【目的】 探讨骨伤外洗颗粒联合体外冲击波（ESWT）治疗早中期寒湿痹阻型膝骨关节炎（KOA）的临床疗效。【方法】 选取 2022年7月 ~ 2023年7月就诊于广州中医药大学东莞医院（东莞市中医院）骨科门诊的84例早中期寒湿痹阻型KOA患者，采 用随机数字表法将患者随机分为观察组和对照组，每组各42例。2组患者均给予ESWT治疗，观察组在此基础上加用骨伤外 洗颗粒外洗治疗，2组患者的疗程均为4周。观察2组患者治疗前后的中医证候积分、疼痛视觉模拟量表（VAS）评分、西安大 略和麦克马斯特大学骨关节炎指数（WOMAC）评分的变化情况，并评价2组患者的临床疗效。【结果】（1）疗效方面，治疗4周 后，观察组的总有效率为95.24%（40/42），对照组为76.19%（32/42），组间比较（χ2 检验），观察组的疗效明显优于对照组，差 异有统计学意义（P＜0.05）。（2）疼痛症状改善方面，治疗后，2组患者的疼痛 VAS评分均较治疗前明显降低，差异均有统计 学意义（P＜0.01）；但治疗后组间比较，差异无统计学意义（P＞0.05）。（3）膝关节功能改善方面，治疗后，2 组患者的 WOMAC 评分均较治疗前明显降低（P＜0.01）；且观察组对 WOMAC 评分的降低幅度明显优于对照组，差异有统计学意义 （P＜0.01）。（4）中医证候积分方面，治疗后，2组患者的畏寒肢冷、屈伸不利、僵硬麻木积分均较治疗前明显降低（P＜0.01）， 且观察组对各项中医证候积分的降低幅度均明显优于对照组，差异均有统计学意义（P＜0.01）。【结论】 骨伤外洗颗粒联合 ESWT治疗早中期寒湿痹阻型KOA患者疗效显著，能够有效缓解临床症状，改善膝关节功能，提高患者生活质量。

Objective To evaluate the clinical efficacy of Gushang External Wash Granules combined with extracorporeal shockwave therapy （ESWT） in treating early-to-middle-stage knee osteoarthritis （KOA） with colddamp obstruction syndrome. Methods A total of 84 patients diagnosed as early-to- middle-stage KOA （cold-damp obstruction syndrome） at the Orthopedic Outpatient Clinic of Dongguan Hospital of Guangzhou University of Chinese Medicine （Dongguan Traditional Chinese Medicine Hospital） from July 2022 to July 2023 were enrolled. Patients were randomly assigned to either the observation group or control group using a random number table，with 42 cases in each group. Both groups received ESWT，while the observation group additionally underwent topical washing with Gushang External Wash Granules. The treatment course lasted 4 weeks for both groups. The changes in traditional Chinese medicine （TCM） syndrome scores， Visual Analogue Scale （VAS） scores for pain， and Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） scores in the two groups were measured before and after treatment，and the clinical efficacy was evaluated after treatment. Results （1）After 4 weeks of treatment，the total effective rate was 95.24%（40/42） in the observation group versus 76.19%（32/42） in the control group. Intergroup comparison （tested by chi-square test） showed significantly superior efficacy in the observation group （P＜0.05）.（2） After treatment，both groups demonstrated significant reductions in VAS pain scores compared to those before treatment （P＜0.01）， while no statistically significant difference was found between groups （P＞0.05）.（3）WOMAC scores were decreased significantly in both groups after treatment （P＜ 0.01），and the observation group showed significantly greater reduction than the control group（P＜0.01），with statistically significance.（4） After treatment，the scores for the TCM symptoms of intolerance of cold and limb chilling，restricted flexion-extension，and stiffness and numbness in the extremities were significantly reduced in both groups （P＜0.01），and the observation group demonstrated significantly greater improvements in all TCM syndrome scores than the control group （P＜0.01）. Conclusion The combination of Gushang External Wash Granules and ESWT demonstrates significant efficacy for the patients with early-to-middle-stage KOA of colddamp obstruction type，and is effective on alleviating clinical symptoms and improving knee function and quality of life of the patients.

R274.9

广东省中医药局科研项目（编号：20241353）；东莞市社会发展科技项目（编号：20231800903833）