伤科冷痛贴治疗寒湿痹阻型膝骨关节炎的临床随机对照研究  

A Randomized Controlled Clinical Study on the Treatment of Knee Osteoarthritis with Cold-Dampness Arthralgia Obstruction by Shangke Lengtong Patch

作　　者：张立[1,2] 丁亮[1,2] 黄正泉[1,2] 梅伟[1,2] 邢润麟[1,2] 殷松江[1,2] 吴鹏[1,2] 李晓辰 马振源[1,2] 张农山 茆军[1,2] 王培民[1,2] ZHANG Li;DING Liang;HUANG Zhengquan;MEI Wei;XING Runlin;YIN Songjiang;WU Peng;LI Xiaochen;MA Zhenyuan;ZHANG Nongshan;MAO Jun;WANG Peimin(Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;Clinical Specialized Research Institute for Knee Osteoarthritis,Nanjing University of Chinese Medicine,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]南京中医药大学膝骨关节炎临床专病研究院,江苏南京210029

出　　处：《南京中医药大学学报》2025年第3期393-398,共6页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：江苏省医学重点学科/实验室建设单位项目(JSDW202252);江苏省中医院中医膝骨关节炎临床医学创新中心项目(Y2023zx05);江苏省中医药管理局重点项目(ZD202213);南京中医药大学膝骨关节炎临床专病研究院项目(LCZBYJYZZ2024-003);江苏省中医院第三批高峰学术人才项目(y2021rc02)。

摘　　要：目的探讨伤科冷痛贴治疗寒湿痹阻型膝骨关节炎有效性及可能的作用机制。方法选取2024年11—12月南京中医药大学附属医院骨伤科门诊符合寒湿痹阻型膝骨关节炎纳入标准的70例患者,随机分为试验组和对照组各35例,治疗期间试验组脱落1例,对照组脱落3例、中止1例。试验组采用伤科冷痛贴外敷治疗,对照组采用复方南星止痛膏外用治疗。比较2组患者治疗前后WOMAC评分、中医证候积分以综合评价临床疗效,ELISA法检测2组血清中CGRP、P物质、HMGB1、IL-1β、CXCL12、CXCR4表达水平变化情况。结果治疗3、7、14 d后,2组患者WOMAC评分及中医证候积分均明显降低(P<0.05,P<0.01),试验组在治疗7 d时得寒加重评分优于对照组(P<0.05);治疗14 d后,2组血清中CGRP、P物质、HMGB1、IL-1β、CXCL12、CXCR4表达水平均显著降低(P<0.05),2组间无统计学差异。结论伤科冷痛贴能明显缓解寒湿痹阻型膝骨关节炎患者的疼痛症状,改善患者关节功能,可能通过抑制HMGB1/CXCL12/CXCR4通路改善滑膜炎症从而发挥治疗作用。OBJECTIVE To explore the effectiveness and possible mechanism of Shangke Lengtong Patch in treating knee osteoarthritis with cold-dampness arthralgia obstruction.METHODS A total of 70 patients who met the inclusion criteria of knee osteoarthritis with cold-dampness arthralgia obstruction in the Orthopedics Department of Affiliated Hospital of Nanjing University of Chinese Medicine from November to December 2024 were randomly divided into an experimental group and a control group,with 35 cases in each group.During the treatment,1 case dropped out of the experimental group,3 cases dropped out of the control group,and 1 case was discontinued.The experimental group was treated with Shangke Lengtong Patch,and the control group was treated with Compound Nanxing Zhitong Ointment.The WOMAC scores and TCM syndrome scores of the two groups before and after treatment were compared to comprehensively evaluate the clinical efficacy.The changes in the expression levels of CGRP,substance P,HMGB1,IL-1β,CXCL12,and CXCR4 in the serum of the two groups were detected by ELISA.RESULTS After 3,7,and 14 d of treatment,the WOMAC scores and TCM syndrome scores of the two groups were significantly reduced(P<0.05,P<0.01),and the score of aggravated cold in the experimental group was better than that in the control group at 7 d of treatment(P<0.05);after 14 d of treatment,the expression levels of CGRP,substance P,HMGB1,IL-1β,CXCL12,and CXCR4 in the serum of the two groups were significantly reduced(P<0.05),and there was no statistical difference between the two groups.CONCLUSION Shangke Lengtong Patch can significantly relieve the pain symptoms of knee osteoarthritis patients with cold-dampness arthralgia obstruction and improve the joint function of patients.It may improve synovial inflammation by inhibiting the HMGB1/CXCL12/CXCR4 pathway,thereby exerting a therapeutic effect.

关 键 词：膝骨关节炎 寒湿痹阻型 中医外治法 疼痛 伤科冷痛贴 临床研究 滑膜炎症 HMGB1/CXCL12/CXCR4 

分 类 号：R285.5[医药卫生—中药学]