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采用正丁基氰基丙烯酸酯固定网片在腹腔镜腹股沟疝修补术中的效率和安全性:超过 1300 次网片固定的长期生物相容性。

Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations.

出版信息

Hernia. 2012 Apr;16(2):153-62. doi: 10.1007/s10029-011-0887-9. Epub 2011 Oct 21.

DOI:10.1007/s10029-011-0887-9
PMID:22015810
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3315639/
Abstract

INTRODUCTION

In adult patients, most inguinal hernias are treated by implanting a prosthetic mesh. To prevent mesh dislocation and thus recurrence, different types of fixation have been proposed. In contrast to penetrating fixation known to cause acute chronic pain, adhesive fixation is becoming increasingly popular as it reduces markedly the risk of injury and chronic pain. Apart from the biological sealants (e.g., fibrin glue), surgical adhesives include a group of synthetic glues and genetically engineered protein glues. For example, cyanoacrylate is used in various medical and veterinary indications due to its fast action, excellent bonding strength and low price.

OBJECTIVE

The main objective of this paper was to communicate positive results obtained using n-butyl-cyanoacrylate glue to fix prosthetic meshes in over 1,300 TAPP repairs of primary and recurrent inguinal hernias. The secondary objective was to highlight the rationale (e.g., safety) for using non-fibrin based glue in this type of procedure.

METHOD

We present the in vitro and in vivo data necessary for the approval of n-butyl cyanoacrylate Histoacryl(®) glue. We use an equivalent glue, Glubran-2(®), to fix prosthetic meshes in 1,336 laparoscopic TAPP repairs.

RESULTS

Standardized tests to detect sensitization, irritation, genotoxicity or systemic toxicity demonstrated the safety and biocompatibility of Histoacryl(®), which met all requirements, including those of ISO 10993. Histological long-term studies in rabbits yielded results comparable to routine suture fixations, with full integration of the mesh into the abdominal wall. The clinical results showed the following advantages: fast application of the glue, reduced postoperative pain, 0.0% infection rate, continuously low recurrence rate and shorter hospital stay. No adverse effects and no complaints were recorded.

CONCLUSION

The experimental and clinical data demonstrate the safe use and the excellent cost-benefit ratio of n-butyl cyanoacrylate compared with other techniques of mesh fixation.

摘要

简介

在成年患者中,大多数腹股沟疝通过植入假体网片来治疗。为了防止网片移位从而导致复发,提出了不同类型的固定方法。与已知会引起急性慢性疼痛的穿透性固定方法相比,黏合固定法越来越受欢迎,因为它显著降低了损伤和慢性疼痛的风险。除了生物密封剂(例如纤维蛋白胶),外科用黏合剂包括一组合成黏合剂和基因工程蛋白黏合剂。例如,由于氰基丙烯酸酯具有快速作用、优异的黏合强度和低廉的价格,因此在各种医学和兽医适应症中得到应用。

目的

本文的主要目的是交流在超过 1300 例原发性和复发性腹股沟疝的 TAPP 修复中使用丁基氰基丙烯酸酯胶固定假体网片所获得的积极结果。次要目的是强调在这种类型的手术中使用非纤维蛋白基胶的合理性(例如安全性)。

方法

我们介绍了 n-丁基氰基丙烯酸酯Histoacryl(®)胶获得批准所需的体外和体内数据。我们使用等效的 Glubran-2(®)胶固定 1336 例腹腔镜 TAPP 修复中的假体网片。

结果

用于检测致敏、刺激、遗传毒性或全身毒性的标准化测试表明,Histoacryl(®)具有安全性和生物相容性,符合包括 ISO 10993 在内的所有要求。在兔子中的长期组织学研究结果与常规缝线固定相当,网片完全整合到腹壁中。临床结果显示出以下优点:胶的快速应用、术后疼痛减轻、0.0%的感染率、持续较低的复发率和较短的住院时间。未记录到不良反应和投诉。

结论

实验和临床数据表明,与其他网片固定技术相比,n-丁基氰基丙烯酸酯的使用具有安全性和优异的成本效益比。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/f182ab87994d/10029_2011_887_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/f1f93c105c2f/10029_2011_887_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/405aee925291/10029_2011_887_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/35e9305ea315/10029_2011_887_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/b7bacd87c00d/10029_2011_887_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/6b11b5d6fd4b/10029_2011_887_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/dc7404ac85c5/10029_2011_887_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/c7ed9b3980d7/10029_2011_887_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/f182ab87994d/10029_2011_887_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/f1f93c105c2f/10029_2011_887_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/405aee925291/10029_2011_887_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/35e9305ea315/10029_2011_887_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/b7bacd87c00d/10029_2011_887_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/6b11b5d6fd4b/10029_2011_887_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/dc7404ac85c5/10029_2011_887_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/c7ed9b3980d7/10029_2011_887_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8465/3315639/f182ab87994d/10029_2011_887_Fig8_HTML.jpg

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