| Citation: |
ZHANG Li, DING Liang, HUANG Zhengquan, MEI Wei, XING Runlin, YIN Songjiang, WU Peng, LI Xiaochen, MA Zhenyuan, ZHANG Nongshan, MAO Jun, WANG Peimin. A Randomized Controlled Clinical Study on the Treatment of Knee Osteoarthritis with Cold-Dampness Arthralgia Obstruction by Shangke Lengtong Patch[J]. Journal of Nanjing University of traditional Chinese Medicine, 2025, 41(3): 393-398. DOI: 10.14148/j.issn.1672-0482.2025.0393
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To explore the effectiveness and possible mechanism of Shangke Lengtong Patch in treating knee osteoarthritis with cold-dampness arthralgia obstruction.
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.
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.
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.
| [1] |
LI D H, LI S J, CHEN Q, et al. The prevalence of symptomatic knee osteoarthritis in relation to age, sex, area, region, and body mass index in China: A systematic review and meta-analysis[J]. Front Med, 2020, 7: 304. DOI: 10.3389/fmed.2020.00304
|
| [2] |
吕世伟, 关雪峰, 杨永菊, 等. 膝骨关节炎之中医病因病机概述[J]. 中华中医药学刊, 2024, 42(11): 85-88.
LYU S W, GUAN X F, YANG Y J, et al. Overview of traditional Chinese medicine etiology and pathogenesis of knee osteoarthritis[J]. Chin Arch Tradit Chin Med, 2024, 42(11): 85-88.
|
| [3] |
连亦丰, 许辉, 边艳琴, 等. 中医外治法治疗膝骨关节炎的临床研究进展[J]. 中华养生保健, 2024, 42(19): 65-68.
LIAN Y F, XU H, BIAN Y Q, et al. Clinical research progress of external treatment of traditional Chinese medicine in the treatment of knee osteoarthritis[J]. Chinese Health Care, 2024, 42(19): 65-68.
|
| [4] |
李斌, 单鹏飞, 梁晖, 等. 膝骨关节炎的中医药治疗进展[J]. 云南中医中药杂志, 2024, 45(11): 93-97.
LI B, SHAN P F, LIANG H, et al. Progress of traditional Chinese medicine in the treatment of knee osteoarthritis[J]. Yunnan J Tradit Chin Med Mater Med, 2024, 45(11): 93-97.
|
| [5] |
庄若语, 张霆, 侯炜. 石氏三色敷膏研究进展[J]. 河北中医, 2024, 46(6): 1052-1056.
ZHUANG R Y, ZHANG T, HOU W. Research progress of Shishi tricolor ointment[J]. Hebei J Tradit Chin Med, 2024, 46(6): 1052-1056.
|
| [6] |
魏义保, 张力, 廖太阳, 等. 基于HMGB1/CXCL12/CXCR4信号轴探讨伤科冷痛贴缓解KOA小鼠冷痛敏的机制研究[J]. 南京中医药大学学报, 2025, (2): 195-202. DOI: 10.14148/j.issn.1672-0482.2025.0195
WEI Y B, ZHANG L, LIAO T Y, et al. Investigation of the mechanism of cold hyperalgesia in KOA mice relieved by Shangke Lengtongtie based on HMGB1/CXCL12/CXCR4 signaling axis[J]. J Nanjing Univ Tradit Chin Med, 2025, (2): 195-202. DOI: 10.14148/j.issn.1672-0482.2025.0195
|
| [7] |
中国骨关节炎诊疗指南专家组, 中国老年保健协会疼痛病学分会, 黄东, 等. 中国骨关节炎诊疗指南(2024版)[J]. 中华疼痛学杂志, 2024, 20(3): 323-338.
