Tsai H Y, Huang L M, Chiu H H, Hsueh P R, Lee P I, Lu C Y, Chiu T F, Lin H C, Lee C Y
Department of Pediatrics, National Taiwan University Hospital, Taipei, ROC.
J Microbiol Immunol Infect. 1998 Sep;31(3):165-70.
An open-labeled and randomized trial was conducted to compare the efficacy and safety of once daily cefpodoxime proxetil suspension (10mg/kg/day) and thrice daily cefaclor (45mg/kg/day) in the treatment of acute otitis media in children. A total of 57 children aged from 6 months to 9 years were enrolled; 23 were treated with cefpodoxime and 34 with cefaclor. Satisfactory clinical outcome, either cure or improvement, was achieved at the end of treatment in 90% of patients in the cefaclor group and 95% of patients in the cefpodoxime group (p > 0.05). Clinical recurrence was identified at the follow-up visits in one case of the cefaclor group (3%), and none in the cefpodoxime group (p > 0.05). These drugs were well tolerated by 14/21 (67%) in the cefpodoxime-treated group and 27/32 (84%) in the cefaclor-treated group. The incidence of adverse events was slightly higher in the cefpodoxime group than in the cefaclor group, however the difference did not reach statistical significance (p > 0.05). The daily cost of once-daily cefpodoxime was lower than that of thrice-daily cefaclor. We conclude that cefpodoxime administered once daily is as effective and safe as cefaclor administered thrice daily in the treatment of acute otitis media in children. The less dosing frequency and lower daily price of cefpodoxime provide additional benefits.
进行了一项开放标签随机试验,比较每日一次头孢泊肟酯干混悬剂(10mg/kg/天)和每日三次头孢克洛(45mg/kg/天)治疗儿童急性中耳炎的疗效和安全性。共纳入57例6个月至9岁的儿童;23例接受头孢泊肟治疗,34例接受头孢克洛治疗。头孢克洛组90%的患者和头孢泊肟组95%的患者在治疗结束时获得了满意的临床结果,即治愈或改善(p>0.05)。随访时头孢克洛组有1例(3%)出现临床复发,头孢泊肟组无复发(p>0.05)。头孢泊肟治疗组14/21(67%)、头孢克洛治疗组27/32(84%)对这些药物耐受性良好。头孢泊肟组不良事件发生率略高于头孢克洛组,但差异无统计学意义(p>0.05)。每日一次头孢泊肟的费用低于每日三次头孢克洛。我们得出结论,每日一次给予头孢泊肟在治疗儿童急性中耳炎方面与每日三次给予头孢克洛一样有效和安全。头孢泊肟给药频率较低且每日价格较低,具有额外优势。