新格兰医学——洗必泰醇与聚维酮碘在预防SSI中的效果比较

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在去年新英格兰发表一篇研究报道，在6家医院中，开展前瞻性，随机化的临床实验，评价了“洗必泰醇（Chlorhexidine–Alcohol）与聚维酮碘（Povidone–Iodine）在预防SSI中的效果比较”。文献出处：N Engl J Med 2010;362:18-26.
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翻译摘要：
BACKGROUND

Since the patient’s skin is a major source of pathogens that cause surgical-site infection, optimization of preoperative skin antisepsis may decrease postoperative infections. We hypothesized that preoperative skin cleansing with chlorhexidine–alcohol is more protective against infection than is povidone–iodine.
METHODS
We randomly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine–alcohol scrub or povidone–iodine scrub and paint. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections.
RESULTS
A total of 849 subjects (409 in the chlorhexidine–alcohol group and 440 in the povidone–iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine–alcohol group than in the povidone–iodine group (9.5% vs. 16.1%; P = 0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine–alcohol was significantly more protective than povidone–iodine against both superficial incisional infections (4.2% vs. 8.6%, P = 0.008) and deep incisional infections (1% vs. 3%, P = 0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups.
CONCLUSIONS
Preoperative cleansing of the patient’s skin with chlorhexidine–alcohol is superior to cleansing with povidone–iodine for preventing surgical-site infection after clean contaminated surgery.
由于病人的皮肤是引起外科手术部位感染主要的致病原，最佳的术前皮肤消毒可能减少术后感染的发生。我们假设，洗必泰醇在预防感染中保护作用优于聚维酮碘。我们将成年人随机分配在进行试验的6家医院，分成两组洗必泰醇擦拭组合聚维酮碘擦拭和涂抹组。本研究的主要预后是术后30天内发生的SSI。第二结局包括SSI的个体类型。共有849例患者符合本项干预-处理研究的分析（洗必泰醇组：409例；聚维酮碘组：440例）。研究表明，洗必泰醇组发生SSI的风险要显著低于聚维酮碘组（9.5% vs. 16.1%; P = 0.004; RR, 0.59; 95% CI, 0.41 to 0.85）。洗必泰醇对表皮切口感染和深部切口感染均有显著的保护效应（4.2% vs. 8.6%, P = 0.008；1% vs. 3%, P = 0.05）但是对于OSI的保护效应并不显著（4.4% vs. 4.5%）。相似的结果页在“完成治疗分析”中发现，在这项分析中，共随访30天，合计813例病患。两组药物的负作用相似。术前病患使用洗必泰醇进行皮肤清洁在预防清创术后的SSI的效果优于聚维酮碘。