【摘要】 背景 盐酸芬太尼离子渗透经皮给药系统（fentanyl Hcl iontophoretic transdermal system, fentanyl, ITS）是通过电离子渗透技术经体表的微弱电场由皮肤给予芬太尼，产生镇痛作用的给药装置。已在美国和欧洲批准上市，用于治疗中到重度的手术后疼痛。目的 主要回顾了在欧美针对该给药系统所进行的一系列临床试验。内容 安慰剂对照试验和阳性药物平行对照试验均证实，以离子渗透技术经皮给予芬太尼对多种手术后疼痛有良好的治疗作用。该给药系统具有与标准的吗啡患者自控镇痛（patient-controlled analgesia, PCA）相似的有效性和安全性。趋向 芬太尼离子渗透经皮给药系统具有无创，有效，安全，简单，易于为患者接受等优点，为临床提供了一种全新的PCA方式。
【Abstract】Background The fentanyl hydrochloride iontophoretic transdermal system (fentanyl ITS) is a needle-free, self-contained drug-delivery system that uses iontophoretic technology to deliver fentanyl through the skin by application of a low-intensity electrical field. It has been approved in the USA and Europe for the management of acute, moderate-to-severe postoperative pain. Objective This review focus on several clinical trails of fentanyl ITS, which have been carried out in America and Europe. Content In three phase 3 placebo-controlled trials, fentanyl ITS was shown to be superior to placebo for the treatment of postoperative pain following major abdominal, orthopedic and thoracic surgery. The results of several active-comparator phase 3 trial demonstrated comparable safety and efficacy with a standard morphine IV PCA dosing regimen, without significant difference in the side effect profile. Trend Fentanyl ITS is a novel patient-controlled analgesia (PCA) system allowing patients to self-administer pre-programmed doses of fentanyl. It represents a safe, easy to use, non-invasive and convenient alternative to current acute postoperative pain management modalities.
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