A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media
A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media
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DOI：
10.1067/s0022-3476(03)00293-2
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发表时间：
2003-09-01
影响因子：
5.1
通讯作者：
McCormick, DP
中科院分区：
文献类型：
--
作者：
Chonmaitree, T;Saeed, K;McCormick, DP
目的 确定辅助药物抗组胺药和皮质类固醇是否可以改善急性中耳炎 (AOM) 的近期和长期结局。 研究设计 患有 AOM 的儿童（3 个月至 6 岁）被纳入一项随机、双盲、安慰剂对照试验。所有 179 名儿童均接受一剂肌肉注射头孢曲松，并被分配接受马来酸扑尔敏（0.35 毫克/公斤/天）和/或泼尼松龙（2 毫克/公斤/天）或安慰剂，为期 5 天。主要结局指标是前 2 周的治疗失败率、中车积液的持续时间以及 6 个月内 AOM 的复发率。结果 临床结局和复发率在治疗过程中没有显着差异。单独接受抗组胺药治疗的儿童的中耳积液持续时间（中位时间为 73 天）明显长于其他治疗组的受试者（中位时间为 23 至 36 天，P = .04）。在皮质类固醇治疗组中，第 5 天鼓室导抗测试结果暂时正常化的情况更为常见 (P = .04)。结论 除抗生素外，使用抗组胺药或皮质类固醇进行为期五天的治疗并没有改善 AOM 结局。应避免在 OM 急性发作期间使用抗组胺药，因为该药物可能会延长中车积液的持续时间。除抗生素外，使用皮质类固醇治疗 AOM 7 至 10 天的疗效值得进一步研究。
Objectives To determine whether the adjunctive drugs antihistamine and corticosteroid improve immediate and long-term outcomes of acute otitis media (AOM).Study design Children with AOM (3 mos-6 y) were enrolled in a randomized, double-blind, placebo-controlled trial. All 179 children received one dose of intramuscular ceftriaxone and were assigned to receive either chlorpheniramine maleate (0.35 nig/kg/d) and/or prednisolone (2 mg/kg/day) or placebo for 5 days. Main outcome measures were rate of treatment failure during the first 2 weeks, duration of middle car effusion, and rate of recurrences of AOM to 6 months.Results Clinical outcomes and recurrence rates did not differ significantly with treatment. Children who received antihistamine alone had significantly longer duration of middle ear effusion (median, 73 days) than subjects in other treatment groups (median, 23 to 36 days, P = .04). Temporary normalization of tympanometric findings on day 5 occurred more frequently in the corticosteroid-treated group (P = .04).Conclusions Five-day treatment with antihistamine or corticosteroid, in addition to antibiotic, did not improve AOM outcomes. Antihistamine use during an acute episode of OM should be avoided, since the drug may prolong the duration of middle car effusion. The efficacy, of 7- to 10-day treatment of AOM with corticosteroid, in addition to antibiotic, deserves further investigation.