【目的】评价活血消肿散 （双柏散） 治疗轻中度气滞血瘀证膝骨关节炎 （KOA） 患者的短期临床疗效。 【方法】将60例轻中度气滞血瘀证KOA患者随机分为治疗组和对照组，每组各30例。治疗组给予活血消肿散外敷治疗，对照组给予扶他林 （双氯芬酸二乙胺乳胶剂） 外涂治疗，疗程均为1周。观察2组患者治疗前后疼痛视觉模拟量表 （VAS） 评分、西安大略麦克马斯特大学骨关节炎指数 （WOMAC） 评分和血沉 （ESR） 、C反应蛋白 （CRP） 水平及超声下滑膜厚度的变化情况，并评价2组患者的临床疗效和用药安全性。 【结果】（1） 疗效方面，治疗1周后，治疗组的总有效率为93.33% （28/30） ，对照组为73.33% （22/30） ；组间比较 （秩和检验） ，治疗组的疗效明显优于对照组 （P＜0.05） 。 （2） 评价指标方面，治疗后，2组患者的疼痛VAS评分、WOMAC评分和ESR、CRP水平及超声下滑膜厚度均较治疗前明显改善 （P＜0.01） ，且治疗组对WOMAC评分、CRP水平及超声下滑膜厚度的改善作用均明显优于对照组 （P＜0.01） 。 （3） 安全性方面，治疗期间，2组患者均未出现明显皮肤红肿、瘙痒等不良反应，具有较高的安全性。 【结论】针对轻中度气滞血瘀证KOA患者，单独使用活血消肿散外敷治疗也可取得较好的短期疗效，能有效减轻疼痛症状，降低炎性指标及滑膜厚度。

Objective To evaluate the short-term efficacy of Huoxue Xiaozhong Powder （i.e.，Shuangbai San） for the treatment of patients with mild-to-moderate knee osteoarthritis（KOA） of qi stagnation and blood stasis syndrome. Methods Sixty patients with mild-to-moderate KOA of qi stagnation and blood stasis syndrome were randomly divided into the treatment group and the control group，with 30 cases in each group. The treatment group was treated with external application of Huoxue Xiaozhong Powder，and the control group was treated with external application of Voltaren （diclofenac diethylamide emulsion） . Both groups were treated for one week as a course. The changes of visual analogue scale（VAS） score，Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） score and erythrocyte sedimentation rate（ESR）， C-reactive protein（CRP） level and synovial thickness under ultrasound in the two groups before and after treatment were observed. Moreover，the clinical efficacy and safety of the two groups were evaluated. Results （1） After one week of treatment，the total effective rate of the treatment group was 93.33% （28/30） ，and that of the control group was 73.33% （22/30） . The intergroup comparison （tested by rank sum test） showed that the clinical efficacy of the treatment group was significantly superior to that of the control group （P＜0.05） . （2） After treatment，the VAS score，WOMAC score，ESR，CRP level and synovial thickness under ultrasound in the two groups were significantly improved compared with those before treatment （P＜0.01） ，and the treatment group had stronger effect on the improvement of VAS score，WOMAC score，ESR，CRP level and synovial thickness under ultrasound than the control group （P＜0.01） . （3） During treatment，no obvious adverse reactions such as skin redness，swelling and itching occurred in the two groups of patients，which had a high safety. Conclusion For the patients with mild- to-moderate KOA of qi stagnation and blood stasis syndrome，the use of Huoxue Xiaozhong Powder for external treatment alone can also achieve good short-term clinical effects，which can effectively alleviate the symptoms of pain，and reduce the levels of inflammatory indicators and synovial thickness.

R274.9

国家自然科学基金项目 （编号：81804124）；深圳市卫生健康菁英人才项目 （编号：2021XKG004）