Pharmacoeinetic and clinical studies of Azithromycin on otorhinolaryngological infections

Abstract

Pharmacokinetic and clinical studies were carried out to evaluate the effectiveness and safety of azithromycin (AZM) for the treatment of otorhinolaryngological infections. The results were as follows: The distribution of AZM to both the humor and tissue was good, in Particular, in the tympanium mucosa, tonsils, maxillary sinus mucosa, ethmodial sinus mucosa and submandibular gland. In addition, these tissue concentrations were also maintained for a long period of time. AZM was orally administered to 180 patients, and most received 250 mg or 500 mg daily for 3 days. The clinical efficacy rates, evaluated in 139 patients, were 73% for otitis media, 77% for sinusitis, 79% for tonsillitis and 74% for pharyngolaryngitis, with an overall efficacy rate of 76%. The bacteriological efficacy rates were, based on the eradication rete, 90% for monobacterial infections caused by Gram-positive organisms, 89% for monobacterial infections caused by Gram-negative orgamisms and 77% for polybacterial infections, while the overall eradication rate was 85%. Side effects were observed in 1 patient (1%) out of 170 patients, while clinical laboratory abnormalities were observed in 8 patients (6%) out of 131 patients who underwent clinical laboratory tests after treatment. Based on the above results, AZM was found to be highly useful for the treatnment of various otorhinolaryngological infections such as otitis media, sinusitis, tonsillitis and pharyngoloryngitis.