Expert Group of Chinese Guidelines for Diagnosis and Treatment of Osteoarthritis, The Pain Disease Branch of the Chinese Aging Well Association, HUANG D, et al. Chinese guidelines for diagnosis and treatment of osteoarthritis(2024 edition)[J]. Chin J Painology, 2024, 20(3): 323-338.
|
| [8] |
KELLGREN J H, LAWRENCE J S. Radiological assessment of osteo-arthrosis[J]. Ann Rheum Dis, 1957, 16(4): 494-502. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1006995/pdf/annrheumd00183-0090.pdf
|
| [9] |
中华中医药学会. 膝骨关节炎中西医结合诊疗指南(2023年版)[J]. 中医正骨, 2023, 35(6): 1-10.
China Association of Chinese Medicine. Guidelines for INTEGRATED TCM WM diagnosis and treatment of knee osteoarthritis(2023 edition)[J]. J Tradit Chin Orthop Traumatol, 2023, 35(6): 1-10.
|
| [10] |
中药新药临床研究指导原则: 试行[M]. 北京: 中国医药科技出版社, 2002.
Guiding principles for clinical research of new Chinese medicine: Trial implementation[M]. Beijing: China Medical Science Press, 2002.
|
| [11] |
陈蔚, 郭燕梅, 李晓英, 等. 西安大略和麦克马斯特大学骨关节炎指数的重测信度[J]. 中国康复理论与实践, 2010, 16(1): 23-24.
CHEN W, GUO Y M, LI X Y, et al. Test-retest reliability of western Ontario and McMaster University osteoarthritis index[J]. Chin J Rehabil Theory Pract, 2010, 16(1): 23-24.
|
| [12] |
李健雄, 张程, 辛鹏飞, 等. 膝骨关节炎疼痛机制研究进展[J]. 中华关节外科杂志(电子版), 2021, 15(5): 596-600.
LI J X, ZHANG C, XIN P F, et al. Research progress on pain mechanism of knee osteoarthritis[J]. Chin J Jt Surg Electron Ed, 2021, 15(5): 596-600.
|
| [13] |
章梓虹, 范华娜, 陈艳芬. 膝骨关节炎的中医病因病机及外治法研究进展[J]. 广东药科大学学报, 2024, 40(5): 139-143.
ZHANG Z H, FAN H N, CHEN Y F. Research progress on the etiology, pathogenesis, and external treatment of knee osteoarthritis in traditional Chinese medicine[J]. J Guangdong Pharm Univ, 2024, 40(5): 139-143.
|
| [14] |
张云华, 王钢, 彭仕波, 等. 中草药辨证外治膝骨关节炎的研究进展[J]. 中医临床研究, 2024, 16(27): 77-81.
ZHANG Y H, WANG G, PENG S B, et al. Research progress of Chinese herbal medicine external differentiation and treatment of knee osteoarthritis[J]. Clin J Chin Med, 2024, 16(27): 77-81.
|
| [15] |
王培民, 邢润麟. 以痛为枢、截断扭转诊治膝骨关节炎理论研究[J]. 南京中医药大学学报, 2016, 32(6): 501-505. https://xb.njucm.edu.cn/article/id/ZR20160601
WANG P M, XING R L. Theoretic study on diagnosis and treatment of knee osteoarthritis with pain as pivot and truncating and reversing[J]. J Nanjing Univ Tradit Chin Med, 2016, 32(6): 501-505. https://xb.njucm.edu.cn/article/id/ZR20160601
|
| [16] |
陈卫衡. 膝骨关节炎中医诊疗指南(2020年版)[J]. 中医正骨, 2020, 32(10): 1-14.
CHEN W H. Guidelines for TCM diagnosis and treatment of knee osteoarthritis(2020 edition)[J]. J Tradit Chin Orthop Traumatol, 2020, 32(10): 1-14.
