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一项关于纤维蛋白胶减少扁桃体切除术后疼痛和出血的前瞻性随机双盲试验。

A prospective randomized double-blind trial of fibrin glue for reducing pain and bleeding after tonsillectomy.

作者信息

Segal Nili, Puterman Moshe, Rotem Eran, Niv Alexander, Kaplan Daniel, Kraus Mordechai, Brenner Hilel, Nash Michael, Tal Asher, Leiberman Alberto

机构信息

Department of Otolaryngology-Head & Neck Surgery, Box 151, Soroka University Medical Center, Beer Sheva 84101, Israel.

出版信息

Int J Pediatr Otorhinolaryngol. 2008 Apr;72(4):469-73. doi: 10.1016/j.ijporl.2007.12.011. Epub 2008 Feb 20.

Abstract

OBJECTIVES

Varying surgical techniques as well as a large selection of analgesics and other medications have been evaluated over the years in the hopes of reducing post-tonsillectomy pain. Several publications in recent years have demonstrated the efficacy of fibrin glue in reducing post-tonsillectomy bleeding and pain. The objectives of this study were to evaluate the effect of fibrin glue on pain and bleeding after tonsillectomy.

STUDY DESIGN

A prospective randomized double-blind study was performed on 168 consecutive patients undergoing tonsillectomy for obstructive sleep apnea and chronic tonsillitis.

METHODS

Patients were randomly assigned to the treatment protocol. In the study group, the tonsillar beds were coated with fibrin glue (Quixil, OMRIX biopharmaceuticals) at the end of the operation. Patients in the controlled group underwent tonsillectomy without the use of fibrin glue. The patients were then monitored for postoperative bleeding, and a patient-based pain assessment instrument was used to evaluate pain, ability to eat and analgesics consumption for 10 days after surgery.

RESULTS

Ninety-six patients returned for postoperative follow up and filled in the questionnaire. As our medical center is the only hospital in the southern district of Israel and we hospitalize every person who presents with post-tonsillectomy bleeding, we can assume that any patient from either group who presented with post-tonsillectomy bleeding would be familiar to us. Analysis showed that no statistically significant differences relating to postoperative pain, bleeding, use of analgesics and postoperative eating resumption were detected between the patients treated with fibrin glue and controls.

CONCLUSIONS

We cannot substantiate a significant beneficial effect of fibrin glue in post-tonsillectomy pain control, prevention of bleeding or facilitating eating and thus find no indication for the routine use of fibrin glue in tonsillectomy.

摘要

目的

多年来,人们对各种手术技术以及大量的镇痛药和其他药物进行了评估,以期减轻扁桃体切除术后的疼痛。近年来的一些出版物已证明纤维蛋白胶在减少扁桃体切除术后出血和疼痛方面的疗效。本研究的目的是评估纤维蛋白胶对扁桃体切除术后疼痛和出血的影响。

研究设计

对168例因阻塞性睡眠呼吸暂停和慢性扁桃体炎接受扁桃体切除术的连续患者进行了一项前瞻性随机双盲研究。

方法

将患者随机分配至治疗方案组。在研究组中,手术结束时在扁桃体床涂抹纤维蛋白胶(Quixil,OMRIX生物制药公司)。对照组患者在不使用纤维蛋白胶的情况下接受扁桃体切除术。然后对患者进行术后出血监测,并使用基于患者的疼痛评估工具评估术后10天的疼痛、进食能力和镇痛药消耗情况。

结果

96例患者返回进行术后随访并填写问卷。由于我们的医疗中心是以色列南部地区唯一的医院,并且我们收治每一位出现扁桃体切除术后出血的患者,所以我们可以假设两组中任何出现扁桃体切除术后出血的患者我们都会熟悉。分析表明,使用纤维蛋白胶治疗的患者与对照组患者在术后疼痛、出血、镇痛药使用和术后进食恢复方面未发现统计学上的显著差异。

结论

我们无法证实纤维蛋白胶在控制扁桃体切除术后疼痛、预防出血或促进进食方面有显著的有益效果,因此未发现扁桃体切除术中常规使用纤维蛋白胶的指征。

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