The Leo M. Davidoff Department of Neurological Surgery, The Albert Einstein College of Medicine, Bronx 10461, NY, USA.
Spine J. 2010 Dec;10(12):1065-8. doi: 10.1016/j.spinee.2010.09.017.
Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.
Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure.
STUDY DESIGN/SETTING: Review of the manufacturers' inserts and a focused review of the literature concerning the pros and cons for two "sealants" (DuraSeal [Confluent Surgical Inc., Waltham, MA, USA] and BioGlue [Cryolife, Kennesaw, GA, USA]) and two "fibrin glues" (EVICEL [Johnson and Johnson Wound Management, Ethicon Inc., Somerville, NJ, USA] and Tisseel [fibrin sealant; Baxter International Inc., Westlake Village, CA, USA]) were assessed.
A focused review of the literature using four different "sealants" or "fibrin glues" was performed.
Documentation of persistent/recurrent postoperative cerebrospinal fluid fistulas was an end point for failure for the four different "sealants" and "fibrin glues."
Manufacturers' inserts and a focused review of the literature concerning the relative safety and efficacy of two "sealants" (DuraSeal and BioGlue) and two "fibrin glues" (EVICEL and Tisseel) used to augment dural closure were assessed.
Although DuraSeal is approved by the Federal Drug Administration (FDA) for intracranial and spinal application, two instances of paralysis are described in the literature. BioGlue is classified by the manufacturer as neurotoxic. EVICEL, one of the "fibrin glues," appeared in just two animal studies, whereas Tisseel, the other "fibrin glue," has been used in many large clinical series without adverse events.
Despite the lack of FDA approval, Tisseel (fibrin glue) has seen wide adoption in "off-label" use. DuraSeal, which is FDA approved, was associated with two instances of paralysis. Alternatively, BioGlue was described as neurotoxic even by the manufacturer.
蓄意或外伤性硬脑膜瘘通常通过“密封剂”或“纤维蛋白胶”来增强硬脑膜闭合的强度。
对于用于硬脑膜闭合的两种特定的“密封剂”和两种特定的“纤维蛋白胶”，人们对与之相关的风险和并发症知之甚少。
研究设计/设置：审查制造商的插入物，并对有关两种“密封剂”（DuraSeal [Confluent Surgical Inc.，马萨诸塞州沃尔瑟姆，美国]和BioGlue [Cryolife，佐治亚州肯尼索，美国]）和两种“纤维蛋白胶”（EVICEL [Johnson and Johnson Wound Management，Ethicon Inc.，新泽西州萨默维尔]和Tisseel [纤维蛋白密封剂；Baxter International Inc.，加利福尼亚州西湖村]）的优缺点进行了重点文献回顾。
使用四种不同的“密封剂”或“纤维蛋白胶”进行了重点文献回顾。
四种不同的“密封剂”和“纤维蛋白胶”的失败终点是记录持续性/复发性术后脑脊液瘘。
评估了制造商的插入物以及有关两种“密封剂”（DuraSeal 和 BioGlue）和两种“纤维蛋白胶”（EVICEL 和 Tisseel）用于增强硬脑膜闭合的相对安全性和有效性的重点文献回顾。
尽管 DuraSeal 已获得美国食品和药物管理局（FDA）批准用于颅内和脊柱应用，但文献中描述了两例瘫痪病例。制造商将 BioGlue 归类为神经毒性。EVICEL 是一种“纤维蛋白胶”，仅在两项动物研究中出现，而另一种“纤维蛋白胶”Tisseel 已在许多大型临床系列中使用，且没有不良事件。
尽管缺乏 FDA 批准，但 Tisseel（纤维蛋白胶）已被广泛用于“标签外”用途。获得 FDA 批准的 DuraSeal 与两例瘫痪病例有关。相反，即使是制造商也将 BioGlue 描述为神经毒性。
