Kaleida P H, Casselbrant M L, Rockette H E, Paradise J L, Bluestone C D, Blatter M M, Reisinger K S, Wald E R, Supance J S
Otitis Media Research Center, Children's Hospital of Pittsburgh, PA 15213-2583.
Pediatrics. 1991 Apr;87(4):466-74.
A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.
共有536名患有急性中耳炎的婴幼儿被随机分配到六种为期一年的治疗方案中，这些方案包括用阿莫西林或安慰剂治疗非严重发作，用阿莫西林、阿莫西林加鼓膜切开术，或在2岁及以上儿童中用安慰剂加鼓膜切开术治疗严重发作。通过初始治疗失败的比例（3.9%对7.7%，P = .009）以及发作后2周和6周中耳积液的比例（分别为46.9%对62.5%，P小于.001；45.9%对51.5%，P = .09）来衡量，非严重发作的患儿接受阿莫西林治疗比接受安慰剂治疗有更有利的结果。在初始发作非严重的患儿中，接受阿莫西林治疗的患儿在随后一年中平均积液时间比接受安慰剂治疗的患儿少（36.0%对44.4%，P = .004），但两组急性中耳炎的复发率相似。在2岁及以上年龄组中，严重发作导致单独接受鼓膜切开术的患儿比接受阿莫西林加或不加鼓膜切开术的患儿有更多的初始治疗失败（23.5%对3.1%对4.1%，P = .006）。在整个研究人群中，单独接受阿莫西林治疗和阿莫西林加鼓膜切开术的严重发作患儿的结果相当。得出的结论是，急性中耳炎患儿应常规用阿莫西林（或等效抗菌药物）治疗。数据不支持单独或辅助常规使用鼓膜切开术。
