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双盲、随机、对照试验:药物治疗与非药物治疗美乐沙尔海绵在功能性内窥镜鼻窦手术中的应用比较。

Double-blinded, randomized, controlled trial of medicated versus nonmedicated merocel sponges for functional endoscopic sinus surgery.

机构信息

St. Paul's Sinus Centre, ENT Clinic, St. Paul's Hospital, 1081 Burrard Street, Vancouver, V6Z1Y6.

出版信息

J Otolaryngol Head Neck Surg. 2011 Feb;40 Suppl 1:S14-9.

Abstract

OBJECTIVE

This study aimed to compare differences between medicated and nonmedicated Merocel middle meatal spacers (MMSs) on sinonasal mucosal healing (histopathologic and endoscopic difference), patient discomfort, and pain on removal of the MMS following functional endoscopic sinus surgery.

METHODS

Forty-eight patients with chronic rhinosinusitis undergoing bilateral functional endoscopic sinus surgery were enrolled in a prospective study. Patients were randomized and blinded to receive a medication-soaked Merocel MMS (either one of budesonide, gentamicin, or manuka honey) in one nostril and a nonmedicated Merocel MMS in the contralateral side. Patients were seen on postoperative day 7 and were asked to complete a visual analogue score to report the level of discomfort from nasal packing on each side. Under endoscopic visualization, biopsies of mucosa were taken from both middle meati and assessed by a blinded pathologist to determine the level of mucosal inflammation on a scale of 0 to 4.

RESULTS

The budesonide-soaked Merocel MMS showed a trend toward reduced mucosal inflammation when compared to the control Merocel MMS, but the results were not statistically significant. There was no statistically significant difference in the degree of discomfort and pain on the removal of the packings between the medication-soaked Merocel MMS and the nonmedicated Merocel MMS, although there was a trend toward less pain for the manuka honey-soaked Merocel MMS.

CONCLUSIONS

Although our study failed to show any significant benefit from the addition of medication to the Merocel MMS, further studies with different compounds are recommended to determine whether a medicated MMS could indeed be a superior alternative to the standard MMS.

摘要

目的

本研究旨在比较经药物处理和未经药物处理的 Merocel 中鼻甲间隔物(MMS)在鼻黏膜愈合(组织病理学和内镜差异)、患者不适以及功能性鼻窦手术后 MMS 取出时的疼痛方面的差异。

方法

48 例慢性鼻-鼻窦炎患者行双侧功能性鼻窦手术,纳入一项前瞻性研究。患者随机分组并接受单侧浸药 Merocel MMS(布地奈德、庆大霉素或麦卢卡蜂蜜中的一种)和对侧非浸药 Merocel MMS。术后第 7 天,患者接受访视并完成视觉模拟评分,报告双侧鼻腔填塞引起的不适程度。在内镜可视化下,从双侧中鼻甲取活检,由盲法病理学家评估黏膜炎症程度,评分为 0 至 4 级。

结果

与对照组 Merocel MMS 相比,布地奈德浸药 Merocel MMS 显示出减轻黏膜炎症的趋势,但差异无统计学意义。浸药 Merocel MMS 和非浸药 Merocel MMS 之间,在取出填塞物时的不适和疼痛程度方面无统计学差异,但麦卢卡蜂蜜浸药 Merocel MMS 有减轻疼痛的趋势。

结论

尽管我们的研究未显示药物添加到 Merocel MMS 中带来任何显著益处,但推荐进行进一步研究以确定含药 MMS 是否确实是标准 MMS 的更好替代物。

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