中药熏洗联合气压弹道式冲击波治疗风寒 湿痹型膝骨关节炎：基于MRI及炎症因子 的疗效评价

Fumigation and Washing with Traditional Chinese Medicine Combined with Pneumatic Ballistic Shock Wave Therapy for Knee Osteoarthritis of Wind-Cold-Dampness Bi Type: Efficacy Evaluation Based on MRI and Inflammatory Factors

摘要: 目的：探讨中药熏洗联合气压弹道式体外冲击波(ESWT)治疗风寒湿痹型膝关节骨性关节炎(KOA)的临床疗效，及其对患膝MRI客观影像特征与关节腔滑液炎症因子的影响。方法：采用前瞻性随机对照研究设计，选取220例风寒湿痹型KOA患者，采用随机数字表法分为对照组和治疗组各110例。对照组给予常规电针与灸法治疗，治疗组在对照组基础上联合气压弹道式ESWT (每周2次)与自拟中药方熏洗(每日1次)治疗，两组基础干预疗程均为14天。分别于治疗前、治疗14天后及治疗后12周进行多维度疗效评价。比较两组患者的视觉模拟评分(VAS)、WOMAC骨关节炎指数；同步评估6分钟步行试验(6MWT)及世界卫生组织生存质量测定量表简表(WHOQOL-BREF)；抽取患侧膝关节腔滑液采用ELISA法检测白细胞介素-1β (IL-1β)、白细胞介素-6 (IL-6)及肿瘤坏死因子-α (TNF-α)水平；并于12周随访时采用3.0T MRI测量关节积液最大截面积、滑膜厚度及软骨下骨髓水肿WORMS评分。同时监测并记录不良反应。结果：治疗前，两组各项基线指标比较差异均无统计学意义(P > 0.05)。① 近期临床疗效与生化指标：治疗组VAS评分降至(2.38 ± 1.41)分，WOMAC评分降至(34.78 ± 9.67)分，6MWT步行距离提升至(426.87 ± 49.53) m，WHOQOL-BREF总分升高至(78.84 ± 13.40)分；局部滑液中IL-1β、IL-6及TNF-α浓度呈现显著下降，上述主客观功能、生活质量及微观炎症因子的改善幅度均显著优于对照组(P < 0.001)。② 远期影像学微环境(治疗后12周)：治疗组关节积液最大截面积缩小至(249.61 ± 64.44) mm²，滑膜厚度退缩变薄至(1.93 ± 0.58) mm，骨髓水肿WORMS评分降至(1.47 ± 1.22)分，其继发性滑膜炎及微环境形态学改善程度显著优于对照组(P < 0.001)。③ 安全性评价：两组不良反应发生率极低且症状轻微，全程无严重不良事件发生。结论：中药熏洗联合气压弹道式ESWT能强效靶向下调风寒湿痹型KOA患者关节局部的促炎细胞因子表达，加速局部炎性渗出液与骨髓水肿的吸收。该多模态方案从微观生化与宏观影像学层面有效改善了关节局部微环境，进而安全、快速地缓解了患者疼痛并提升了膝关节综合运动功能，具有极高的临床应用与推广价值。

Abstract: Objective: To investigate the clinical efficacy of traditional Chinese medicine (TCM) fumigation and washing combined with pneumatic ballistic extracorporeal shock wave therapy (ESWT) in the treatment of knee osteoarthritis (KOA) of the wind-cold-dampness Bi type, and its effects on objective MRI features of the affected knee and inflammatory factors in the synovial fluid of the knee joint. Methods: A prospective randomized controlled trial design was adopted. A total of 220 patients with wind-cold-dampness Bi type KOA were selected and randomly divided into a control group and a treatment group using a random number table method, with 110 cases in each group. The control group received conventional electroacupuncture and moxibustion therapy. The treatment group received additional pneumatic ballistic ESWT (twice weekly) and self-formulated TCM fumigation and washing (once daily) on the basis of the control group. The duration of the basic intervention for both groups was 14 days. Multidimensional efficacy evaluations were conducted before treatment, after 14 days of treatment, and at 12 weeks post-treatment. The Visual Analog Scale (VAS) and WOMAC Osteoarthritis Index were compared between the two groups. The 6-minute walk test (6MWT) and the World Health Organization Quality of Life Brief Scale (WHOQOL-BREF) were also assessed simultaneously. Synovial fluid from the affected knee joint cavity was collected, and levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were detected using ELISA. At the 12-week follow-up, 3.0T MRI was used to measure the maximum cross-sectional area of joint effusion, synovial thickness, and WORMS score for subchondral bone marrow edema. Adverse reactions were also monitored and recorded. Results: Before treatment, there were no statistically significant differences in baseline indicators between the two groups (P > 0.05). ① Short-term clinical efficacy and biochemical indicators: In the treatment group, the VAS score decreased to (2.38 ± 1.41), the WOMAC score decreased to (34.78 ± 9.67), the 6MWT distance increased to (426.87 ± 49.53) m, and the total WHOQOL-BREF score increased to (78.84 ± 13.40). Concentrations of IL-1β, IL-6, and TNF-α in local synovial fluid showed significant decreases. The improvements in subjective and objective function, quality of life, and microscopic inflammatory factors were significantly better in the treatment group than in the control group (P < 0.001). ② Long-term imaging microenvironment (12 weeks post-treatment): In the treatment group, the maximum cross-sectional area of joint effusion was reduced to (249.61 ± 64.44) mm², synovial thickness decreased to (1.93 ± 0.58) mm, and the WORMS score for bone marrow edema decreased to (1.47 ± 1.22). The improvements in secondary synovitis and morphological changes in the microenvironment were significantly superior to those in the control group (P < 0.001). ③ Safety evaluation: The incidence of adverse reactions was very low in both groups, and symptoms were mild, with no serious adverse events occurring throughout the entire process. Conclusion: TCM fumigation and washing combined with pneumatic ballistic ESWT can potently and targetedly downregulate the expression of pro-inflammatory cytokines in the joints of patients with wind-cold-dampness Bi type KOA, accelerating the absorption of local inflammatory exudate and bone marrow edema. This multimodal regimen effectively improves the local joint microenvironment at both the microscopic biochemical and macroscopic imaging levels, thereby safely and rapidly alleviating pain and enhancing comprehensive motor function of the knee joint, demonstrating high clinical application and promotion value.