Feng Jiamei, Chen Zheng, Sun Jiaye, Shao Shijun, Xie Lu, Qu Wenchao, Gao Qingqian, Wu Xueqing, Wan Hua
Department of Mammary, Shuguang Hospital, Shanghai University of Tradition Chinese Medicine, No.185 Pu 'an Road, Huangpu District, Shanghai, 200011, China.
Department of Traditional Chinese Medicine, Yichuan Street Community Health Service Center, Putuo District, Shanghai, 200065, China.
Hereditas. 2025 May 19;162(1):82. doi: 10.1186/s41065-025-00451-2.
The objective of this study is to evaluate the efficacy of red ointment, a widely used topical agent in traditional Chinese medicine, in promoting wound cavity repair following debridement for non-puerperal mastitis (NPM).
A prospective, randomized controlled trial was conducted, including 88 patients diagnosed with NPM. Patients were randomly assigned to either the treatment group or the control group. All patients underwent debridement during the acute inflammatory phase. Postoperatively, the treatment group received daily dressing changes using sterile gauze strips infused with red ointment, whereas the control group received sterile gauze strips soaked in rivanol. The effectiveness of treatment was assessed after two weeks by evaluating the total effective rate, wound cavity score, symptom and sign score, laboratory parameters, and adverse events.
In the intention to treat analysis, the total effective rate was 90.9% in the red ointment group, which was higher than the 86.4% observed in the rivanol group. In the per protocol analysis, the total effective rate was 97.6% in the red ointment group, exceeding the 92.7% in the rivanol group. Compared with rivanol-treated gauze strips, the use of red ointment gauze strips resulted in a significantly greater reduction in wound cavity volume (p < 0.05), improved local breast symptoms (p < 0.05), and a lower wound cavity score (p < 0.001). Granulation tissue in the red ointment group exhibited a significantly fresher color compared to the rivanol group (p < 0.05). No significant differences were observed between the two groups regarding adverse effects on hepatic and renal function following treatment.
The use of red ointment gauze strips for wound cavity filling following NPM debridement demonstrated favorable clinical efficacy and safety, providing a viable option for postoperative drainage management.
本研究旨在评估中药中广泛使用的外用制剂红油膏在促进非产褥期乳腺炎（NPM）清创术后创面修复中的疗效。
进行了一项前瞻性随机对照试验，纳入88例诊断为NPM的患者。患者被随机分为治疗组或对照组。所有患者在急性炎症期均接受清创术。术后，治疗组每天使用浸有红油膏的无菌纱布条换药，而对照组使用浸有雷佛奴尔的无菌纱布条。两周后通过评估总有效率、创面评分、症状体征评分、实验室指标和不良事件来评估治疗效果。
在意向性分析中，红油膏组的总有效率为90.9%，高于雷佛奴尔组的86.4%。在符合方案分析中，红油膏组的总有效率为97.6%，超过雷佛奴尔组的92.7%。与雷佛奴尔处理的纱布条相比，使用红油膏纱布条可使创面体积显著减小（p < 0.05），改善局部乳房症状（p < 0.05），且创面评分更低（p < 0.001）。与雷佛奴尔组相比，红油膏组的肉芽组织颜色明显更新鲜（p < 0.05）。两组治疗后对肝肾功能的不良反应无显著差异。
NPM清创术后使用红油膏纱布条填充创面显示出良好的临床疗效和安全性，为术后引流管理提供了一种可行的选择。
