Rotter M L, Simpson R A, Koller W
Hygiene-Institute of University, Vienna, Austria.
Infect Control Hosp Epidemiol. 1998 Oct;19(10):778-81. doi: 10.1086/647723.
To establish the concentration of isopropanol that exerts the same immediate and sustained effects as n-propanol 60% v/v in surgical scrubbing, and to assess the performance of the test method proposed as the European standard in parallel experiments.
Isopropanol at concentrations of 70%, 80%, and 90% v/v was tested in comparison with n-propanol 60%, the proposed reference preparation, in the draft method proposed by the European standard. A Latin square design was used with four balanced blocks of five volunteers each in four experimental runs that were spaced by intervals of 1 week each. Volunteers were allotted randomly to one of the four blocks. Independently, the volunteers' right and left hands also were randomized into two groups for the assessment of either immediate or sustained effects.
Two laboratories supervised by two investigators, one from Vienna, Austria, and one from London, The United Kingdom.
The release of skin flora from the fingertips of clean hands was assessed before and after treatment by immediate sampling from one hand and by sampling of the other, gloved hand after 3 hours. The mean log10 reductions (RF) of bacterial release achieved by rubbing the alcoholic preparations for 3 minutes onto the hands were established.
For both experiments, the immediate effects of isopropanol 70% (RF, 2.0 and 2.1, respectively) were significantly smaller than those of the reference n-propanol 60% (RF, 2.4 and 2.6, respectively). This also was found with the sustained effects (RF, 0.7 and 1.1 vs 1.0 and 1.6, respectively). At 90%, isopropanol equalled the immediate effect of n-propanol 60%, whereas at 80% it proved slightly (although not significantly) less active. There were no significant differences in the results of both investigators. The sustained effects of isopropanol 80% and 90% were both larger than the reference in Vienna but were found smaller by the London investigator; none of the differences were significant. Mean RFs were significantly different between Vienna and London with n-propanol 60% and isopropanol 70%, but not with isopropanol at 80% or 90%.
At 90%, isopropanol is as effective as n-propanol 60%, which was proposed by the European Committee for Standardization as a reference in testing products for surgical hand disinfection. It could, therefore, serve as an alternative if the proposed agent is undesirable for any reason. In parallel experiments by two investigators, the proposed test method proved well workable; the results were very similar and the conclusions identical.
确定在外科洗手过程中产生与60%（v/v）正丙醇相同即时和持续效果的异丙醇浓度，并在平行实验中评估作为欧洲标准提出的测试方法的性能。
按照欧洲标准草案中的方法，对体积分数为70%、80%和90%的异丙醇与建议的参比制剂60%正丙醇进行了测试。采用拉丁方设计，在四个实验批次中，每个批次有四个平衡区组，每个区组有五名志愿者，批次间隔为1周。志愿者被随机分配到四个区组之一。另外，志愿者的右手和左手也被随机分为两组，分别用于评估即时效果或持续效果。
由两名研究者监督的两个实验室，一名来自奥地利维也纳，一名来自英国伦敦。
通过在洗手前从一只手即时采样以及在洗手3小时后从戴手套的另一只手采样，评估清洁手部指尖皮肤菌群的释放情况。确定通过将酒精制剂在手上揉搓3分钟所实现的细菌释放的平均log10减少量（RF）。
在两个实验中，70%异丙醇的即时效果（RF分别为2.0和2.1）均显著小于参比制剂60%正丙醇的即时效果（RF分别为2.4和2.6）。持续效果方面也是如此（RF分别为0.7和1.1，对比1.0和1.6）。90%的异丙醇即时效果与60%正丙醇相当，而80%的异丙醇活性略低（尽管不显著）。两位研究者的结果无显著差异。在维也纳，80%和90%异丙醇的持续效果均大于参比制剂，但伦敦的研究者发现其较小；所有差异均不显著。60%正丙醇和70%异丙醇在维也纳和伦敦的平均RFs有显著差异，但80%和90%异丙醇则无。
90%的异丙醇与欧洲标准化委员会提议作为外科手消毒产品测试参比的60%正丙醇效果相同。因此，如果出于任何原因建议使用的制剂不合适，它可以作为替代。在两位研究者进行的平行实验中，提议的测试方法证明可行；结果非常相似，结论相同。
