CEFMINOX VERSUS CEFOXITIN IN HYSTERECTOMY PROPHYLAXIS - CLINICAL EFFICACY AND SERUM AND TISSUE CONCENTRATIONS

This phase III, prospective, randomised, open, controlled clinical tri al compared the efficacy of single-dose cefminox (2g) versus triple-do se cefoxitin (2g every 4 hours) as antibiotic prophylaxis in 112 women undergoing gynaecological surgery (vaginal or abdominal hysterectomy) . Peak, intraoperative and trough serum concentrations were determined for both antibiotics, as well as their concentrations in myometrial t issue in a subset of patients from the study (22 patients from the cef minox group and 18 from the cefoxitin group). Clinical response was sa tisfactory in all women treated with cefminox (59 of 59) and in 52 of 53 patients treated with cefoxitin. Fever-related morbidity, hospital stay and adverse reactions were similar in both groups. Peak serum con centrations were 132.3 mg/L for cefminox and 82.2 mg/L for cefoxitin. 12-hour concentrations were 2.82 mg/L for cefminox and 2.17 mg/L for c efoxitin, and were higher than the respective minimum inhibitory conce ntrations (MICs) for pathogens commonly associated with this pathology . Uterine tissue concentrations were 24.5 and 41.6 mg/L for cefminox a nd cefoxitin, respectively, and also clearly exceeded MIG. It was show n that the use of a single preoperative dose of cefminox was similar i n efficacy to 3 doses of cefoxitin administered every 4 hours, and tha t the serum and tissue concentrations attained provide adequate antibi otic coverage. In view of the general trend towards the use of a singl e dose for prophylaxis, cefminox offers a new alternative fur antibiot ic prophylaxis in gynaecological surgery.