可降解神经套接管制备及临床试验流程专家共识  

Expert consensus on the preparation and clinical trial process of biodegradable nerve conduits

作　　者：中国医学装备协会医用增材制造专业委员会 李慈 齐大虎 张蒙 袁博[4] 朱皓 肖骏 康皓 方忠[3] 赵宇[5] 胡懿郃[6] 戴红莲[7] 周钢[8] 张培训[2] Medical Additive Manufacturing Professional Committee,China Association of Medical Equipment;Li Ci;Qi Dahu;Zhang Meng;Yuan Bo;Zhu Hao;Xiao Jun;Kang Hao;Fang Zhong;Zhao Yu;Hu Yihe;Dai Honglian;Zhou Gang;Zhang Peixun(不详;Department of Orthopedics,Peking University People's Hospital,Beijing,100044;Department of Orthopedics,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan Hubei,430030;Tianjin Center for Quality Supervision and Inspection of Medical Devices,Tianjin,300384;Department of Orthopedics,Peking Union Medical College Hospital Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100730;Department of Orthopedics,Xiangya Hospital,Central South University,Changsha Hunan,410008;State Key Laboratory of Advanced Technology for Composite Materials,Wuhan University of Technology,Wuhan Hubei,430070;State Key Laboratory of Material Forming and Mould Technology,Huazhong University of Science and Technology,Wuhan Hubei,430074,China)

机构地区：[1]不详 [2]北京大学人民医院创伤骨科,北京100044 [3]华中科技大学同济医学院附属同济医院骨科,湖北武汉430030 [4]天津市医疗器械质量监督检验中心,天津300384 [5]中国医学科学院北京协和医学院北京协和医院骨科,北京100730 [6]中南大学湘雅医院骨科,湖南长沙410008 [7]武汉理工大学材料复合新技术国家重点实验室,湖北武汉430070 [8]华中科技大学材料成形与模具技术国家重点实验室,湖北武汉430074

出　　处：《生物骨科材料与临床研究》2021年第4期1-7,共7页Orthopaedic Biomechanics Materials and Clinical Study

基　　金：国家重点研发计划(2018YFB1105500)。

摘　　要：周围神经损伤是一种常见临床疾病,损伤后的有效修复是减少损伤并发症、改善预后的重要措施。临床上治疗单纯横断伤或微小缺损的神经损伤多采用显微外科对位缝合方式吻合神经断端,但临床修复效果难达到预期。基于周围神经选择性再生学说,研究者发现小间隙套接缝合的修复效果明显好于传统的神经外膜缝合方法。因此,研发一种用来桥接周围神经断端的周围神经套接管具有重要的科学和临床意义。为达到更好的周围神经损伤临床修复效果,专家组研发并制作了具有良好的可降解性、生物相容性、无免疫毒性的周围神经套接管。该套接管的应用可以减少操作难度及手术时间,有效促进周围神经的选择性再生。然而关于可降解神经套接管治疗周围神经损伤的临床科研应用流程还缺乏统一的定论和共识,为了规范周围神经套接管的制备和临床试验流程,本共识专家组结合周围神经损伤特点并经过反复讨论,达成了此共识。本共识为临床医师研发和使用周围神经套接管提供建议和指导。Peripheral nerve injury(PNI)is a common clinical disease.Effective repair after injury is an important measure to reduce complications and improve prognosis.Clinically,it is difficult to achieve the expected effect even though microsurgical epineurial neurorrhaphy is the most common treatment method for nerve transection and small nerve gap defect.Based on the theory of peripheral nerve chemotaxis regeneration,it has been proved that the repair effect of the small gap tubulization method is significantly better than the traditional epineurium neurorrhaphy.Thus,it has important scientific and clinical significance to develop a peripheral nerve conduit to bridge the stumps of peripheral nerve.To achieve a better clinical repair effect,the expert group developed and produced practical peripheral nerve conduits with good degradability,biocompatibility,and non-immune toxicity.The application of the conduits can reduce the difficulty and time of operation,and effectively promote peripheral nerve regeneration.However,there is no unified conclusion and consensus on the clinical scientific application process of the degradable nerve conduits in the PNI.In order to standardize the preparation and operation procedures of peripheral nerve conduits in clinical trials,the expert group combined the characteristics of biomaterials and PNI,and reached the consensus after repeated discussions.This consensus is expected to provide the advice and guidance for clinicians to develop and use peripheral nerve conduits.

关 键 词：周围神经套接管 小间隙套接缝合 周围神经损伤 降解材料 临床应用 

分 类 号：R65[医药卫生—外科学]