在头骨外科手术中含有白细胞和血小板丰富的纤维素:单盲,前性,随机对照的非劣势性试验
Birgit Coucke1,2, Steven De Vleeschouwer1,3, Johannes van Loon1,3
11Department of Neurosciences, Research Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven.
Journal of neurosurgery
|February 23, 2024
概括
富含白细胞和血小板的纤维素 (L-PRF) 与商业密封剂相比,在部手术后防止CSF泄漏方面没有劣势. 这种具有成本效益的自主选择显示了可比的安全性和有效性,并提供了潜在的成本节省.
科学领域:
- 神经外科 神经外科
- 生物材料是一种生物材料.
- 手术并发症 手术并发症
背景情况:
- 脑脊液 (CSF) 泄漏是头骨手术后的一个严重并发症.
- 纤维素密封剂通常用于持久封闭,但对安全性,有效性和成本存在担忧.
- 富含白细胞和血小板纤维素 (L-PRF) 提供了一种可访问和廉价的自身替代品.
研究的目的:
- 评估L-PRF与商业纤维素密封剂相比在预防术后CSF泄漏方面的非劣势.
- 评估CSF泄漏的风险因素,并比较L-PRF和商业密封剂之间的不良事件.
- 为了确定L-PRF在长期关闭中的成本效益.
主要方法:
- 进行了一次单盲,前性,随机对照试验.
- 350名接受选择性部神经外科手术的患者被随机分配 (1:1) 接受L-PRF或商业纤维素密封剂以进行持续关闭.
- 主要终点是需要干预的CSF泄漏的发生率.
主要成果:
- 证实了非劣质性,其中1名L-PRF患者和5名对照患者经历了需要干预的CSF泄漏 (p=0.11).
- 在对照组中,只有一个患者需要因为CSF泄漏而进行修复手术.
- 感染和脑膜炎等不良事件与L-PRF较低,尽管出血事件略高.
结论:
- 与商业纤维素密封剂相比,L-PRF是持久增强的非劣质选择,没有发现安全问题.
- 使用L-PRF可以在临床实践中节省大量成本,因为其可访问性和较低的价格.
- 在部外科手术中,L-PRF代表了一种可行且具有成本效益的替代方案,用于长期关闭.
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