壳聚糖基液体敷料与重组人表皮生长因子对急性肢体皮肤伤口愈合的比较研究：一项随机对照试验。
Comparative study of chitosan-based liquid dressing and recombinant human epidermal growth factor on acute limb skin wound healing: A randomized controlled trial.
作者信息
Tan Dunyong, Guo Jiawei, Chen Xiaoqiang, Liu Jianquan, Yang Siyao, Wang Daping, Li Wencui
机构信息
Department of Hand and Foot Surgery, Shenzhen Second People' s Hospital (The First Hospital Affiliated to Shenzhen University), Shenzhen, Guangdong, 518028, China.
Guangdong Key Laboratory for Biomedical Measurements and Ultrasound Imaging, National-Regional Key Technology Engineering Laboratory for Medical Ultrasound, School of Biomedical Engineering, Shenzhen University Medical School, Shenzhen 518060, China.
出版信息
JPRAS Open. 2025 Mar 26;44:379-389. doi: 10.1016/j.jpra.2025.03.018. eCollection 2025 Jun.
BACKGROUND
Several traditional dressings may have limitation in treating wounds. A novel chitosan-based dressing designed for improved hemostasis, moisture, and sealing shows promise in wound healing. However, its efficacy and safety are yet to be sufficiently verified in patients.
METHODS
This randomized controlled trial enrolled 40 patients suffering from acute skin wounds in the limbs from 12/2022 to 12/2023. They were randomly divided into two groups (20 vs. 20) and received regular treatments in the Shenzhen Second People's Hospital. The experimental group was treated with chitosan-based liquid dressing, whereas the control group was treated with traditional dressing with recombinant human epidermal growth factor (rhEGF). The therapeutic effects (scar area and pigment deposition), adverse events, visual analogue scale (VAS), healing time, cost, and the patient and observer scar assessment scale (POSAS) were evaluated on days 0, 7, 14, and 28.
RESULTS
No adverse events were observed throughout the trial. On day 28, effective rate between groups were not statistically significant between the groups (70% vs. 85%, = 0.256). Other parameters that were not significant included VAS (5.10 ± 1.62 vs. 6.35 ± 2.39, = 0.06), healing time (8.45 ± 4.26 vs. 8.60 ± 5.44 days, = 0.923), and cost (49.00 ± 22.48 vs. 57.40 ± 27.59, = 0.298). However, on day 28, the patient- and observer-reported SAS of the chitosan (CS) group was significantly lower than that of the rhEGF group (12.00 vs. 9.50, z = 2.477, = 0.013; 18.50 vs. 12.50, z = 2.209, = 0.026; respectively), and the total POSAS (30.50 vs. 22.00, z = 2.374, = 0.017).
CONCLUSION
Compared to rhEGF, the CS-based liquid dressing showed reliable safety and equivalent performance in treating acute limb skin wounds, as revealed by improvements in healing time and rate, pain relief, and costs. Moreover, liquid dressing significantly reduced scar formation, indicating its potential in wound therapy.
背景
几种传统敷料在伤口治疗中可能存在局限性。一种新型的基于壳聚糖的敷料，设计用于改善止血、保湿和封闭功能，在伤口愈合方面显示出前景。然而，其疗效和安全性在患者中尚未得到充分验证。
方法
本随机对照试验纳入了2022年12月至2023年12月期间40例四肢急性皮肤伤口患者。他们被随机分为两组（每组20例），并在深圳市第二人民医院接受常规治疗。实验组使用基于壳聚糖的液体敷料治疗，而对照组使用含重组人表皮生长因子（rhEGF）的传统敷料治疗。在第0、7、14和28天评估治疗效果（瘢痕面积和色素沉着）、不良事件、视觉模拟评分（VAS）、愈合时间、成本以及患者和观察者瘢痕评估量表（POSAS）。
结果
在整个试验过程中未观察到不良事件。在第28天，两组之间的有效率无统计学差异（70%对85%，P = 0.256）。其他无显著差异的参数包括VAS（5.10±1.62对6.35±2.39，P = 0.06）、愈合时间（8.45±4.26对8.60±5.44天，P = 0.923）和成本（49.00±22.48对57.40±27.59，P = 0.298）。然而，在第28天，壳聚糖（CS）组患者和观察者报告的SAS显著低于rhEGF组（分别为12.00对9.50，z = 2.477，P = 0.013；18.50对12.50，z = 2.209，P = 0.026），以及总POSAS（30.50对22.00，z = 2.374，P = 0.017）。
结论
与rhEGF相比，基于CS的液体敷料在治疗急性肢体皮肤伤口方面显示出可靠的安全性和等效的性能，在愈合时间和速率、疼痛缓解和成本方面均有改善。此外，液体敷料显著减少了瘢痕形成，表明其在伤口治疗中的潜力。
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