Adam D, Hostalek U, Tröster K
Dr. von Haunersches Kinderspital, München.
Klin Padiatr. 1996 Sep-Oct;208(5):310-3. doi: 10.1055/s-2008-1046489.
160 children aged 1 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis were treated either with cefixime ready-to-use-suspension or penicillin V in an open, controlled and randomized multicenter study. Before treatment a rapid antigen detection test was accomplished and throat swabs were taken. After randomization, the children were either treated for 5 days with 8 mg cefixime/kg bodyweight ready-to-use suspension once daily or with 20,000 I.U. penicillin V/kg bodyweight t.i.d. also administered as suspension. The data of 151 children could be evaluated for clinically efficacy. In the cefixime-group 86.7% of the children were cured and 9.3% significantly improved. After initial improvement, in one child (1.3%) a relapse occurred and in the two remaining children (2.7%) therapy failed. 90.8% of the patients treated with penicillin V were cured, 6.6% improved and in one child each a relapse was registered resp. therapy failed. Complete microbiological data were available in 137 patients. In the cefixime-group in 82.6% of the patients the pathogens were eradicated. The elimination rate in the penicillin-group was 88.2%. At the follow-up 3-4 weeks after end of treatment 6 relapses were seen in the cefixime-group, and 8 in the patients treated with penicillin. Both regimes were safe. Mild to moderate adverse events at least possibly related to the study medication were seen in only 4 children treated with cefixime and in 5 treated with penicillin. A 5 day treatment of bacterial pharyngitis and tonsillitis with cefixime was as effective as a ten day treatment with penicillin V.
在一项开放、对照、随机的多中心研究中,160名年龄在1至12岁、临床诊断为细菌性咽炎和/或扁桃体炎的儿童,分别接受头孢克肟即用型混悬液或青霉素V治疗。治疗前进行了快速抗原检测试验并采集了咽拭子。随机分组后,儿童分别接受为期5天的治疗,其中一组每天一次服用8mg/kg体重的头孢克肟即用型混悬液,另一组每天三次服用20,000IU/kg体重的青霉素V,均以混悬液形式给药。151名儿童的数据可用于临床疗效评估。在头孢克肟组中,86.7%的儿童治愈,9.3%显著改善。初始改善后,1名儿童(1.3%)复发,另外2名儿童(2.7%)治疗失败。接受青霉素V治疗的患者中,90.8%治愈,6.6%改善,各有1名儿童出现复发和治疗失败。137名患者有完整的微生物学数据。在头孢克肟组中,82.6%的患者病原体被根除。青霉素组的根除率为88.2%。治疗结束后3至4周的随访中,头孢克肟组出现6例复发,青霉素治疗组出现8例复发。两种治疗方案均安全。仅4名接受头孢克肟治疗的儿童和5名接受青霉素治疗的儿童出现了至少可能与研究药物相关的轻至中度不良事件。用头孢克肟治疗细菌性咽炎和扁桃体炎5天与用青霉素V治疗10天效果相同。