Clinical evaluation of Ceftazidime in suppurative otitis media (Acute infections and acute exacerbation of chronic infections)

A comparative study with Cefotiam

Abstract

For objective evaluation of the clinical efficacy, safety and usefulness of Ceftazidime (CAZ) in the treatment of acute suppurative otitis media or acute exacerbation of chronic suppurative otitis media, a comparative study was carried out using Cefotiam (CTM) as the comparator. Patients were given an intravenous bolus injection of either CAZ or CTM lg bid, for 7 consecutive days in principle. 1. In the evaluation of overall clinical effectiveness, efficacy rates by the assessment of doctors in charge in the CAZ group and the CTM group were 73.6% (64/87) and 62.9% (56/89), respectively, and those by the Efficacy Assessment Committee's assessment were 66.7% (58/87) and 61.8% (55/89), respectively. Neither of these assessments showed a statistically significant difference between the two treatment groups. Also, when the clinical effectiveness was assessed for each background factor of the patients, there was no significant difference between the two groups. 2. There was no significant difference between the two treatment groups in any of the categories of overall improvement, improvement in subjective symptoms, or that of objective findings, all assessed on the 3rd and 7th day of administration. 3. Bacteriologically, in the total cases and in the cases suffering from acute exacerbation of chronic suppurative otitis media, bacteriological response of CAZ was significantly superior to that of CTM. Also, complete bacterial elimination rate (excluding ‘ Replaced ’) was significantly higher in the CAZ group than in the CTM group. In elimination rates (if ‘ Replaced ’ cases ware included), no statistically significant difference was noted. When assessed for each type of infection, CAZ showed significantly better bacteriological response in monomicrobial infections caused by Gram-positive and Gram-negative organisms. Also in monomicrobial infections by Cram-positive ogranisms, the rate of ‘Eliminated’ for CAZ was statistically higher than that of CTM. 4. In overall safety, no significant difference was observed between the two groups. Adverse events occurred in 4 cases out of 90 (4.3%) in the CAZ group and in 2 cases out of 92 (2.1%) in the CTM group. As for abnormal laboratory findings, 7 abnormal values were noted in the CAZ group, and 5 were noted in the CTM group. There was no statistically significant difference between the two groups in the incidences of adverse events or laboratory findings. 5. The rates of clinical usefulness in the total cases in the CAZ group and the CTM group were 71.6% and 66.7%, respectively, without significant difference between the groups. From the above findings, CAZ, like CTM, is considered to be useful in the treatment of suppurative otitis media.