Kafetzis D A
Second Department of Pediatrics, Aglaia Kuriakov Children's Hospital, Athens, Greece.
Eur J Clin Microbiol Infect Dis. 1994 Oct;13(10):857-65. doi: 10.1007/BF02111353.
Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
在三项开放性、随机、多中心比较临床试验中，对头孢丙烯治疗急性分泌性中耳炎的效果进行了评估。在两项试验中，891名儿科患者被纳入头孢丙烯或阿莫西林-克拉维酸剂量方案组。治疗组在人口统计学特征方面具有可比性，耳镜检查时均有耳痛、中耳积液或鼓膜充血或膨出症状。所有患者均需进行鼓膜穿刺和培养。评估了两种头孢丙烯口服剂量，即30mg/kg/天和40mg/kg/天，分两次等量给药（每日两次）。阿莫西林-克拉维酸以40mg/kg/天，分三次给药（每日三次）。推荐疗程为十天。分离出的主要细菌为流感嗜血杆菌和卡他莫拉菌。头孢丙烯（83%）和阿莫西林-克拉维酸（81%）的总体临床满意反应率相似。细菌学反应率无显著差异，分别为84%和82%。头孢丙烯根除最常见病原体肺炎链球菌的比例更高，为91%，而阿莫西林-克拉维酸为84%。对流感嗜血杆菌和卡他莫拉菌的根除率相似。与接受阿莫西林-克拉维酸治疗的患者（20%）相比，接受头孢丙烯治疗的患者不良临床事件发生率较低（11%）。在接受阿莫西林-克拉维酸治疗的患者中，报告了更多胃肠道不良事件，包括腹泻。在研究3中，将388名儿科患者急性中耳炎治疗中30mg/kg/天（每日两次）的头孢丙烯与40mg/kg/天（每日三次）的头孢克洛和8mg/kg/天（每日一次）的头孢克肟进行了比较。患者接受治疗10天，随访18天。总体临床治愈率分别为85%、89%和85%。（摘要截断于250字）
