[1]罗钰鑫,白金山,马玉峰,等.真实世界的复方南星止痛膏治疗颈肩腰背部肌肉骨骼系统慢性疼痛的临床疗效研究[J].中国中医骨伤科杂志,2026,34(06):83-89.[doi:10.20085/j.cnki.issn1005-0205.260612]
　LUO Yuxin,BAI Jinshan,MA Yufeng,et al.Clinical Efficacy of Compound Nanxing Analgesic Plaster in Treating Chronic Musculoskeletal Pain in the Neck,Shoulder,Waist and Back[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2026,34(06):83-89.[doi:10.20085/j.cnki.issn1005-0205.260612]
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真实世界的复方南星止痛膏治疗颈肩腰背部肌肉骨骼系统慢性疼痛的临床疗效研究()

《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第34卷
期数:
2026年06期
页码:
83-89
栏目:
临床研究
出版日期:
2026-06-15

文章信息/Info

Title:
Clinical Efficacy of Compound Nanxing Analgesic Plaster in Treating Chronic Musculoskeletal Pain in the Neck,Shoulder,Waist and Back
文章编号:
1005-0205(2026)06-0083-07
作者:
罗钰鑫1; 2; 3; 白金山1; 2; 3; 马玉峰1; 2; 3; 王宇坤1; 2; 3; 史宇航1; 2; 3; 梁志1; 2; 3; 王雪惠1; 2; 3; 马新豫1; 2; 3; 杨国智1; 2; 3; 宓保宏1; 2; 3; 吴卓耘1; 2; 3; 康鹏德4; 黄泽宇4; 郑玮5; 杨永奇6; 何利雷7; 周晓庆8; 张宝庆9; 杨政博10; 陈月峰1; 2; 3; 王荣田1; 2; 3△; 陈卫衡1; 2; 3△
1北京中医药大学第三附属医院(北京,100021)
2北京中医药大学中医骨伤治疗与运动康复智能化教育部工程研究中心
3北京中医药大学骨伤科研究所
4四川大学华西医院
5邯郸市中医院
6新乡市中医院
7佛山市中医院
8宝鸡高新医院
9陕西省中医医院<
Author(s):
LUO Yuxin1; 2; 3; BAI Jinshan1; 2; 3; MA Yufeng1; 2; 3; WANG Yukun1; 2; 3; SHI Yuhang1; 2; 3; LIANG Zhi1; 2; 3; WANG Xuehui1; 2; 3; MA Xinyu1; 2; 3; YANG Guozhi1; 2; 3; MI Baohong1; 2; 3; WU Zhuoyun1; 2; 3; KANG Pengde4; HUANG Zeyu4; ZHENG Wei5; YANG Yongqi6; HE Lilei7; ZHOU Xiaoqing8; ZHANG Baoqing9; YANG Zhengbo10; CHEN Yuefeng1; 2; 3; WANG Rongtian1; 2; 3△; CHEN Weiheng1; 2; 3△
1The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing,100021,China; 2The Intelligent Engineering Research Center for Traditional Chinese Medicine Orthopedic Treatment and Sports Rehabilitation of Beijing University of Chinese Medicine,Beijing 100021,China; 3The Orthopedic Research Institute of Beijing University of Chinese Medicine,Beijing 100021,China; 4West China Hospital of Sichuan University,Chengdu 610041,China; 5Handan Hospital of Traditional Chinese Medicine,Handan 056699,Hebei China; 6Xinxiang Hospital of Traditional Chinese Medicine,Xinxiang 453800,Henan China; 7Foshan Hospital of Traditional Chinese Medicine,Foshan 528099,Guangdong China; 8Baoji High-Tech Hospital,Baoji 721013,Shaanxi China; 9Shaanxi Provincial Hospital of Traditional Chinese Medicine,Xi’an 710003,China; 10Shenyang Orthopedics Hospital,Shenyang 110000,China.
关键词:
复方南星止痛膏;  慢性肌肉骨骼疼痛;  真实世界研究;  临床疗效评价
Keywords:
compound Nanxing analgesic plaster;  chronic musculoskeletal pain;  real-world study;  clinical efficacy evaluation
分类号:
R274
DOI:
10.20085/j.cnki.issn1005-0205.260612
文献标志码:
A
摘要:
目的:通过真实世界研究,评价复方南星止痛膏治疗颈肩腰背部肌肉骨骼系统慢性疼痛的临床疗效,为其临床合理用药提供依据。方法:采用多中心、前瞻性真实世界队列研究,共收集2021年11月30日至2022年12月29日在全国38家临床医院就诊的3 029例慢性肌肉骨骼疼痛患者,分析其中颈肩腰背部位的慢性肌肉骨骼疼痛患者,最终1 182例病例纳入分析。根据观察周期内复方南星止痛膏的使用情况,将单独使用复方南星止痛膏治疗患者设为观察组,将单独使用非甾体抗炎药患者设为对照组。以疼痛视觉模拟量表(VAS)评分为主要疗效指标; 以整体疼痛评估量表评分(GPS评分)、健康调查简表评分(SF-12评分)、中医证候(症状)评分为次要疗效指标。治疗前及治疗后第2,4,8,12周随访。采用R语言进行数据统计分析,正态分布数据采用t检验,非正态分布数据采用 Mann-Whitney U检验。结果:共纳入观察组814例,对照组380例。以两组患者治疗前的性别、年龄、体重指数、VAS评分、GPS评分、SF-12评分作为匹配因素,按照1:1的比例进行匹配,得到380对匹配数据,匹配后男性患者共305例(40.1%),女性患者共455例(59.9%),匹配后两组基线资料及疼痛病情差异无统计学意义(P>0.05)。与本组治疗前及上一时间点比较,观察组和对照组的VAS评分、GPS评分、中医证候(症状)评分各项指标均随治疗时间减轻下降,差异有统计学意义(组内比较P<0.05),SF-12评分随治疗时间好转上升,差异无统计学意义(组内比较P>0.05)。治疗后第2,4,8,12周时观察组与对照组VAS评分与治疗前下降差值的均值分别为2,3,4,5分,差异有统计学意义(第12周访视组间比较P<0.05); 治疗后第2和12周观察组与对照组的SF-12量表评分与治疗前上升差值的均值皆为0分,差异无统计学意义(组间比较P>0.05); 观察组GPS评分在第2和12周下降差值的均值分别为22和71分,高于对照组下降差值的均值17和61分,差异有统计学意义(第12周访视组间比较P<0.05); 观察组中医证候(症状)评分总分在治疗后第2,4,8,12周下降差值的均值分别为5,7,10,11分,高于对照组下降差值的均值3,6,7,8分,差异有统计学意义(组间比较P<0.05); 其中观察组患处恶风畏寒评分在治疗后第2,4,8,12周下降差值的均值分别为2,2,2,2分,高于对照组下降均值0,2,2,2分,差异有统计学意义(组间比较P<0.05); 观察组活动不利评分在治疗后第2,4,8,12周下降差值的均值分别为0,1,1,2分,高于对照组下降差值的均值0,1,1,1分,差异有统计学意义(组间比较P<0.05); 观察组僵硬评分在治疗后第2,4,8,12周下降差值的均值分别为1,1,1,1分,高于对照组下降差值的均值0,1,1,1分,差异有统计学意义(组间比较P<0.05)。结论:复方南星止痛膏的止痛效果与非甾体抗炎药物相当,且在缓解患处局部“恶风畏寒、活动不利、部位僵硬等‘寒证’”症状方面有独特的优势。
Abstract:
