Boulesteix J, Bégué P, Dubreuil C, Mégraud F, Dabernat H, Geslin P, de La Rocque F, Trinh A
Service de Pédiatrie II, Centre Hospitalier Régional et Universitaire de Limoges.
Infection. 1995;23 Suppl 2:S79-82. doi: 10.1007/BF01742989.
We conducted a large, multicenter, randomized, open-label study throughout France comparing the efficacy and safety of cefixime suspension (8 mg/kg/day, b.i.d., for 10 days) versus amoxicillin-clavulanate suspension (80 mg/kg/day, t.i.d., for 10 days) in 510 children (ages 6 to 36 months) with acute otitis media. The most frequent microorganisms colonizing the nasopharynx at the start of treatment were Streptococcus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella catarrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95.3% for H. influenzae and M. catarrhalis, respectively. Decreased susceptibility of S. pneumoniae to penicillin was found in 39.7% of isolates. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relapse had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We conclude that these two regimens are equally effective in acute otitis media in children.
我们在法国全境开展了一项大型、多中心、随机、开放标签研究，比较头孢克肟混悬液（8毫克/千克/天，每日两次，共10天）与阿莫西林-克拉维酸混悬液（80毫克/千克/天，每日三次，共10天）对510名（6至36个月大）急性中耳炎儿童的疗效和安全性。治疗开始时，在鼻咽部定植的最常见微生物是肺炎链球菌（51.5%）、流感嗜血杆菌（45%）和卡他莫拉菌（30.2%）。流感嗜血杆菌和卡他莫拉菌的β-内酰胺酶阳性率分别为32.1%和95.3%。在39.7%的分离株中发现肺炎链球菌对青霉素的敏感性降低。头孢克肟的临床疗效为87.8%（223/254），阿莫西林-克拉维酸为87.0%（215/247）。在5周的随访中，头孢克肟治疗的患者中有15.7%（31/197）复发，阿莫西林-克拉维酸治疗的患者中有15.6%（32/205）复发。我们得出结论，这两种治疗方案对儿童急性中耳炎同样有效。
