鼓膜切开术置管或药物治疗复发性急性中耳炎。
Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.
机构信息
From the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
出版信息
N Engl J Med. 2021 May 13;384(19):1789-1799. doi: 10.1056/NEJMoa2027278.
BACKGROUND
Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.
METHODS
We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.
RESULTS
In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial.
CONCLUSIONS
Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).
背景
对于反复发作急性中耳炎的儿童，鼓膜置管的适应证存在官方推荐意见的差异。
方法
我们将 6 至 35 月龄、6 个月内至少发作 3 次急性中耳炎、或 12 个月内至少发作 4 次且此前 6 个月内至少发作 1 次的儿童随机分为鼓膜置管组或接受包括间歇性抗菌药物治疗的药物治疗组。主要结局是 2 年内每名儿童的急性中耳炎发作次数的平均值（发生率）。
结果
在主要的意向治疗分析中，2 年内每名儿童的急性中耳炎发作次数的发生率（±SE）在鼓膜置管组为 1.48±0.08，在药物治疗组为 1.56±0.08（P=0.66）。由于 10%的鼓膜置管组儿童未行鼓膜置管，且 16%的药物治疗组儿童因父母要求而行鼓膜置管，我们进行了符合方案分析，相应的发作率分别为 1.47±0.08 和 1.72±0.11。在主要分析的次要结局中，结果不一。支持鼓膜置管的因素有首次急性中耳炎发作的时间、各种与发作相关的临床发现，以及符合特定治疗失败标准的儿童比例。支持药物治疗的因素有儿童耳溢液的累积天数。无明显差异的结局包括急性中耳炎发作的频数分布、认为严重的发作比例以及呼吸道分离株的抗生素耐药性。试验相关不良事件仅限于试验的次要结局中包括的那些。
结论
在 6 至 35 月龄、反复发作急性中耳炎的儿童中，与药物治疗相比，鼓膜置管并不能显著降低 2 年内急性中耳炎的发作率。（由美国国立耳聋和其他交流障碍研究所等资助；ClinicalTrials.gov 注册号：NCT02567825。）
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