Fundamental and clinical studies on a new
cephalosporin antibiotic,
cefpiramide (CPM), was carried out under a joint study program, in order to evaluate the usefulness of the
drug in treating
infection of the female genital organs. The results obtained were as follows: CPM was readily transported to female genital organ tissues, and the concentrations of the
drug exceeded 35 micrograms/g in various organ tissues in about 1 hour, following
intravenous injection of 1 g. A level of more than 2 micrograms/g was maintained even 14 hours after the injection. The transport of CPM to various tissues was also studied following
intravenous drip infusion of 1 g for 1 hour. The concentrations in tissues were slightly low but similar to those following
intravenous injection. The peak concentration of the
drug in the dead space exudate was 3.1-20.4 micrograms/ml, following
intravenous injection and
intravenous drip infusion of 1 g. The MIC80 of CPM were 3.13-12.5 micrograms/ml against S. aureus, Klebsiella sp., P. mirabilis and P. aeruginosa. Clinical effects of CPM were analyzed in 158 patients, including 56 cases with intrauterine
infection, 37 cases with intrapelvic
infection, 22 cases with external genital
infection, 31 cases with
adnexitis, 6 cases with
postoperative wound infection and 6 cases with other
infections. Excellent response was seen in 28 cases (17.7%), good response in 120 (75.9%) poor response in 10 (6.3%). The rate of response was calculated as 93.7%. Safety of the
drug was analyzed in 258 patients, and side effects occurred in 4 (1.6%). Of these 4 patients,
rash was in 1 patient, heat sensation in 1 patient,
nausea in 1 patient and
rash accompanying
edema in 1 patient. Abnormal values in clinical laboratory findings were seen in 7 patients. Elevations of
transaminase were seen in 5 patients and decrease of platelet was seen in a patient, and then elevations of
transaminase with decrease of platelet was seen in a patient, and no other changes of particular note appeared.