Cohen R, Levy C, Doit C, De La Rocque F, Boucherat M, Fitoussi F, Langue J, Bingen E
Association Clinique et Thérapeutique Infantile du Val de Marne, Association Française de Pédiatrie Ambulatoire, Paris, France.
Pediatr Infect Dis J. 1996 Aug;15(8):678-82. doi: 10.1097/00006454-199608000-00008.
To compare the efficacy and safety of amoxicillin (50 mg/kg/day divided twice daily) for 6 days and penicillin V (45 mg/kg/day divided into three doses/day) for 10 days in children with group A streptococcal (GAS) tonsillopharyngitis.
In a prospective, comparative, open, randomized, multicenter trial, children were scheduled to return for visits 4 days (main end point) and 1 month after the completion of treatment for clinical and bacteriologic assessment. Total DNA restriction fragment length polymorphism was used to compare pre- and posttreatment GAS isolates.
Between September, 1993, and February, 1995, 321 children (161 amoxicillin, 160 penicillin V) were enrolled, among whom 318 (160 amoxicillin, 158 penicillin V) were evaluable for safety, and 277 were evaluable for efficacy. Four days after the completion of treatment, pretreatment GAS were eradicated from 118 of the 141 children receiving amoxicillin (83.7%) and 116 of the 136 (85.3%) taking penicillin. One month after the outset of treatment, bacteriologic relapses were observed in 9.9% (n = 11) of the children receiving amoxicillin and 5.7% (n = 6) of those treated with penicillin V, bacteriologic recurrences in 5 and 3 patients, respectively. Adverse events related to the study medications were reported in 4 patients in the amoxicillin group and 8 in the penicillin V group. Drug-related adverse events leading to treatment discontinuation occurred in 3 patients, all in the penicillin V group. Compliance, based on diary cards and the weight of study drugs returned, was significantly better in the amoxicillin group. CONCLUSIONS. The efficacy and safety of amoxicillin (50 mg/kg/day twice daily) for 6 days were not statistically different from those of penicillin (45 mg/kg/d three times a day) for 10 days in the treatment of GAS tonsillopharyngitis.
比较阿莫西林（50毫克/千克/天，分两次服用）治疗6天与青霉素V（45毫克/千克/天，分三次服用）治疗10天对A组链球菌（GAS）扁桃体咽炎患儿的疗效和安全性。
在一项前瞻性、比较性、开放性、随机、多中心试验中，安排患儿在治疗结束后4天（主要终点）和1个月复诊，进行临床和细菌学评估。采用总DNA限制性片段长度多态性比较治疗前后的GAS分离株。
1993年9月至1995年2月，共纳入321例患儿（161例使用阿莫西林，160例使用青霉素V），其中318例（160例使用阿莫西林，158例使用青霉素V）可进行安全性评估，277例可进行疗效评估。治疗结束4天后，141例接受阿莫西林治疗的患儿中有118例（83.7%）、136例接受青霉素治疗的患儿中有116例（85.3%）的治疗前GAS被清除。治疗开始1个月后，接受阿莫西林治疗的患儿中有9.9%（n = 11）出现细菌学复发，接受青霉素V治疗的患儿中有5.7%（n = 6）出现细菌学复发，分别有5例和3例出现细菌学再感染。阿莫西林组有4例、青霉素V组有8例报告了与研究药物相关的不良事件。导致治疗中断的药物相关不良事件发生在3例患者中，均在青霉素V组。根据日记卡和归还的研究药物重量，阿莫西林组的依从性明显更好。结论：在治疗GAS扁桃体咽炎方面，阿莫西林（50毫克/千克/天，每日两次）治疗6天的疗效和安全性与青霉素（45毫克/千克/天，每日三次）治疗10天相比，在统计学上无差异。
