中国药业2025，Vol.34Issue(23)：1-5,5.DOI:10.3969/j.issn.1006-4931.2025.23.001
非植入类能量源械字号医美设备临床前有效性评价模型的研究现状与发展路径
Research Status,Challenges,and Future Paths of Preclinical Efficacy Evaluation Models for Non-Implantable Energy-Based Medical Aesthetic Devices
摘要
Abstract
Objective To investigate the development path of non-implantable energy-based medical aesthetic devices.Methods This classification,mechanism of action,quantitative indicators of clinical efficacy endpoints,and the research status and challenges faced by clinical effectiveness evaluation models of non-implantable energy-based devices were analyzed,and future optimization paths were put forward.Results and Conclusion Non-implantable energy-based devices are mainly categorized into three types based on their dominant mechanism of action:thermal-based,photochemical-based,and mechanical-based.Preclinical efficacy evaluation models are mainly classified into in vitro models,animal models,and limited human models.The challenges faced in the application of models mainly include the limitations of in vitro models,the difficulty in transforming animal models,and the difficulty in modeling clinical efficacy endpoints.It is recommended to strengthen research and regulation on 3D bioprinting and organ-on-a-chip technologies in the future to promote continuous innovation and standardized use of non-implantable energy-based devices.关键词
非植入类能量源设备/医美设备/临床前有效性评价/射频/激光/发展路径Key words
non-implantable energy-based devices/aesthetic devices/preclinical efficacy evaluation/radiofrequency/laser/development pathway分类
医药卫生引用本文复制引用
王嫦鹤,曹涵博,蔡虎,杨晓玲,崔亚丽,宋俊贞..非植入类能量源械字号医美设备临床前有效性评价模型的研究现状与发展路径[J].中国药业,2025,34(23):1-5,5.基金项目
陕西省重点研发计划项目[2023-ZDLSF-08]. （）
