Dagan R, Johnson C E, McLinn S, Abughali N, Feris J, Leibovitz E, Burch D J, Jacobs M R
Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Pediatr Infect Dis J. 2000 Feb;19(2):95-104. doi: 10.1097/00006454-200002000-00002.
To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis.
In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28.
Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up.
Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.
比较阿莫西林/克拉维酸与阿奇霉素治疗急性中耳炎（AOM）患者的细菌学疗效和临床疗效，尤其是通过强制性第二次鼓膜穿刺术评估从中耳液中根除主要AOM病原体的能力。
在这项单盲研究中，238例AOM婴幼儿和儿童被随机分为两组，分别接受阿莫西林/克拉维酸（45/6.4mg/kg/天，分两次给药，共10天）或阿奇霉素（第1天10mg/kg，然后第2至5天每天5mg/kg）治疗。在首剂给药前进行鼓膜穿刺术，并在第4、5或6天重复进行。在治疗结束后第12至14天以及随访第22至28天评估临床反应。
与阿奇霉素相比，阿莫西林/克拉维酸更有可能根除中耳液中的所有细菌病原体[83%（65例中的54例）对49%（71例中的35例），P = 0.001]和流感嗜血杆菌[87%（30例中的26例）对39%（33例中的13例），P = 0.0001]。阿莫西林/克拉维酸也更有可能根除肺炎链球菌，但差异无统计学意义[90%（20例中的18例）对68%（19例中的13例）[校正后]，P = 0.095]。在第12至14天，所有培养阳性患者[86%（70例中的60例）对70%（73例中的51例），P = 0.023]以及流感嗜血杆菌感染患者[91%（33例中的30例）对65%（34例中的22例），P = 0.010]中，接受阿莫西林/克拉维酸治疗的患者的体征和症状更有可能完全缓解或改善。除此之外，在第12至14天或随访时，两组之间的临床结局没有显著差异。
我们的研究结果表明，在AOM儿童中，阿莫西林/克拉维酸与阿奇霉素相比具有更好的细菌学疗效和临床疗效。
