Casellas Javier María, Israele Víctor, Marín Marcelo, Ishida María T, Heguilen Ricardo, Soutric Jorge, Arenoso Héctor, Sibbald Andrés, Stamboulian Daniel
Pediatric Infectious Diseases, Hospital de Niños de San Isidro, French 3085, 1425 Buenos Aires, Argentina.
Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1225-33. doi: 10.1016/j.ijporl.2005.03.016.
Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6-48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80 mg/(kg day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120 Ax/S and 127 Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range < or = 0.016-1.0 and < or = 0.016-0.25 mg/L, respectively). Clinical efficacy at Days 12-14 and 28-42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.
肺炎链球菌（Sp）和流感嗜血杆菌（Hi）是急性中耳炎（AOM）的主要细菌病因，其储存宿主为鼻咽部（NP）。2001年10月，我们开展了一项前瞻性、多中心、随机、评估者盲法研究，比较阿莫西林-舒巴坦（Ax/S）和阿莫西林-克拉维酸（Ax/C）治疗非复发性AOM（nr-AOM）的疗效。评估了研究儿童（6至48个月，患有nr-AOM）携带的Sp和Hi对Ax/S和Ax/C的抗菌敏感性（AS），以及用高剂量Ax/C（7:1）或Ax/S（4:1）（阿莫西林剂量：80mg/（kg·天），每日两次，共10天）治疗后的临床结果。在第0天采集鼻拭子培养（NCs）样本。仅对Sp携带者进行随访NCs检测。最终分析时，247/289例患者（85.5%）可进行全面评估（120例接受Ax/S治疗，127例接受Ax/C治疗）。第0天Hi和Sp在NP的携带率分别为32.2%（93/289例患者）和28.7%（83/289例患者）。仅在2例患者中检测到持续性Sp携带。Hi的β-内酰胺酶阳性率为13%（12/93）。针对Sp和Hi分离株测试时，Ax/S和Ax/C的最低抑菌浓度（MICs）相同（范围分别为≤0.016 - 1.0和≤0.016 - 0.25mg/L）。Ax/S在第12 - 14天和第28 - 42天的临床疗效分别为98.3%（115/117）和94.2%（97/103）；Ax/C分别为98.3%（115/117）和95.1%（98/103）（p无统计学差异）。我们得出结论，从nr-AOM患者的NCs中分离出的Sp和Hi对这两种药物均高度敏感，且与高临床有效率相关。
