节肿大积分均更低（P＜0.05）。治疗后，两组WOMAC评分、VAS评分均较前显著降低（P＜0.05）；治疗后，与对照组对比，治疗组WOMAC评分、VAS评分均更低（P＜0.05）。治疗后，两组SP、MMP-3、TNF-α、5-HT水平均显著降低（P＜0.05）；治疗后，与对照组对比，治疗组SP、MMP-3、TNF-α、5-HT水平均更低（P＜0.05）。结论 关节克痹丸联合洛索洛芬钠凝胶贴膏治疗膝骨关节炎风寒湿痹证疗效显著，可缓解炎症反应及疼痛状态，恢复关节功能，且药物安全，值得借鉴与应用。

Objective To explore the clinical efficacy of Guanjie Kebi Pills combined with loxoprofen sodium in treatment of knee osteoarthritis with wind cold dampness arthralgia syndrome. Methods A total of 90 patients with knee osteoarthritis admitted to the Joint Department of Nanyang Hospital of Traditional Chinese Medicine from March 2023 to March 2025 were selected and divided into control group and treatment group according to random number table method, with 45 cases in each group. Patients in control group were given Loxoprofen Sodium Cataplasms applied to the affected area of knee joint, once daily. The patches were removed after 12 h of use and used again after a 12 h interval. Patients in treatment group were po administered with Guanjie Kebi Pills on the basis of control group, 8 pills each time, twice daily. Both groups were treated continuously for 6 weeks. The clinical efficacy of two groups was observed, and the levels of traditional Chinese medicine symptom score, VAS score for pain, WOMAC score, TNF-α, MMP-3, SP, and 5-HT between two groups were compared. Results After treatment, the total effective rate of treatment group was 97.78%, significantly higher than that of control group (82.22%, P < 0.05). After treatment, the cold pain score of knee joint, the score of poor knee joint movement, the score of knee joint stiffness, and the score of knee joint swelling in both groups were significantly lower than before (P < 0.05). After treatment, compared with control group, the cold pain score of knee joint, the score of poor knee joint movement, the score of knee joint stiffness, and the score of knee joint swelling in treatment group were all lower (P < 0.05). After treatment, the WOMAC scores and VAS scores of both groups were significantly lower than those before (P < 0.05). After treatment, compared with control group, the WOMAC score and VAS score of treatment group were both lower (P < 0.05). After treatment, the levels of SP, MMP-3, TNF-α, and 5-HT in both groups were significantly decreased (P < 0.05). After treatment, compared with control group, the levels of SP, MMP-3, TNF-α, and 5-HT in treatment group were all lower (P < 0.05). Conclusion Guanjie Kebi Pills combined with loxoprofen sodium has a remarkable therapeutic effect in treatment of knee osteoarthritis with wind cold dampness arthralgia syndrome, and can relieve inflammatory responses and pain states, restore joint function, and the drug is safe, which is worth learning from and applying.

R982

河南省中医药科学研究专项课题（2024ZY2198）