Objective:To evaluate the clinical efficacy of compound Nanxing analgesic plaster in treating of chronic musculoskeletal pain of the neck,shoulders,waist,and back through a real-world study,and to provide evidence for its rational clinical use.Methods:A multicenter,prospective,real-world cohort study was conducted.A total of 3 029 patients with chronic musculoskeletal pain,who visited 38 clinical hospitals nationwide between November 30,2021 and December 29,2022,were enrolled; among them,1 182 patients with chronic musculoskeletal pain localized to the neck,shoulders,waist and back were included in this study.According to treatment during the observation period,patients who received compound Nanxing analgesic plaster alone were assigned to the observation group,and those who received non-steroidal anti-inflammatory drugs(NSAIDs)alone were assigned to the control group.The primary efficacy endpoint was the visual analogue scale(VAS)score for pain; secondary efficacy endpoints included the global pain scale(GPS)score,the short form-12 health survey(SF-12)score,and traditional Chinese medicine(TCM)syndrome(symptom)scores.Follow-up was conducted before treatment and at 2,4,8,and 12 weeks after treatment.Data were statistically analyzed using R software: the t-test was used for normally distributed data,and Mann-Whitney U test was used for non-normally distributed data.Results:A total of 814 patients were included in the observation group,and 380 patients were included in the control group.Propensity score matching(1:1)was performed using gender,age,body mass index(BMI),VAS score,GPS score,and SF-12 score measured before treatment as covariates,yielding 380 matched pairs.After matching,there were 305 male patients(40.1%)and 455 female patients(59.9%),with no statistically significant differences in baseline characteristics or pain-related outcomes between the two groups(P>0.05).Compared with pre-treatment baseline and the previous time point within each group,the VAS score,GPS score,and TCM syndrome(symptom)scores of both groups decreased gradually over the course of treatment(within-group P<0.05),whereas the SF-12 score improved and increased(within-group P>0.05).At 2,4,8,and 12 weeks after treatment,the mean decreases in VAS score from baseline were 2,3,4,and 5 points,respectively,in both groups(inter-group P>0.05); the mean increases in SF-12 score from baseline were 0 points at both 2 and 12 weeks after treatment in both groups(inter-group P>0.05).The mean decreases in GPS score in the observation group were 22 and 71 points at 2 and 12 weeks,respectively-both significantly higher than those in the control group(17 and 61 points,inter-group P<0.05).The mean decreases in total TCM syndrome(symptom)scores in the observation group were 5,7,10,and 11 points at weeks 2,4,8,and 12,respectively-greater than those in the control group(3,6,7,and 8 points,inter-group P<0.05).Among them,the mean reductions in the “aversion to wind and cold at the affected area” score were 2,2,2,and 2 points at each time point in the observation group-higher than those in the control group(0,2,2,and 2 points,inter-group P<0.05); the mean decreases in the “impaired mobility” score in the observation group were 0,1,1,and 2 points-higher than those in the control group(0,1,1,and 1 point,inter-group P<0.05); the mean decreases in the “stiffness” score in the observation group were 1,1,1,and 1 point-higher than those in the control group(0,1,1,and 1 point,inter-group P<0.05).Conclusion:Compound Nanxing analgesic plaster demonstrates analgesic efficacy comparable to that of NSAIDs and offers unique advantages in alleviating local “cold syndrome” symptoms-such as aversion to cold(and wind),impaired mobility,and local stiffness at the affected site.

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(收稿日期:2026-01-07)

备注/Memo

备注/Memo:
基金项目:中央高校基本科研业务费专项资金资助项目(2026-JYB-KYPT-07)
首都卫生发展科研专项(首发2022-1-7032)
△通信作者 E-mail:drchenweiheng@bucm.edu.cn(陈卫衡)
wrt135@163.com(王荣田)
更新日期/Last Update: 2026-06-15