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一项评价壳聚糖凝胶在鼻内镜鼻窦手术后吻合口狭窄中疗效的双盲随机对照试验。

A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery.

机构信息

Department of Surgery-Otorhinolaryngology, Head and Neck Surgery, University of Adelaide, Adelaide, Australia.

出版信息

Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.

DOI:10.1002/alr.21136
PMID:23322408
Abstract

BACKGROUND

Stenosis of sinus ostia following endoscopic sinus surgery (ESS) is the most common reason for revision surgery. Chitosan-dextran (CD) gel has been shown to be an effective hemostatic agent; however, its effects on ostial stenosis are unknown. This study aims to quantify the effect of CD gel on circumferential scarring following ESS.

METHODS

A prospective, blinded, randomized, controlled trial was conducted in 26 patients undergoing ESS. Measurements of neo-ostia were taken using a standard-sized measuring probe. CD gel was applied unilaterally, while contralateral sides received no gel. Ostial diameters were measured by a blinded observer at 2, 8, and 12 weeks postoperation. Sinus ostial areas calculated as a proportion of the original were compared for each ostium at each time point.

RESULTS

Intraoperative ostial areas were comparable for CD gel and control sides (38 mm(2) vs 39 mm(2) , 131 mm(2) vs 120 mm(2) , and 203 mm(2) vs 193 mm(2) , in frontal, sphenoid, and maxillary ostia, respectively; p > 0.05). CD gel significantly improved sinus ostial patency. The largest difference was seen when ostial areas at 12 weeks were compared with their corresponding baseline areas (66% vs 31% frontal, p < 0.001; 85% vs 47% sphenoid, p < 0.001; and 74% vs 54% maxillary ostia, p = 0.002). The difference between raw ostial areas reached statistical significance in sphenoid (p < 0.001) and maxillary (p = 0.01), but not in frontal ostia (p > 0.05) at 12 weeks.

CONCLUSION

CD gel produced significantly less stenosis of all neo-ostia following ESS and may reduce the necessity for revision surgery in patients with chronic rhinosinusitis.

摘要

背景

内镜鼻窦手术后(ESS)窦口狭窄是再次手术的最常见原因。壳聚糖-葡聚糖(CD)凝胶已被证明是一种有效的止血剂;然而,其对窦口狭窄的影响尚不清楚。本研究旨在定量评估 CD 凝胶对 ESS 后环状瘢痕形成的影响。

方法

对 26 例行 ESS 的患者进行前瞻性、盲法、随机、对照试验。使用标准尺寸的测量探头测量新窦口的大小。单侧应用 CD 凝胶,对侧不应用凝胶。术后 2、8 和 12 周由盲法观察者测量窦口直径。在每个时间点,比较每个窦口的原始窦口面积计算出的窦口面积比例。

结果

术中 CD 凝胶侧和对照组侧的窦口面积相当(额窦分别为 38mm² 比 39mm²,蝶窦分别为 131mm² 比 120mm²,上颌窦分别为 203mm² 比 193mm²;p>0.05)。CD 凝胶显著改善了鼻窦窦口通畅性。12 周时窦口面积与相应基线面积的差异最大(额窦分别为 66%比 31%,p<0.001;蝶窦分别为 85%比 47%,p<0.001;上颌窦分别为 74%比 54%,p=0.002)。12 周时,蝶窦(p<0.001)和上颌窦(p=0.01)的原始窦口面积差异具有统计学意义,但额窦(p>0.05)无统计学意义。

结论

CD 凝胶可显著减少 ESS 后所有新窦口的狭窄程度,并可能减少慢性鼻-鼻窦炎患者再次手术的必要性。

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