Leach Amanda, Wood Yvonne, Gadil Edna, Stubbs Elizabeth, Morris Peter
Menzies School of Health Research, Darwin, Australia.
Pediatr Infect Dis J. 2008 Aug;27(8):692-8. doi: 10.1097/INF.0b013e31816fca9d.
Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear.
Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding.
Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare.
This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.
慢性化脓性中耳炎（CSOM）影响着许多弱势群体中的儿童。对于持续性疾病患儿，最合适的局部抗生素治疗尚不明确。
尽管接受了标准局部治疗，但仍患有CSOM的儿童被随机分为两组，分别接受为期6 - 8周的局部环丙沙星（CIP）治疗或局部新霉素 - 短杆菌肽 - 地塞米松（FGD）治疗。使用标准化评估和盲法测量耳镜检查、听力检查和微生物学结果。
97名儿童被随机分组。无论分配情况如何，70%的儿童在治疗结束时耳漏仍未解决[风险差异 = -2%；（95%置信区间：-20至16）]。CIP组50名儿童中有1名鼓膜愈合，FGD组47名儿童中无一例鼓膜愈合。每组超过50%的儿童耳漏严重程度未改善，CIP组和FGD组的平均听力阈值（38 dB和35 dB）以及听力损失大于25 dB的儿童比例（98%和88%）无显著差异。副作用罕见。
本研究表明，对于持续性CSOM患儿，CIP和FGD局部治疗的改善或治愈率同样较低。并发症和副作用不足以导致停止治疗或为任何一种治疗的处方提供依据。
