Abstract
A clinical study on panipenem/betamipron (PAPM/BP), a new carbapenem antibiotic for injection, was carried out in surgical infections, especially intraabdominal infection, postoperative infection, and dermal soft tissue infection.
PAPM/BP was administered in 46 patients, 9 with peritonitis, 8 with cholecystitis and/or cholangitis, 4 with periproctal abscess, 4 with phlegmon, 2 with abdominal wall abscess, 3 with wound infection, 3 with intra-abdominal abscess, 2 with sepsis, 1 each with liver abscess, ischiorectal fossa abscess, perirectal abscess, psoas abscess, purulent ophthalmia, osteomyelitis, infective endocarditis, pleurisy, pyelonephritis, and 2 with postoperative pneumonia. The severity of these diseases was classified as serious in 7 (15.2%), moderate in 35 (76.1%), and mild in 4 (8.7%).
Of the 46 patients the clinical efficacy was excellent in 11, good in 26, fair in 6, and poor in 3, disclosing an 80.4% efficacy rate.
Pathogens were isolated from 22 of 46 patients. The clinical efficacy according to isolates was excellent in 6 patients, good in 12, fair 3, and poor in 1, disclosing an 81.8% efficacy rate. In bacteriological study, of 22 cases pathogens were eradicated in 14, replaced in 4, partially eradicated in 2, unchanged in 1, and unknown in 1, disclosing an 85.7% eradication rate.
The clinical efficacy in the cases having poor responses to previous treatment was found to be good or better in 15 of 19 patients, disclosing a 78.9% efficacy rate.
As for side effects, nausea occurred in a patient as a subjective or objective side effect of the treatment. As for abnormal laboratory findings, eosinophilia and abnormal liver function values were respectively found in 1 and 6 patients. Thus the incidence of side effects was calculated to be 15.2%.
MICs against 50 strains of 29 species isolated from clinical specimens were distributed over 6.25μg/ml or below in 49 of the 50 strains (98%).