Objective  Using Meta-analysis to observe the therapeutic effect and safety of traditional Chinese medicine (TCM) external treatment for acute soft tissue injury and to make corresponding evaluations.

Methods  Computerized searches were performed in CNKI, VIP, WanFang, SinoMed, PubMed, Embase, Web of Science, and the Cochrane Library databases for randomized controlled trials (RCTs) on the treatment of acute soft tissue injury with TCM external treatment published from the establishment of the databases to November 30, 2024. The experimental group included TCM external treatment or TCM external treatment combined with conventional Western medicine treatment. The control group included conventional treatment, oral non-steroidal anti-inflammatory drugs, or conventional products such as Yunnan Baiyao aerosol. The risk of bias in all included studies was evaluated according to the Cochrane Handbook for Systematic Reviews, and RevMan 5.4 and Stata 18.0 software were used to conduct a Meta-analysis of the effective rate, marked improvement rate, VAS score, pain score, tenderness score, swelling score, ecchymosis score, functional disability, and TCM syndrome score.

Results  A total of 14 articles were ultimately included, involving 1,648 patients, with 903 in the experimental group and 745 in the control group. The results of the Meta-analysis showed that the pain score, VAS score, tenderness score, swelling score, ecchymosis score, functional impairment score, and TCM syndrome score were all lower in the experimental group than in the control group (P﹤0.05); the effective rate and marked effective rate were higher in the experimental group than in the other treatment groups (P﹤0.05). In terms of safety, no serious adverse reactions occurred in all included studies, and the adverse reaction rate in the experimental group was lower than that in the control group (P﹤0.05).

Conclusion  TCM external treatment has significant advantages over other therapeutic measures in the treatment of acute soft tissue injury in terms of effective rate, pain score, VAS score, tenderness score, swelling score, functional impairment score, and TCM syndrome score with good safety.

1.国家创伤医学中心, 中华医学会疼痛学分会, 中国医师协会创伤外科医师分会, 等. 急性闭合性软组织损伤诊疗与疼痛管理专家共识[J]. 中华医学杂志, 2021, 101(21): 1553-1559. [National Trauma Medical Center, Pain Branch of Chinese Medical Association, Trauma Surgeons Branch of Chinese Medical Association, et al. Expert consensus on diagnosis, treatment and pain management of acute closed soft tissue injury[J]. National Medical Journal of China, 2021, 101(21): 1553-1559.] DOI: 10.3760/cma.j.cn112137-20210123-00225.

2.国家卫生健康委员会医管中心加速康复外科专家委员会, 浙江省医师协会临床药师专家委员会, 浙江省药学会医院药学专业委员会, 等. 中国加速康复外科围手术期非甾体抗炎药临床应用专家共识[J]. 中华普通外科杂志, 2019, 34(3): 283-288. [National Health Commission Medical Management Center Accelerated Rehabilitation Surgery Expert Committee, Zhejiang Medical Association Clinical Pharmacist Expert Committee, Zhejiang Pharmaceutical Association Hospital Pharmacy Professional Committee, et al. China accelerated rehabilitation surgery perioperative nsaids clinical application expert consensus[J]. Chinese Journal of General Surgery, 2019, 34(3): 283-288.] DOI: 10.3760/cma.j.issn.1007-631X.2019.03.032.

3.中华医学会. 临床诊疗指南. 创伤学分册[M]. 北京: 人民卫生出版社, 2007: 25.

4.中华医学会. 临床诊疗指南. 骨科分册[M]. 北京: 人民卫生出版社, 2009: 108.

5.国家中医药管理局. 中医病症诊断疗效标准[S]. 南京: 南京大学出版社, 1994: 209.

6.中华人民共和国卫生部. 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社, 2002: 361-364.

7.Higgins JPT, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials[J]. BMJ, 2011, 343: d5928. DOI: 10.1136/bmj.d5928.

8.于潮将. 许氏伤药外敷治疗急性软组织损伤的临床效果观察 [J]. 中外医药研究, 2023, 2(22): 90-92. [Yu CJ. Observation on the clinical effect of external application of xu's injury medicine in the treatment of acute soft tissue injury[J]. Chinese and Foreign Medical Research, 2023, 2(22): 90-92.] DOI: 10.3969/j.issn.2096-6229.2023.22.031.

