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1、1,SOURCE INFORMATION,N Engl J Med, 2011, 364:105-115(had been cited by 16 articles) From the Department of Pediatrics, University of Pittsburgh School of Medicine, USA. Correspondence author: Dr. Hoberman E-mail:hobermanchp.edu.,2,美国科学信息所（ISI）公布,3,Introduction of The New England Journal of Medicine
2、(NEJM),1812年创刊，由美国麻州医学协会所出版的同行评审性质之综合性医学期刊。 全科医学周刊，每年52期 出版风格：重要的研究成果、临床发现以及观点。注重文章的实用性，多为指导临床实践。 严格的审稿程序，稿件的处理流程通常需1012周。来稿的刊用率约为7%。,4,BACKGROUND,Acute otitis media(AOM) is the most frequently diagnosed illness in children in the US. Most children have routinely been treated with antimicrobial drug
3、s in the US.,1.Tahtinen PA, et al. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med 2011;364:116-126 2.Klein JO. Is acute otitis media a treatable disease? N Engl J Med 2011;364:168-169,5,A watchful-waiting strategy has long been applied in several countries
4、 to minimize the use of antimicrobial drugs. -Netherlands and Scotland4,5 -USA,2004,6,7 -Canada 8,4.Appelman CL, et al. Otitis media acuta: NHG-standaard (eerste herziening). Huisarts Wet 1999;42:362-366 5.Scottish Intercollegiate Guidelines Network. Diagnosis and management of childhood otitis medi
5、a in primary care. Guideline no. 66. Edinburgh: Royal College of Physicians in Edinburgh, 2003. 8.Forgie S, Zhanel G, Robinson J. Management of acute otitis media. Paediatr Child Health (Oxford) 2009;14:457-464,6,AOM in children aged 6 to 23 months is “nonsevere” 6(mild otalgia and T 39 during the p
6、receding 24 hours) Diagnosis of AOM is uncertain.7,Indications of Watchful Waiting,6.Kaleida PH, et al. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics 1991;87:466-474 7.American Academy of Pediatrics Subcommittee on Management of Acute O
7、titis Media. Diagnosis and management of acute otitis media. Pediatrics 2004;113:1451-1465,7,The watchful waiting strategy has been based on the results of clinical trials3 that showed relatively high rates of spontaneous improvement in children with acute otitis media.,Fundament,3.Rosenfeld RM, et
8、al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr 1994;124:355-367,8,Limitations of earlier trials : -The lack of stringent diagnostic criteria; -The inclusion of few very young children; -Antimicrobial d
9、rug had limited efficacy or was administered in suboptimal doses.9,9.Paradise JL. Short-course antimicrobial treatment for acute otitis media: not best for infants and young children. JAMA 1997;278:1640-1642,To choose amoxicillinclavulanate(the most effective treatment for AOM) 7,10 in this study.,1
10、0.Hoberman A, et al. Large dosage amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children. Pediatr Infect Dis J 2005;24:525-532,9,Rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo ha
11、ve not been found uniformly.6 Therefore, for children with AOM, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear.,10,OBJECTIVES,To evaluate the extent to which antimicrobial treatment(Amoxicillin-clavulanate) and placebo treatment affect th
12、e course of both symptoms and signs of AOM in children aged 6 to 23 months .,11,METHODS,Eligibility and Enrollment Randomization Assessment of Symptoms Otoscopic Examination, Overall Assessment, and Management Outcomes Statistical Analysis,12,1.Eligibility and Enrollment,From November 2006 to March
13、2009 at the Childrens Hospital of Pittsburgh and Armstrong Pediatrics, Pennsylvania. The study protocol was approved by the institutional review board at the University of Pittsburgh; written informed consent was obtained from a parent of each enrolled child. The protocol is available with the full
14、text of this article at NEJM.org.,13,Inclusion Criteria,Eligible children (1) will be aged 6 to 23 months, (2) have received pneumococcal conjugate vaccine, and (3) have evidence of AOM defined as: Recent (within 48 hours), onset of signs and symptoms and a score of 3 on the AOM-SOS scale. Presence
15、of middle-ear effusion Moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.,14,AOM-SOS,The Acute Otitis Media Severity of Symptoms (AOM-SOS) scale11,12 The AOM-SOS scale consists of seven items: tugging of ears, cryin
16、g, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. As “none,” “a little,” or “a lot,” with corresponding scores of 0, 1, and 2 scores range from 0 to 14, with higher scores indicating greater severity of symptoms,11.Shaikh N, et al. Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis media. Pediatr Infect Dis J 2009;28:5-8 12.Shaikh N, et al. Responsiveness and construct validity of a symptom scale for acute otitis media. Pediatr Infect Dis J 2009;28:9-12,
