Leibovitz E, Piglansky L, Raiz S, Press J, Leiberman A, Dagan R
Pediatric Infectious Disease Unit, Soroka University Medical Center, and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Pediatr Infect Dis J. 2000 Nov;19(11):1040-5. doi: 10.1097/00006454-200011000-00003.
One dose of intramuscular ceftriaxone has been recently licensed in the United States for the treatment of acute otitis media. However, data regarding the bacteriologic and clinical efficacy of this regimen in the treatment of nonresponsive acute otitis media are incomplete.
To determine the bacteriologic and clinical efficacy of a 1-day 50-mg/kg vs. a 3-day 50-mg/kg/day intramuscular ceftriaxone regimen in the treatment of nonresponsive acute otitis media in children.
In an open, prospective study 109 patients ages 3 to 36 months with culture-proved, nonresponsive acute otitis media were randomized to receive 1 (n = 49) or 3 (n = 60) 50-mg/kg/day intramuscular ceftriaxone doses, respectively. Middle ear fluid was aspirated for culture by tympanocentesis on the day of enrollment (Day 1); a second tympanocentesis with middle ear fluid culture was performed on Days 4 to 5. Additional middle ear fluid cultures were obtained if clinical relapse occurred after completion of therapy. Bacteriologic failure was defined by positive cultures on Days 4 to 5. Patients were followed until Day 28 after completion of therapy. Susceptibility of the middle ear pathogens was measured by E-test.
Organisms recovered (n = 133) were Streptococcus pneumoniae (30 and 35 isolates for the 1-day and 3-day treatment group, respectively), Haemophilus influenzae (26 and 38, respectively) and Moraxella catarrhalis (n = 4). Of the 30 S. pneumoniae isolated from the 1-day group, 27 (90%) and 6 (20%) were nonsusceptible to penicillin and ceftriaxone, respectively; 9 of 27 (33%) were fully resistant to penicillin. Thirty-four (97%) and 6 (17%) of the 35 S. pneumoniae isolated from the 3-day group were nonsusceptible to penicillin and ceftriaxone, respectively; 16 of 34 (47%) were fully resistant to penicillin. Bacterial eradication of all H. influenzae and penicillin-susceptible S. pneumoniae was achieved in both treatment groups. Bacterial eradication of 14 of 27 (52%) and 33 of 34 (97%) penicillin-nonsusceptible S. pneumoniae was achieved in the 1-day and 3-day group, respectively. Seven (50%) of the 14 patients from the 2 groups who did not achieve bacterial eradication did not improve clinically on Days 4 to 5 and required additional ceftriaxone treatment.
The 3-day intramuscular ceftriaxone regimen was significantly superior to the 1-day intramuscular ceftriaxone regimen in the treatment of nonresponsive acute otitis media caused by penicillin-resistant S. pneumoniae.
近期在美国，单剂量肌内注射头孢曲松已获许可用于治疗急性中耳炎。然而，关于该疗法治疗难治性急性中耳炎的细菌学及临床疗效的数据尚不完整。
确定1天50mg/kg与3天50mg/kg/天肌内注射头孢曲松方案治疗儿童难治性急性中耳炎的细菌学及临床疗效。
在一项开放性前瞻性研究中，109例年龄3至36个月、经培养证实为难治性急性中耳炎的患者被随机分为两组，分别接受1天（n = 49）或3天（n = 60）50mg/kg/天的肌内注射头孢曲松治疗。在入组当天（第1天）通过鼓膜穿刺抽取中耳积液进行培养；在第4至5天进行第二次鼓膜穿刺及中耳积液培养。若治疗完成后出现临床复发，则获取额外的中耳积液培养样本。细菌学失败定义为第4至5天培养结果为阳性。对患者随访至治疗完成后第28天。采用E试验测定中耳病原体的敏感性。
分离出的病原体（n = 133）包括肺炎链球菌（1天治疗组和3天治疗组分别分离出30株和35株）、流感嗜血杆菌（分别为26株和38株）和卡他莫拉菌（n = 4）。从1天治疗组分离出的30株肺炎链球菌中，分别有27株（90%）和6株（20%）对青霉素和头孢曲松不敏感；27株中有9株（33%）对青霉素完全耐药。从3天治疗组分离出的35株肺炎链球菌中，分别有34株（97%）和6株（17%）对青霉素和头孢曲松不敏感；34株中有16株（47%）对青霉素完全耐药。两个治疗组均实现了对所有流感嗜血杆菌及对青霉素敏感的肺炎链球菌的细菌清除。1天治疗组和3天治疗组分别实现了对27株中14株（52%）和34株中33株（97%）对青霉素不敏感的肺炎链球菌的细菌清除。两组中未实现细菌清除的14例患者中有7例（50%）在第4至5天临床症状未改善，需要额外的头孢曲松治疗。
在治疗由耐青霉素肺炎链球菌引起的难治性急性中耳炎方面，3天肌内注射头孢曲松方案显著优于1天肌内注射头孢曲松方案。
