周围神经修复材料的临床应用进展及审评思考  

A Review of Clinical Application Progress and Evaluation Considerations on Peripheral Nerve Repair Materials

作　　者：王雅文 WANG Yawen(Center for Medical Device Evaluation,NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国医药导刊》2024年第12期1171-1178,共8页Chinese Journal of Medicinal Guide

摘　　要：周围神经损伤严重影响患者的生活质量。当周围神经损伤发生时,机体会通过一系列复杂的过程进行神经再生和修复。自体神经移植可提供生长轴突所需的基底膜管,免疫排斥反应小,被认为是周围神经修复的金标准,但由于自体神经来源不足、切除供体部位后留下新的病变和功能丧失等问题,人工神经移植材料的研发和临床应用逐渐发展。理想的神经修复材料除应满足生物相容性、可降解、对再生神经提供机械支撑和保护,还应在防止纤维瘢痕长入的同时允许小分子营养物质通过、方便储存运输,最大限度地模拟体内生长环境,为神经修复提供良好的空间和营养物质等条件。本研究通过检索中美两国该类产品注册的公开信息,及相关法律法规标准的要求,对比了美国和中国批准的多款神经修复材料的结构组成、性能和适应证等,总结了此类产品理化性能、生物学性能、动物试验等安全有效性要求,动物试验还包括时间点的选择、动物模型的考虑以及评价指标的考量,以期为该类产品的注册和技术审评提供思路。Peripheral nerve injury seriously affects the life quality of patients.When peripheral nerve injury occurs,the body will regenerate and repair nerves through a series of complex processes.Autologous nerve transplantation can provide the basal membrane tube needed for the growth of axons with little immune rejection and is considered the gold standard for peripheral nerve repair.However,due to problems such as insufficient source of autologous nerve,new lesions and loss of function after resection of the donor site,the development and clinical application of artificial nerve transplantation materials have gradually developed.In addition to being biocompatible,degradable,and providing mechanical support and protection for the regenerated nerves,the ideal nerve repair material should also prevent the growth of fiber scars while allowing the passage of small molecular nutrients,convenient storage and transportation,maximize the simulation of the growth environment in the body,and provide good space and nutrient conditions for nerve repair.By searching the public information of the registration of such products in China and the United States,as well as the requirements of relevant laws and regulations,this paper compared the structural composition,performance and indications of various neural repair materials approved by the United States and China,and summarized the safety and effectiveness requirements of such products such as physical and chemical properties,biological properties and animal experiments,animal experiments also include the selection of the time point,the consideration of animal models and the consideration of evaluation indicators,in order to provide ideas for the registration and technical review of such products.

关 键 词：周围神经损伤 周围神经修复 审评 注册 评价指标 

分 类 号：R95[医药卫生—药学]