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六种用于卫生手消毒的含酒精手部消毒剂的皮肤耐受性和用户可接受性的临床双盲试验。

Clinical double-blind trial on the dermal tolerance and user acceptability of six alcohol-based hand disinfectants for hygienic hand disinfection.

作者信息

Kramer A, Bernig T, Kampf G

机构信息

Institut für Hygiene und Umweltmedizin, Ernst-Moritz-Arndt-Universität Greifswald, Hainstr. 26, Germany.

出版信息

J Hosp Infect. 2002 Jun;51(2):114-20. doi: 10.1053/jhin.2002.1223.

Abstract

Six commercially available alcohol-based hand rubs [AHD 2000, Desderman, Mucasept A, Manorapid (Poly-Alkohol, Spitacid, and Sterillium] were investigated in a clinical double-blind trial involving 10 participants who had no previous experience of using hand rubs (Group 1), and seven who had substantial professional experience of using hand rubs (Group 2; virology laboratory staff). Group 1 was studied for one week with 20 applications on day 1 and then five applications per day for six days. Transepidermal water loss, dermal water content and superficial sebum content of the skin were measured before and after the seven-day application of the products, as well as user acceptability (self-assessment of smell, speed of drying, emolliant effect, skin dryness). Group 2 used each preparation twice for two weeks in a random sequence, and carried out self assessment at the end of each fortnight. Transepidermal water loss (mean baseline: 18.7 g/m(2)h), dermal water content (mean baseline dorsum: 75.6) and superficial sebum content (mean baseline dorsum: 4.8 microg/cm(2)) did not change significantly. In both groups assessments of the smell and the speed of drying did not reveal any significant differences between the six products. Sterillium had the best emollient effect of all products (P<0.05; Wilcoxon test and Mann-Whitney-U test) and was significantly better than Desderman, AHD 2000, and Mucasept A, causing less skin dryness after seven days use in Group 1 (P<0.05; Mann-Whitney-U test). Manorapid caused significantly less dryness than Spitacid, AHD 2000, and Mucasept A in Group 2 after the first use, but no significant difference was observed after the second use. Thus alcohol-based hand rubs that contain emolliants, irrespective of the type of alcohol (n-propanol, iso-propanol or ethanol), are well tolerated and do not dry out or irritate the skin. Personal assessments showed significant differences for the emolliant effect and the extent of dryness. Both factors are very important, as user acceptability has an impact on compliance. Sterillium is the only hand disinfectant containing mecetronium etilsulphate which has been shown to have an emolliant effect. Future research should focus on user acceptability in order to improve compliance.

摘要

在一项临床双盲试验中,对六种市售酒精基洗手液[AHD 2000、Desderman、Mucasept A、Manorapid(聚醇、Spitacid和Sterillium)]进行了研究。该试验涉及10名此前没有使用过洗手液经验的参与者(第1组),以及7名有大量使用洗手液专业经验的人员(第2组;病毒学实验室工作人员)。第1组进行为期一周的研究,第1天使用20次,然后连续六天每天使用5次。在产品使用七天前后,测量皮肤的经表皮水分流失、真皮含水量和皮肤表面皮脂含量,以及用户接受度(对气味、干燥速度、润肤效果、皮肤干燥程度的自我评估)。第2组以随机顺序对每种制剂使用两周,每次两次,并在每两周结束时进行自我评估。经表皮水分流失(平均基线:18.7 g/m²·h)、真皮含水量(背部平均基线:75.6)和皮肤表面皮脂含量(背部平均基线:4.8 μg/cm²)没有显著变化。在两组中,对六种产品的气味和干燥速度的评估未发现显著差异。Sterillium在所有产品中具有最佳的润肤效果(P<0.05;Wilcoxon检验和Mann-Whitney-U检验),并且明显优于Desderman、AHD 2000和Mucasept A,在第1组使用七天后导致的皮肤干燥程度更低(P<0.05;Mann-Whitney-U检验)。在第2组中,首次使用后,Manorapid导致的干燥程度明显低于Spitacid、AHD 2000和Mucasept A,但第二次使用后未观察到显著差异。因此,含有润肤剂的酒精基洗手液,无论酒精类型(正丙醇、异丙醇或乙醇)如何,耐受性良好,不会使皮肤干燥或产生刺激。个人评估显示在润肤效果和干燥程度方面存在显著差异。这两个因素都非常重要,因为用户接受度会影响依从性。Sterillium是唯一一种含有乙硫酸美西铵且已被证明具有润肤效果的手部消毒剂。未来的研究应关注用户接受度,以提高依从性。

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