RESUMO
BACKGROUND: Pharyngotonsillitis (PT) caused by group A beta hemolytic streptococci (GABHS) is one of the most common infections of childhood. Two antibiotic suspensions, cefaclor (CEF) and amoxicillin/clavulanate (AMC), are commonly used in Poland for the treatment of PT caused by GABHS in children. MATERIAL/METHODS: This multi-center, randomized, single-blinded study was undertaken in order to compare the efficacy and safety of CEF (20 mg/kg/d) and AMC (25 mg/kg/d) in 10 days treatment of GABHS-related PT. 100 children (mean age 6 years) were enrolled into the study. Clinical and bacteriological assessments were done on the 14-18 th, and 38-45 th days after randomization. RESULTS: No GABHS strain isolated from throat smears was resistant in vitro to both antibiotics. Both antibiotics had almost 98% effectiveness at the post therapy visit. On follow-up, significantly more relapses and recurrences were observed in the AMC-treated group than in the CEF-treated group (relapse rate 21.28% vs 15.56%, p<0.02, recurrence 10.64% vs 6.66%, p<0.002). The relapse odds ratio in the AMC group was 1.7 times greater than in the CEF group, and recurrence was 1.5 times higher. There were significantly higher rates of gastrointestinal adverse events in children treated by AMC (p<0.02). CONCLUSIONS: CEF provides a clinically and bacteriologically effective treatment for children with PT caused by GABHS, comparable to AMC but significantly safer in terms of gastrointestinal side effects. AMC shows a greater risk of relapse and recurrence than CEF.
Assuntos
Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Cefaclor/uso terapêutico , Faringite/tratamento farmacológico , Infecções Estreptocócicas/tratamento farmacológico , Streptococcus pyogenes , Tonsilite/tratamento farmacológico , Combinação Amoxicilina e Clavulanato de Potássio/efeitos adversos , Antibacterianos/efeitos adversos , Antibacterianos/uso terapêutico , Cefaclor/efeitos adversos , Criança , Pré-Escolar , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/uso terapêutico , Feminino , Humanos , Masculino , Recidiva , Segurança , Método Simples-CegoRESUMO
BACKGROUND: Acute exacerbations of chronic bronchitis (AECB) are the most common complication of chronic bronchitis. The majority of AECB are caused by infection. The choice of appropriate antibacterial therapy for AECB is becoming more difficult and is usually empirically. Cefaclor and cefuroxime are used for ambulatory treatment of AECB. MATERIAL/METHODS: This multicenter, randomized, single blind study was undertaken in order to compare efficacy and safety of cefaclor AF (500 mg BID) and cefuroxime axetil (250 mg BID) in 10 days treatment of ambulatory patients with AECB. 170 adults were enrolled into the study. Clinical responses were assessed on 17th-24th day after randomization. RESULTS: Both antibiotics had high over 97% effectiveness in the treatment of AECB. There was statistically significant 1.7 times higher rate of patients with cough release after cefaclor treatment compared to cefuroxime (p<0.03). There was a significantly 2.25 higher rate of patients with AECB symptoms release like: increasing dyspnea, sputum volume and sputum purulence or cough in cefaclor group compared to cefuroxime (p<0.0187). Both treatments resulted in significant improvement of pulmonary peak expiratory flow (PEF). There were no differences between the rates of gastrointestinal and other side effects in both groups. CONCLUSIONS: 1. Cefaclor and cefuroxime have similar high efficacy and safety in 10 days treatment of patients with AECB. 2. Cefaclor treatment significantly higher 2.25 times reduces the rate of principle symptoms of AECB compared to cefuroxime. 3. Both antibiotics treatment significantly increase PEF, with higher tendency observed in after cefaclor treatment.
