Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, USA.
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Clin Infect Dis. 2017 Apr 15;64(8):1052-1058. doi: 10.1093/cid/cix032.
This study investigated whether quinolone ear drops, with or without corticosteroids, increase the risk of perforation requiring tympanoplasty following tympanostomy tube (TT) placement in children.
This was a retrospective cohort study using Medicaid encounter and pharmacy billing data from 29 US states between 1999 and 2006. Children <18 years old without predisposing factors for perforation during a 6-month look-back period entered the cohort after TT placement and first dispensing of antibiotic ear drops. Included ear drops were quinolones (ofloxacin, ciprofloxacin plus hydrocortisone, or ciprofloxacin plus dexamethasone) or neomycin plus hydrocortisone. Children were followed until end of 2006, end of Medicaid enrollment, or occurrence of study outcome. A Cox regression model, adjusted for age, sex, race/ethnicity, initial TT indication, reinsertion of TT, adenoidectomy, and number of ear drop prescriptions was used to compare the rate of perforation between quinolone and neomycin plus hydrocortisone ear drop-exposed children. Perforation was defined by its diagnosis code followed by a tympanoplasty code.
A total of 96595 children entered the study cohort. Patients exposed to quinolone ear drops had a higher risk of perforation, with an adjusted hazard ratio of 1.61 (95% confidence interval [CI], 1.15-2.26). The adjusted hazard ratios were 1.49 (95% CI, 1.05-2.09) for ofloxacin, 1.94 (95% CI, 1.32-2.85) for ciprofloxacin plus hydrocortisone, and 2.00 (95% CI, 1.18-3.41) for ciprofloxacin plus dexamethasone.
Exposure of children with TT to quinolone ear drops is associated with increased risk of perforations requiring tympanoplasty, which appears to be further exaggerated by corticosteroids. Clinicians should consider the risk of perforation and counsel patients/families accordingly when prescribing quinolone ear drops.
本研究旨在探讨在儿童行鼓膜切开置管术（TT）后，使用含有或不含有皮质类固醇的喹诺酮类滴耳液是否会增加需要行鼓膜成形术的穿孔风险。
这是一项回顾性队列研究，使用了 1999 年至 2006 年间 29 个美国州的医疗补助（Medicaid）就诊记录和药房计费数据。在 TT 放置和首次给予抗生素滴耳液后，无穿孔易感因素的 18 岁以下儿童进入队列。包括的滴耳液为喹诺酮类（氧氟沙星、环丙沙星加氢化可的松或环丙沙星加地塞米松）或新霉素加氢化可的松。儿童随访至 2006 年底、医疗补助结束或发生研究结局。使用 Cox 回归模型，根据年龄、性别、种族/民族、初始 TT 适应证、TT 再插入、腺样体切除术和滴耳液处方数量，比较接受喹诺酮类和新霉素加氢化可的松滴耳液暴露的儿童之间穿孔的发生率。穿孔的定义是其诊断代码后紧接着是鼓膜成形术代码。
共有 96595 名儿童进入研究队列。接受喹诺酮类滴耳液暴露的患者穿孔风险较高，调整后的危险比为 1.61（95%置信区间[CI]，1.15-2.26）。调整后的危险比分别为氧氟沙星 1.49（95%CI，1.05-2.09）、环丙沙星加氢化可的松 1.94（95%CI，1.32-2.85）和环丙沙星加地塞米松 2.00（95%CI，1.18-3.41）。
TT 置管患儿接触喹诺酮类滴耳液与需要行鼓膜成形术的穿孔风险增加相关，皮质类固醇似乎进一步加重了这种风险。临床医生在开具喹诺酮类滴耳液时应考虑穿孔风险，并相应地向患者/家属提供咨询。
