Pichichero M E, Gooch W M, Rodriguez W, Blumer J L, Aronoff S C, Jacobs R F, Musser J M
Department of Pediatrics, University of Rochester, NY.
Arch Pediatr Adolesc Med. 1994 Oct;148(10):1053-60. doi: 10.1001/archpedi.1994.02170100051010.
To compare bacteriologic and clinical efficacy and safety of 10 vs 5 days of cefpodoxime proxetil vs 10 days of penicillin V potassium for the treatment of acute group A beta-hemolytic streptococcal tonsillopharyngitis in children.
Prospective, randomized, observer-blind, multicenter study.
PATIENTS/INTERVENTIONS: Four hundred eighty-four children (age range, 2 to 17 years) with signs and symptoms of acute tonsillopharyngitis were enrolled; 377 had a positive throat culture for group A beta-hemolytic streptococci and were fully evaluable. One hundred twenty-one patients received cefpodoxime once a day for 10 days, 126 received cefpodoxime twice a day for 5 days, and 130 received penicillin V three times a day for 10 days.
Cefpodoxime for 10 days vs cefpodoxime for 5 days vs penicillin V for 10 days produced bacteriologic eradication at the end of therapy in 95%, 90%, and 78% of the patients, respectively. The 10- and 5-day cefpodoxime treatment regimens were more efficacious than penicillin V (P = .003 and P = .02, respectively). The cumulative bacteriologic failure rate among assessable patients by the 32- to 38-day posttreatment visit was 20 (17%) of 121 patients who were treated with cefpodoxime for 10 days, 24 (19%) of 125 patients who were treated with cefpodoxime for 5 days, and 45 (35%) of 130 patients who were treated with penicillin V for 10 days (P = .001 and P = .005, respectively). Clinical cure or improvement was observed at the end of therapy in 96%, 94%, and 91% of the patients, respectively (P = not significant). Adverse events were infrequent and similar in all three treatment groups, with minor gastrointestinal side effects predominating.
Five days of treatment with cefpodoxime is as efficacious in bacteriologic eradication and clinical response (cure plus improvement) as 10 days of cefpodoxime therapy, and both cefpodoxime regimens produced superior bacteriologic efficacy compared with a 10-day regimen of penicillin V in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitis in children.
比较头孢泊肟酯10天与5天疗法以及青霉素V钾10天疗法治疗儿童急性A组β溶血性链球菌扁桃体咽炎的细菌学疗效、临床疗效及安全性。
前瞻性、随机、观察者盲法、多中心研究。
患者/干预措施:纳入484例有急性扁桃体咽炎体征和症状的儿童(年龄范围2至17岁);377例咽拭子培养A组β溶血性链球菌阳性且可进行全面评估。121例患者接受头孢泊肟酯每日1次,共10天治疗;126例患者接受头孢泊肟酯每日2次,共5天治疗;130例患者接受青霉素V每日3次,共10天治疗。
治疗结束时,接受头孢泊肟酯10天疗法、5天疗法以及青霉素V 10天疗法的患者细菌学清除率分别为95%、90%和78%。头孢泊肟酯10天和5天治疗方案比青霉素V更有效(P值分别为0.003和0.02)。在治疗后32至38天的访视中,可评估患者中,接受头孢泊肟酯10天治疗的121例患者中有20例(17%)细菌学治疗失败,接受头孢泊肟酯5天治疗的125例患者中有24例(19%)细菌学治疗失败,接受青霉素V 10天治疗的130例患者中有45例(35%)细菌学治疗失败(P值分别为0.001和0.005)。治疗结束时,分别有96%、94%和91%的患者临床治愈或改善(P值无统计学意义)。所有三个治疗组的不良事件均不常见且相似,主要为轻微胃肠道副作用。
在治疗儿童A组β溶血性链球菌扁桃体咽炎时,头孢泊肟酯5天疗法在细菌学清除和临床反应(治愈加改善)方面与10天疗法效果相同,且两种头孢泊肟酯治疗方案的细菌学疗效均优于青霉素V 10天疗法。