<italic style="font-style: italic">Xiaozhong Zhitong Mixture</italic>（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients

WEI Xiaotao; HE Zhijun; LIU Tao; JIANG Zhenxing; LI Fei; LI Yan; LI Jinpeng; CHEN Wen; BAI Bihui; DONG Xuan; SUN Bo

doi:10.13288/j.11-2166/r.2025.07.009

您当前的位置：

首页 >

文章列表页 >

Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients

更新时间：2025-03-27

- Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients
- Journal of Traditional Chinese Medicine Vol. 66, Issue 7, Pages: 704-709(2025)
- 作者机构：
  
  1.甘肃省中医院，甘肃省兰州市七里河区瓜州路418号，730000
  2.甘肃中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.07.009
  CLC：
- Received：18 October 2024，
  
  Revised：2025-01-20，
  
  Published：02 April 2025
- 稿件说明：
移动端阅览
魏晓涛,何志军,刘涛等.消肿止痛合剂联合抗生素骨水泥治疗糖尿病足溃疡湿热阻滞证患者35例随机对照试验[J].中医杂志,2025,66(07):704-709.

WEI Xiaotao,HE Zhijun,LIU Tao,et al.Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients[J].Journal of Traditional Chinese Medicine,2025,66(07):704-709.
魏晓涛,何志军,刘涛等.消肿止痛合剂联合抗生素骨水泥治疗糖尿病足溃疡湿热阻滞证患者35例随机对照试验[J].中医杂志,2025,66(07):704-709. DOI： 10.13288/j.11-2166/r.2025.07.009.

WEI Xiaotao,HE Zhijun,LIU Tao,et al.Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients[J].Journal of Traditional Chinese Medicine,2025,66(07):704-709. DOI： 10.13288/j.11-2166/r.2025.07.009.

摘要

目的

观察消肿止痛合剂联合抗生素骨水泥治疗湿热阻滞证糖尿病足溃疡（DFU）患者的临床疗效和安全性。

方法

选取DFU湿热阻滞证患者72例，随机分为治疗组和对照组各36例。两组均给予基础治疗，同时给予创面抗生素骨水泥治疗，治疗组在对照组基础上口服消肿止痛合剂（每次50 ml，每日3次）。两组患者均每日换药1次，连续治疗21天后比较两组患者溃疡愈合率。比较两组患者治疗前后血清肿瘤坏死因子α（TNF-α）、白细胞介素1β（IL-1β）、丙二醛（MDA）、超氧化物歧化酶（SOD）、C反应蛋白（CRP）水平及白细胞计数（WBC），并于治疗前后进行创面疼痛程度模拟视觉量表（VAS）评分、中医证候评分、创面局部糖尿病足溃疡愈合量表（DMIST量表）评分。治疗前后进行肝肾功能指标检测，同时观察治疗过程中过敏、溃疡疼痛加重等不良反应的发生情况。

结果

治疗组35例、对照组33例患者纳入结果分析。治疗组溃疡愈合率为（87.93±9.34）%，显著高于对照组的（81.82±12.02）%（

=0.035）。与本组治疗前比较，两组患者治疗后血清CRP、MDA、IL-1β、TNF-α水平及WBC均降低，SOD水平升高（

＜0.05）；中医证候评分、VAS评分、DMIST评分均明显降低（

＜0.05），且治疗后治疗组各指标改善均优于对照组（

＜0.05）。两组患者治疗过程中均未发生明显不良反应。

结论

消肿止痛合剂联合抗生素骨水泥治疗在促进DFU湿热阻滞证患者创面愈合、减轻炎症反应和氧化应激方面具有显著优势，且安全性良好。

Abstract

Objective

To observe the clinical effectiveness and safety of

Xiaozhong Zhitong Mixture

（消肿止痛合剂） combined with antibiotic bone cement in the treatment of diabetic foot ulcer （DFU） with damp-heat obstructing syndrome.

Methods

A total of 72 DFU patients with damp-heat obstructing syndrome were randomly assigned to treatment group （36 cases） and the control group （36 cases）. Both groups received standard treatment and topical antibiotic bone cement for ulcer wounds， while the treatment grou

p received oral

Xiaozhong Zhitong Mixture

（50 ml per time， three times daily） in additionally. Both groups underwent daily wound dressing changes for 21 consecutive days. Ulcer healing rate， serum levels of tumor necrosis factor-alpha （TNF-α）， interleukin-1 beta （IL-1β）， malondialdehyde （MDA）， superoxide dismutase （SOD）， C-reactive protein （CRP）， and white blood cell （WBC） count were observed before and after treatment， and visual analog scale （VAS） scores for wound pain， traditional Chinese medicine （TCM） syndrome scores， and the DFU Healing Scale （DMIST scale） were also compared. Liver and kidney function were evaluated before and after treatment， and adverse events such as allergic reactions， worsening ulcer pain were recorded.

