CLINICAL EVALUATION OF CEFMENOXIME (SCE-1365) IN CHRONIC RESPIRATORY TRACT INFECTIONS
A COMPARATIVE STUDY WITH CEFOTIAM BY A RANDOMIZED DOUBLE BLIND TECHNIQUE
1982 Volume 30 Issue 6 Pages 613-636
Details
1982 Volume 30 Issue 6 Pages 613-636
Efficacy and safety of cefmenoxime (CMX, SCE-1365) and cefotiam (CTM) were compared by a randomized, double blind method. CMX as well as CTM were administered daily 2 gms, i. e. 2 times of 1 gm intravenous drip infusion, for consecutive 7 to 14 days. In total 162 cases, which consist of each 81 CMX and CTM allocated cases, were subjected to the analysis, and the following results were obtained.
1) In the distribution of patient-characteristics (background factor) between CMX and CTM allocated group, the statistical analysis showed there was no bias, which will virtually influence on the results.
2) Overall clinical efficacy rates of CMX and CTM were 77.0% and 60.3% respectively. CMX showed significantly higher clinical efficacy rate than CMX.(P<0.05).
3) As for the clinical efficacy rate by standard criteria, proposed by the representative investigators committee of this study, clinical efficacy rate of CMX and CTM were 71.6% and 58.8% respectively, and the higher clinical efficacy rate of CMX than CTM was shown.
4) Assessment of clinical usefulness judged by the physicians in charge revealed the higher clinical usefulness of CMX than CTM.
5) Reg.irding the bacteriulogical effect, CMX showed the higher elimination rate of H. infiuenzae than CTM.(P<0.1).
6) Improvement (if the puruleucy of sputum and rale were significantly faster in CMX than CTM.(P<0.05). In the stratified group, consisting of the cases whose prior chemotherapies were ineffective, CMX showed significantly higher clinical efficacy rate than CTM.
7) The incidence of side effects and the abnormal change of laboratory findings were significantly less in CMX than CTM, and there was no severe adverse reaction in either medication.
From the results of clinical response and side effects, it is considered that CMX clearly has a greater clinical usefulness than CTM in the treatment of chronic respiratory tract infections.
