Gaonkar T A, Geraldo I, Shintre M, Modak S M
Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
J Hosp Infect. 2006 Aug;63(4):412-7. doi: 10.1016/j.jhin.2006.03.005. Epub 2006 Jun 8.
Alcohol-based surgical hand disinfectants are widely available in healthcare settings. Some currently marketed alcohol-based products use active concentrations of antimicrobials to achieve the required efficacy, raising the risk for exposure to potentially irritating levels of antimicrobials. This study compares the in vitro and in vivo efficacy of an alcohol-based surgical hand preparation containing 70% ethanol and preservative levels of chlorhexidine gluconate (CHG) and benzalkonium chloride (BZK) in synergistic combination with ethylhexylglycerin (Surgicept) with a surgical hand disinfectant containing 61% ethanol and 1% CHG (Avagard). The in vivo efficacy of Surgicept and Avagard was evaluated in volunteers using the Tentative Final Monograph method of the Food and Drug Administration (FDA), and their prolonged effect against transient pathogens was compared using a pig skin model. Surgicept exceeded the FDA requirements for surgical hand antiseptic with mean log(10) reductions of 2.36, 3.3 and 3.54 in resident flora 1 min after initial application, and showed a persistent effect with mean log(10) reductions of 2.23, 2.73 and 3.3, 6h post application on days 1, 2 and 5, respectively. Surgicept showed a superior prolonged effect against transient bacteria compared with Avagard. Surgicept (70% alcohol and preservative levels of CHG and BZK) may provide similar in vivo efficacy as Avagard (61% ethanol and 1% CHG).
含酒精的外科手消毒剂在医疗机构中广泛可得。目前市场上一些含酒精的产品使用抗菌剂的有效浓度来达到所需的功效，这增加了接触潜在刺激性水平抗菌剂的风险。本研究比较了一种含70%乙醇、葡萄糖酸氯己定（CHG）和苯扎氯铵（BZK）与乙基己基甘油协同组合作为防腐剂的含酒精外科手消毒剂（Surgicept）和一种含61%乙醇和1%CHG的外科手消毒剂（Avagard）的体外和体内功效。使用美国食品药品监督管理局（FDA）的暂行最终专论方法在志愿者中评估了Surgicept和Avagard的体内功效，并使用猪皮模型比较了它们对暂居病原体的长效作用。Surgicept在初次应用1分钟后对常驻菌群的平均对数（10）减少量分别为2.36、3.3和3.54，超过了FDA对外科手消毒的要求，并且在第1天、第2天和第5天应用后6小时分别显示出持续作用，平均对数（10）减少量为2.23、2.73和3.3。与Avagard相比，Surgicept对暂居细菌显示出更优的长效作用。Surgicept（70%酒精以及CHG和BZK的防腐剂水平）可能提供与Avagard（61%乙醇和1%CHG）相似的体内功效。
