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三维打印生物材料聚己内酯(PCL)在隆鼻术中的临床应用。

Clinical Application of Three-Dimensionally Printed Biomaterial Polycaprolactone (PCL) in Augmentation Rhinoplasty.

机构信息

Kangnam-Samsung Aesthetic Plastic Surgery, 1306-1, HyoBong 601, Seocho-Dong, Seoul, 06614, South Korea.

Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Irwon-dong 50, Gangnam-gu, Seoul, 135-710, South Korea.

出版信息

Aesthetic Plast Surg. 2019 Apr;43(2):437-446. doi: 10.1007/s00266-018-1280-1. Epub 2018 Nov 29.

DOI:10.1007/s00266-018-1280-1
PMID:30498936
Abstract

BACKGROUND

This clinical study aimed to investigate the safety and surgical outcome of three-dimensionally (3D) fabricated polycaprolactone (PCL) mesh in rhinoplasty. In particular, this study explored how a 3D-printed PCL mesh performs as a bioabsorbable scaffold after a long period following implantation.

METHODS

A retrospective review of 101 patients who received primary or secondary rhinoplasty with a PCL mesh was performed. Patient demographics and surgery-related outcomes were examined. Clinical efficacy and safety were evaluated using the Global Aesthetic Improvement Scale at postoperative 18 months. From two revisional cases, a biopsy specimen of implanted PCL was acquired and histopathological analysis was performed.

RESULTS

Of all the patients, 98.0% showed no postoperative infection-related foreign body reaction or distinct abnormal reaction, and the implants were observed to maintain long-term efficacy until 18-month follow-up. In patients who received spreader grafts, significant differences between preoperative and postoperative Cottle sign scores were found. Histopathological analysis showed features of adjacent tissue infiltration into pores of the PCL mesh and regeneration of neo-cartilaginous tissue and collagen around the mesh 20 months after implantation.

CONCLUSION

This study demonstrates that a novel biodegradable PCL mesh with a 3D structure is a safe and effective material for corrective rhinoplasty because it is easy to use and capable of maintaining its volume in the long term without foreign body response. This biocompatible material will have a wide range of applications as the most suitable alternative to nonabsorbable materials in rhinoplasty and reconstruction surgeries, such as fashioning spreader grafts and septal extension grafts.

LEVEL OF EVIDENCE IV

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

背景

本临床研究旨在探讨三维(3D)制备聚己内酯(PCL)网片在鼻整形术中的安全性和手术效果。特别是,本研究探讨了 3D 打印 PCL 网片在植入后很长一段时间内作为生物可吸收支架的性能。

方法

对 101 例接受 PCL 网片行原发性或继发性鼻整形术的患者进行回顾性分析。检查患者的人口统计学资料和手术相关结果。术后 18 个月,采用整体美学改善量表(Global Aesthetic Improvement Scale)评估临床疗效和安全性。从 2 例修复病例中获取植入 PCL 的活检标本,并进行组织病理学分析。

结果

所有患者均无术后感染相关异物反应或明显异常反应,植入物长期有效,直至 18 个月随访。在接受扩鼻器移植的患者中,术前和术后 Cottle 征评分有显著差异。组织病理学分析显示,术后 20 个月时,相邻组织已渗透至 PCL 网孔中,在网片周围有新生软骨组织和胶原再生。

结论

本研究表明,新型 3D 结构可生物降解的 PCL 网片是一种安全有效的矫正性鼻整形术材料,因其易于使用且能长期保持体积,无异物反应。这种生物相容性材料将在鼻整形术和重建手术中具有广泛的应用前景,可作为非吸收性材料的最佳替代品,例如制作扩鼻器移植和鼻中隔延伸移植。

证据等级 IV:本刊要求作者为每篇文章指定一个证据等级。如需详细了解这些循证医学评级,请参考目录或在线作者指南 www.springer.com/00266 。

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