Treatment of Acute Otitis Media in Children under 2 Years of Age

被引:177
作者
Hoberman, Alejandro [1 ]
Paradise, Jack L.
Rockette, Howard E. [2 ]
Shaikh, Nader
Wald, Ellen R.
Kearney, Diana H.
Colborn, D. Kathleen
Kurs-Lasky, Marcia [2 ]
Bhatnagar, Sonika
Haralam, Mary Ann
Zoffel, Lisa M.
Jenkins, Carly
Pope, Marcia A.
Balentine, Tracy L.
Barbadora, Karen A.
机构
[1] Univ Pittsburgh, Med Ctr, Childrens Hosp Pittsburgh, Dept Pediat,Div Gen Acad Pediat,Sch Med, Pittsburgh, PA 15224 USA
[2] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Biostat, Pittsburgh, PA 15224 USA
关键词
YOUNG-CHILDREN; MANAGEMENT; INFANTS; TRIALS;
D O I
10.1056/NEJMoa0912254
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. METHODS We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. RESULTS Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P = 0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P = 0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P = 0.02). The rate of clinical failure - defined as the persistence of signs of acute infection on otoscopic examination - was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination.
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收藏
页码:105 / 115
页数:11
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