Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, Gainesville.
Department of Epidemiology, College of Public Health and Health Professions, University of Florida, Gainesville.
Clin Infect Dis. 2020 Mar 3;70(6):1103-1109. doi: 10.1093/cid/ciz345.
This study examined whether the use of quinolone ear drops increased the risk of perforation with intact tympanic membranes and acute otitis externa (AOE).
This was a retrospective cohort study using Medicaid clinical encounter and pharmacy billing records from 1999 through 2010. Children and adults had to have 24 months continuous enrollment in Medicaid prior to the first antibiotic ear drop dispensing (index date), and they had to maintain their enrollment for at least 18 months thereafter. Included ear drops were ofloxacin, ciprofloxacin plus hydrocortisone, ciprofloxacin plus dexamethasone, and neomycin plus hydrocortisone. Tympanic membrane perforation (TMP) was identified as 2 inpatient or outpatient encounters associated with TMP diagnosis at least 30 days apart. A Cox regression model adjusting for patient demographics, calendar year, and the number of ear drop prescriptions was used to compare TMP risk between quinolone and neomycin-exposed patients.
A total of 94 333 patients entered the study cohort. Use of quinolone ear drops was associated with increased risk for TMP compared with neomycin plus hydrocortisone, with an adjusted hazard ratio of 2.26 (95% confidence interval [CI], 1.34-3.83). Adjusted hazard ratios were 2.53 (95% CI, 1.27-5.05) for ofloxacin, 2.24 (95% CI, 1.03-4.85) for ciprofloxacin plus hydrocortisone, and 2.30 (95% CI, 1.09-4.87) for ciprofloxacin plus dexamethasone. Sensitivity analyses were consistent with the primary analysis.
Use of quinolone ear drops to treat AOE is associated with a previously unreported increased risk of developing TMPs. Selection of otic preparations to treat self-limited conditions with intact tympanic membranes should consider TMP risk.
本研究旨在探讨使用喹诺酮类滴耳液是否会增加鼓膜完整的急性外耳炎（AOE）穿孔的风险。
这是一项使用 1999 年至 2010 年医疗补助临床就诊和药房计费记录的回顾性队列研究。儿童和成人必须在首次使用抗生素滴耳液之前连续 24 个月参加医疗补助计划（索引日期），并且此后必须至少保持 18 个月的入组。包括的滴耳液有氧氟沙星、环丙沙星加氢化可的松、环丙沙星加地塞米松和新霉素加氢化可的松。鼓膜穿孔（TMP）是指相隔至少 30 天的 2 次门诊或住院与 TMP 诊断相关的就诊。使用 Cox 回归模型调整患者人口统计学特征、日历年份和滴耳液处方数量，比较喹诺酮类和新霉素加氢化可的松暴露患者的 TMP 风险。
共有 94333 名患者进入研究队列。与新霉素加氢化可的松相比，使用喹诺酮类滴耳液与 TMP 风险增加相关，调整后的风险比为 2.26（95%置信区间[CI]，1.34-3.83）。调整后的风险比分别为 2.53（95%CI，1.27-5.05）、2.24（95%CI，1.03-4.85）和 2.30（95%CI，1.09-4.87）。敏感性分析与主要分析一致。
使用喹诺酮类滴耳液治疗 AOE 与以前未报告的 TMP 发生率增加有关。在治疗鼓膜完整的自限性疾病时，选择滴耳剂应考虑 TMP 风险。
