Study of the efficacy and safety of ciprofloxacin in the treatment of chronic sinusitis.

Over a 12-month period, 56 patients with acute exacerbations of chronic sinusitis were included in this study. The mean age of the patients was 48.6 +/- 10.1 years. The period between the onset of sinus symptoms and inclusion in the study was 10.1 +/- 12.1 years and the exacerbation had lasted 2.4 +/- 4.4 months. Patients were given 500 mg ciprofloxacin twice daily for 9 days. Bacteriological specimens taken at inclusion were positive in 53.6% of cases, 25 Gram-positive and 16 Gram-negative pathogens being isolated. At the end of the treatment, rhinorrhoea, which was the main criterion for evaluation of the efficacy of treatment, had disappeared in 46/54 (85%) patients who were examined. Of the 30 patients whose sinusitis was confirmed by bacteriological test, the bacteria were eradicated in 90% of cases. At the end of a 4-week follow-up period after the end of treatment, the clinical success rate was 74.5%, the partial success rate 21.2% and the failure rate 4.3%. There were no bacteriological recurrences. Ten adverse events were observed in seven patients and in four (7%) of these treatment had to be withdrawn. This study showed ciprofloxacin to be an effective and well tolerated treatment for exacerbations of chronic sinusitis treated in non-hospital practice.

Study of the efficacy and safety of ciprofloxacin in the treatment of chronic otitis.

Over a period of 18 months 76 patients presenting with acute exacerbations of chronic otitis were enrolled in this study. The mean age of the patients was 46.4 +/- 16.8 years, the interval between the onset of symptoms of otitis and enrollment in the study was 22.1 +/- 19.4 years and the infective episode had been developing for 36.4 +/- 72.4 days. The patients received either 500 or 750 mg ciprofloxacin twice daily for a period of 9 days with no topical antibiotic treatment. The bacteriological specimen taken at enrollment was positive in 93% of the patients and led to the isolation of 85 microorganisms, 65% of which were Pseudomonas aeruginosa, Staphylococcus aureus or Proteus mirabilis. At the end of the treatment period, discharge from the ears (the primary clinical evaluation criterion) had ceased in 44/69 (64%) patients examined. The clinical cure rate was 23/39 (59%) for patients treated with 500 mg ciprofloxacin twice daily and 21/30 (70%) for those treated with 750 mg twice daily (difference was not statistically significant). At the end of a 4-week post-treatment follow-up, the clinical relapse rate was 7%. There was no relapse in the patients with chronic otitis which had been bacteriologically documented. Eight adverse effects were observed in five patients and treatment had to be discontinued in one case. This study shows ciprofloxacin to be an effective and safe agent for use in the treatment of acute exacerbations of chronic otitis treated in general practice. In certain cases, however, additional treatment with a topical antibiotic may be desirable.