Mclinn S E, Mccarty J M, Perrotta R, Pichichero M E, Reidenberg B E
Scottsdale Pediatric Center, AZ 85251, USA.
Pediatr Infect Dis J. 1995 Jul;14(7 Suppl):S108-14. doi: 10.1097/00006454-199507001-00007.
The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of amoxicillin/clavulanate (Augmentin 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of acute otitis media in children. This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of otitis were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six patients (146 ceftibuten and 150 amoxicillin/clavulanate) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group. Five percent (6 of 127) of ceftibuten patients and 11% (14 of 127) of amoxicillin/clavulanate patients received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two patients (121 ceftibuten and 101 amoxicillin/clavulanate) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and amoxicillin/clavulanate groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)
在儿童急性中耳炎的经验性治疗中，比较了头孢布烯（每日9mg/kg，共10天）与阿莫西林/克拉维酸（奥格门汀，40mg/kg/天，每8小时给药1次，共10天）的疗效和安全性。这是一项多中心、研究者设盲的1:1随机研究。前瞻性收集治疗前、治疗期间3至5天、治疗后1至3天以及2至4周随访时中耳炎的总体临床反应和体征及症状。除了其他不良事件的自发报告外，每次访视时还前瞻性引出胃肠道不良事件。296例患者（146例头孢布烯和150例阿莫西林/克拉维酸）接受了至少1剂研究药物治疗。根据每个治疗组127例患者消耗药物的重量评估给药依从性。5%（127例中的6例）的头孢布烯患者和11%（127例中的14例）的阿莫西林/克拉维酸患者接受的药物低于规定剂量的80%（P = 0.10），因此无效。222例患者（121例头孢布烯和101例阿莫西林/克拉维酸）接受了至少80%的规定药物治疗，符合研究方案。头孢布烯组和阿莫西林/克拉维酸组在人口统计学变量和基线体征及症状方面具有可比性。（摘要截短至250字）
