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美国食品药品监督管理局/欧洲合格认证批准的用于外周神经和颅神经临床修复的可吸收神经导管。

US Food and Drug Administration/Conformit Europe-approved absorbable nerve conduits for clinical repair of peripheral and cranial nerves.

作者信息

Meek M F, Coert J H

机构信息

Pulvertaft Hand Centre, Derby, United Kingdom.

出版信息

Ann Plast Surg. 2008 Jan;60(1):110-6. doi: 10.1097/SAP.0b013e31804d441c.

DOI:10.1097/SAP.0b013e31804d441c
PMID:18281807
Abstract

Several absorbable nerve conduits are approved by the US Food and Drug Administration (FDA) and Conformit Europe (CE) for clinical repair of peripheral and cranial nerves. Surgeons are often not aware of the different (bio)materials of these conduits when performing nerve repair. An overview of these FDA- and CE-approved absorbable nerve conduits for clinical use is presented. PubMed, MEDLINE, and the companies selling the conduits were consulted. The available FDA and CE absorbable nerve conduits for peripheral and cranial nerve repair are 2 collagen- and 2 synthetic-polyester-based conduits. The available clinical data, the price, the length, and the composition of the tube show significant differences. Based on the available data in this paper at this moment, we favor the PGA (Neurotube) nerve conduit for repair of peripheral and cranial nerve defects because of its advantages in length, price, and availability of clinical data. However, no prospective studies comparing the available nerve conduits have been published.

摘要

美国食品药品监督管理局(FDA)和欧洲合格认证(CE)已批准多种可吸收神经导管用于外周神经和颅神经损伤的临床修复。外科医生在进行神经修复时,往往并不了解这些导管所使用的不同(生物)材料。本文将概述这些已获FDA和CE批准用于临床的可吸收神经导管。我们检索了PubMed、MEDLINE以及销售这些导管的公司。目前,已获FDA和CE批准用于外周神经和颅神经修复的可吸收神经导管有2种基于胶原蛋白的导管和2种基于合成聚酯的导管。现有临床数据、价格、长度和导管组成均存在显著差异。基于本文目前所掌握的现有数据,我们更倾向于使用聚乙醇酸(Neurotube)神经导管来修复外周神经和颅神经缺损,这是因为它在长度、价格以及临床数据可获取性方面具有优势。然而,尚未有比较现有神经导管的前瞻性研究发表。

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