Jeng D K, Severin J E
Allegiance Healthcare Corporation, McGaw Park, IL 60085, USA.
Am J Infect Control. 1998 Oct;26(5):488-94. doi: 10.1016/s0196-6553(98)70021-5.
Simplifying and shortening the skin-preparation application procedure is desirable for many reasons, which include labor-cost savings and improved suite utilization. A new formulation, PVP-I Gel Alcohol (PGA) that contains 5% PVP-I and 62% ethanol in gel form, was developed to achieve a shorter preparation time with a rapid and persistent efficacy on a broad spectrum of microorganisms and to minimize the potential for iodine irritation.
The test methods outlined in the Federal Register, 21 CFR Parts 333 and 369, "Tentative Final Monograph for Health-Care Antiseptic Drug Products;" Proposed Rule, 1994 (Monograph), were adapted in this study. Efficacy of PGA was evaluated, both in vitro and in vivo. The in vitro time-kill and minimum inhibition concentration tests were conducted by using 33 strains of aerobic and anaerobic gram-positive bacteria, gram-negative bacteria, yeasts, and antibiotic-resistant bacteria. In the clinical test, the inguinal and abdominal skin sites of human subjects were exposed to PGA for 30 seconds to assess the antimicrobial efficacy on normal skin flora. Betadine PVP-I scrub was tested in a 5-minute application as a control.
The time-kill test showed that PGA delivered a rapid antimicrobial activity--reducing greater than 3 to 8 log microorganisms in 15 seconds in all of the 33 species of microorganisms tested. Within 30 seconds, all challenge organisms were reduced below detection level. Results of the minimum inhibition concentration test showed that PGA demonstrated an equivalent activity to Betadine control under the testing conditions. In the clinical test, PGA was effective in the reduction of greater than 3 log and 2 log of normal skin flora, respectively, in inguinal and abdominal sites in a single-step 30-second application. Bacteria levels remained significantly below the baseline for 6 hours in the primary study and for 24 hours in a secondary study. These results show that the current PGA formulation with a 30-second application delivers an efficacy equivalent to Betadine scrub in a 5-minute application and that the PGA formulation has a long-lasting effect--up to 24 hours.
The PGA formulation delivered rapid and persistent antimicrobial activity against a broad spectrum of bacteria both in vitro and in vivo. PGA is an effective skin-preparation formulation for use in a single-step 30-second application.
出于多种原因，简化和缩短皮肤准备应用程序是很有必要的，这些原因包括节省劳动力成本和提高手术室利用率。一种新的配方，即含有5%聚乙烯吡咯烷酮碘（PVP-I）和62%乙醇的凝胶形式的PVP-I凝胶酒精（PGA）被开发出来，以实现更短的准备时间，对广泛的微生物具有快速且持久的功效，并将碘刺激的可能性降至最低。
本研究采用了《联邦法规汇编》第21 CFR部分333和369中概述的测试方法，即“保健抗菌药品暂行最终专论”；1994年的拟议规则（专论）。对PGA的功效进行了体外和体内评估。使用33株需氧和厌氧革兰氏阳性菌、革兰氏阴性菌、酵母菌和耐抗生素菌进行了体外时间杀灭和最低抑菌浓度测试。在临床试验中，将人体受试者的腹股沟和腹部皮肤部位暴露于PGA 30秒，以评估其对正常皮肤菌群的抗菌功效。以5分钟涂抹的聚维酮碘擦洗剂（Betadine PVP-I scrub）作为对照进行测试。
时间杀灭测试表明，PGA具有快速的抗菌活性——在所有33种受试微生物中，15秒内可使微生物数量减少超过3至8个对数级。在30秒内，所有受试微生物均减少至检测水平以下。最低抑菌浓度测试结果表明，在测试条件下，PGA表现出与聚维酮碘对照相当的活性。在临床试验中，PGA在单次30秒涂抹时，分别有效减少了腹股沟和腹部部位超过3个对数级和2个对数级的正常皮肤菌群。在主要研究中，细菌水平在6小时内显著低于基线，在次要研究中在24小时内显著低于基线。这些结果表明，当前30秒涂抹的PGA配方在功效上等同于5分钟涂抹的聚维酮碘擦洗剂，并且PGA配方具有持久的效果——长达24小时。
PGA配方在体外和体内均对广泛的细菌具有快速且持久的抗菌活性。PGA是一种有效的皮肤准备配方，可用于单次30秒的涂抹。
