| 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 |
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| DOI： |
| 中文关键词: 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 |
| 英文关键词:Peripheral nerve conduit Small gap tubulization suture Peripheral nerve injury Degradable material Clinical application |
| 基金项目: |
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| 通讯作者:中国医学装备协会医用增材制造专业委员会 李慈1# 齐大虎2# 张蒙1# 袁博3# 朱皓2# 肖骏2* 康皓2* 方忠2* 赵宇4* 胡懿郃5* 戴红莲6* 周钢7* 张培训1* |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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