9.奚小冰, 孙波, 胡劲松, 等. 魏氏伤科验方消肿散改良方（巴布膏剂型）治疗97例急性软组织损伤多中心临床研究 [J]. 中华中医药杂志, 2011, 26(10): 2463-2466. [Xi XB, Sun B, Hu JS, et al. Multi-center clinical study on 97 cases of acute soft tissue injury treated by modified Xiaozhong powder (Babu ointment formulation) of wei's shangke prescription[J]. Chinese Journal of Traditional Chinese Medicine, 2011, 26(10): 2463-2466.] https://d.wanfangdata.com.cn/conference/ChtDb25mZXJlbmNlTmV3U29scjlTMjAyNTExMTcSBzgzNjczNTAaCDQ4MmtkeG10.

10.张志强, 秘淑坤, 潘丽娟, 等. 伤科散治疗急性闭合性软组织损伤50例[J]. 医药导报, 2008, 27(6): 655-658. [Zhang ZQ, Mi SK, Pan LJ, et al. A Clinical research on shangkesan for acute closed injury of parenchyma[J]. Herald of Medicine, 2008, 27(6): 655-658.] DOI: 10.3870/j.issn.1004-0781.2008.06.017.

11.张成亮, 韩涛. 青鹏软膏治疗急性软组织肿痛疗效观察[J]. 临床和实验医学杂志, 2011, 10(24): 1913-1914, 1917. [Zhang CL, Han T. The effectiveness of Qizheng Qingpeng plaster in treatment of acute soft tissue swelling[J]. Journal of Clinical and Experimental Medicine, 2011, 10(24): 1913-1914, 1917.] DOI: 10.3969/j.issn.1671-4695.2011.24.013.

12.曹灵红, 章成, 罗昌彬. 奇正消痛贴膏治疗急性软组织损伤临床疗效观察[J]. 中国实用医药, 2010, 5(15): 193-194. [Cao LH, Zhang C, Luo CB. Clinical observation of Qizheng Xiaotai plaster in the treatment of acute soft tissue injury[J]. China Practical Medical, 2010, 5(15): 193-194.] DOI: 10.3969/j.issn.1673-7555.2010.15.141.

13.段戡, 青恒臻, 袁长深, 等. 十一方药酒治疗急性软组织损伤的临床研究[J]. 中国中医骨伤科杂志, 2022, 30(9): 26-30. [Duan K, Qing HZ, Yuan CS, et al. Clinical study on the treatment of acute soft tissue injury with 11 prescriptions of medicated liquor[J]. Chinese Journal of orthopedics and traumatology of traditional Chinese medicine, 2022, 30(9): 26-30.] https://www.cnki.com.cn/Article/CJFDTOTAL-ZGZG202209005.htm.

14.温建强, 陈志维, 何影浩. 白药贴膏外敷治疗急性闭合性软组织损伤的临床研究[J]. 河南外科学杂志, 2009, 15(6): 14- 15. [Wen JQ, Chen ZW, He YH. Clinical study on the treatment of acute closed soft tissue injury with Baiyao plaster[J]. Henan Journal of Surgery, 2009, 15(6): 14-15.] DOI: 10.3969/j.issn.1007-8991.2009.06.009.

15.王培民, 严培军, 丁亮, 等. 易层贴敷治疗踝关节急性软组织损伤的临床研究[J]. 南京中医药大学学报, 2014, 30(6): 513-515. [Wang PM, Yan PJ, Ding L, et al. Clinical effect of layers adjusting external application therapy on acute ankle soft tissue injury[J]. Journal of Nanjing University of Traditional Chinese Medicine, 2014, 30(6): 513-515.] DOI: 10.14148/j.issn.1672-0482.2014.06.005.

16.王晓菲, 胡怀强. 栀黄软膏治疗急性软组织损伤的临床研究[J]. 天津中医药, 2010, 27(6): 465-466. [Wang XF, Hu HQ. Clinical study of Zhihuang ointment in the treatment of acute soft tissue injury[J]. Tianjin Journal of Traditional Chinese Medicine, 2010, 27(6): 465-466.] https://www.cnki.com.cn/Article/CJFDTOTAL-TJZY201006013.htm.

17.王爽, 王爱国, 谷福顺, 等. 神效贴治疗急性软组织损伤的临床观察[J]. 内蒙古中医药, 2020, 39(7): 97-98. [Wang S, Wang AG, Gu FS, et al. Clinical observation of Shenxiao plaster in the treatment of acute soft tissue injury[J]. Nei Mongol Journal of Traditional Chinese Medicine, 2020, 39(7): 97-98.] https://www.cnki.com.cn/Article/CJFDTOTAL-NZYY202007059.htm.

18.甘曙光, 王雨来, 熊永坚, 等. 神农镇痛膏治疗急性软组织损伤多中心临床研究[J]. 时珍国医国药, 2020, 31(10): 2429-2432. [Gan SG, Wang YL, Xiong YJ, et al. Multi-center clinical study of Shennong analgesic ointment in the treatment of acute soft tissue injury[J]. Lishizhen Medicine and Materia Medica Research, 2020, 31(10): 2429-2432.] DOI: 10.3969/j.issn.1008-0805.2020.10.036.

