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目的 对生活在北方乡村和偏远地区的原住患急性中耳炎的儿童用阿奇红霉素单剂量治疗与阿莫西林7日治疗的临床效果进行比较。设计、机构和参试者生活在16个乡村和偏远地区6个月~6岁的原住儿童做了急性中耳炎筛查。将那些诊断为急性中耳炎的儿童随机分配,接受阿奇红霉素(30 mg/kg,单剂量)或阿莫西林(50 mg/kg/d,分2次,最少用7日)。为了保持盲性,采用双模拟方法。试验期为2003-03-24—2005-07-20。主要结果测量治疗末,急性中耳炎未能治愈,鼻携带肺炎链球菌和无荚膜嗜血流感杆菌。结果 对分配治疗组的320名中306名儿童进行了跟踪。与阿莫西林[54%,失败率(83/155)]比较,阿奇红霉素单剂量并未减少(或增加)临床失败风险[50%,失败率(82/165);风险差(RD)=-4%,95%CI为(-15%,-7%);P=0.504]。与阿莫西林比较,阿奇红霉素明显降低了儿童鼻携带肺炎链球菌[27%v 63%;RD=-36%,95%CI为(-47%,-26%);P<0.001]和无荚膜流感嗜血杆菌的比例[55%v 85%;RD=-30%,95%CI为(-40%,-21%);P<0.001]。阿奇红霉素治疗组,鼻携带肺炎链球菌对青霉素部分或完全耐药较低(不明显),但此组携带阿奇红霉素耐药肺炎链球菌。两组携带β-内酰胺酶无荚膜流感嗜血杆菌发生率约5%。结论 虽然阿奇红霉素减少了鼻携带肺炎链球菌和无荚膜流感嗜血杆菌的比例,两组均属临床失败。对于每周用阿奇红霉素治疗儿童难治急性中耳炎的可能性还需做进一步评估研究。
Objectives To compare the clinical efficacy of azithromycin single-dose and amoxicillin 7-day treatment in children with native otitis media with acute otitis media living in rural northern and remote areas. Design, Institution and Participants Indigenous children aged 6 months to 6 years living in 16 villages and remote areas were screened for acute otitis media. Those children diagnosed with otitis media were randomized to receive azithromycin (30 mg / kg, single dose) or amoxicillin (50 mg / kg / d in 2 doses, minimum 7 days). In order to remain blinded, a dual simulation method is used. The test period is 2003-03-24-2005-07-20. MAIN OUTCOME MEASURES At the end of the treatment, acute otitis media was not cured, with nasal carriage of Streptococcus pneumoniae and non-capsular Haemophilus influenzae. Results Three hundred and thirty-six of the 320 children in the assigned treatment group were followed up. Compared with amoxicillin [54%, failure rate (83/155)], single-dose azithromycin did not reduce (or increase) the risk of clinical failure [50%, failure rate (82/165); poor risk RD) = -4%, 95% CI (-15%, -7%); P = 0.504]. Compared with amoxicillin, azithromycin significantly reduced children’s nasal carriage of Streptococcus pneumoniae [27% v 63%; RD = -36%, 95% CI (-47%, -26%]; P <0.001 ] And no H. influenzae [55% v 85%; RD = -30%, 95% CI (-40%, -21%); P <0.001]. Azithromycin treatment group, nasal carriage of Streptococcus pneumoniae to penicillin partially or completely resistant to low (not obvious), but this group carry azithromycin resistant Streptococcus pneumoniae. The two groups carried β-lactamase non-Hackers influenzae incidence of about 5%. Conclusions Although azithromycin reduced the proportion of nasal carriage of S. pneumoniae and non-capsulatus influenzae, both were clinically unsuccessful. The weekly evaluation of the possibility of refractory acute otitis media in children with azithromycin needs to be further evaluated.