【目的】 评估倍他米松对全膝关节置换术（TKA）后膝关节疼痛及肤温异常升高的疗效，探讨双柏膏冷敷对其的协同作 用。【方法】 采用前瞻性随机对照研究，纳入90例于2023年9月至2024年12月在广东省中医院大学城医院和广东省中医院大 德路医院进行单侧 TKA术后 3周复诊中出现术侧膝关节周围皮肤温度异常升高，并自诉疼痛的膝关节骨性关节炎（KOA）患 者，采用随机数字表法将患者随机分为对照组、试验1组和试验2组，每组各30例。对照组给予依托考昔片治疗，试验1组 在对照组的基础上联合倍他米松治疗，试验2组在试验1组的基础上联合双柏膏冷敷治疗，疗程为8周。观察3组患者治疗 前后皮肤温度、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）评分及改良欧洲生活质 量学会三水平五维健康量表（EQ-5D-3L）评分的变化情况。【结果】（1）皮肤温度差方面，髌上囊区（B区）的皮肤温度差最显著 （75.6%）。治疗后，3组患者的B区温度差和9个区域温度差平均值均持续下降，与前1个时间点比较，差异均有统计学意义 （P＜0.01）；且试验组在各个访视时间点的 B区温度差和 9个区域温度差平均值均显著低于对照组（P＜0.01）；试验 1组与试 验2组在第二次访视中的下降趋势相近（P＞0.05），但试验2组在第三、四次访视中的B区温度差及在第四次访视中的9个区 域温度差平均值均显著低于试验1组（P＜0.01）。（2）疼痛程度评估方面，治疗后，3组患者的疼痛VAS评分均持续下降，与前 1个时间点比较，差异均有统计学意义（P＜0.01）；且试验组在第三、四次访视中的 VAS评分均显著低于对照组（P＜0.01）， 试验2组在第三、四次访视中的疼痛VAS评分又均显著低于试验1组（P＜0.01）。（3）WOMAC评分方面，治疗后，3组患者的 WOMAC 评分均持续下降，与前 1 个时间点比较，差异均有统计学意义（P＜0.01）；且试验组在第二、三、四次访视时的 WOMAC 评分均显著低于对照组（P＜0.01），试验 2 组在第二、三、四次访视时的 WOMAC 评分又均显著低于试验 1 组（P＜ 0.01）。（4）生活质量方面，治疗后，3组患者的改良EQ-5D-3L评分均持续升高，与前1个时间点比较，差异均有统计学意义 （P＜0.01）；且试验1组在第三、四次访视及试验2组在第二、三、四次访视中的改良EQ-5D-3L评分均显著高于对照组（P＜ 0.01），试验2组在第二、三、四次访视中的改良EQ-5D-3L评分又均显著高于试验1组（P＜0.01）。【结论】 倍他米松可有效改 善TKA术后疼痛及皮温异常升高，联合双柏膏冷敷具有协同增效作用。

Objective To evaluate the efficacy of betamethasone in alleviating knee pain and abnormal skin temperature elevation after total knee arthroplasty （TKA）， and to explore the synergistic effects of Shuangbai Paste cold compress. Methods A prospective randomized controlled trial was conducted in 90 patients who exhibited abnormal skin temperature elevation around the operated knee and self-reported pain during 3-week follow-up after unilateral TKA at Guangdong Provincial Hospital of Chinese Medicine （Higher Education Mega Center Branch） and Guangdong Provincial Hospital of Chinese Medicine （Dade Road Branch） from September 2023 to December 2024. Patients were randomly divided into control group，trial group 1，and trial group 2（n= 30 each） using a random number table method. The three groups received etoricoxib tablets，trial group 1 received additional betamethasone，and trial group 2 received additional Shuangbai Paste cold compress plus trial group 1's regimen，all the groups were treated for 8 weeks. Changes in skin temperature，Visual Analogue Scale （VAS） pain scores，Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） scores，and modified EuroQol-5D-3L （EQ-5D-3L）scores were observed. Results （1） Regarding the skin temperature difference， the suprapatellar bursa area （zone B） exhibited the most pronounced difference （75.6%）. After treatment，the temperature difference in zone B and the mean temperature difference across the nine regions consistently decreased in all three groups，with statistically significant differences compared to the previous time point （P＜ 0.01）. Furthermore， the trial groups demonstrated significantly lower temperature differences in zone B and mean temperature differences across the nine regions than the control group at all follow-up visits （P＜0.01）. Trial group 2 and trial group 1 showed similar decreasing trends at the second follow-up visit （P＞0.05）. However， trial group 2 exhibited significantly lower temperature differences in zone B at the third and fourth follow-up visits， as well as a significantly lower mean temperature difference across the nine regions at the fourth follow-up visit， compared to trial group 1（P＜0.01）.（2） In terms of pain assessment， the pain VAS scores consistently decreased in all three groups after treatment，with statistically significant differences compared to the previous time point （P＜0.01）. Moreover， the trial groups had significantly lower VAS scores than the control group at the third and fourth follow-up visits （P＜0.01）， and trial group 2 showed significantly lower pain VAS scores than trial group 1 at the third and fourth follow-up visits （P＜0.01）.（3） For the WOMAC scores， all three groups exhibited consistent decreases after treatment， with statistically significant differences compared to the previous time point （P＜0.01）. Additionally，the trial groups had significantly lower WOMAC scores than the control group at the second ， third， and fourth follow-up visits （P＜0.01）， and trial group 2 demonstrated significantly lower WOMAC scores than trial group 1 at the second，third，and fourth followup visits （P＜0.01）.（4） Regarding quality of life， the modified EQ-5D-3L scores consistently increased in all three groups after treatment， with statistically significant differences compared to the previous time point （P＜0.01）. Specifically， trial group 1 had significantly higher modified EQ-5D-3L scores than the control group at the third and fourth follow-up visits， while trial group 2 showed significantly higher scores than the control group at the second，third，and fourth follow-up visits （P＜0.01）. Furthermore，trial group 2 exhibited significantly higher modified EQ-5D-3L scores than trial group 1 at the second，third，and fourth follow-up visits （P＜0.01）. Conclusion Betamethasone effectively improves post-TKA pain and abnormal skin temperature elevation，and Shuangbai Paste cold compress demonstrates synergistic action.

R274.9

江西省重点研发计划项目（编号：20192BBH80015）；江西省科学技术厅主要学科学术和技术带头人培养计划--领军人才项目 （编号：20204BCJ22035）