Amland P F, Andenaes K, Samdal F, Lingaas E, Sandsmark M, Abyholm F, Giercksky K E
Department of Plastic Surgery, Norwegian National Hospital, Oslo, Norway.
Plast Reconstr Surg. 1995 Nov;96(6):1378-83. doi: 10.1097/00006534-199511000-00022.
Over a 9-month period from September of 1991 to May of 1992, 339 patients were included in a randomized, double-blind, placebo-controlled study using azithromycin as the prophylactic agent to determine whether it effects a clinically meaningful reduction in postoperative surgical infections in plastic surgery. Azithromycin was given as prophylaxis in 171 patients and placebo in 168 patients. The study medication was a single oral dose taken at 8 P.M. the day before surgery. The patients were followed up for a minimum of 4 weeks after surgery. The patients who received wound infection prophylaxis had 5.1 percent infections compared with 20.5 percent in the placebo group (p = 0.00009). Eighty percent of all wound infections were first seen after discharge, explaining why plastic surgeons might overlook their infectious complications. There was a significant reduction in postoperative complications (p = 0.04) and in the additional use of antibiotics postoperatively (p = 0.007) in the prophylaxis group. Subgroup analysis showed a significant reduction in surgical infections in breast surgery (p < 0.05) and reconstructive surgery with flaps (p < 0.05). No effect of the prophylactic regime was demonstrated in patients undergoing secondary surgery for cleft lip and palate disease.
在1991年9月至1992年5月的9个月期间，339名患者被纳入一项随机、双盲、安慰剂对照研究，使用阿奇霉素作为预防药物，以确定其是否能在整形外科手术中使术后手术感染实现具有临床意义的减少。171名患者接受阿奇霉素预防治疗，168名患者接受安慰剂治疗。研究药物为手术前一天晚上8点服用的单次口服剂量。患者术后至少随访4周。接受伤口感染预防治疗的患者感染率为5.1%，而安慰剂组为20.5%（p = 0.00009）。所有伤口感染中有80%在出院后首次出现，这解释了整形外科医生可能忽视其感染并发症的原因。预防组术后并发症（p = 0.04）和术后额外使用抗生素的情况（p = 0.007）均有显著减少。亚组分析显示，乳房手术（p < 0.05）和皮瓣重建手术（p < 0.05）中的手术感染显著减少。在接受唇腭裂疾病二次手术的患者中，未证明预防方案有效果。
