A Randomized Double-Blind Controlled Trial of Phosphorylcholine-Coated Tympanostomy Tube Versus Standard Tympanostomy Tube in Children with Recurrent Acute and Chronic Otitis Media

作者：Hong Paul^*; Smith Neil; Johnson Liane B; Corsten Gerard

来源：Laryngoscope, 2011, 121(1): 214-219.

DOI：10.1002/lary.21156

• Phosphorylcholine-coating
• tympa-nostomy tube
• tympanostomy tube complications
• tympanostomy tube extrusion
• tube otorrhea

Objective: To compare the postoperative complication rates of phosphorylcholine-coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes.
Methods: A prospective randomized double-blind controlled trial in children with recurrent acute otitis media and chronic otitis media with effusion; 240 children were randomized to receive a phosphorylcholine-coated tube in one ear and an uncoated tube in the other. Postoperatively, patients were assessed at 2 weeks and 4, 8, 12, 18, and 24 months to ascertain the incidence of otorrhea, tube lumen blockage, and early extrusion.
Results: Out of 240 children, 5 withdrew and 16 were lost to early follow-up. The mean age was 43.8 months. There were no statistically significant differences in the incidence of postoperative otorrhea, tube blockage, and extrusion.
Conclusions: Phosphorylcholine-coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes.

• 出版日期2011-1