目的 回顾性分析通滞苏润江胶囊与氨糖美辛联合应用于膝骨关节炎的临床疗效。方法 选取河南省洛阳正骨医院2022年2月—2025年1月收治的186例膝骨关节炎患者作为研究对象，根据临床治疗方案的不同分为对照组（93例）和治疗组（93例）。对照组餐后口服氨糖美辛肠溶片，1片/次，每日2次。治疗组在对照组基础上，餐后口服通滞苏润江胶囊，5粒/次，2次/d。两组患者连续治疗6周。对比两组患者临床疗效，治疗前后的中医证候总分及各维度积分、美国特种外科医院（HSS）膝关节评分、下肢功能评价量表（LEFS）评分、膝骨关节炎指数（WOMAC）评分，同时检测血清炎症相关因子水平，评估两组平衡步态功能及不良反应发生情况。结果 治疗6周后，治疗组与对照组的总有效率分别为94.62%及82.80%，组间对比差异具有统计学意义（P＜0.05）。中医证候总分及各维度评分均较治疗前显著下降（P＜0.05），且治疗组上述评分的改善幅度显著优于对照组（P＜0.05）。治疗6周后，与基线水平相比，两组患者血清白细胞介素-1β（IL-1β）、肿瘤坏死因子-α（TNF-α）、一氧化氮（NO）、一氧化氮（NO）、骨钙素（BGP）及碱性磷酸酶（ALP）浓度均显著下降（均P＜0.05），而基质金属蛋白酶组织抑制剂-1（TIMP-1）水平则明显上升（P＜0.05）；在各项实验室指标的改善程度上，治疗组均较对照组更为突出（P＜0.05）。同时，两组平衡功能评分、步态功能评分以及量表总得分均高于干预前（P＜0.05），且治疗组上述各维度评分的提升幅度显著大于对照组，组间差异有统计学意义（P＜0.05）。结论 通滞苏润江胶囊联合氨糖美辛治疗膝骨关节炎的临床效果确切，可有效减轻患者关节疼痛症状、改善膝关节及下肢功能，缓解中医证候表现，抑制炎症反应，保护关节软骨，且安全性良好，具有显著的协同增效作用。

Objective To retrospectively analyze the clinical efficacy of combined treatment with Tongzhi Surunjiang Capsules and glucosamine indomethacin for knee osteoarthritis. Methods A total of 186 patients with knee osteoarthritis admitted to Luoyang Orthopedic-Traumatological Hospital of Henan Province from February 2022 to January 2025 were enrolled and divided into a control group and a treatment group according to different therapeutic regimens, with 93 cases in each group. The control group received oral glucosamine indomethacin enteric-coated tablets after meals, 1 tablet each time, twice a day. On the basis of the control regimen, the treatment group was additionally given oral Tongzhi Surunjiang Capsules after meals, 5 capsules each time, twice a day. Both groups received continuous treatment for 6 weeks. The clinical efficacy, total and dimensional scores of traditional Chinese medicine (TCM) syndromes, Hospital for Special Surgery (HSS) knee score, Lower Extremity Functional Scale (LEFS) score and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were compared before and after treatment. Serum levels of inflammatory factors were detected, and balance, gait function and adverse reactions were also evaluated. Results After 6 weeks of treatment, the total effective rate was 94.62% in the treatment group and 82.80% in the control group, with a statistically significant difference between the two groups (P < 0.05). The total and dimensional TCM syndrome scores were significantly decreased in both groups after treatment (P < 0.05), and the improvements were more remarkable in the treatment group (P < 0.05). Compared with baseline, serum concentrations of interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), nitric oxide (NO), osteocalcin (BGP) and alkaline phosphatase (ALP) were markedly reduced, while the level of tissue inhibitor of metalloproteinase-1 (TIMP-1) was obviously elevated in two groups (P < 0.05). The treatment group presented superior improvements in all laboratory indicators (P < 0.05). Additionally, the balance function score, gait function score and total scale scores were increased in both groups after intervention (P < 0.05), and the increases were significantly greater in the treatment group (P < 0.05). Conclusion The combination of Tongzhi Surunjiang Capsules and glucosamine indomethacin has definite clinical effects on knee osteoarthritis. It can effectively relieve joint pain, improve knee and lower limb function, alleviate TCM symptoms, suppress inflammatory responses and protect articular cartilage with good safety. This combined regimen exerts an obvious synergistic effect.

R982

河南省中医药科学研究专项课题（20-21ZY2250）