|
| [17] |
SRIWATANANUKULKIT O, DESCLAUX S, TAWONSAWATRUK T, et al. Effectiveness of losartan on infrapatellar fat pad/synovial fibrosis and pain behavior in the monoiodoacetate-induced rat model of osteoarthritis pain[J]. Biomed Pharmacother, 2023, 158: 114121. http://www.ncbi.nlm.nih.gov/pubmed/37878123
|
| [18] |
WEI Y B, MA Z Y, LI Z H, et al. Gentiopicroside ameliorates synovial inflammation and fibrosis in KOA rats by modulating the HMGB1-mediated PI3K/AKT signaling axis[J]. Int Immunopharmacol, 2025, 147: 113973. DOI: 10.1016/j.intimp.2024.113973
|
| [19] |
LIU J, LI Y P, WANG J J, et al. Integrated skin metabolomics and network pharmacology to explore the mechanisms of Goupi Plaster for treating knee osteoarthritis[J]. J Tradit Complementary Med, 2024, 14(6): 675-686.
|
| [20] |
PALUMBO A, ATZENI F, MURDACA G, et al. The role of alarmins in osteoarthritis pathogenesis: HMGB1, S100B and IL-33[J]. Int J Mol Sci, 2023, 24(15): 12143. http://openurl.ebsco.com/contentitem/doi:10.3390%2Fijms241512143?sid=ebsco:plink:crawler&id=ebsco:doi:10.3390%2Fijms241512143
|
| [21] |
DU O, YAN Y L, YANG H Y, et al. ALPK1 signaling pathway activation by HMGB1 drives microglial pyroptosis and ferroptosis and brain injury after acute ischemic stroke[J]. Int Immunopharmacol, 2025, 149: 114229. DOI: 10.1016/j.intimp.2025.114229
|
| [22] |
PIRANI E, PAPARODITIS P, PECORARO M, et al. Tumor cells express and maintain HMGB1 in the reduced isoform to enhance CXCR4-mediated migration[J]. Front Immunol, 2024, 15: 1358800. http://openurl.ebsco.com/contentitem/doi:10.3389%2Ffimmu.2024.1358800?sid=ebsco:plink:crawler&id=ebsco:doi:10.3389%2Ffimmu.2024.1358800
|
| [23] |
DING M L, GAO Y Q, GU Y, et al. HMGB1 can activate cartilage progenitor cells in response to cartilage injury through the CXCL12/CXCR4 pathway[J]. Endokrynol Pol, 2023, 74(1): 74-82.
|
| [24] |
邢润麟, 王培民, 茆军, 等. 基于thermoTRP介导冷痛敏机制对膝骨关节炎虚寒冷痛的研究[J]. 南京中医药大学学报, 2016, 32(4): 347-351. https://xb.njucm.edu.cn/article/id/zr20160412
XING R L, WANG P M, MAO J, et al. Mechanism of thermoTRP participating in cold hyperalgesia of rat with experimental knee osteoarthritis[J]. J Nanjing Univ Tradit Chin Med, 2016, 32(4): 347-351. https://xb.njucm.edu.cn/article/id/zr20160412
|
| [25] |
苗明三, 刘浩哲, 彭孟凡, 等. 中药外用的现状、存在问题及未来发展思考[J]. 南京中医药大学学报, 2022, 38(11): 961-969. DOI: 10.14148/j.issn.1672-0482.2022.0961
MIAO M S, LIU H Z, PENG M F, et al. Current situation, existing problems and future development of external use of traditional Chinese medicine[J]. J Nanjing Univ Tradit Chin Med, 2022, 38(11): 961-969. DOI: 10.14148/j.issn.1672-0482.2022.0961
|
| [26] |
王鹏, 沈劼, 施圣杰, 等. 中医外治法历史源流与现代研究进展[J]. 南京中医药大学学报, 2022, 38(11): 990-999. DOI: 10.14148/j.issn.1672-0482.2022.0990
WANG P, SHEN J, SHI S J, et al. The historical origin and modern research progress of external treatment of traditional Chinese medicine[J]. J Nanjing Univ Tradit Chin Med, 2022, 38(11): 990-999. DOI: 10.14148/j.issn.1672-0482.2022.0990
|
| 1. |
刘静，龙凯花，马战平，杜霞，张红. 基于UHPLC-Q Exactive Focus MS/MS的益肺解毒颗粒化学成分分析. 中国药学杂志. 2023(21): 1940-1954 .
|
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