Lewis R T, Weigand F M, Mamazza J, Lloyd-Smith W, Tataryn D
Department of Surgery, Queen Elizabeth Hospital, McGill University, Montreal, Quebec, Canada.
Surgery. 1995 Oct;118(4):742-6; discussion 746-7. doi: 10.1016/s0039-6060(05)80044-3.
The incidence of surgical site infection (SSI) after clean surgical procedure has traditionally been regarded as too low for routine antibiotic prophylaxis. But we now know that host factors may increase the risk of SSI to as high as 20%. We assessed the value of prophylactic cefotaxime in patients stratified for risk of SSI in a randomized double-blind trial.
Patients admitted for clean elective operations were enrolled, stratified for risk by National Nosocomial Infection Survey criteria, and randomized to receive intravenous cefotaxime 2 gm or placebo on call for operation. They were followed for 4 to 6 weeks for SSI diagnosed by Centers for Disease Control and Prevention criteria.
Analysis of 775 patients showed that the 378 evaluable patients who received cefotaxime had 70% fewer SSI than those who did not--Mantel-Haenszel risk ratio (MH-RR) 0.31; 95% confidence intervals (CI) 0.11 to 0.83. Benefit was clear in the 616 low risk patients--0.97% versus 3.9% SSI (MH-RR 0.25, CI 0.07 to 0.87, p = 0.018), but only a trend was seen in 136 high risk patients--2.8% versus 6.1% SSI (MH-RR 0.48, CI 0.09 to 2.5).
The results indicate clear benefit for routine antibiotic prophylaxis in clean surgical procedures. High risk patients need more study.
传统上认为清洁手术术后手术部位感染（SSI）的发生率过低，无需常规使用抗生素预防。但我们现在知道，宿主因素可能会使SSI的风险增加至20%。我们在一项随机双盲试验中评估了预防性使用头孢噻肟对分层后的SSI风险患者的价值。
纳入因择期清洁手术入院的患者，根据国家医院感染调查标准进行风险分层，并随机分为两组，一组在手术前静脉注射2克头孢噻肟，另一组注射安慰剂。按照美国疾病控制与预防中心的标准对患者进行4至6周的随访，以诊断是否发生SSI。
对775例患者的分析显示，接受头孢噻肟治疗的378例可评估患者的SSI发生率比未接受治疗的患者低70%——曼特尔-亨塞尔相对危险度（MH-RR）为0.31；95%置信区间（CI）为0.11至0.83。在616例低风险患者中，受益明显——SSI发生率分别为0.97%和3.9%（MH-RR 0.25，CI 0.07至0.87，p = 0.018），但在136例高风险患者中仅呈现出一种趋势——SSI发生率分别为2.8%和6.1%（MH-RR 0.48，CI 0.09至2.5）。
结果表明在清洁手术中进行常规抗生素预防有明显益处。高风险患者需要更多研究。
