Fibrin Sealants in Dura Sealing: A Systematic Literature Review.
Fibrin Sealants in Dura Sealing: A Systematic Literature Review.
复制标题
硬脑膜密封中的纤维蛋白密封剂：系统文献综述。
DOI：
10.1371/journal.pone.0151533
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Cappabianca P
中科院分区：
文献类型：
--
作者：
Esposito F;Angileri FF;Kruse P;Cavallo LM;Solari D;Esposito V;Tomasello F;Cappabianca P
纤维蛋白密封剂广泛用于神经外科以密封缝合线、提供防水闭合并防止脑脊液渗漏。本系统综述的目的是总结当前纤维蛋白密封剂在硬脑膜密封和预防/治疗脑脊液漏方面的功效和安全性文献。在以下数据库中进行了全面的电子文献检索：Cochrane 系统评价数据库、Cochrane Central Resister of Controlled Trials、clinicaltrials.gov、MEDLINE/PubMed 和 EMBASE。潜在感兴趣文章的标题和摘要由 3 位作者独立审阅。总共识别出 1006 条数据库记录和其他记录。在筛选重复项和相关性后，研究人员对总共 78 篇文章的资格进行了评估。定性综合中排除了 38 篇文章，并纳入了 40 篇文章的全文。其中七项仅包含安全数据并包含在安全评估中。其余 33 篇文章包括 32 项研究的结果，这些研究总共招募了 2935 名接触纤维蛋白密封剂的患者。在这33项研究中，只有3项随机对照试验，其余为前瞻性队列分析、病例对照研究、前瞻性或回顾性病例系列。一项对 89 名患者进行纤维蛋白密封剂暴露的随机对照试验发现，纤维蛋白密封剂组术中硬脑膜水密闭合率高于对照组（92.1% vs 38.0%，p<0.001）；然而，与对照组患者相比，使用纤维蛋白密封剂的患者术后发生脑脊液漏的比例更高（6.7% vs 2.0%，p>0.05）。其他临床试验评估了纤维蛋白密封剂在术后预防脑脊液漏中的效果。这些通常是较低水平的证据研究（即不是前瞻性、随机、对照试验），其设计或动力不是为了证明使用纤维蛋白密封剂的显着优势。两项小型病例系列研究评估了纤维蛋白封闭剂治疗持续性脑脊液漏的效果，但没有得出确切的疗效结论。使用纤维蛋白密封剂进行硬脑膜密封的具体不良报告有限，自 1987 年以来，在神经外科手术中仅报告了 8 例病例，并且大多数报告仅与纤维蛋白密封剂暴露存在推测性关系/关联。本系统文献综述的一个主要发现是，缺乏评估纤维蛋白密封剂在提供术中水密硬脑膜闭合和术后脑脊液漏方面的有效性和安全性的随机研究。在现有的有限研究中，来自一项随机对照试验的证据表明，与对照相比，纤维蛋白密封剂提供的硬脑膜缝合线术中水密闭合率更高，尽管术后脑脊液漏率更高。非随机对照试验的证据表明，纤维蛋白密封剂可能有效预防脑脊液漏，且安全性可接受。非常需要随机对照临床试验或精心设计的前瞻性观察试验，因为进行随机试验无法充分评估纤维蛋白密封剂的使用对术中硬脑膜闭合率、术后脑脊液漏和安全性的影响。
Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.