【目的】 探究下肢消肿方（以桃红四物汤为底方化裁而成）对全膝关节置换术（TKA）后气滞血瘀型患者下肢肿胀的临床 疗效，分析手术前后中医证型的变化情况。【方法】 选取2024年11月至2025年1月在广州中医药大学第一附属医院人工关节 与膝关节科住院，明确诊断为膝骨关节炎，且TKA术后下肢肿胀的气滞血瘀型患者共60例。根据患者意愿和术后用药的不 同情况将其分为3组，分别为中药组25例，理伤组15例，迈之灵组20例。以患侧腿围变化描述膝关节的体积变化，分别于 术前和术后第 1、3、30 天进行测量。【结果】（1）下肢肿胀方面，3 组患者术后患侧小腿及大腿腿围均呈“早期加重（术 后第 1、3 天）-后期缓解（术后第30天）”的趋势，术后第3天均达肿胀峰值，术后第1、3天与术前比较，差异均有统计学意 义（P＜0.05）；随后肿胀逐渐缓解，患侧小腿及大腿腿围均逐渐缩小，术后第30天与术后第1、3天比较，差异均有统计学意 义（P＜0.05）。但3组患者在改善患侧小腿、大腿腿围方面差异均无统计学意义（P＞0.05）。（2）不良反应方面，理伤组与迈之 灵组各报告2例不良反应事件，包括术后伤口渗血、皮下瘀斑、肺部感染和便秘等；中药组未报告胃肠道不良反应事件，患 者治疗依从性优于理伤组和迈之灵组。（3）中医辨证分型方面，每位患者均在不同时间段（术前和术后第1、3、30天）共接受 了 4 次评估，故共纳入 240 例有效数据。其中，气滞血瘀证最多，共 170 例（占 70.83%）；肝肾亏虚证次之，共 64 例（占 26.67%）；气血虚弱证最少，只有 6例（占 2.50%）。（4）比较不同组别与辨证分型的关系发现，不同组别与证型分布之间无明 显关联（P＞0.05）；进一步行广义估计方程分析发现，不同组别对中医辨证分型无明显影响（P＞0.05）。（5）比较不同时间点与 辨证分型的关系发现，术前以肝肾亏虚证为主（占96.67%），术后第1天和第3天全部为气滞血瘀证（占100.00%），术后第30天以气滞血瘀证为主（占80.00%）。不同时间点与证型分布之间存在明显关联（P＜0.05）；进一步行广义估计方程分析发现，不 同时间点会显著影响中医辨证分型（P＜0.001）。【结论】 下肢消肿方在改善 TKA术后气滞血瘀型患者下肢肿胀方面的疗效与 理伤消肿口服液及迈之灵片相当；该方剂通过活血化瘀、健脾消积的作用，减少了患者术后伤口渗血、皮下瘀斑和便秘等 不良反应的发生，为TKA术后下肢肿胀的治疗提供了新的药物选择，尤其适用于气滞血瘀兼有脾虚的患者群体。

Objective To investigate the clinical efficacy of the Lower Limb Detumescence Formula （derived from Taohong Siwu Decoction） in treating lower limb swelling in patients with qi stagnation and blood stasis syndrome after total knee arthroplasty （TKA），and to analyze the changes in traditional Chinese medicine （TCM） syndrome types before and after surgery. Methods A total of 60 patients diagnosed with knee osteoarthritis and lower limb swelling with qi stagnation and blood stasis syndrome after TKA，hospitalized in the Department of Artificial Joints and Knee Surgery，The First Affiliated Hospital of Guangzhou University of Chinese Medicine between November 2024 and January 2025，were selected. Based on patients’ preferences and postoperative medication，the patients were divided into three groups：the Chinese medicine Group （25 cases），the Lishang Group （15 cases），and the Aescuven Forte Group （20 cases）. Changes in limb circumference on the affected side were used to describe knee volume changes，and were measured preoperatively and on postoperative days 1，3，and 30. Results （1）Regarding lower limb swelling，the calf and thigh circumferences of the affected side in all three groups showed a trend of early exacerbation （on postoperative days 1 and 3） followed by later relief （on postoperative day 30）. Peak swelling occurred on postoperative day 3，with statistically significant differences compared to preoperative measurements （P＜0.05）. Subsequently，swelling gradually alleviated，and the calf and thigh circumferences of the affected side progressively decreased，the circum ferences on postoperative day 30 differed from those on postoperative days 1 and 3（P＜0.05）. However， there were no statistically significant differences in improving calf and thigh circumferences among the three groups （P＞0.05）.（2） In terms of adverse reactions，the Lishang Group and the Aescuven Forte Group each reported two adverse events，including postoperative wound bleeding，subcutaneous ecchymosis， pulmonary infection， and constipation. The Chinese medicine group reported no gastrointestinal adverse events，and patient treatment compliance was better than that in the Lishang Group and the Aescuven Forte Group.（3）Regarding TCM syndrome differentiation，each patient received four assessments at different time points （preoperatively and on postoperative days 1，3，and 30），resulting in 240 valid data entries. Among these，qi stagnation and blood stasis syndrome was the most common （170 cases，70.83%），followed by liver and kidney deficiency syndrome （64 cases，26.67%），and qi and blood deficiency syndrome was the least common （6 cases， 2.50%）.（4）Comparison of the relationship between different groups and syndrome types revealed no significant association between group distribution and syndrome type （P＞0.05）. Further generalized estimating equation analysis showed that grouping had no significant effect on TCM syndrome differentiation （P＞0.05）. （5）Comparison of the relationship between different time points and syndrome types revealed that preoperative syndromes predominantly consisted of liver and kidney deficiency （96.67%），while on postoperative days 1 and 3， all cases were classified as qi stagnation and blood stasis syndrome （100.00%）. On postoperative day 30， qi stagnation and blood stasis syndrome remained the most common （80.00%）. There was a significant association between time points and syndrome distribution （P＜0.05）. Further generalized estimating equation analysis indicated that time points significantly influenced TCM syndrome differentiation （P＜0.001）. Conclusion The Lower Limb Detumescence Formula demonstrates efficacy comparable to Lishang Xiaozhong Oral Liquid and Aescuven Forte Tablets in improving lower limb swelling in patients with qi stagnation and blood stasis syndrome after TKA. By promoting blood circulation， resolving stasis， strengthening the spleen， and eliminating accumulation， this formula reduces the incidence of adverse reactions such as postoperative wound bleeding， subcutaneous ecchymosis，and constipation. It provides a new pharmacological option for treating lower limb swelling after TKA， and is particularly suitable for patients with qi stagnation and blood stasis syndrome accompanied by spleen deficiency.

R274.9

国家自然科学基金项目（编号：82374484）