[Experimental and clinical evaluation of cefotetan in obstetrics and gynecology].

Fundamental and clinical studies on a new cephamycin antibiotic, cefotetan (CTT) was carried out under a joint study programme, in order to evaluate the usefulness of the drug in treating infections of the female genital organs. The results obtained were as follows. CTT was readily transported to female genital organ tissues, and the concentrations of the drug exceeded 20 micrograms/g in various organ tissues in about 1 hour, following intravenous injection of 1 g. A level of more than 1 microgram/g was maintained even 12 hours after the injection. The transport of CTT to various tissues was also studied following intravenous drip of 1 g in 30 minutes or 1 hour. The results were similar to those following intravenous injection. The peak concentration of the drug in the dead space exudate tended to appear slightly later than those in the organ tissues. However, the concentration reached a level of more than 10 micrograms/ml following intravenous injection of 1 g. Clinical effects of CTT were analyzed in 225 patients, including 65 cases with intrauterine infection, 60 cases with intrapelvic infection, 22 cases with external genital infection, 55 cases with adnexitis, 8 cases with mastitis, 8 cases with postoperative wound infection and 7 cases with other infections. Excellent response was seen in 53 (23.6%), moderate response in 150 (66.7%), and no response in 22 (9.8%). The rate of response was calculated as 90.2%. Safety of the drug was analyzed in 273 patients, and side effects occurred in 11 (4.0%) patients. Of these 11 patients, rash was seen in 4 patients, rash accompanying edema in 1, rash accompanying diarrhea in 1, chest discomfort in 2 and feeling of general fatigue in 2. Abnormal values in clinical laboratory findings were seen in 10 patients. Elevations of transaminase were seen in 7 patients, and no other changes of particular note appeared.