A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection
A multicenter, open label, double tympanocentesis study of high dose cefdinir in children with acute otitis media at high risk of persistent or recurrent infection
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DOI：
10.1097/01.inf.0000202138.12950.3c
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发表时间：
2006-03-01
影响因子：
3.6
通讯作者：
Paris, M
中科院分区：
文献类型：
--
作者：
Arguedas, A;Dagan, R;Paris, M
背景资料：鉴于复发性和持续性急性中耳炎（AOM）的相对高患病率以及肺炎链球菌（尤其是青霉素不敏感菌株）在患有这些病症的儿童中的突出病原学作用，需要新的替代治疗。6个月至4岁的AOM儿童被认为有复发或持续感染的风险，接受大剂量头孢地尼25 mg/kg。kg口服混悬液，每日1次，连续10天。儿童在治疗前（第1天）、治疗中（第4-6天）、治疗结束时（第12-14天）和随访时（第25-28天）进行评估。所有儿童在入组时均进行了鼓室穿刺术。在培养阳性的儿童，鼓室穿刺术重复后3-5天（第4-6天），除非没有中耳积液的证据是documented.Results：447名儿童参加，230临床和细菌学评价（74%2岁或以下，57%的AOM治疗前3个月）。在第4-6天重复鼓膜穿刺的基础上，74%（170/230）的儿童实现了细菌学根除; 76%（201/266）的AOM病原体被根除。根除青霉素敏感、中间和耐药S.肺炎克雷伯氏菌根除率分别为91%（50/55）、67%（18/27）和43%（10/23）（P < 0.001）;流感占72%（90/125）。第12-14天的总体临床应答率为83%（S. pneumoniae和Haemophilus influenzae）。第25-28天的持续临床应答率为85%。临床反应为83%的培养阳性的儿童与96%的培养阴性的儿童在基线鼓膜穿刺术（P < 0.001）。结论：在AOM的儿童在持续或复发性感染的风险，大剂量头孢地尼导致在治疗结束时的总体成功的临床反应为83%。该方案对青霉素敏感的S. pneumoniae，但对非敏感菌株的有效性显著降低，对H.流感病毒株。
Background: Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable.Methods: Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 rng/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented.Results: Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001).Conclusions: In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.