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Journal of the Korean Society of Neonatology 2005;12(1):17-24.
Published online May 1, 2005.
Efficacy and Safety of Amoxicillin-sulbactam and Ampicillin-sulbactam in Full Term Neonates.
Soo Jeong Lee, Eun Ae Park
Department of Pediatrics, College of Medicine, Ewha Womans University, Seoul, Korea. pea8639@ewha.ac.kr
만삭 신생아에서 아목시실린-설박탐 복합제제와 암피실린-설박탐 복합제제의 유효성, 안전성 비교
Since neonatal sepsis dose not have typical symptoms and signs, whenever suspected antibiotic therapy is the mainstay of treatment. Ampicillin-sulbactam has been widely used in the newborn nursery as the empirical antibiotics as well as ampicillin and gentamicin. The purpose of this study was to compare the efficacy and safety of amoxicillin-sulbactam to ampicillin-sulbactam in treating neonatal sepsis. METHODS: A randomized, controlled study was conducted in 60 full term neonates who were suspected to have sepsis. The patients were randomly assigned to receive amoxicillin-sulbactam 30 mg/kg/day (based on amoxicillin component) intravenously divided every 12 hours or ampicillin-sulbactam 75 mg/kg/day (based on ampicillin component) intravenously divided every 8 hours for at least 7 consecutive days. Clinical symptoms and signs, complete blood cell counts, blood chemistry and body fluid cultures were taken before, during and after the treatment. All patients were evaluated for clinical efficacy on the basis of the clinical, microbiological responses and side effects.
The clinical success rates after 7 days of treatment were 100% for both groups. Drug related serious side effects did not occur in all patients. There were three cases (10%) of bacterial culture positive patients in amoxicillin-sulbactam treated group during treatment. But no more bacterial growth had found after 7 days antibiotics treatment. CONCLUSION: Amoxicillin-sulbactam was as effective and safe as ampicillin-sulbactam for whom neonatal sepsis was suspected.
Key Words: Amoxicillin-sulbactam; Ampicillin-sulbactam; Efficacy; Safety; Neonatal sepsis
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