A Double Blind Comparative Study on Cefapirin and Cefazolin in the Treatment of Otitis Media

Abstract

Cefapirin (CEPR) was compared to Cefazolin (CEZ) for efficacy, safety and utility in the treatment of acute otltls media (including acute suppurative otitis media and chronic otitis media in acute aggravating stage) under multicentered double blind clinical trials.
1. The total number of 148 subjects were enrolled at 16 collaborated hospital clinics. Of the 148 subjects enrolled, 145 (72 treated with CEPR and 73 treated with CEZ) were evaluable. Three exclusions were due to improper drug administration.
2. In Final Global Improvement Rating (FGIR), both CEPR and CEZ exhibited no statistically significant difference in either of the 3 methods employed for analysis (U-test, Chi-square test and Fisher's).
3. In Overall Safety Rating (OSR), CEPR was found safer than CEZ at the level of p<0.05 in the U-test and at p<0.1 in both Chi-square and Fisher's tests.
4. In Global Utility Rating (GUR), CEPR was found to be superior to CEZ at the level of p<0.1 in the U-test whereas the 2 drugs exhibited no statistically significant difference in both Chi-square and Fisher's tests.
5. When analyzed in terms of background factor classifications in the GUR, CEPR was found superior to CEZ in the following 6 categories:
a) Females
b) Acute suppurative infections
c) “Mild” in the severity rating
d) Patients with no concomitant disease status
e) Patients taking no other drugs adjunct to CEPR
f) Patients treated within 3 days infection
6. With regard to MIC's against clinical isolates, CEPR was found to be one-fold more active against Proteus sp. With regard to clinical efficacy, however, there was no statistically significant difference.