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纤维蛋白胶在肺切除术中的应用:一项前瞻性、随机、双盲研究。

Fibrin glue in pulmonary resection: a prospective, randomized, blinded study.

作者信息

Fabian Thomas, Federico John A, Ponn Ronald B

机构信息

Department of Surgery, The Hospital of St. Raphael, New Haven, Connecticut, USA.

出版信息

Ann Thorac Surg. 2003 May;75(5):1587-92. doi: 10.1016/s0003-4975(02)04994-9.

DOI:10.1016/s0003-4975(02)04994-9
PMID:12735583
Abstract

BACKGROUND

In contrast to the rare large-airway bronchopleural fistulas after lung resection, peripheral or alveolar air leaks (AAL) are very common, often prolong hospital stay, increase utilization of resources, and on occasion result in significant morbidity. Various adjuncts have been used in attempts to reduce AAL. One of these, the topical application of fibrin glue, has to date failed to demonstrate efficacy in small clinical trials. This study reexamines the role of fibrin glue in routine lobar and wedge pulmonary resections.

METHODS

Of 113 patients enrolled, 13 became ineligible because of intraoperative findings. The remaining 100 patients were randomly assigned to one of two groups at the conclusion of lung resection, regardless of the presence or absence of identifiable air leak. The control group received no additional intervention. The experimental group underwent application of 5 mL of fibrin glue delivered by a pressurized, aerosolized spraying mechanism. Postoperatively a blinded clinical observer recorded outcomes including the incidence and duration of AAL, prolonged AAL (PAAL), the volume of pleural drainage, the time to tube removal, and the postoperative length of stay (LOS), as well as any complications related to treatment.

RESULTS

Both groups were comparable with regard to demographics, diagnoses, and procedures. Statistically significant reductions were found in the experimental group in the overall incidence of AAL (34% versus 68%, p = 0.001), mean duration of AAL (1.1 versus 3.1 days, p = 0.005), mean time to chest tube removal (3.5 versus 5.0 days, p = 0.02), and the incidence of PAAL (2% versus 16%, p = 0.015). There was no significant difference in the volume of chest tube drainage or LOS (4.6 days glue and 4.9 days control, p = 0.318). There were no complications related to the use of fibrin glue.

CONCLUSIONS

Aerosolized fibrin glue appears to be safe and effective in reducing AAL. The overall incidence of AAL was reduced by 50% and PAAL occurred in only 1 treated patient (2% versus the usually reported 15%). Further studies with this and other methods are required to delineate routine versus selective use, to compare methods, and clarify cost benefit.

摘要

背景

与肺切除术后罕见的大气道支气管胸膜瘘不同,外周或肺泡漏气(AAL)非常常见,常延长住院时间,增加资源利用,有时还会导致严重的发病情况。人们尝试了各种辅助手段来减少AAL。其中之一,即局部应用纤维蛋白胶,在小型临床试验中迄今未能证明其有效性。本研究重新审视了纤维蛋白胶在常规肺叶和楔形肺切除术中的作用。

方法

在纳入的113例患者中,13例因术中发现而不符合条件。其余100例患者在肺切除结束时被随机分为两组,无论是否存在可识别的漏气。对照组未接受额外干预。试验组通过加压雾化喷射机制应用5毫升纤维蛋白胶。术后,一名不知情的临床观察者记录结果,包括AAL的发生率和持续时间、持续性AAL(PAAL)、胸腔引流量、拔管时间、术后住院时间(LOS)以及与治疗相关的任何并发症。

结果

两组在人口统计学、诊断和手术方面具有可比性。试验组在AAL的总体发生率(34%对68%,p = 0.001)、AAL的平均持续时间(1.1天对3.1天,p = 0.005)、胸管拔除的平均时间(3.5天对5.0天,p = 0.02)以及PAAL的发生率(2%对16%,p = 0.015)方面有统计学意义的降低。胸管引流量或LOS无显著差异(纤维蛋白胶组4.6天,对照组4.9天,p = 0.318)。未出现与使用纤维蛋白胶相关的并发症。

结论

雾化纤维蛋白胶在减少AAL方面似乎安全有效。AAL的总体发生率降低了50%,仅1例接受治疗的患者发生了PAAL(2%,而通常报道为15%)。需要对这种方法和其他方法进行进一步研究,以确定常规使用与选择性使用的情况,比较各种方法,并阐明成本效益。

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