Noel Gary J, Blumer Jeffrey L, Pichichero Michael E, Hedrick James A, Schwartz Richard H, Balis Dainius A, Melkote Rama, Bagchi Partha, Arguedas Adriano
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ 08869, USA.
Pediatr Infect Dis J. 2008 Jun;27(6):483-9. doi: 10.1097/INF.0b013e318168d2cb.
The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections.
In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM.
A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent.
Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.
对于儿童复发性和持续性急性中耳炎（AOM），需要替代抗菌治疗方法，这引发了人们对评估氟喹诺酮类药物治疗这些感染的疗效和安全性的兴趣。
在一项评估者盲法、活性对照、非劣效性、多中心研究中，将6个月至未满5岁的儿童按1:1随机分组，分别接受左氧氟沙星（10mg/kg，每日两次）或阿莫西林/克拉维酸（14:1；阿莫西林45mg/kg，每日两次）治疗10天，并在治疗4 - 6天（访视2）、完成治疗后2 - 5天（访视3）以及最后一剂后10 - 17天（访视4）进行评估。主要结局是基于AOM临床体征和症状的缓解情况在访视3时达到临床治愈。
共有1650名儿童被随机分组，1305名儿童在访视3时可进行临床评估（630名接受左氧氟沙星治疗，675名接受对照治疗）。接受左氧氟沙星治疗的儿童临床治愈率为72.4%（630名中的456名），接受阿莫西林/克拉维酸治疗的儿童临床治愈率为69.9%（675名中的472名）。每个年龄组（≤24个月：68.9%对66.2%；>24个月：76.9%对75.1%）左氧氟沙星组和对照组的治愈率也相似。左氧氟沙星组和阿莫西林/克拉维酸组在访视4时的治愈率分别为74.9%和73.8%。置信区间的上限低于10%的非劣效性界值，表明左氧氟沙星治疗总体上以及在婴儿（6个月至2岁）和2 - 5岁儿童中均不劣于对照治疗。治疗组之间在不良事件的频率或类型方面没有明显差异。
在治疗婴幼儿和儿童复发性和/或持续性AOM方面，左氧氟沙星不劣于阿莫西林/克拉维酸。
