A double blind comparative study was conducted to objectively evaluate the clinical efficacy and safety of Cefuzonam (CZON) in the treatment of chronic respiratory infections. Cefmenoxime (CMX) was used as a control drug. Each drug was administered by intravenous drip infusion 1g at a time, twice daily, for 14 days as a rule.
The results were as follows:
1. Treated in this study were 167 cases in total, 88 of CZON group and 79 of CMX group, but subjected for clinical evaluation by the evaluation committee were 147 cases, 77 of CZON group and 70 of CMX group, with 20 cases (11 of CZON group and 9 of CMX group) excluded from the committee's evaluation.
2. Clinical effectiveness assessed by the committee showed the efficacy rates of 81.8%(63 cases our of 77) for CZON group and 80.0%(56 cases out of 70) for CMX group, with no significant difference observed between the two drug groups. Also, there was no significant difference between the two groups in clinical efficacy evaluation by physicians in charge.
3. Classified by causal bacteria, clinical efficacy rates were 85.2% for CZON group and 78.6% for CMX group, and in single infection cases of gram-positive bacteria the effectiveness rates were 100% for CZON group and 75.0% for CMX group. In these two evaluations, CZON group showed higher efficacy percentages but no statistically significant difference was observed between the two drug groups. As for bacterial eradication rate, CZON group showed higher percentage but no significant difference was noted.
4. The incidence rate of abnormality in laboratory tests was lower for CZON than for CMX, but no significant difference was observed. Side effects incidence rates showed no significant difference between the two groups.
5. Usefulness rates by the evaluation of the committee were 77.9%(60 cases out of 77) for CZON group and 77.1%(54 cases out of 70) for CMX group, whereas evaluation by physicians in charge were 71.1%(54 cases out of 76) for CZON group and 82.6%(57 cases out of 69) for CMX group. In either evaluation, there was no significant difference observed between the two drug groups.
These results show that CZON is a useful drug in the treatment of chronic respiratory infections.
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