Departments of Pediatrics, University of Turku, Finland.
Departments of Pediatrics and Adolescent Medicine, Turku University Hospital, Finland.
J Pediatric Infect Dis Soc. 2018 Feb 19;7(1):64-70. doi: 10.1093/jpids/pix008.
Acute otitis media (AOM) induces middle-ear effusion (MEE), which affects hearing. The effect of antimicrobial treatment on the resolution of MEE is controversial, and the factors that affect resolution are unknown.
We studied the effect of antimicrobial treatment on the time to the resolution of MEE as a secondary objective in our randomized double-blind placebo-controlled trial. Children aged 6 to 35 months with stringently diagnosed AOM were allocated to receive amoxicillin-clavulanate (161 patients) or placebo (158 patients) for 7 days and closely followed for 3 months. This study was registered at ClinicalTrials.gov (identifier NCT00299455).
The median times to resolution of MEE were 20 days (95% confidence interval [CI], 16-24 days) and 29 days (95% CI, 26-32 days) in the amoxicillin-clavulanate and placebo groups, respectively (P = .10). The resolution of MEE was confirmed in 138 (86%) of 161 and 132 (84%) of 158 patients in the amoxicillin-clavulanate and placebo groups, respectively (P = .59). In multivariable analysis, the resolution of MEE was prolonged most significantly by at least 1 recurrence of AOM during follow-up. MEE resolved in 65 (65%) of 100 patients with a recurrence of AOM during follow-up and in 205 (94%) of 219 of those without a recurrence (P < .001) (median times to resolution, 67 vs 15 days, respectively; P < .001).
Immediate antimicrobial treatment of AOM does not significantly affect the resolution of MEE in young children. Subsequent recurrences of AOM are a major reason for the persistence of MEE.
急性中耳炎（AOM）可导致中耳积液（MEE），从而影响听力。抗菌治疗对 MEE 消退的影响存在争议，且影响 MEE 消退的因素尚不清楚。
我们在一项随机、双盲、安慰剂对照试验中，将抗菌治疗对 MEE 消退时间的影响作为次要目标进行了研究。严格诊断为 AOM 的 6 至 35 月龄儿童被分配接受阿莫西林克拉维酸（161 例）或安慰剂（158 例）治疗 7 天，并密切随访 3 个月。本研究在 ClinicalTrials.gov 注册（标识符 NCT00299455）。
阿莫西林克拉维酸组和安慰剂组的 MEE 中位消退时间分别为 20 天（95%置信区间[CI]，16-24 天）和 29 天（95%CI，26-32 天）（P=.10）。阿莫西林克拉维酸组和安慰剂组分别有 138（86%）例和 132（84%）例患者的 MEE 得到确认（P=.59）。多变量分析显示，随访期间至少有 1 次 AOM 复发时 MEE 的消退时间最长。在随访期间发生 AOM 复发的 100 例患者中，65（65%）例 MEE 消退，未发生 AOM 复发的 219 例患者中，205（94%）例 MEE 消退（P<.001）（中位消退时间分别为 67 天和 15 天，P<.001）。
急性中耳炎患儿立即接受抗菌治疗并不会显著影响 MEE 的消退。随后的 AOM 复发是 MEE 持续存在的主要原因。
