Gl. Klein et al., CIPROFLOXACIN VERSUS CEFUROXIME AXETIL IN THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SINUSITIS, Journal of otolaryngology, 27(1), 1998, pp. 10-16
Objective: This study compared the use and efficacy of ciprofloxacin t
o cefuroxime axetil for adult patients with acute bacterial sinusitis.
Method: We conducted a prospective, randomized, double-blind pilot st
udy of oral ciprofloxacin (500 mg twice daily) versus cefuroxime axeti
l (250 mg twice daily) for 2 to 3 weeks in the treatment of adult pati
ents with a clinical diagnosis of acute bacterial maxillary sinus infe
ctions or acute exacerbation of chronic bacterial sinusitis. Patients
with microbiologically and radiologically confirmed sinusitis infectio
n composed the efficacy population. Results: Of the 83 patients enroll
ed, 13 of 42 (31%) ciprofloxacin-and 19 of 41 (46%) cefuroxime axetil-
treated patients had a respiratory pathogen isolated from a sinus aspi
ration. The most frequent pretherapy isolates included Haemophilus inf
luenzae (11), streptococcus species (20), staphylococcus species (7),
Proteus mirabilis (3), and Neisseria sicca (3). At the end of therapy,
clinical resolution or improvement in efficacy-valid patients was ach
ieved in 12 (100%) ciprofoxacin-treated patients and in 14 (74%) cefur
oxime axetil recipients. The five (26%) cefuroxime axetil clinical fai
lures were due to development of superinfection. Bacteriologic eradica
tion occurred in 12 (100%) and 14 (100%) ciprofloxacin and cefuroxime
axetil patients, respectively. Similar clinical and bacteriologic resp
onse rates were observed at the 2- to 4-week follow-up. Among 83 inten
t-to-treat patients, 19 (45%) ciprofloxacin and 14 (34%) cefuroxime ax
etil patients had drug-related adverse events. The most common adverse
event in both treatment groups was gastrointestinal. Conclusion: This
pilot study suggests that ciprofloxacin is efficacious in the managem
ent of acute bacterial sinusitis.