本文要点 Alejandro Hoberman等人对291个6到23个月患急性中耳炎的宝宝进行了10天的临床对照试验，发现使用阿莫西林克拉维酸片的宝宝比使用安慰剂的宝宝更快地康复、更好地缓解、更少地遗留感染体征。所以宝宝确诊急性中耳炎时该用抗生素是还是得用，10天的阿莫西林克拉维酸片是个值得考虑的选择。
急性中耳炎是美国儿童最常见的疾病，也是常规使用抗生素的指征。但在荷兰等欧洲国家，提倡的是等待观察，以减少抗生素对小儿的使用。2004年，美国儿科协会和美国家庭医师协会颁布了一个指南，即6到23周的急性中耳炎小儿患者，症状不严重和不确诊者，可选择暂不使用抗生素，等待观察。加拿大儿童传染病和免疫协会也给出了类似的推荐。他们之所以这样做是因为之前有临床试验显示儿童急性中耳炎的患者自发缓解率较高，故抗生素的作用不被强调。但作者认为这些研究没有严格地选择急性中耳炎患者，年龄较小的患儿数量不足，没有使用足够效力的抗生素，并且关于患儿自发缓解率的数据不一致，故不具说服力。所以本次试验的样本个体是经严格标准确诊为急性中耳炎的患儿，年龄为6-23个月，使用对急性中耳炎最为有效的抗生素阿莫西林克拉维酸片进行试验组的治疗。试验中，患儿的随机分组考虑到了是否初次发病，之前是否有传染源接触等问题，随访时每天与家长电话访问，并分别在治疗开始时、治疗进行中、治疗结束后和后续随访时定期对患儿进行耳镜等检查，使用ACM-SOS（急性中耳炎危重程度）评分系统对患儿的状况进行评估，结果发现试验组和安慰剂组的患儿症状缓解率具有差异，如下表。
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| 初始缓解率（P=0.14） | 第2天 | 第4天 | 第7天 |
| 试验组 | 35% | 61% | 80% |
| 安慰剂组 | 28% | 54% | 74% |
表1
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| 持续缓解率(P=0.04) | 第2天 | 第4天 | 第7天 |
| 试验组 | 20% | 41% | 67% |
| 安慰剂组 | 14% | 36% | 53% |
表2
由上可见，及时的抗生素治疗不但可以尽早缓解患儿的症状，还可以防止再次感染的发生。同时，治疗结束时试验组的患儿平均症状危重程度评分低于安慰剂组，耳镜检查所示遗留的急性感染体征也低于安慰剂组，且均具有统计学差异，证明了抗生素治疗的有效性。另外，在安慰剂组中有一例患儿发生了乳突炎，试验组中患儿普遍患腹泻和尿布区皮炎，而两组中鼻咽部非感染性肺炎链球菌的定植率无显著差异。综上，作者认为6至23个月的患儿急性中耳炎时10天阿莫西林克拉维酸片的治疗能带来短期的收益，但此收益也需要权衡抗生素的副作用和细菌的耐药性问题，这些考虑强调了需要限制滥用抗生素和过度医疗。
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来源 Alejandro Hoberman, M.D., Jack L. Paradise, M.D., Howard E. Rockette, Ph.D.N , Treatment of Acute Otitis Media in Children under 2 Years of Age, Engl J Med 2011; 364:105-115, Jan 13 2011</p>