Seal Lawton A, Rizer Ronald L, Maas-Irslinger Rainer
Research and Development, HEALTHPOINT, Ltd., Fort Worth, TX 76107, USA.
Am J Infect Control. 2005 May;33(4):207-16. doi: 10.1016/j.ajic.2004.11.009.
The Centers for Disease Control and Prevention (CDC) has published guidelines for hand hygiene practices, recommending a handwash regimen that alternates between waterless alcohol products and antimicrobial or nonantimicrobial soap and water. The advent of an alcohol-based product that can be used with or without water (ie, water optional) to decontaminate the hands while providing immediacy of kill and antimicrobial persistence could reduce the confusion associated with handwash guidelines. Such a product has been developed, is alcohol-based (61%), and zinc pyrithione (ZPT) preserved (61% alcohol-ZPT) and has proven to be fully compliant with the Food and Drug Administration (FDA) and CDC guidelines.
FDA-required testing of the 61% alcohol-ZPT product for the health care personnel handwash indication was performed as outlined in the Tentative Final Monograph (TFM) for Health-Care Antiseptic Drug Products, employing waterless and water-aided product applications. It was next assessed for antimicrobial persistence and residual effects by comparing it, in separate waterless and water-aided applications, with commonly available handwashes containing various antimicrobials in a 5-day study employing 49 subjects, in which samples were collected immediately and at 4 hours and 8 hours postapplication. The skin conditioning properties of this formulation were investigated via appropriate methods.
The 61% alcohol-ZPT product easily produced >3.0 log 10 reduction in the indicator strain ( Serratia marcescens ) following the first wash, exceeding the 2.0 log 10 FDA requirement. This level of performance was maintained through the tenth wash, surpassing the 3.0 log 10 FDA requirement for the handwash indication. For the assessment of persistence and residual effect in the waterless mode, the water-optional, 61% alcohol-ZPT product consistently produced log 10 reductions of nearly 3.5 or greater at every point over the entire study period. In the water-aided configuration, similar results were obtained as log 10 reductions of 2.5 were observed. The formulation is nonirritating, actually contributing to hand skin condition.
The 61% alcohol-ZPT product exceeds all FDA criteria for the health care personnel handwash indication and is a significant advancement in the concept of skin antisepsis. It represents a single product suitable for use in all hand hygiene settings, demonstrating improved antimicrobial persistence and residual effects. The 61% alcohol-ZPT formulation contributes positively to overall hand conditioning, and a previously reported study has documented it to be virucidal for several DNA and RNA viruses.
美国疾病控制与预防中心（CDC）已发布手部卫生规范指南，推荐一种洗手方案，即无水酒精产品与抗菌或非抗菌肥皂和水交替使用。一种基于酒精的产品问世，该产品在洗手时可加水使用也可不加水使用（即是否用水可选），在快速杀菌和抗菌持续性方面表现出色，这可能会减少与洗手指南相关的困惑。这样一种产品已经研发出来，它以酒精为基础（61%），并添加了吡啶硫酮锌（ZPT）进行保存（61%酒精-ZPT），且已证明完全符合美国食品药品监督管理局（FDA）和CDC的指南。
按照《医疗保健用抗菌药品暂行最终专论》（TFM）中概述的方法，对61%酒精-ZPT产品进行FDA要求的医护人员洗手适应症测试，采用无水和加水辅助的产品应用方式。接下来，在一项为期5天、有49名受试者参与的研究中，通过将其在单独的无水和加水辅助应用中与含有各种抗菌剂的市售洗手液进行比较，评估其抗菌持续性和残留效果，在应用后立即、4小时和8小时采集样本。通过适当方法研究了该配方的皮肤调理特性。
61%酒精-ZPT产品在首次洗手后能轻松使指示菌株（粘质沙雷氏菌）的数量减少>3.0 log₁₀，超过了FDA要求的2.0 log₁₀。这种性能水平在第十次洗手时仍保持，超过了FDA对手洗适应症要求的3.0 log₁₀。对于无水模式下的持续性和残留效果评估，在整个研究期间的每个时间点，这种是否用水可选的61%酒精-ZPT产品始终能使数量减少近3.5 log₁₀或更多。在加水辅助模式下，也观察到了类似结果，数量减少了2.5 log₁₀。该配方无刺激性，实际上有助于手部皮肤状况。
61%酒精-ZPT产品超出了FDA对医护人员洗手适应症的所有标准，是皮肤消毒概念的一项重大进展。它代表了一种适用于所有手部卫生场景的单一产品，展示出了更好的抗菌持续性和残留效果。61%酒精-ZPT配方对整体手部调理有积极作用，并且此前的一项研究已证明它对多种DNA和RNA病毒具有杀病毒作用。
