Comparative clinical study of ceftazidime and cefotiam for respiratory tract infections by a double-blind method

Abstract

For objective evaluation of the efficacy and safety of ceftazidime (CAZ), a new cephem antibiotic, in respiratory tract infections, a double blind comparative study was carried out against cefotiam (CTM). Either of the drugs was administered by intravenous drip infusion in the unit dose of 1 g (potency) twice daily for 14 days, and the following results were obtained.1. In the assessment by the efficacy Assessment Committee, the overall clinical efficacy rate was 73.2%(90/123) in the CAZ group and 72.0%(90/125) in the CTM group, with no statistically significant difference between the two treatments. When reviewed for each diagnosis, the efficacy rate was slightly lower in the CAZ group than that in the CTM group 60.6%(40/66) and 74.2%(49/66), respectively, in bacterial pneumonia and lung abscess, although there was no significant difference between the two treatments. Whereas in chronic RTI the efficacy rate was higher in the CAZ group (86.0%, 43/50) than that in the CTM group (66.7%, 36/54) with significant difference (χ2-test, <0.05).2. In the assessment by the physicians in charge, the overall clinical efficacy rate for all cases was 70.7%(104/147) in the CAZ group and 63.7%(101/147) in the CTM group, with no significant difference between the two treatments. When reviewed for each diagnosis, efficacy rate was 70.1%(68/97) in the CAZ group and 71.7%(66/92) in the CTM group in the treatment of bacterial pneumonia and lung abscess, and there was statistically no significant difference between the two treatments. In chronic RTI, the efficacy rate in the CAZ group (79.5%, 35/44) tended to be higher than that in the CTM group (66.7%, 34/51) (U-test, p<0.10).3. In the 112 cases (55 cases in the CAZ group, 57 cases in the CTM group) in which the bacteriological response could be assessed, elimination of bacteria was achieved in more cases in the CAZ group than in the CTM group, with significant difference (U-test, χ2-test, p<0.01). As to the eradication rate including “replaced”, there was no statistically significant difference between the two treatments.4. As far as the incidence of side effects and abnormal laboratory findings were concerned, there was no significant difference between the two treatments.5. The Committee assessed the overall utility (efficacy + safety) as 84.0%(42/50) in the CAZ groupand 66.7%(36/54) in the CTM group in chronic RTI, and the utility in the CAZ group tended to be higher than that in the CTM group (χ2-test, p<0.10). In other diagnoses and also in all cases, there was no significant difference between the two treatments. In the assessment by the physicians in charge, there was no significant difference between the two drugs in the utility.From the above results, CAZ was considered to be as useful as CTM, based on the efficacy and safety in respiratory tract infections.