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葡萄糖酸氯己定防腐剂的安全性和有效性。

Safety and efficacy of the antiseptic chlorhexidine gluconate.

作者信息

Rosenberg A, Alatary S D, Peterson A F

出版信息

Surg Gynecol Obstet. 1976 Nov;143(5):789-92.

PMID:982260
Abstract

Chlorhexidine gluconate, an antiseptic for the skin, has recently been investigated in a series of clinical studies on its safety and efficacy. By using standard methods, Hibiclens, Hibitane tinted tincture and 0.5 per cent aqueous chlorhexidine gluconate were shown to have an extremely low potential for the production of irritation, allergic contact sensitization, photoallergic contact sensitization and phototoxicity. In the glove fluid test for efficacy against resident flora of the hand, Hibiclens produced log10 reductions over the control of 1.9398, 2.5371 and 2.6885 for test days 1, 2 and 5, respectively. Corresponding reductions for Hibitane tinted tincture were 3.6903, 4.0984 and 4.1253 and for the aqueous formulation, 1.5003, 1.5721 and 1.8692. In a transient flora skin contamination study, Serratia marcescens was applied at an average level of 6.8363 log10 organisms per milliliter to persons' hands, after which a 15 second Hibiclens hand wash was performed. Following five of these contaminations and hand washes, there was an over-all log10 reduction in recoverable Serratia of 3.8500. Counts were further determined after ten, 15, 20 and 25 contaminations and hand washes, resulting in corresponding reductions of 4.2649, 4.6661, 4.8501 and 5.1725, respectively. Chlorhexidine gluconate offers an alternative to available antiseptics for the skin. It has been shown to be a fast acting, broad spectrum antimicrobial agent, with an extremely low potential for eliciting dermal reactions.

摘要

葡萄糖酸洗必泰是一种皮肤消毒剂,最近在一系列临床研究中对其安全性和有效性进行了调查。通过使用标准方法,洗必泰抗菌皂、洗必泰着色酊剂和0.5%的葡萄糖酸洗必泰水溶液显示出产生刺激、过敏性接触致敏、光过敏性接触致敏和光毒性的可能性极低。在针对手部常驻菌群的手套液效力测试中,洗必泰抗菌皂在第1、2和5个测试日相对于对照组的对数减少量分别为1.9398、2.5371和2.6885。洗必泰着色酊剂的相应减少量为3.6903、4.0984和4.1253,水性制剂的相应减少量为1.5003、1.5721和1.8692。在一项短暂性菌群皮肤污染研究中,将粘质沙雷氏菌以每毫升6.8363 log10个生物体的平均水平涂抹在人的手上,之后进行15秒的洗必泰抗菌皂洗手。在进行五次这样的污染和洗手后,可培养的粘质沙雷氏菌总体对数减少量为3.8500。在进行十次、十五次二十次和二十五次污染和洗手后进一步测定菌落数,相应的减少量分别为4.2649、4.6661、4.8501和5.1725。葡萄糖酸洗必泰为现有的皮肤消毒剂提供了一种替代选择。它已被证明是一种快速起效的广谱抗菌剂,引起皮肤反应的可能性极低。

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