托里消毒散联合贝复济治疗慢性皮肤溃疡的临床疗效及作用机制*

作者：涂雅玲1，陈其华1，席建元1，彭 恋2，喻环宇2，祁 林1

单位：1.湖南中医药大学第一附属医院，湖南 长沙 410007； 2.湖南中医药大学，湖南 长沙 410208

引用：引用：涂雅玲，陈其华，席建元，彭恋，喻环宇，祁林.托里消毒散联合贝复济治疗慢性皮肤溃疡的临床疗效及作用机制[J].中医药导报,2025,31(12):149-154.

DOI：10.13862/j.cn43-1446/r.2025.12.024

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摘要：目的：探讨托里消毒散联合贝复济治疗慢性皮肤溃疡的临床疗效及作用机制。方法：纳入慢性皮肤溃疡患者94例（后脱落4例），采用随机数字表法分为中药对照组、西药对照组和联合治疗组，每组30例。中药对照组口服托里消毒散，西药对照组外用贝复济，联合治疗组在口服托里消毒散基础上加用贝复济，每组疗程均为4周。比较3组患者创面愈合时间、治疗2周和4周创面愈合率、创面中医综合积分、创面肉芽皮肤组织中转化生长因子β1（TGF-β1）、缺氧诱导因子1α（HIF-1α）、血管内皮生长因子（VEGF）、白细胞介素-8（IL-8）水平，随访3、6个月时患者复发率，并观察记录治疗期间不良反应。结果：联合治疗组患者的愈合时间短于中药对照组和西药对照组（P＜0.05），治疗2周和4周时患者创面愈合率及中医综合积分改善幅度均优于中药对照组和西药对照组（P＜0.05）。随访3个月时患者复发率，联合治疗组为0.00%（0/30）、中药对照组为10.00%（3/30）、西药对照组为13.33%（4/30），差异无统计学意义（P＞0.05）；随访6个月时患者复发率，联合治疗组为3.33%（1/30），中药对照组为23.33%（7/30），西药对照组为26.67%（8/30），差异有统计学意义（P＜0.05）；两两比较结果显示，中药对照组与联合治疗组差异有统计学意义（P=0.05），西药对照组与联合治疗组差异亦有统计学意义（P＜0.05）。治疗2周和4周时，联合治疗组患者创面肉芽组织中TGF-β1、VEGF浓度较治疗前显著升高，HIF-1α、IL-8浓度显著降低，与中药对照组和西药对照组比较，差异均有统计学意义（P＜0.05）。治疗期间3组患者未见皮肤疼痛、过敏等严重不良反应，生命体征稳定，肝肾功能正常。结论：托里消毒散联合贝复济可下调慢性皮肤溃疡创面组织HIF-1α和IL-8水平，上调TGF-β1和VEGF表达，促进血管生成、抑制炎症反应及促进肉芽组织修复，进而加速创面愈合并降低复发率，具有良好的安全性和临床疗效。

关键词：慢性皮肤溃疡；托里消毒散；贝复济；创面愈合；炎症因子；作用机制

Abstract：

Objective: To investigate the clinical efficacy and potential mechanism of Tuoli Xiaodu Powder (托里消毒散) combined with Beifuji (Recombinant Bovine Basic Fibroblast Growth Factor For External Use) in the treatment of chronic skin ulcers. Methods: A total of 94 patients with chronic skin ulcers were enrolled (4 later dropped out). They were randomly divided using a random number table into a Traditional Chinese Medicine (TCM) control group, a Western medicine control group, and a combination therapy group, with 30 patients in each group. The TCM control group received oral Tuoli Xiaodu Powder; the Western medicine control group received topical Beifuji; the combination therapy group received both oral Tuoli Xiaodu Powder and topical Beifuji. The treatment course was 4 weeks for all groups. The wound healing time, wound healing rates at 2 and 4 weeks, TCM comprehensive wound scores, and the levels of transforming growth factor-β1 (TGF-β1), hypoxia-inducible factor-1α (HIF-1α), vascular endothelial growth factor (VEGF), and interleukin-8 (IL-8) in wound granulation tissue were compared among the three groups. Recurrence rates were recorded at 3 and 6 months of follow-up, and adverse reactions during treatment were observed and documented. Results: The wound healing time in the combination therapy group was significantly shorter than that in both the TCM control group and the Western medicine control group (P<0.05). At both 2 and 4 weeks of treatment, the wound healing rates and the improvement in TCM comprehensive wound scores in the combination therapy group were superior to those in the other two groups (P<0.05). At the 3-month follow-up, the recurrence rates were 0.00% (0/30) in the combination therapy group, 10.00% (3/30) in the TCM control group, and 13.33% (4/30) in the Western medicine control group, with no statistically significant difference (P>0.05). At the 6-month follow-up, the recurrence rates were 3.33% (1/30), 23.33% (7/30), and 26.67% (8/30) for the combination therapy, TCM control, and Western medicine control groups, respectively, showing a statistically significant difference (P<0.05). Pairwise comparisons revealed a significant difference between the TCM control group and the combination therapy group (P=0.05), and a significant difference between the Western medicine control group and the combination therapy group (P<0.05). At both 2 and 4 weeks of treatment, the levels of TGF-β1 and VEGF in wound granulation tissue of the combination therapy group were significantly increased compared to pre-treatment levels, while the levels of HIF-1α and IL-8 were significantly decreased. These changes were significantly different compared to both the TCM control group and the Western medicine control group (P<0.05). During the treatment period, no severe adverse reactions such as skin pain or allergy were observed in any of the three groups. Vital signs remained stable, and liver and kidney functions were normal. Conclusion: The combination of Tuoli Xiaodu Powder and Beifuji can downregulate the levels of HIF-1α and IL-8, upregulate the expression of TGF-β1 and VEGF in chronic skin ulcer tissue, thereby promoting angiogenesis, inhibiting inflammatory responses, facilitating granulation tissue repair, accelerating wound healing, and reducing the recurrence rate. This combined therapy demonstrates good safety and clinical efficacy.

Key words：chronic skin ulcer; Tuoli Xiaodu Powder; Beifuji; wound healing; inflammatory cytokines; mechanism of action

发布时间：2026-01-30

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