Reduction of epidural fibrosis in lumbar surgery with Oxiplex adhesion barriers of carboxymethylcellulose and polyethylene oxide.

Reduction of epidural fibrosis in lumbar surgery with Oxiplex adhesion barriers of carboxymethylcellulose and polyethylene oxide.
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DOI:
10.1016/s1529-9430(03)00035-4
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发表时间:
2003-07-01
期刊:
The spine journal : official journal of the North American Spine Society
影响因子:
--
通讯作者:
Berg, Richard A
Berg, Richard A
中科院分区:
其他
文献类型:
--
作者:
Rodgers, Kathleen E;Robertson, James T;Berg, Richard A

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背景:腰椎间盘突出症术后硬膜外粘连和纤维化是正常伤口愈合的结果。纤维化的存在使再次手术的风险,在某些患者中纤维化可能导致神经根tethering.Purpose:一种方法,以尽量减少发展硬膜外粘连的风险是提供一个屏障之间的硬脑膜和愈合的结缔组织。这些研究的目的是评价这样的屏障装置。研究设计/设置:在大学实验室的动物模型中进行体内研究。患者样品:兔子。结果测量:大体和组织形态学评价。方法:屏障由羧甲基纤维素(CMC)和聚环氧乙烷(PEO)(Oxiplex; FzioMed,Inc.,San Luis Obispo,CA)作为减少兔椎板切开术和椎板切除术模型中硬膜外粘连形成的器械。测试的屏障是单独的凝胶(凝胶)或覆盖有膜的凝胶(凝胶/膜组合)。在每只家兔的L4和L 6处创建两个椎板切开术或椎板切除术部位(取决于手术方法)。一个部位用CMC/PEO凝胶或CMC/PEO凝胶/薄膜组合治疗,另一个部位作为手术对照。两种手术模型,不同的程度的粘连形成在未经处理的损伤部位和方法的损伤generationwere used.RESULTS:模型A,其中没有纳入硬脑膜磨损,导致高达40%的无粘连椎板切除术部位的控制。模型B,其中包括硬脑膜磨损,导致对照组中少于10%的无粘连椎板切开术部位。在两种模型中测试CMC/PEO凝胶(2.5%至10%PEO)和膜(22.5%PEO)的组合物。疗效参数包括测量无硬膜外纤维化的部位数量和纤维化(粘连)严重程度的降低。凝胶和凝胶/膜组合一致地降低了两种模型中硬膜外纤维化的频率和程度。含有较高含量PEO(10%)和较高分子量PEO(4.4 mD)的CMC/PEO凝胶在模型B中最有效,并导致高达84%的椎板切开术部位具有最小或无硬膜外纤维化,而对照组显示超过90%的部位具有硬膜外纤维化。手术部位的组织学评价表明,硬膜外纤维化的减少伴随着正常的骨愈合。此外,这些实验表明,凝胶/薄膜组合提供了没有额外的好处,通过单独的凝胶获得的结论:凝胶CMC/PEO减少硬膜外纤维化,并没有损害正常愈合。
BACKGROUND CONTEXT: Postsurgical epidural adhesions and fibrosis after surgery for lumbar disc herniation are a consequence of normal wound healing. The presence of fibrosis renders reoperations risky, and in some patients fibrosis may lead to nerve root tethering.PURPOSE: One approach to minimizing the risk of developing epidural adhesions is to provide a barrier between the dural membrane and the healing connective tissues. The purpose of these studies was to evaluate such a barrier device.STUDY DESIGN/SETTING: In vivo investigation in an animal model at a university laboratory.PATIENT SAMPLE: Rabbit.OUTCOME MEASURES: Gross and histomorphic evaluation.METHODS: Barriers comprised of carboxymethylcellulose (CMC) and polyethylene oxide (PEO) (Oxiplex; FzioMed, Inc., San Luis Obispo, CA) were studied as devices to reduce epidural adhesion formation in rabbit laminotomy and laminectomy models. The barriers tested were either a gel alone (gel) or a gel covered with a film (gel/film combination). Two laminotomy or laminectomy sites (depending on the surgical method) were created in each rabbit at L4 and L6. One site was treated with a CMC/PEO gel, or CMC/PEO gel/film combination, and the other site served as a surgical control. Two surgical models that differed in the extent of adhesion formation at untreated injury sites and the method of injury generation were used.RESULTS: Model A, which did not incorporate dural abrasion, resulted in up to 40% adhesion-free laminectomy sites in controls. Model B, which did incorporate abrasion of the dural membrane, resulted in less than 10% adhesion-free laminotomy sites in controls. Compositions of CMC/PEO gels (2.5% to 10% PEO) and films (22.5% PEO) were tested in both models. Efficacy parameters included measuring the number of sites free of epidural fibrosis and reduction in the severity of fibrosis (adhesions). Both gels and gel/film combinations consistently reduced the frequency and the extent of epidural fibrosis in both models. Gels of CMC/PEO containing a higher content of PEO (10%) and a higher molecular weight of PEO (4.4 mD) were most effective in Model B and resulted in up to 84% laminotomy sites with minimal or no epidural fibrosis, whereas controls exhibited over 90% of the sites with epidural fibrosis. Histological evaluation of the surgical sites indicated that the reduction of epidural fibrosis was accompanied by normal bone healing. In addition, these experiments demonstrated that the gel/film combination provided no additional benefit to that obtained by the gel alone.CONCLUSIONS: Gels of CMC/PEO reduced epidural fibrosis and did not impair normal heal ing.