Montoro Victoria, Asensio Carlos, Martínez Ángel, Lorente Juan, Rodríguez Francisco J, Montojo José, Gavilanes Javier, Sarría Pedro, Langdon Cristóbal, Prades Eduard
1 Otolaryngology Department, Hospital de Mollet, Mollet del Vallès, Spain.
2 Otolaryngology Department, Hospital Nuestra señora del Prado, Talavera de la Reina, Spain.
J Int Med Res. 2018 Oct;46(10):4050-4060. doi: 10.1177/0300060518765333. Epub 2018 Aug 24.
Objectives To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1-7) with an 8-day follow-up (days 9-15). Outcome measures included change in itching from baseline (day 1) to study days 4-8 and 9-15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with placebo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4-8 and 9-15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.
目的 评估0.025%醋酸氟轻松耳用溶液与安慰剂治疗耳部湿疹患者的疗效和安全性。方法 在2012年3月至2013年3月期间于12个西班牙中心进行的这项多中心、随机、双盲、平行组3期临床试验中，患者每天两次接受0.025%醋酸氟轻松耳用溶液或安慰剂，持续7天（第1 - 7天），并进行8天的随访（第9 - 15天）。观察指标包括从基线（第1天）到研究第4 - 8天和第9 - 15天瘙痒的变化，以及从基线到治疗结束（第8天）和随访结束（第15天）耳镜检查体征（红斑、水肿和脱屑）的变化。结果 与接受安慰剂治疗的患者（n = 69）相比，接受0.025%醋酸氟轻松治疗的患者（n = 66）从基线到研究第4 - 8天和第9 - 15天瘙痒明显减轻，从基线到治疗结束（第8天）和随访结束（第15天）的个体和总体耳镜检查体征也明显减轻。氟轻松组和安慰剂组不良事件的发生率和严重程度相似。结论 每天两次给予0.025%醋酸氟轻松耳用溶液，持续7天，是治疗耳部湿疹的一种有效且安全的疗法。
