A CLINICAL STUDY ON PANIPENEM/BETAMIPRON IN CHRONIC RESPIRATORY TRACT INFECTIONS

Abstract

Panipenem/betamipron (CS-976, PAPM/BP), a new carbapenem antibiotic, was administered a single dose of 500mg or 750mg via intravenous drip infusion twice a day for teatment of chronic respiratory infection to study its clinical efficacy, bacteriological efficacy and safety. Twenty nine cases were studied for the efficacy evaluation. Only the safety evaluation was made in 6 cases which were judged to be unsuitable, because in some of them pneumonia and other diseases were not specified as the subject diseases, of serious illness in some the conditions were too serious, and in the other cases the duration of administration was insufficient since administration had to be discontinued due to side-effects. The duration of administration was 6 to 18 days with 1g divided into 2 doses daily or 4 to 15 days with 1.5g in 2 divided doses daily.
When clinical efficacies were classified according to different diseases, this preparation was effective in 11 cases and slightly effective in 1 case of 12 cases of chronic bronchitis with an efficacy rate of 91.7%. It was effective in 10 cases, slightly effective in 1 case and ineffective in 1 case of 12 cases of bronchiectasis with an efficacy rate of 83.3%. It was slightly effective in 2 and ineffective in 1 out of 3 cases of diffuse panbronchiolitis, and was effective in 2 cases of pulmonary emphysema with infections. PAPM/BP was given at a dose level of 1g in 2 divided doses daily to 17 cases and that of 1.5 g in 2 divided doses daily to 10 cases. For the remaining 2 cases, changes in the dose level were made in middle course of treatment. The efficacy rate in the 1g regimen was 76.5% and that with the 1.5g regimen was 90%. The overall results in the 29 cases included 23 effective, 4 slightly effective and 2 ineffective cases, thus the overall efficacy rate was 79.3%. As pathogens, 11 species including 24 strains were isolated and identified from 19 cases. They were Gram-positive cocci including 2 strains each of Staphylococcus aureus and Streptococcus pneumoniae, 1 strain each of Staphylococcus epidermidis, Streptococcus sanguis, and Streptococcus viridans and a strain of Streptococcus spp., and Gram-negative rods including 9 strains of Psudomonas aeruginosa, 4 strains of Haemophilus influenzae and 1 strain each of Klebsiella pneumoniae, Enterobacter cloacae and Pseudomonas spp. Bacteriological efficacies against these 24 strains of pathogens were: disappearance, 8; decreased, 2; substituted, 8; unchanged, 3; and unassessed, 3 strains, hence the eradication rate was 76.2% (16/21). Three of the unchanged strains and the 2 decreased strains were P. aeruginosa. Side effects were noted in 2 cases in which the dose level was 1g daily administered in 2 divided doses. They included 1 cases each of rash and palpitation/sleeplessness/ itching. All these symptoms were mild and disappeared rapidly upon discontinuance of the regimen. Abnormal laboratory test results were observed in 8 cases including 2 cases of elevation of LDH, 1 case of eosinophilia, 1 case of increased basophilic leukocytes and 1 case each of elevation of GOT, bilirubin, BUN and NAG. They were all mild and transient, and posed no clinical problems at all.