An open multicentre study to compare the efficacy and safety of sultamicillin with that of cefuroxime axetil in acute ear nose and throat infections in adults.
A total of 110 adults with acute ear, nose and throat infections were treated orally with 750 mg/day (n = 9) or 1500 mg/day (n = 46) sultamicillin, or 500 mg/day (n = 51) or 1000 mg/day (n = 4) cefuroxime axetil for a minimum of 5 days. Variations in dose and duration of treatment were due to severity of symptoms. After treatment with sultamicillin for 8.1 +/- 1.5 days or with cefuroxime axetil for 7.9 +/- 1.6 days, local pain, erythema, exudate, oedema and adenopathies were improved in both treatment groups and all sultamicillin-treated patients were apyretic. All sultamicillin-treated and all but three cefuroxime axetil-treated patients experienced cure or improvement; only one cefuroxime axetil-treated patient discontinued treatment due to treatment failure. Gastrointestinal adverse events occurred in both treatment groups (eight sultamicillin-treated patients and three cefuroxime axetil-treated patients); one patient receiving cefuroxime axetil discontinued treatment due to nausea. Pruritus was reported by one sultamicillin-treated patient.
Alvart
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Pfizer France SA, Orsay.
D000328:Adult; D000667:Ampicillin / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002444:Cefuroxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D010033:Otitis Media / Q000188:drug therapy; D010612:Pharyngitis / Q000188:drug therapy; D012140:Respiratory Tract Diseases / Q000188:drug therapy*; D012220:Rhinitis / Q000188:drug therapy; D012852:Sinusitis / Q000188:drug therapy; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use*; D014069:Tonsillitis / Q000188:drug therapy
C035444:sultamicillin; D000667:Ampicillin; D002444:Cefuroxime; D013407:Sulbactam; C040738:cefuroxime axetil