Dajani A S, Kessler S L, Mendelson R, Uden D L, Todd W M
Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.
Pediatr Infect Dis J. 1993 Apr;12(4):275-9. doi: 10.1097/00006454-199304000-00003.
This multicenter, randomized, parallel treatment, observer-blinded study was designed to evaluate the safety and efficacy of cefpodoxime proxetil (5 mg/kg twice daily for 10 days) compared with penicillin V (13.4 mg/kg three times daily for 10 days) for treatment of Group A streptococcal pharyngitis and tonsillitis in pediatric patients. Clinical and microbiologic results were evaluated before therapy, during therapy (Study Days 3 to 5), at the end of therapy (Study Days 14 to 18) and at long term follow-up (Study Days 30 to 32). Both drugs were well-tolerated in 578 patients evaluable for safety. Mild gastrointestinal complaints were noted in 6.7% of 386 cefpodoxime-treated patients and in 5.2% of 192 penicillin-treated patients. In 413 patients evaluable for efficacy, both treatment regimens resulted in comparably favorable clinical outcome; cure rates were 83.8% for 275 cefpodoxime-treated patients and 77.5% for 138 penicillin-treated patients. However, eradication of S. pyogenes at end of therapy was significantly higher with cefpodoxime (93.1%) than with penicillin (81.2%) (P < 0.01). Cefpodoxime proxetil provides an effective alternative to penicillin V for the treatment of streptococcal pharyngitis and tonsillitis.
这项多中心、随机、平行治疗、观察者盲法研究旨在评估头孢泊肟酯（每日两次，每次5mg/kg，共10天）与青霉素V（每日三次，每次13.4mg/kg，共10天）治疗儿童A组链球菌性咽炎和扁桃体炎的安全性和有效性。在治疗前、治疗期间（研究第3至5天）、治疗结束时（研究第14至18天）和长期随访（研究第30至32天）评估临床和微生物学结果。在578例可评估安全性的患者中，两种药物耐受性均良好。在386例接受头孢泊肟治疗的患者中，6.7%出现轻度胃肠道不适；在192例接受青霉素治疗的患者中，5.2%出现轻度胃肠道不适。在413例可评估疗效的患者中，两种治疗方案的临床结局相当；275例接受头孢泊肟治疗的患者治愈率为83.8%，138例接受青霉素治疗的患者治愈率为77.5%。然而，治疗结束时头孢泊肟对化脓性链球菌的根除率（93.1%）显著高于青霉素（81.2%）（P<0.01）。头孢泊肟酯为治疗链球菌性咽炎和扁桃体炎提供了一种有效的青霉素V替代药物。
