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鞘内药物输注系统植入术后通过预防性纤维蛋白胶应用预防硬膜穿刺后头痛:一项回顾性研究。

Preventing Post Dural Puncture Headache after Intrathecal Drug Delivery System Implantation Through Preventive Fibrin Glue Application: A Retrospective Study.

机构信息

Anesthesia and Pain Department, Institut de cancérologie de l'ouest - Paul Papin, Angers, France.

Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA.

出版信息

Pain Physician. 2021 Mar;24(2):E211-E220.

Abstract

BACKGROUND

Cerebrospinal fluid (CSF) leakage resulting in post dural puncture headache (PDPH) is a frequent adverse effect observed after intrathecal drug delivery system (IDDS) implantation. CSF leakage symptoms negatively affect patient quality of life and can result in additional complications. Fibrin glue was used to treat CSF leakage syndrome. We developed a procedure to reduce the incidence of PDPH by preventing CSF leakage with the use of fibrin glue during surgery.

OBJECTIVES

The main outcome criterion for this study was the incidence of PDPH syndrome after IDDS implantation with or without preventive fibrin glue application during the procedure.

STUDY DESIGN

We designed a monocentric retrospective cohort study to compare the incidence of PDPH due to CSF leakage syndrome after lumbar puncture in patients with an implanted intrathecal pump, with or without preventive fibrin glue application during the procedure.

SETTING

The study was held in the Anesthesiology and Pain department of the  Integrative Cancer Institute (ICO), Angers - France.

METHODS

The study compared 2 patient cohorts over 2 successive periods. Fibrin glue was injected into the introducer needle puncture pathway after placement of the catheter immediately following needle removal.

RESULTS

The no-glue group included 107 patients, whereas the glue group included 92 patients.Two application failures were observed (2.04%). Fibrin glue application results in a significant decrease in PDPH incidence, from 32.7% in the no-glue group to 10.92 % (P < 0.001) in the glue group. In regard to severity, in the no-glue group, 37.1% of PDPH syndromes were mild, 34.3% were moderate, and 28.6% were severe. In the fibrin glue group, 80% of PDPH syndromes were mild, and 20% were moderate. No severe PDPHs were reported after fibrin glue application. Duration of symptoms was also statistically shorter in the fibrin glue group (maximum of 3 days vs. 15 days in the no-glue group). In a univariate analysis, preventive fibrin glue application and age are significant to prevent PDPH. In multivariate analysis, only fibrin glue application was statistically significant (odds ratio, 0.26; P = 0.0008). No adverse effects linked to fibrin glue were observed.

LIMITATIONS

The main limitation of this study is its retrospective nature. In addition, this study is from a single center with a potential selection bias and a center effect.

CONCLUSIONS

The novel use of fibrin glue is promising in terms of its effect on PDPH and its safety profile. Its moderate cost and reproducibility make it an affordable and efficient technique.

摘要

背景

鞘内药物递送系统(IDDS)植入后发生脑脊液(CSF)漏导致的硬膜穿刺后头痛(PDPH)是一种常见的不良反应。CSF 漏的症状会降低患者的生活质量,并可能导致其他并发症。纤维蛋白胶曾被用于治疗 CSF 漏综合征。我们开发了一种在手术过程中使用纤维蛋白胶预防 CSF 漏以降低 PDPH 发生率的程序。

目的

本研究的主要结局标准是比较在手术过程中应用或不应用纤维蛋白胶预防 CSF 漏时,IDDS 植入后 CSF 漏综合征引起的 PDPH 综合征的发生率。

研究设计

我们设计了一项单中心回顾性队列研究,比较了在植入鞘内泵后因腰椎穿刺导致的 CSF 漏综合征引起的 PDPH 发生率,比较了在手术过程中应用或不应用纤维蛋白胶预防 CSF 漏的患者。

设置

该研究在法国昂热的综合癌症研究所(ICO)的麻醉与疼痛科进行。

方法

该研究在 2 个连续时期比较了 2 个患者队列。在导管放置后立即拔出针时,将纤维蛋白胶注入导针穿刺途径。

结果

无胶组包括 107 例患者,而胶组包括 92 例患者。观察到 2 例应用失败(2.04%)。纤维蛋白胶的应用显著降低了 PDPH 的发生率,从无胶组的 32.7%降至胶组的 10.92%(P<0.001)。在严重程度方面,在无胶组中,37.1%的 PDPH 综合征为轻度,34.3%为中度,28.6%为重度。在纤维蛋白胶组中,80%的 PDPH 综合征为轻度,20%为中度。应用纤维蛋白胶后无严重的 PDPH 发生。在纤维蛋白胶组中,症状持续时间也明显缩短(最长 3 天,而无胶组为 15 天)。在单因素分析中,预防性应用纤维蛋白胶和年龄是预防 PDPH 的重要因素。多因素分析中,只有纤维蛋白胶的应用具有统计学意义(比值比,0.26;P=0.0008)。未观察到与纤维蛋白胶相关的不良反应。

局限性

本研究的主要局限性是其回顾性性质。此外,这项研究来自一个单一的中心,存在潜在的选择偏倚和中心效应。

结论

纤维蛋白胶的新用途在预防 PDPH 及其安全性方面具有很大的前景。其适中的成本和可重复性使其成为一种负担得起且有效的技术。

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