19.肖潇, 邵先舫, 刘志军. 新伤湿敷液治疗急性闭合性软组织损伤60例临床观察[J]. 湖南中医杂志, 2018, 34(3): 87-88. [Xiao X, Shao XF, Liu ZJ. Clinical observation of 60 cases of acute closed soft tissue injury treated with Xinshang wet compress[J]. Hunan Journal of Traditional Chinese Medicine, 2018, 34(3): 87-88.] DOI: 10.16808/j.cn ki. Issn1003-7705.2018.03.039.

20.谭庆琴, 沈楚龙, 陈凯, 等. 伤柏膏贴剂外敷治疗急性软组织损伤的临床研究[J]. 中国实用医药, 2012, 7(21): 1-3. [Tan  QQ, Shen CL, Chen K, et al. The value of the use of Shangbaigao dressing in the treatment of acute soft-tissue injury[J]. China Practical Medical , 2012, 7(21): 1-3.] DOI: 10.3969/j.issn.1673-7555.2012.21.001.

21.银玲. 伤科黄水对急性膝关节软组织损伤的作用研究[J]. 中医临床研究, 2020, 12(11): 97-99. [Yin L. Study on the effect of traumatology yellow water on acute soft tissue injury of knee joint[J]. Chinese Medicine Clinical Research, 2020, 12(11): 97-99.] https://www.cnki.com.cn/Article/CJFDTOTAL-ZYLY202011036.htm.

22.钟金贝, 林亚平, 卢新国, 等. 在癌症分类中基于PPS抽样的集成神经网络算法[J]. 计算机应用, 2008, 28(S2): 109-110. [Zhong JB, Lin YP, Lu XG, et al. Neural network ensemble method based on PPS technique in tumor classification[J]. Journal of Computer Applications, 2008, 28(S2): 109-110.] https://www.cnki.com.cn/Article/CJFDTOTAL-JSJY2008S2035.htm.

23.袁建迪, 朱少兵, 沈彦, 等. 中医外治急性软组织损伤的临床研究进展[J]. 中医外治杂志, 2008, 17(1): 41-43. [Yuan  JD, Zhu SB, Shen Y, et al. Clinical research progress of external treatment of acute soft tissue injury with traditional Chinese medicine[J]. Journal of External Therapy of Traditional Chinese Medicine, 2008, 17(1): 41-43.] DOI: 10.3969/j.issn.1006-978X.2008.01.022.

24.李万平. 中西医结合治疗急性软组织损伤临床研究[J]. 中医学报, 2013, 28(10): 1582-1583. [Li WP. Clinical research on combination of traditional Chinese and western medicine treatment of acute soft tissue injury[J].  China Journal of Chinese Medicine, 2013, 28(10): 1582-1583.] DOI: 10.16368/j.issn.1674-8999.2013.10.066.  

25.陈贵珍, 许云祥, 刘颂豪. 刺血疗法治疗急性软组织损伤的研究思路[J]. 辽宁中医杂志, 2009, 36(6): 896-898. [Chen  GZ, Xu YX, Liu SH. Research thinking of bloodletting therapy in the treatment of acute soft tissue iniury[J]. Liaoning Journal of Traditional Chinese Medicine, 2009, 36(6): 896-898.] https://www.cnki.com.cn/Article/CJFDTOTAL-LNZY200906016.htm.

26.蔡巍, 王晓红. 消肿散瘀汤联合双氯芬酸钠治疗膝关节急性软组织损伤的疗效及对血清TNF-α、IL-6和IL-1β水平的影响[J]. 中华中医药学刊, 2021, 39(8): 237-241. [Cai W, Wang XH. Effect of Xiaozhong Sanyu decoction combined with diclofenac sodium on acute soft tissue injury of knee joint and its effect on serum TNF-α, IL-6 and IL-1β levels[J]. Chinese Archives of Traditional Chinese Medicine, 2021, 39(8): 237-241.] DOI: 10.13193/j.issn.1673-7717.2021.08.057.

27.赖爱云, 徐健, 陶丽. 非布司他片联合依托考昔治疗痛风性关节炎的效果及对血清炎症因子的影响[J]. 中国医药导报, 2018, 15(9): 101-104. [Lai AY, Xu J, Tao L. Effect of fenbuxostat tablets combined with etoricoxib in the treatment of gouty arthritis and its effect on serum inflammatory factors[J]. Smart Healthcare, 2018, 15(9): 101-104.] DOI: 10.19335/j.cnki.2096-1219.2020.36.092.

