Cantekin E I, McGuire T W, Griffith T L
Department of Otolaryngology, University of Pittsburgh, PA.
JAMA. 1991 Dec 18;266(23):3309-17.
To determine the effectiveness of antimicrobial treatment for otitis media with effusion ("secretory" otitis media) in children.
We report the reexamination of a previously published study by Mandel et al that evaluated the efficacy of a 2-week course of antimicrobials (amoxicillin trihydrate) with and without a 4-week course of an oral decongestant-antihistamine combination in a double-blind, placebo-controlled, randomized trial involving 518 infants and children with otitis media with effusion.
At 4 weeks, amoxicillin efficacy as determined by a tympanometric criterion (P = .121) or by a measure of improvement in hearing (P = .311) was insignificant. Only by otoscopic judgment, which is shown to contain a systematic bias as used in this clinical trial, could an argument be made for a marginal efficacy of amoxicillin at the 4-week end point. Logistic regression analyses of the combined effects of treatment and prognostic factors showed no significant differences between placebo- and antibiotic-treated groups for unilateral effusions and for bilateral effusions. When subjects with unilateral and bilateral effusions were combined, the estimated efficacy of antibiotic treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry (P = .171). We also demonstrate the sensitivity of outcome to diagnostic measures used and provide statistical evidence questioning the validity of otoscopic observations in this study. Six weeks after the termination of amoxicillin therapy, the recurrence of effusion was two to six times higher in the amoxicillin-treated children than in those treated with placebo (P = .001), and resolution of effusion was not significantly different among antibiotic and placebo groups (13.6% and 11.3%, respectively; P = .477).
Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children.
确定抗菌治疗对儿童分泌性中耳炎（“分泌性”中耳炎）的有效性。
我们报告了对曼德尔等人先前发表的一项研究的重新审视，该研究在一项双盲、安慰剂对照、随机试验中，评估了为期2周的抗菌药物（三水合阿莫西林）疗程联合或不联合为期4周的口服减充血剂 - 抗组胺药组合对518例分泌性中耳炎婴幼儿及儿童的疗效。
在4周时，通过鼓室图标准（P = 0.121）或听力改善测量（P = 0.311）确定的阿莫西林疗效不显著。仅通过耳镜检查判断（在本临床试验中显示存在系统偏差），才能认为阿莫西林在4周终点时有微弱疗效。对治疗和预后因素的综合影响进行的逻辑回归分析显示，安慰剂组和抗生素治疗组在单侧积液和双侧积液方面无显著差异。当单侧和双侧积液的受试者合并时, 通过耳镜检查估计抗生素治疗的有效率为12.3%（P = 0.014），通过鼓室图检查为4.8%（P = 0.171）。我们还证明了结果对所用诊断措施的敏感性，并提供了统计学证据质疑本研究中耳镜观察结果的有效性。阿莫西林治疗终止6周后，接受阿莫西林治疗的儿童积液复发率比接受安慰剂治疗的儿童高2至6倍（P = 0.001），抗生素组和安慰剂组的积液消退情况无显著差异（分别为13.6%和11.3%；P = 0.477）。
无论是否联合减充血剂 - 抗组胺药，阿莫西林对治疗婴幼儿及儿童持续性无症状中耳积液均无效。
