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弗洛塞尔(®)止血剂在头颈外科手术中的安全性试验。

Safety trial of Floseal(®) haemostatic agent in head and neck surgery.

作者信息

Ujam A, Awad Z, Wong G, Tatla T, Farrell R

机构信息

North West London Hospitals NHS Trust, UK.

出版信息

Ann R Coll Surg Engl. 2012 Jul;94(5):336-9. doi: 10.1308/003588412X13171221590971.

DOI:10.1308/003588412X13171221590971
PMID:22943229
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3954375/
Abstract

INTRODUCTION

Floseal(®) can be of value in reducing blood loss and haematoma rates. The manufacturer's warnings include allergic reaction, poor wound healing and intravascular thrombosis. We aimed to determine whether Floseal(®) is safe to use in various head and neck surgery procedures.

METHODS

A prospective trial was conducted using Floseal(®) in 42 various consecutive head and neck surgery procedures. Adverse incidents were used as the main outcome measure, including allergic reaction, wound breakdown, wound infection and thrombosis. Secondary outcome measures included haematoma formation, hospital stay, drain times and output.

RESULTS

No adverse incidents were recorded in the trial period. Two patients developed haematomas and required surgical exploration where a bleeding vessel was identified and dealt with.

CONCLUSIONS

Floseal(®) is safe to be used in head and neck surgery with no adverse effects. A larger number and a control group are required to ascertain its value in reducing blood loss, haematoma formation, drain usage and hospital stay.

摘要

引言

弗洛塞尔(Floseal)在减少失血和血肿发生率方面可能具有价值。制造商的警告包括过敏反应、伤口愈合不良和血管内血栓形成。我们旨在确定弗洛塞尔在各种头颈外科手术中使用是否安全。

方法

对42例连续进行的各种头颈外科手术使用弗洛塞尔进行前瞻性试验。不良事件用作主要结局指标,包括过敏反应、伤口裂开、伤口感染和血栓形成。次要结局指标包括血肿形成、住院时间、引流时间和引流量。

结果

试验期间未记录到不良事件。两名患者出现血肿,需要进行手术探查,术中发现并处理了出血血管。

结论

弗洛塞尔用于头颈外科手术是安全的,无不良影响。需要更多病例数和设立对照组来确定其在减少失血、血肿形成、引流使用和住院时间方面的价值。

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本文引用的文献

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Ann Ital Chir. 2010 Sep-Oct;81(5):343-7.
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Small bowel obstruction associated with use of a gelatin-thrombin matrix sealant (FloSeal) after laparoscopic gynecologic surgery.腹腔镜妇科手术后使用明胶-纤维蛋白胶(FloSeal)引起的小肠梗阻。
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FloSeal hemostatic matrix in persistent epistaxis: prospective clinical trial.FloSeal 止血基质在持续性鼻出血中的应用:前瞻性临床试验。
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Video-assisted thyroidectomy: lessons learned after more than one decade.视频辅助甲状腺切除术:十余年经验总结。
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Caseating granulomata caused by hemostatic agent posing as metastatic leiomyosarcoma.伪装成转移性平滑肌肉瘤的止血剂所致的干酪样肉芽肿。
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Eosinophil-rich inflammatory response to FloSeal hemostatic matrix presenting as postoperative pelvic pain.对弗洛塞尔止血基质的富含嗜酸性粒细胞的炎症反应表现为术后盆腔疼痛。
Am J Obstet Gynecol. 2009 Apr;200(4):e10-1. doi: 10.1016/j.ajog.2008.10.052. Epub 2008 Dec 27.
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AJR Am J Roentgenol. 2008 Nov;191(5):1371-3. doi: 10.2214/AJR.08.1041.
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