28.芦斗苗. 冷敷联合中药外敷治疗急性软组织损伤的效果[J]. 护理研究, 2014, 28(3): 349. [Lu DM. Effect of cold compress combined with external application of TCM herbs for treatment of patients with acute soft tissue injury[J]. Chinese Nursing Research, 2014, 28(3): 349.] DOI: 10.3969/j.issn.1009-6493.2014.03.046.

29.张志强, 刘强. 中药治疗急性软组织损伤的研究进展[J]. 实用医学杂志, 2008(1): 4-6. [Zhang ZQ, Liu Q. Research progress of traditional Chinese medicine in the treatment of acute soft tissue injury[J]. The Journal of Practical Medicine, 2008, 24(1): 4-6.] DOI: 10.3969/j.issn.1006-5725.2008.01.002.

30.李飞跃, 奚小冰, 傅文彧, 等. 改良消肿散（巴布剂）治疗急性软组织损伤临床研究[J]. 中成药, 2005(3): 68-70. [Li FY, Xi XB, Fu WY, et al. Clincal study of treatment of acute soft tissue injury with improved Xiaozhong San (Babu'dose)[J]. Chinese Traditional Patent Medicine, 2005, 27(3): 312-314.] DOI: 10.3969/j.issn.1001-1528.2005.03.021.

31.午玉琦, 李辉, 付译节, 等. 鼻窦炎口服液治疗鼻-鼻窦炎有效性和安全性的系统评价与Meta分析[J]. 中国中药杂志, 2024, 49(2): 534-549. [Wu YQ, Li H, Fu YJ, et al. Systematic review and Meta-analysis of efficacy and safety of Bidouyan oral liquid in treatment of rhinosinusitis[J]. China Journal of Chinese Materia Medica, 2024, 49(2): 534-549.] DOI: 10.19540/j.cn ki.cjcmm.20230918.502.

32.曾奕云, 霍志浩, 周建仪, 等. 伤科黄水外敷治疗急性软组织损伤的疗效观察[J]. 中国中医急症, 2021, 30(10): 1789-1792. [Zeng YY, Huo ZH, Zhou JY, et al. Effects of external application of Shangke Huangshui on acute soft tissue injury[J]. Journal of Emergency in Traditional Chinese Medicine, 2021, 30(10): 1789-1792.] DOI: 10.3969/j.issn.1004-745X.2021.10.026.

33.陈琦翔, 黄解元, 钟泽林, 等. 改良五黄散水剂治疗急性软组织损伤93例临床研究[J]. 新中医, 2015, 47(5): 163-165. [Chen  QX, Huang JY, Zhong ZL, et al. Clinical study on 93 cases of acute soft tissue injury treated with modified Wuhuang powder aqueous solution[J]. Journal of New Chinese Medicine, 2015, 47(5): 163-165.] DOI: 10.13457/j.cn ki. Jncm.2015.05.077.

34.罗文利, 陈泰澍, 黄学成, 等. 消瘀膏外敷配合水穴消肿手法治疗急性软组织损伤的临床疗效及安全性观察[J]. 广州中医药大学学报, 2024, 41(7): 1765-1771. [Luo WL, Chen  TS, Huang XC, et al. Observation on clinical efficacy and safety of Xiayu ointment combined with water acupoint detumescence manipulation in the treatment of acute soft tissue injury[J]. Journal of Guangzhou University of Traditional Chinese Medicine, 2024, 41(7): 1765-1771.] DOI: 10.13359/j.cnki.gzxbtcm.2024.07.016.

35.黄开月, 黄金科, 王凤云, 等. 中医药治疗功能性消化不良临床试验中的中药安慰剂效应Meta分析[J]. 中医杂志, 2024, 65(5): 479-488. [Huang KY, Huang JK, Wang FY, et al. Meta-analysis of placebo effect of traditional Chinese medicine in clinical trials of traditional Chinese medicine for functional dyspepsia[J]. Journal of Traditional Chinese Medicine, 2024, 65(5): 479-488.] DOI: 10.13288/j.11-2166/r.2024.05.008.

36.孙恒, 邢作英, 黄金雨, 等. 参芍胶囊治疗冠心病心绞痛的Meta分析与试验序贯分析[J]. 中国中药杂志, 2024, 49(12): 3385-3395. [Sun H, Xing ZY, Huang JY, et al. Meta-analysis and trial sequential analysis of Shenshao capsule in the treatment of angina pectoris of coronary heart disease[J]. China Journal of Chinese Materia Medica, 2024, 49(12): 3385-3395.] DOI: 10.19540/j.cn ki.cjcmm.20240219.501.