Clinical evaluation of Ofloxacin on otorhinolaryngological infections

Abstract

Ofloxacin is a new oral antibacterial agent of pyridonecarboxylic acid, and has broad and strong antibacterial activity. Clinical trial on patients with otorhinolaryngological infections are reported below. Patients enrolled in this study were grouped in the following manner, Chronic otitis media: 36, chronic sinusitis: 14, acute lacunar tonisillitis: 11, and other: 11. Ofloxacin was administered three times a day for a daily dose of 600 mg. Concomitant administration of other antibacterial agents and antiiflammatories was prohibited. The doctors evaluated clinical effect on patients given ofloxacin for more than three days as either excellent, effective, slightly effective, or ineffective. Efficacy of ofloxacin was rated by patients as either effective or excellent. One patient with chronic otitis media was excluded from the efficacy analysis bacause sufficient dosing was impossible, due to side effects. Clinical effectiveness was excellent in 11, effective in 47, slightly effective in 11 and ineffective in 2. Clinical efficacy by disease was 77.1% for chronic otitis media, 85.7% for chronic sinusitis, 81.8% for acute lacunar tonsillitis. Overall clinical efficacy was 81.7%. Side effects of nausea and vomiting occurred in one patient, but these symptoms disappeared after ofloxacin dosing was discontinued. The occurence rate of side effects was 1.4%. Laboratory examinations, including a hepatic function test, were performed on 9 patients and no abnormalities were noted. Since the clinical efficacy rate of ofloxacin was as high as 81.7% and there were no problems in safety, it was concluded that ofloxacin is a useful drug for treating otorhinolaryngological infections.