Gabarain Gabriel, Baird Rachel, Morisada Megan, Anne Samantha, Hopkins Brandon
1 Cleveland Clinic Otolaryngology, Cleveland, OH, USA.
2 Cleveland Clinic, Lerner College of Medicine, Cleveland, OH, USA.
Ann Otol Rhinol Laryngol. 2019 Aug;128(8):760-766. doi: 10.1177/0003489419843550. Epub 2019 Apr 16.
The objectives of this study are to evaluate incidence, duration, and quality of life (QOL) impact of early tympanostomy tube otorrhea and tube patency when comparing topical ciprofloxacin versus normal saline use in the perioperative period.
Overall, 200 patients undergoing tube placement between November 19, 2015, and September 12, 2016, were randomized to intraoperative plus 5 days of either topical ciprofloxacin or normal saline. Parents or caregivers reported the incidence, duration, and QOL impact of early otorrhea via 4 weekly surveys. In addition, the patient's otorrhea history and tube patency were evaluated at a 4- to 6-week postoperative visit.
Survey and in-office follow-ups were completed on 128 patients. The overall otorrhea incidence was 23.9% for normal saline and 16.7% for ciprofloxacin ( = .32). The week-by-week otorrhea incidence was not statistically different. The percentage of days otorrhea was present, likewise, was not statistically different (normal saline 4.5%, ciprofloxacin 2.8%; = .74). The QOL impact was not statistically different (normal saline 1.2, ciprofloxacin 1.5; = .71). Tube patency was not statistically different, with only 1 of 280 ears occluded at follow-up.
We find no difference in the incidence, duration, and QOL impact of early tympanostomy tube otorrhea or tube patency between ciprofloxacin and normal saline. This supports the option to substitute normal saline for ciprofloxacin in ears without an active ear infection at the time of tube placement, which would reduce both cost and unnecessary antibiotic use.
1b.
本研究的目的是比较围手术期局部使用环丙沙星与生理盐水时，评估早期鼓膜置管耳漏的发生率、持续时间及对生活质量（QOL）的影响，以及置管通畅情况。
总体而言，2015年11月19日至2016年9月12日期间接受置管的200例患者被随机分为术中加术后5天局部使用环丙沙星组或生理盐水组。父母或照料者通过每周4次的调查汇报早期耳漏的发生率、持续时间及对生活质量的影响。此外，在术后4至6周的随访中评估患者的耳漏病史及置管通畅情况。
128例患者完成了调查及门诊随访。生理盐水组的总体耳漏发生率为23.9%，环丙沙星组为16.7%（P = 0.32）。每周的耳漏发生率无统计学差异。耳漏出现的天数百分比同样无统计学差异（生理盐水组4.5%，环丙沙星组2.8%；P = 0.74）。对生活质量的影响无统计学差异（生理盐水组1.2，环丙沙星组1.5；P = 0.71）。置管通畅情况无统计学差异，随访时280只耳朵中仅有1只堵塞。
我们发现环丙沙星与生理盐水在早期鼓膜置管耳漏的发生率、持续时间及对生活质量的影响或置管通畅情况方面无差异。这支持了在置管时耳部无活动性感染的情况下用生理盐水替代环丙沙星的选择，这将降低成本并减少不必要的抗生素使用。
1b。
