Abstract

The clinical efficacy and safety of Aztreonam (AZT), a new monobactam antibiotic, was objectively compared with that of Cefoperazone (CPZ) in patients with chronic respiratory tract infections, bacterial pneumonia or lung abscess by gram-negative pathogens in a well controlled study.Each drug was administered by intravenous drip infusion b. i. d.for 14 days at a daily dose of two grams.The following results were obtained.1. On the basis of committee judgement, the overall clinical efficacy rate was 71.2%(99/139) in the AZT group and 76.3%(100/131) in the CPZ group with no statistically significant difference between the two drug groups.2. In the assessment by the physicians in charge, the overall clinical efficacy rate was 74.8%(98/131) in the AZT group and 77.5%(100/129) in the CPZ group with no significant difference between the two treatments. When reviewed for each diagnosis, there was no significant difference between the two drug groups with regard to clinical efficacy rate. For example, the rates were 78.4%(40/51) in the AZT group and 80.4%(37/46) in the CPZ group for those with bacterial pneumonia or lung abscess, and 72.2%(57/79) in the AZT group and 75.9%(60/79) in the CPZ group for those with chronic respiratory tract infections.3. The bacteriological elimination rate judged by committee was 81.8%(72/88) for the AZT group and 79.2%(61/77) for the CPZ group with no significant difference between the two drug groups. In particular, H. influenzae, P. aeruginosa and K. pneumoniae were eliminated in a slightly higher rate in the AZT group than in the CPZ group, although there was no significant difference between the two treatments.4. Some side effects were observed in 6 patients out of 162 in the AZT group and 6 out of 148 in the CPZ group, but there was no significant intergroup difference in the incidence of these side effects. Some abnormal laboratory findings were observed in 57 (36.8%) out of 155 patients in the AZT group and 28 (20.3%) out of 138 in the CPZ group, the difference between these two groups being significant (p<0.01). The observed laboratory abnormalities included GOT in 42 cases (27.6%) in the AZT group and 13 cases (9.6%) in the CPZ group, and GPT in 42 cases (27.6%) in the AZT group and 15 cases (11.0%) in the CPZ group. There was a significant difference in the incidence of GOT and GPT (p<0.01, respectively). However, there was no significant difference observed in other laboratory test findings. The GOT or GPT elevations in the AZT group were relatively mild and transient in every case and all the cases followed up thereafter (GOT elevation 25 cases, GPT 26 cases) reverted to pre-administration levels during or one week after completing or suspending the administration.5. Clinical usefulness judged by the committee was 65.0%(91/140) in the AZT group and 74.8%(98/131) in the CPZ group with no significant difference between the two drug groups. The judgement by the physicians in charge also did not indicate any significant difference.From all the above results, AZT was considered to be a useful drug for respiratory tract infections.

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