Holm S, Henning C, Grahn E, Lomberg H, Staley H
Department of Clinical Microbiology, University of Umeå, Sweden.
Scand J Infect Dis. 1995;27(3):221-8. doi: 10.3109/00365549509019013.
The efficacy of cefuroxime axetil compared with phenoxymethylpenicillin (PcV) was studied in group A beta-haemolytic streptococci (GAS) culture-proven tonsillitis in children aged 3-12 years with a history of at least 1 episode of tonsillopharyngitis requiring antibiotic therapy during the previous 3 months. This was a comparative, randomized, investigator-blind, multicentre study. A total of 236 children received either cefuroxime axetil suspension or PcV syrup. Inclusion criteria were a positive, rapid, group A strep test verified by bacteriological culture and clinical signs and symptoms of tonsillopharyngitis. Cefuroxime axetil treatment gave a significantly higher bacteriological eradication rate and clinical cure rate than PcV. At day 2-5 post treatment the eradication rates were 99/114 (87%) for cefuroxime axetil vs 61/109 (56%) for PcV (p < 0.001). The clinical cure rates were 98/114 (86%) and 73/109 (67%) respectively (p < 0.01). Up to 21-28 days post-treatment, 9/114 (8%) cefuroxime axetil patients and 37/109 (34%) PcV patients were treatment failures or had recurrence/reinfection of GAS tonsillopharyngitis (p < 0.001). More than 90% of the patients who experienced bacteriological treatment failure at either the first or second follow-up had the same serotype isolated pre- and post-treatment. During the study period, 21/114 (18%) patients in the cefuroxime axetil group and 50/109 (46%) patients in the PcV group received additional antibiotics (p < 0.001). No serious adverse events were noted and the mild adverse events were equally distributed among the patients in the 2 study groups: 15% for cefuroxime axetil and 14% for PcV.
在3至12岁、过去3个月内至少有1次扁桃体咽炎发作且需要抗生素治疗的儿童中,对头孢呋辛酯与青霉素V(PcV)治疗A组β溶血性链球菌(GAS)培养确诊的扁桃体炎的疗效进行了研究。这是一项比较性、随机、研究者盲法、多中心研究。共有236名儿童接受了头孢呋辛酯混悬液或PcV糖浆治疗。纳入标准为A组链球菌快速检测阳性,并经细菌培养以及扁桃体咽炎的临床体征和症状证实。头孢呋辛酯治疗的细菌根除率和临床治愈率显著高于PcV。治疗后第2至5天,头孢呋辛酯的根除率为99/114(87%),而PcV为61/109(56%)(p<0.001)。临床治愈率分别为98/114(86%)和73/109(67%)(p<0.01)。治疗后21至28天,头孢呋辛酯组9/114(8%)的患者和PcV组37/109(34%)的患者治疗失败或出现GAS扁桃体咽炎复发/再感染(p<0.001)。在首次或第二次随访中细菌治疗失败的患者中,超过90%治疗前后分离出的是相同血清型。在研究期间,头孢呋辛酯组21/114(18%)的患者和PcV组50/109(46%)的患者接受了额外的抗生素治疗(p<0.001)。未观察到严重不良事件,轻度不良事件在两个研究组的患者中分布相同:头孢呋辛酯组为15%,PcV组为14%。