Results

Totally 35 patients in the treatment group and 33 in the control group were included in the final analysis. The ulcer healing rate in the treatment group was （87.93±9.34）%， significantly higher than （81.82±12.02）% in the control group （

= 0.035）. Compared to pre-treatment levels， both groups showed significant reductions in serum CRP， WBC， MDA， IL-1β， and TNF-α levels， with an increase in SOD level （

＜0.05）. TCM syndrome scores， VAS， and DMIST scores also significantly decreased in both groups （

＜0.05）， with greater improvements in the treatment group （

＜0.05）. No significant adverse reactions were observed in either group during treatment.

Conclusion

Xiaozhong Zhitong Mixture

combined with antibiotic bone cement has significant advantages in promoting DFU healing， reducing inflammatory response， and alleviating oxidative stress in DFU patients with damp-heat obstructing syndrome， with good safety for DFU patients with damp-heat obstructing syndrome.

关键词

Keywords

references

ARMSTRONG DG ， TAN TW ， BOULTON AJM ， et al . Diabetic foot ulcers： a review ［J］. JAMA ， 2023 ， 330 （ 1 ）： 62 - 75 .

CHEN L ， SUN S ， GAO Y ， et al . Global mortality of diabetic foot ulcer： a systematic review and meta-analysis of observational studies ［J］. Diabetes Obes Metab ， 2023 ， 25 （ 1 ）： 36 - 45 .

MATHESON EM ， BRAGG SW ， BLACKWELDER RS . Diabetes-related foot infections： diagnosis and treatment ［J］. Am Fam Physician ， 2021 ， 104 （ 4 ）： 386 - 394 .

中国医师协会中西医结合医师分会内分泌与代谢病学专业委员会 . 糖尿病足病中医病证结合诊疗指南［J］. 中医杂志， 2021 ， 62 （ 12 ）： 1099 - 1104 .

马岁录，何志军，刘涛，等 . 基于TMT蛋白组学探讨消肿止痛合剂治疗皮瓣缺血再灌注损伤的作用机制［J］. 世界科学技术-中医药现代化， 2023 ， 25 （ 6 ）： 1987 - 1997 .

申建军，陈志伟，方鹏飞，等 . 陇中消肿止痛合剂治疗骨筋膜室综合征临床研究［J］. 中国中医药信息杂志， 2019 ， 26 （ 5 ）： 37 - 40 .

DONG T ， HUANG Q ， SUN Z . Antibiotic-laden bone cement for diabetic foot infected wounds： a systematic review and meta-analysis ［J］. Front Endocrinol （Lausanne）， 2023 ， 14 ： 1134318 . doi： 10.3389/fendo.2023.1134318 http://dx.doi.org/10.3389/fendo.2023.1134318 .

刘俊鹏，要星晨，赵会，等 . 抗生素骨水泥增强胫骨横向骨搬运治疗感染创面的能力［J］. 中国组织工程研究， 2024 ， 28 （ 29 ）： 4599 - 4604 .

DING X ， YUAN Y ， LU H ， et al . Analysis of the effect of antibiotic bone cement in the treatment of diabetic foot ulcer through tibia transverse transport ［J］. Orthop Surg ， 2022 ， 14 （ 9 ）： 2141 - 2149 .

中华医学会糖尿病学分会，中华医学会感染病学分会，中华医学会组织修复与再生分会 . 中国糖尿病足防治指南（2019版）（Ⅱ）［J］. 中华糖尿病杂志， 2019 ， 11 （ 3 ）： 161 - 189 .

中华医学会糖尿病学分会 . 中国2型糖尿病防治指南（2020年版）［J］. 中华糖尿病杂志， 2021 ， 13 （ 4 ）： 315 - 409 .

林丽丽，陈林江，王涵菁，等 . 踝肱指数评估2型糖尿病微血管并发症的临床价值［J］. 实用医学杂志， 2019 ， 35 （ 18 ）： 2857 - 2861 .

TAN YD . Two-sample t α -test for testing hypotheses in small-sample experiments ［J］. Int J Biostat ， 2022 ， 19 （ 1 ）： 1 - 19 .

