Zhong Meng, He Hongwei, Wang Liaochuan, Pu Linyun, Liu Zhirong, Wang Jiangtian, Zhang Yanjun, Wang Shiliang, Sun Bingbing, Li Xiaojing, Xiong Lidan, Mi Jiabo, Song Mowei, Ni Panxianzhi, Huang Can, Yuan Tun, Liang Jie, Fan Yujiang, Zhang Xingdong
National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, Sichuan 610064, China; College of Biomedical Engineering, Sichuan University, Chengdu 610064, China.
Sichuan Testing Centre for Biomaterials and Medical Devices, Chengdu, Sichuan 610064, China.
Colloids Surf B Biointerfaces. 2025 Feb;246:114378. doi: 10.1016/j.colsurfb.2024.114378. Epub 2024 Nov 12.
Skin injection filling products must undergo a rigorous evaluation before entering the market, and intradermal reactions are crucial for biocompatibility. However, current evaluation methods for skin injection fillers often lack precision. This study aims to explore a comprehensive evaluation method by incorporating additional indicators: dermoscopy, transepidermal water loss, moisture content, ultrasound, and histological observation. Experimental findings show sodium hyaluronate gel groups exhibited no noticeable erythema or abnormalities, except for skin swelling. The dynamic and quantitative assessment of water content and transdermal water loss provided insights into the injection site skin's edema status. Ultrasound imaging observed subcutaneous material occupation and measured skin protrusion height. Histopathological observations revealed edema and inflammation in positive groups but no significant reactions in any gel samples. The comprehensive use of these methods confirms that the intradermal response of injection fillers in this study is within an acceptable range. However, if solely evaluated based on existing standards, it may exceed the qualified range. Consequently, the study suggests that for sodium hyaluronate gel, a macromolecular injection filler for long-term subcutaneous space occupancy, the traditional intradermal reaction scoring method may be inadequate. The proposed comprehensive evaluation scheme in this study is considered a more objective approach.
皮肤注射填充产品在进入市场前必须经过严格评估,皮内反应对于生物相容性至关重要。然而,目前皮肤注射填充剂的评估方法往往缺乏精确性。本研究旨在通过纳入额外指标探索一种综合评估方法:皮肤镜检查、经表皮水分流失、水分含量、超声检查和组织学观察。实验结果表明,透明质酸钠凝胶组除皮肤肿胀外,未出现明显红斑或异常。对水分含量和经皮水分流失的动态定量评估为注射部位皮肤的水肿状态提供了见解。超声成像观察到皮下物质占据情况并测量了皮肤突出高度。组织病理学观察显示阳性组出现水肿和炎症,但任何凝胶样本均未出现显著反应。综合使用这些方法证实本研究中注射填充剂的皮内反应在可接受范围内。然而,如果仅根据现有标准进行评估,可能会超出合格范围。因此,该研究表明,对于用于长期占据皮下空间的大分子注射填充剂透明质酸钠凝胶,传统的皮内反应评分方法可能不够充分。本研究提出的综合评估方案被认为是一种更客观的方法。