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透明马源胶原蛋白生物基质用于硬脑膜修复:一项前瞻性临床研究。

Transparent equine collagen biomatrix as dural repair. A prospective clinical study.

作者信息

Gazzeri Roberto, Neroni Massimiliano, Alfieri Alex, Galarza Marcelo, Faiola Andrea, Esposito Stefano, Giordano Marco

机构信息

Department of Neurosurgery, San Giovanni Addolorata Hospital, Via Amba Aradam 9, 00184, Rome, Italy.

出版信息

Acta Neurochir (Wien). 2009 May;151(5):537-43. doi: 10.1007/s00701-009-0290-9. Epub 2009 Apr 1.

DOI:10.1007/s00701-009-0290-9
PMID:19337680
Abstract

AIM

Numerous materials have been used to replace defects in the dura mater as result of neurosurgical and spinal procedures. Tissudura is a biomatrix made of cross-linked equine collagen fibrils, mainly of the interstitial type I. The specially engineered dura-like layered structure provides a non porous primary water tight structure, is transparent and allows verification of the efficacy of cerebral hemostasis.

METHODS

A consecutive series of patients between 18 years and 75 years of age were prospectively enrolled from three separate European institutions between May 2007 and February 2008. All patients underwent elective cranial or spinal surgery and required implantation of a dural substitute. We assessed the efficacy and safety of the collagen biomatrix as a dural substitute, intraoperatively and postoperatively, with a median follow-up 4.3 months.

RESULTS

Fifty-six patients had cranial surgery, four patients underwent a spinal operation. Surgical cranial approaches included supratentorial procedures in 45 patients and posterior cranial fossa exploration in 11. At 7-days follow-up, a CSF leak was reported in one patient after excision of a vestibular schwannoma and in another with a thoracic vertebral body fracture and spinal cord transaction. Neither needed reoperation. A subgaleal fluid collection in two patients who had been treated for a supratentorial lesion resolved after tapping. The transparency of the implant was beneficial to inspect the underlying surgical area at the end of the procedure in one patient in whom a hematoma formed after secondary to oozing glioblastoma removal. Of the 56 patients who reached the 3-month follow-up, none had a CSF leak, meningitis, wound infection or fistulae. No duroplasty failure was observed. In one patient who underwent reoperation after 40 days, histopathological findings revealed the replacement of the implant by ingrowth from the original dura.

CONCLUSION

Tissudura is simple, efficacious and safe to use. The use of fibrin glue reduces suturing and facilitates the implantation of the collagen biomatrix. Its transparency makes it unique and beneficial in inspection of the underlying area of operation. The lack of adverse reaction indicates that this graft may be used as an option in the repair of dural defects.

摘要

目的

在神经外科手术和脊柱手术中,已有多种材料用于替代硬脑膜缺损。Tissudura是一种由交联马胶原纤维制成的生物基质,主要为间质I型。这种经过特殊设计的硬脑膜样分层结构提供了一种无孔的初级水密结构,是透明的,并且能够验证脑止血的效果。

方法

在2007年5月至2008年2月期间,从三个不同的欧洲机构前瞻性纳入了一系列连续的18岁至75岁患者。所有患者均接受了择期颅脑或脊柱手术,并且需要植入硬脑膜替代物。我们在术中及术后评估了胶原生物基质作为硬脑膜替代物的有效性和安全性,中位随访时间为4.3个月。

结果

56例患者接受了颅脑手术,4例患者接受了脊柱手术。颅脑手术入路包括45例幕上手术和11例后颅窝探查。在7天随访时,1例前庭神经鞘瘤切除术后患者和另1例胸椎椎体骨折并脊髓横断患者报告有脑脊液漏。两者均无需再次手术。2例接受幕上病变治疗的患者出现帽状腱膜下积液,穿刺后消退。在1例因胶质母细胞瘤切除术后渗血继发形成血肿的患者中,植入物的透明性有利于在手术结束时检查下方的手术区域。在56例达到3个月随访的患者中,无一例出现脑脊液漏、脑膜炎、伤口感染或瘘管。未观察到硬脑膜成形术失败。1例在40天后接受再次手术的患者,组织病理学检查结果显示植入物被原始硬脑膜向内生长所替代。

结论

Tissudura使用简单、有效且安全。纤维蛋白胶的使用减少了缝合,并便于胶原生物基质的植入。其透明性使其在检查下方手术区域时具有独特性和优势。缺乏不良反应表明这种移植物可作为修复硬脑膜缺损的一种选择。

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