中国中西医结合学会周围血管病专业委员会 . 中西医结合防治糖尿病足中国专家共识（第1版）［J］. 血管与腔内血管外科杂志， 2019 ， 5 （ 5 ）： 379 - 402 .

杨蕊，朱雪泉，肖乐，等 . 视觉模拟评定量表与抑郁症状快速评估量表的一致性研究［J］. 中国医刊， 2018 ， 53 （ 8 ）： 918 - 921 .

OE M ， YOTSU RR ， ARISANDI D ， et al . Validity of DMIST for monitoring healing of diabetic foot ulcers ［J］. Wound Repair Regen ， 2020 ， 28 （ 4 ）： 539 - 546 .

GU J ， LI C ， LI D ， et al . A case report of effective treatment of diabetic foot with the integration of traditional Chinese medicine and western medicine ［J］. Heliyon ， 2022 ， 8 （ 11 ）： e11346 .

RAYATE AS ， NAGOBA BS ， MUMBRE SS ， et al . Current scenario of traditional medicines in management of diabetic foot ulcers： a review ［J］. World J Diabetes ， 2023 ， 14 （ 1 ）： 1 - 16 .

SCHAPER NC ， VAN NETTEN JJ ， APELQVIST J ， et al . Practical guidelines on the prevention and management of diabetic foot disease （IWGDF 2019 update）［J］. Diabetes Metab Res Rev ， 2020 ， 36 （ Suppl 1 ）： e3266 .

ZHOU X ， GUO Y ， YANG K ， et al . The signaling pathways of traditional Chinese medicine in promoting diabetic wound healing ［J］. J Ethnopharmacol ， 2022 ， 282 ： 114662 . doi： 10.1016/j.jep.2021.114662 http://dx.doi.org/10.1016/j.jep.2021.114662 .

SENNEVILLE É ， ALBALAWI Z ， VAN ASTEN SA ， et al . IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections （IWGDF/IDSA 2023）［J］. Diabetes Metab Res Rev ， 2024 ， 40 （ 3 ）： e3687 .

魏晓涛，何志军，刘涛，等 . 消肿止痛合剂对糖尿病溃疡模型大鼠创面愈合的影响［J］. 中国病理生理杂志， 2023 ， 39 （ 5 ）： 902 - 909 .

谢婧，何志军，刘涛，等 . 消肿止痛合剂通过抑制TLR4/MyD88/NF-κB信号通路诱导小鼠小胶质细胞的M2极化［J］. 中国病理生理杂志， 2024 ， 40 （ 9 ）： 1589 - 1597 .

赵雅玫，冯磊，谢斌，等 . 抗生素骨水泥治疗糖尿病足溃疡疗效的Meta分析［J］. 中华糖尿病杂志， 2024 ， 16 （ 7 ）： 790 - 798 .

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Treatment for 42 Cases of Diabetic Foot Patients with Qi-Yin Deficiency and Stasis Syndrome Using Taohong Siwu Decoction （桃红四物汤） plus Self-made Buqi Yangyin Decoction （自拟补气养阴汤） Combined with Routine Therapy

Methodological Issues in the Design，Evaluation，and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"

Effect of Electroacupuncture on Metabolism-Inflammation Network in Patients with Simple Obesity：A Randomized Controlled Trial

Effect of Yiqi Yangyin Huoxue Formula（益气养阴活血方）on Oxidative Stress and Inflammatory Injury in Membranous Nephropathy Model Rats：Based on the NOX4-mediated SDF-1α/CXCR4 Signaling Pathway

Acupuncture Treatment for Severe Bell's Palsy and Its Impact on Serum GDNF and NGF：A Randomized Controlled Trial

Related Author

Jiayi FAN

Zhaohui YIN

Yingchao FU

Junli WANG

Linxia MA

Hongmei WANG

Junfeng WANG

WANG Lu

Related Institution

Hebei General Hospital for Veterans

Lung Disease Diagnosis and Treatment，The First Affiliated Hospital of Henan University of Chinese Medicine

Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases，Henan University of Chinese Medicine

School of Chinese Medicine，Hong Kong Baptist University

Research Unit of Evidence-Based Evaluation and Guidelines，Chinese Academy of Medical Sciences，School of Basic Medical Sciences，Lanzhou University

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰

Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients

DOI：10.13288/j.11-2166/r.2025.07.009

摘要

Abstract

关键词

Keywords

references