Abstract | PURPOSE: PATIENTS AND METHODS: Three hundred seventeen patients with clinical and radiographic evidence of acute maxillary sinusitis were enrolled at nine centers and were randomly assigned to receive 10 days of treatment with cefuroxime axetil 250 mg twice daily (n = 157) or amoxicillin/ clavulanate 500 mg three times daily (n = 160). Patients were assessed for both clinical and bacteriologic responses once during treatment (5 to 7 days) and twice after treatment (1 to 3 days and 4 weeks). Bacteriologic assessments were based on needle aspirates of the maxillary sinus obtained pretreatment and, when possible, at the first posttreatment visit. RESULTS: Organisms were isolated from the pretreatment sinus aspirates of 198 of 317 (62%) patients, with the primary isolates being Streptococcus pneumoniae (22%), Haemophilus spp. (17%), Staphylococcus aureus (13%), and Haemophilus influenzae (10%). A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of the clinically evaluable patients treated with cefuroxime axetil or amoxicillin/ clavulanate, respectively (P = 0.446). With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of bacteriologically evaluable patients treated with cefuroxime axetil or amoxicillin/ clavulanate, respectively (p = 0.567). Treatment with amoxicillin/ clavulanate was associated with a significantly higher incidence of drug-related adverse events (13% versus 3%, p = 0.001), particularly diarrhea (8% versus 1%, p = 0.001). Two patients in the cefuroxime axetil group and three patients in the amoxicillin/ clavulanate group withdrew from the study due to adverse events. CONCLUSIONS:
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Authors | A E Camacho, R Cobo, J Otte, S L Spector, C J Lerner, N A Garrison, A Miniti, P K Mydlow, G C Giguere, J J Collins |
Journal | The American journal of medicine
(Am J Med)
Vol. 93
Issue 3
Pg. 271-6
(Sep 1992)
ISSN: 0002-9343 [Print] United States |
PMID | 1524078
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Clavulanic Acids
- Prodrugs
- Amoxicillin-Potassium Clavulanate Combination
- Amoxicillin
- Cefuroxime
- cefuroxime axetil
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Topics |
- Acute Disease
- Adult
- Amoxicillin
(adverse effects, therapeutic use)
- Amoxicillin-Potassium Clavulanate Combination
- Cefuroxime
(adverse effects, analogs & derivatives, therapeutic use)
- Clavulanic Acids
(adverse effects, therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
(adverse effects, therapeutic use)
- Humans
- Maxillary Sinusitis
(drug therapy, microbiology)
- Prodrugs
(adverse effects, therapeutic use)
- Single-Blind Method
- Treatment Outcome
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