Adam D, Hostalek U
Abt. für Antimikrobielle Therapie und Infektionsimmunologie, Dr. von Haunerschen Kinderspitals, Universität München.
Klin Padiatr. 1994 Jan-Feb;206(1):26-9. doi: 10.1055/s-2008-1046576.
154 children aged 2 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis and--in most of the patients--a positive enzyme immunoassay for group A beta-hemolytic streptococci before therapy were enrolled in this open controlled randomized and multicenter trial. The children received either 8 mg/kg bodyweight cefixime once daily or 20,000 I.E. pencillin V/kg bodyweight t.i.d. Clinical evaluation and microbiological tests were carried out before treatment and 1-5 days after end of the treatment. 3-4 weeks after end of the treatment the rate of relapses was evaluated. The data of 149 children could be evaluated for clinical efficacy. In the cefixime group 93.3% of the children were cured and 6.7% improved compared to 89.2% and 10.8%, respectively, in the penicillin V group. Complete microbiological data were obtained from 136 patients. The eradication rate was 82.7% in the cefixime group and 77% in the group of patients treated with penicillin V. At follow up relapses were seen in 7 of the cefixime treated patients and in 6 of those receiving penicillin V. Mild side effects were reported by 4 patients in the cefixime group and by 3 children treated with penicillin V (1 drop out each). These results show that cefixime once daily is at least as effective as penicillin V t.i.d. in pharyngitis and tonsillitis in children. Both compounds are well tolerated.
154名年龄在2至12岁之间、临床诊断为细菌性咽炎和/或扁桃体炎的儿童——大多数患者在治疗前A组β溶血性链球菌酶免疫测定呈阳性——被纳入了这项开放对照随机多中心试验。这些儿童接受每日一次8mg/kg体重的头孢克肟治疗,或每日三次20000国际单位/千克体重的青霉素V治疗。在治疗前以及治疗结束后1至5天进行临床评估和微生物学检测。治疗结束后3至4周评估复发率。149名儿童的数据可用于评估临床疗效。头孢克肟组93.3%的儿童治愈,6.7%病情改善,相比之下,青霉素V组分别为89.2%和10.8%。从136名患者处获得了完整的微生物学数据。头孢克肟组的根除率为82.7%,青霉素V治疗组为77%。随访时,头孢克肟治疗的患者中有7人复发,接受青霉素V治疗的患者中有6人复发。头孢克肟组有4名患者报告有轻微副作用,青霉素V治疗组有3名儿童报告有轻微副作用(每组各有1人退出)。这些结果表明,儿童咽炎和扁桃体炎患者每日一次使用头孢克肟至少与每日三次使用青霉素V一样有效。两种药物耐受性都良好。