RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL PROGRAM OF SINGLE-DOSE CEFTIZOXIME VERSUS MULTIPLE-DOSE CEFOXITIN AS PROPHYLAXIS FOR PATIENTS UNDERGOING VAGINAL AND ABDOMINAL HYSTERECTOMY

In a series of three double-blind, controlled, clinical studies, the e fficacy and safety of a single 1 gram dose of ceftizoxime were compare d with those of a standard regimen, three 2 gram doses of cefoxitin, f or prophylaxis of perioperative infection in women undergoing abdomina l or vaginal hysterectomy. Two hundred and twenty-seven patients recei ved ceftizoxime prophylaxis and 234 patients received cefoxitin prophy laxis. Study I entered 110 patients in Dallas, Texas and Los Angeles, California. Study 2 entered 242 patients in Canada. Study 3 entered 10 9 patients in Denver, Colorado. Within studies, the distribution of su rgical procedures was comparable between antibiotic groups. The groups were similar for demographic and medical factors at each center and o verall. Analyses were performed within and across studies, applying co nsistent criteria to the selection of evaluable patients and to the de finitions of prophylactic success and primary and secondary prophylact ic failure. Three hundred and sixteen patients were evaluable, 160 who received ceftizoxime and 156 who received cefoxitin. Overall, complet e prophylactic success occurred in 138 of 160 evaluable patients (86.3 percent) receiving ceftizoxime and 128 of 156 evaluable patients (82. 1 percent) receiving cefoxitin. Prophylactic success rates differed by study as well as by type of hysterectomy. In studies I and 2, prophyl actic success rates for ceftizoxime were 95.1 and 87.6 percent, respec tively, versus 93.1 and 87.8 percent for cefoxitin. In study 3, succes s rates were lowest, 70.0 percent for ceftizoxime and 59.5 percent for cefoxitin. Among evaluable patients overall, prophylactic success rat es after vaginal hysterectomy were 91.0 percent for those receiving ce ftizoxime and 85.1 percent for those receiving cefoxitin. After abdomi nal hysterectomy, success rates were 78.3 percent for both groups. Feb rile morbidity rates and duration of hospitalization were comparable f or both groups across all studies and within individual studies. Cefti zoxime and cefoxitin were safe and well tolerated. The results of thes e controlled studies indicate that single-dose ceftizoxime is as effec tive and safe as multiple-dose cefoxitin when used as adjunctive chemo prophylaxis in patients at risk of postoperative infection after vagin al or abdominal hysterectomy.