A randomized study of four different types of tympanostomy ventilation tubes - Full-term follow-up
A randomized study of four different types of tympanostomy ventilation tubes - Full-term follow-up
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DOI：
10.1016/j.ijporl.2018.02.012
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发表时间：
2018-04-01
影响因子：
1.5
通讯作者：
von Unge, Magnus
中科院分区：
文献类型：
--
作者：
Knutsson, Johan;Priwin, Claudia;von Unge, Magnus
目的：评价鼓室造口通气管材料（硅胶与氟塑料）和形状（短与长）对挤出时间、耳漏发生、闭塞、拔管及持续性穿孔发生的影响。方法与材料：采用4种不同类型的通气管；长阿姆斯特朗管，唐纳森管，谢泼德管和直管，代表VT材料（硅酮或氟塑料）和形状（短，双法兰或长，单法兰）的四种特定组合。400名安排双侧插管的儿童被纳入一项随机试验。患者在右耳和左耳分别植入一种导管和一种导管。术后每3个月由耳鼻喉科医师监测管挤压和并发症的发生率。结果：手术中排除22例患儿。在被研究的378名儿童中，平均年龄为35.3个月。63.8%是男孩。短管比长管更早挤出；风险比（HR） 4.84 （95% CI 3.50 ~ 6.69, p < 0.001）。长阿姆斯特朗管最不容易挤压。硅胶管导致室内室首次感染时间明显延长，HR 1.68 （95% CI 1.03-2.76, p = 0.039）。唐纳森管平均首次感染时间最长（p = 0.025）。感染对试管挤出率无显著影响（p = 0.879）。在管闭塞、管拔出或持续穿孔方面无显著差异。结论：长管较不容易早期挤压。长阿姆斯壮管的早期挤压倾向最小。硅胶管使首次感染的时间明显延长。唐纳森试管导致的感染最少。感染对挤出率没有显著影响。
Objective: To evaluate the impact of tympanostomy ventilation tube material (silicone vs fluoroplastic) and shape (short vs long) regarding time to extrusion, occurrence of otorrhea, occlusion, tube removal and occurrence of persistent perforation.Methods and material: Four different types of ventilation tubes were used; Long Armstrong tubes, Donaldson tubes, Shepard tubes and straight tubes, representing four specific combinations of VT material (silicone or fluoroplastic) and shape (short, double flanged or long, single flanged). Four hundred children scheduled for bilateral tube insertion were included in a randomized trial. The patients received one type of tube in the right ear and another type in the left ear. The incidence of tube extrusion and complications were monitored post-operatively every third month by an otolaryngologist.Results: Twenty-two children were excluded during surgery. Out of the studied 378 children the mean age was 35.3 months. 63.8% were boys. Short tubes extruded earlier than long tubes; hazard ratio (HR) 4.84 (95% CI 3.50-6.69, p < 0.001). Long Armstrong tubes were least prone to extrude. Silicone tubes resulted in significantly longer time to first infection in a VT ear, HR 1.68 (95% CI 1.03-2.76, p = 0.039). Donaldson tubes rendered the longest mean time to first infection (p = 0.025). Infections did not affect tube extrusion rates significantly (p = 0.879). No significant differences were found regarding tube occlusion, tube extraction or persistent perforation.Conclusions: Long tubes are less prone to extrude early. Long Armstrong tubes have the least propensity to extrude early. Silicone tubes render significantly longer time to first infection. Donaldson tubes result in least infections. Infection does not affect extrusion rates significantly.