Johnson J T, Kachman K, Wagner R L, Myers E N
Department of Otolaryngology and Radiation Oncology, University of Pittsburgh School of Medicine, PA 15213, USA.
Head Neck. 1997 Aug;19(5):367-71. doi: 10.1002/(sici)1097-0347(199708)19:5<367::aid-hed1>3.0.co;2-y.
Patients requiring major oncologic head and neck surgery are at high risk for postoperative wound infection when the surgical site is contaminated by secretions from the upper aerodigestive tract. Studies to identify agents active in the prevention of postoperative wound infection may serve to reduce patient morbidity.
Patients scheduled for a major contaminated head and neck surgical procedure were randomly assigned to receive either ampicillin/sulbactam or clindamycin. Medication was administered 1 to 2 hours prior to surgery and every 6 hours, for a total of five doses. Postoperatively, patients were followed daily for the development of wound infection or other septic complication.
A total of 242 patients were enrolled in the study; 119 received ampicillin/sulbactam, and 123 received clindamycin. A total of 169 patients were considered evaluable. Of the evaluable patients, 14% in each group developed a postoperative wound infection. There were no statistically significant differences between the number of days to onset of wound infection, nor was there a statistically significant difference in the rate of non-wound infections in the two groups. There were no statistically significant differences between the intent to treat group and the evaluable group of patients.
It is concluded that ampicillin/sulbactam is as safe and effective as clindamycin in preventing postoperative wound infection following major head and neck surgery.
当手术部位被上呼吸道消化道分泌物污染时，需要进行大型肿瘤性头颈手术的患者术后伤口感染风险很高。确定预防术后伤口感染有效药物的研究可能有助于降低患者发病率。
计划进行大型污染性头颈外科手术的患者被随机分配接受氨苄西林/舒巴坦或克林霉素治疗。在手术前1至2小时给药，每6小时给药一次，共给药五剂。术后，每天对患者进行随访，观察伤口感染或其他败血症并发症的发生情况。
共有242例患者纳入研究；119例接受氨苄西林/舒巴坦治疗，123例接受克林霉素治疗。共有169例患者被认为可评估。在可评估的患者中，每组有14%发生了术后伤口感染。两组伤口感染发生天数无统计学显著差异，两组非伤口感染率也无统计学显著差异。意向性治疗组和可评估患者组之间无统计学显著差异。
得出结论，在预防大型头颈手术后的术后伤口感染方面，氨苄西林/舒巴坦与克林霉素一样安全有效。
