局部环丙沙星治疗非穿孔性急性中耳炎：一项随机对照试验

文献信息

中文摘要

目的： 急性中耳炎是一种常见的儿童感染，也是口服抗生素处方的主要原因之一。局部抗生素在穿孔性急性中耳炎或鼓膜置管后耳漏中有效，但在鼓膜完整者中缺乏证据。本研究评估在非穿孔性儿童中耳炎中，口服抗生素基础上加用局部环丙沙星滴耳液的辅助治疗作用。
方法： 这项前瞻性开放标签随机对照试验于2024年2月至2025年12月在一家儿科门诊转诊诊所进行。90名（0-15岁）鼓膜完整的急性中耳炎患儿被随机分组（每组45例）。联合治疗为局部环丙沙星滴耳液加口服阿莫西林-克拉维酸。主要结局包括疼痛完全缓解时间、发热缓解时间及每日疼痛轨迹（面部疼痛量表修订版）。时间-事件结局按意向性治疗原则采用Kaplan-Meier法分析。
结果： 联合治疗加快了疼痛和发热的缓解。联合治疗组持续疼痛缓解的中位时间为3天，而单纯口服治疗组为5天（RMST10：3.29 vs. 5.42天；log-rank p < 0.001）。持续发热缓解的中位时间分别为4天和6天（RMST10：4.76 vs. 5.73天；log-rank p = 0.033）。
结论： 在非穿孔性急性中耳炎患儿中，口服抗生素联合辅助局部环丙沙星与更快的疼痛和发热缓解相关，且未增加不良事件，支持其潜在的补充作用。这些发现具有假说生成性质，在改变临床实践之前需要在更大的人群中加以证实。
证据等级： 2。

英文摘要

OBJECTIVE: Acute otitis media is a common pediatric infection and a leading cause of oral antibiotic prescriptions. Topical antibiotics are effective in perforated acute otitis media or tympanostomy tube otorrhea but lack evidence in intact tympanic membrane. This study evaluates adjunctive topical ciprofloxacin ear drops use when added to oral antibiotics in non-perforated pediatric otitis media.
METHODS: This prospective open-labeled randomized controlled trial was conducted between February 2024 and December 2025 at an outpatient pediatric referral clinic. Ninety children (0-15 years) with acute otitis media and intact tympanic membranes were randomized (45 per group). Combined therapy consisted of topical ciprofloxacin ear drops plus oral amoxicillin-clavulanic acid. Primary outcomes included time to complete pain resolution, time to fever resolution, and daily pain trajectory (Faces Pain Scale-Revised). Time-to-event outcomes were analyzed according to the intention-to-treat principle using Kaplan-Meier methods.
RESULTS: Combination therapy accelerated pain and fever resolution. Median time to sustained pain resolution was 3 days with combined therapy versus 5 days with oral therapy alone (RMST10: 3.29 vs. 5.42 days; log-rank p < 0.001). Median time to sustained fever resolution was 4 versus 6 days, respectively (RMST10: 4.76 vs. 5.73 days; log-rank p = 0.033).
CONCLUSION: Adjunctive topical ciprofloxacin combined with oral antibiotics was associated with faster pain and fever resolution in children with non-perforated acute otitis media, without increasing adverse events, supporting a potential complementary role. These findings are hypothesis-generating and require confirmation in larger populations before informing changes in clinical practice.
LEVEL OF EVIDENCE: 2.