For an objective evaluation of the clinical efficacy and safety of carumonam (CRMN) in chronic respiratory infections due to gram-negative rod bacteria, a double-blind study was conducted using cefoperazone (CPZ) as a positive control. Either 1 g of CRMN or CPZ per dose was administered by the intravenous drip infusion twice a day and, as a rule, for 14 consecutive days. The results were as follows:
1) Homogeneity testing of background factors showed that
P. aeruginosa as the causative organism was more frequently detected in the CRMN group with a significant difference (p<0.05) but no bias was found in any other background factor.
2) The clinical efficacy rate (excellent and good ratings combined) was: in the committee evaluation, 51.6%(32/62) for CRMA versus 58.2%(39/67) for CPZ, and in the presiding doctor evaluation, 65.1%(41/63) for CRMN versus 66.7%(44/66) for CPZ. Thus, both evaluations generated similar results.
As
P. aeruginosa was detected more frequently in the CRMN group, the bias was corrected by the direct standardization method. The corrected efficacy rate was: in the committee evaluation, 55.0% for CRMN versus 54.2% for CPZ and in the presiding doctor evaluation, 66.9% for CRMN versus 62.8% for CPZ.
3) There was no intergroup difference in improvement rates for symptoms and laboratory findings. However, when the population for analysis was limited to cases with
P. aeruginosa as a causative organism, the improvement rate for sputum property in the CRMN group was significantly higher than in the CPZ group (p<0.05).
4) As to bacteriological effect, the eradication rate was 56.5%(35/62) for CRMN versus 53.8%(35/65) for CPZ. In regard to
P. aeruginosa which was most frequently isolated, the eradication rate was 51.4%(18/35) for CRMN versus 31.8%(7/22) for CPZ, thus being in favor of CRMN. A more remarkable difference was found when “decreased” ratings were included; thus 71.4% for CRMN versus 45.5% for CPZ (p<0.1).
5) The safety evaluation showed that the two drugs were almost equivalent in regard to the incidence of side effects and abnormal laboratory findings; 23.5%(23/98) for CRMN versus 24.4%(22/90) for CPZ.
With both drugs, allergic symptoms such as fever and eruption and gastrointestinal symptoms such as diarrhea were found as accompanying symptoms. Most of the abnormal laboratory findings were changes in liver function and hematology parameters for both drugs. No side effects were found with CRMN that are particularly different from those reported with the cephem drugs.
6) The clinical usefulness rate covering “useful” and higher ratings was: in the committee evaluation, 48.4%(31/64) for CRMN versus 54.5%(36/66) for CPZ and in the doctor evaluation, 61.9%(39/63) for CRMN versus 62.5%(40/64) for CPZ. Thus, the two drugs generated similar usefulness rates. However, the clinical usefulness rate after correction of the bias in the frequency of
P. aeruginosa according to the same procedure as 2) was: in the committee evaluation, 51.9% for CRMN versus 51.0% for CPZ and in the presiding doctor evaluation, 64.2% for CRMN versus 58.7% for CPZ.
In efficacy and safety, CRMN was found to be equivalent to CPZ. In consideration of the fact that
P. aeruginosa is frequently isolated in chronic respiratory infections, it is concluded that CRMN is an extremely useful drug in the treatment of these infections.
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