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围手术期使用 Sofradex 滴耳液预防鼓膜置管堵塞:一项前瞻性双盲随机对照试验。

The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.

作者信息

Arya A K, Rea P A, Robinson P J

机构信息

Southmead Hospital, North Bristol NHS Trust, Bristol, UK.

出版信息

Clin Otolaryngol Allied Sci. 2004 Dec;29(6):598-601. doi: 10.1111/j.1365-2273.2004.00875.x.

DOI:10.1111/j.1365-2273.2004.00875.x
PMID:15533144
Abstract

Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.

摘要

据报道,约11% - 12%的鼓膜造孔管在手术后会立即被中耳分泌物或血液堵塞,从而失去功能。许多耳科医生在手术时常规滴注含抗生素和类固醇的溶液,认为这可能会减少这种并发症。本研究的目的是调查在插入鼓膜造孔管时滴注含抗生素和类固醇的溶液Sofradex预防鼓膜造孔管堵塞的效果。双盲随机对照试验,比较在接受双侧鼓膜造孔管插入术的患者中,用Sofradex滴剂治疗的耳朵与对照组(不滴注)的鼓膜造孔管堵塞率。获得了61对结果。两组的鼓膜造孔管堵塞率有显著差异。术中滴注Sofradex滴剂的鼓膜造孔管堵塞的可能性比对照组低9倍[1.6%对13.1%,优势比(Sofradex/对照组)= 9.06,95%置信区间(CI):1.04 - 78.82,P = 0.05]。鼓膜造孔管堵塞与术中出血或中耳分泌物的性质及存在情况之间无关联。术中滴注Sofradex滴耳液可有效降低鼓膜造孔管堵塞率。

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Interventions for the prevention of postoperative ear discharge after insertion of ventilation tubes (grommets) in children.预防儿童置入通气管(鼓膜切开置管)术后耳漏的干预措施。
Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD008512. doi: 10.1002/14651858.CD008512.pub2.
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Factors of the blockage of ventilation tubes in the immediate postoperative period.
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Eur Arch Otorhinolaryngol. 2007 Dec;264(12):1393-7. doi: 10.1007/s00405-007-0375-0. Epub 2007 Jul 27.