目的 评估痹祺胶囊治疗膝骨关节炎（knee osteoarthritis，KOA）合并骨髓水肿（bone marrow edema，BME）的疗效。方法 选取90名来自广州中医药大学第二附属医院大学城分院骨科门诊收治的KOA合并BME患者为试验对象。将患者随机分为试验组（痹祺胶囊治疗，45例）和对照组（依托考昔治疗，45例）。观察治疗前后两组患者的西安大略和麦克马斯特大学骨关节炎指数（Western Ontario and McMaster Universities osteoarthritis index，WOMAC）评分、视觉模拟量表（visual analogue scale，VAS）评分、全膝关节磁共振成像评分（whole-organ magnetic resonance imaging score，WORMS）、BME体积占比和外周血炎症指标外周血中性粒细胞淋巴细胞计数比（neutrophil lymphocyte ratio，NLR）与淋巴细胞单核细胞计数比值（lymphocyte monocyte ratio，LMR）来评估痹祺胶囊的疗效。此外，观察BME体积与疼痛之间的相关性对分析结果进行佐证。结果 共纳入90例患者，中途脱落10例，最终入组80例患者。治疗8周后，两组患者的WOMAC与VAS评分均明显下降（P＜0.05），且试验组的WOMAC与VAS评分改善更佳（P＜0.05）；试验组患者WORMS评分与BME体积占比显著减少（P＜0.05），而对照组则无明显变化；BME体积占比与VAS评分具有显著相关性（P＜0.05）；两组患者外周血NLR水平明显下降（P＜0.05），LMR水平明显升高（P＜0.05），体现了两组药物短期内抗炎的作用，而组间对比结果提示依托考昔短期抗炎效果优于痹祺胶囊（P＜0.05）。两组间不良反应无明显区别。结论 痹祺胶囊能有效减轻KOA合并BME患者的疼痛及改善其膝关节功能且效果优于依托考昔。而产生这种优势的原因是痹祺胶囊能针对性地减少BME体积。

Objective This study will assess the efficacy of Biqi Capsules (痹祺胶囊) in the treatment of knee osteoarthritis (KOA) in conjunction with BME. Methods This study was a randomized controlled trial with 90 subjects who were admitted to the outpatient clinic of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine with a diagnosis of KOA combined with BME. The patients were randomly divided into two groups: an experimental group of 45 cases (treated with Biqi Capsules) and a control group of 45 cases (treated with etoricoxib). By comparing Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score, visual analogue scale (VAS) score, whole-organ magnetic resonance imaging score (WORMS), BME volume, and neutrophil lymphocyte ratio (NLR) and lymphocyte monocyte ratio (LMR) of peripheral blood inflammation indices before and after treatment, the efficacy of the Biqi Capsules was assessed and further investigated. Furthermore, the correlation between BME volume and pain will be observed to support the analysis results. Results A total of 90 patients were enrolled with 10 leaving the study midway. In the end, 80 patients were examined. After eight weeks of treatment, clinical results demonstrated a significant reduction in WOMAC and VAS scores in both groups (P < 0.05), whereas an intergroup comparison revealed that Biqi Capsule produced the better efficacy in experimental group (P < 0.05). Results of radiographic showed that Biqi Capsules can significantly reduce WORMS scores and BME volume of patients (P < 0.05), while there was no significant change in the control group (P < 0.05). In addition, there was a significant correlation between BME volume and VAS score (P < 0.05). The NLR levels of patients in both groups were significantly decreased (P < 0.05) and LMR levels were significantly increased (P < 0.05), indicating that both drugs presented the anti-inflammatory effects in the short term. The intergroup comparison results showed that the short-term anti-inflammatory effect of etoricoxib was superior to that of Biqi Capsules (P < 0.05). In terms of adverse reactions, there was no significant difference between the two groups. Conclusion Biqi Capsules is more efficacious than etoricoxib in reducing knee pain and improving knee joint function in KOA patients with BME. The reason for this advantage is that Biqi Capsules can reduce the volume of BME.

R2285.64

广东省自然基金面上项目（2022A1515010793）