Twice-daily dosing of loracarbef 15 mg/kg versus 30 mg/kg in the treatment of children with acute sinusitis.
Loracarbef is an oral synthetic beta-lactam antibiotic of the carbacephem class. The aim of this study was to compare the efficacy and safety of loracarbef 15 mg/kg versus 30 mg/kg in children with acute sinusitis. A randomized, parallel-group, clinical study was conducted. Fifty-eight children aged 5-12 years with acute sinusitis were divided into two groups, which received either loracarbef 15 mg/kg/day or 30 mg/kg/day orally, divided in two doses for 10 days. Clinical examination, anterior rhinoscopy and sinus radiographs were performed at the beginning of treatment. Clinical evaluation was repeated in a second session, 0-2 days after the final dose, and in a third session, 30 days after the beginning of the treatment. Sinus X-rays were repeated selectively in the second session and in all patients in the third session. Nineteen of 29 (65.5%) patients in the 15 mg/kg/day group and 26 of 29 (89.6%) in the 30 mg/kg/day group were characterized as completely or clinically cured at the end of the study. In conclusion, a statistically significant difference between the two treatment groups was shown with better results in the 30 mg/kg group. Despite the slight difference in adverse events between the two groups (with fewer adverse events in the 15 mg/kg group), we recommend that if loracarbef is chosen as initial therapy in acute sinusitis, a regimen of 30 mg/kg/day in two doses is followed.
Balatsouras
D G
DG
Department of Otolaryngology, Tzanion General Hospital, Piraeus, Greece.
Korres
S
S
Rallis
E
E
Eliopoulos
P
P
Ferekidis
E
E
D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D012852:Sinusitis / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; C054920:loracarbef