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 详细处方信息以本药内容附件PDF文件（201111123374728.pdf）的“原文Priscribing Information”为准
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部分中文LidoSite处方资料（仅供参考）

FDA批准LidoSite(TM)用于治疗局部疼痛
    研究药物释放技术的Vyteris公司，基于活性经皮药物释放技术开发了LidoSite(TM)局部系统。该公司宣布美国FDA已经批准了该药物的NDA申请。在这之前，该系统已经被批准用于在表层皮肤处理之前对正常完整皮肤进行局部麻醉，例如静脉穿刺、静脉插管和浅表皮肤损伤的激光切除。这一药物被批准用于5岁以上患者。LidoSite使用名为离子电渗疗法的活性经皮释放技术，利用柔和电流经皮肤给药。该系统使用具有专利的电迁移技术给予患者利多卡因和肾上腺素，使药物在预先确定的时间范围内（从几分钟到若干天不等）控制释放。局部的麻醉药膏和贴剂麻醉皮肤需要一个小时，而LisoSite起效只需要10分钟。这一药品的临床试验圆满结束，期间发现该药物能减轻对成人与儿童进行针刺等处理时的疼痛。

美国FDA批准利多卡因离子渗透透皮释药系统上市
    美国FDA批准维Vyteris公司的利多卡因（Lidocaine）离子渗透型透皮释药系统（LidoSite Topical System）上市，用于皮肤局部镇痛，正常接触进行诸如下述表皮处理前使其麻木：静脉穿刺术（通常用针头从前臂静脉抽血），静脉插管给予补液和（或）药物，表皮损伤的激光切除（高能量激光脉冲）。本品批准用于5岁及其以上的病人。
    本品采用离子渗透透皮释药技术，以温和的电流通过皮肤促进药物释放。本品可在预定的时间内（数分钟至数日）控制药物释放的专利电子传输技术给与利多卡因和肾上腺素（Epinepherine）。表面麻醉乳膏和贴片释药需长达1h才能使皮肤麻木，而LidoSite只需10min。此产品已成功地完成临床研究，表明它可显著减少针头注射的疼痛，成人和儿童获得的结果相似。本品也注重成人的应用，但重点在儿童：针头穿刺、抽血过程和引起的疼痛是儿童和家长关心的大事。
    在1000多例成人和儿童（5～17岁）参加的临床研究中，评价了本品局麻的安全性和有效性。针头注射和静脉插管前使用LidoSite（10%利多卡因和0.1%肾上腺素）与安慰剂进行了2个关键的对照研究。病人用本品治疗较安慰剂显著减轻了针头穿刺皮肤引起的疼痛。

FDA批准Vyteris公司的LidoSite 局部麻醉系统
    致力于药物输送技术领域的Vyteris公司宣布，FDA已批准LidoSite 局部系统（经皮药物释放系统）的补充新药申请（NDA），准许用于5岁以上的患者。此前，FDA已批准该系统用于正常完整的皮肤表面。在进行表层皮肤处理（诸如：静脉穿刺、静脉内插管、浅表皮肤损伤的激光消融等操作）之前，LidoSite系统可实施局部麻醉。
    LidoSite系统采用名为离子电渗的活性经皮释放技术，通过柔和的电流经皮给药。LidoSite系统应用具有专利的电迁移技术，给予患者利多卡因（lidocaine）和肾上腺素（epinepherine），该系统可按照事先预定的时间范围（几分钟至数天不等）控制药物的释放。典型的局部麻醉乳膏和贴剂可在1小时内起效，而LidoSite系统仅仅需要10分钟。临床研究显示，在患儿和成人患者进行针刺等类似操作时，该系统可以显著降低处理时的疼痛。成人患者对Lidosite系统也有强烈的需求，但该系统主要应用于儿科患者，减缓针刺、抽血和免疫接种时的相关疼痛。
    超过1000例的成人和患儿参加了评估LidoSite系统有效性和安全性的临床研究。两项中枢研究比较了肌肉注射或静脉注射前，使用LidoSite系统（10%利多卡因+0.1%肾上腺素）与安慰剂的疗效差异。附加研究评估了在浅表皮肤损伤的切除术（如：切除或激光处理）前使用该系统的疗效。研究结果显示，与安慰剂组比较，采用LidoSite系统的患者显著减少了针刺的疼痛感。LidoSite系统组的多数患者感到轻微疼痛或无疼痛感，仅少数患者出现严重疼痛。
    在这些研究中，采用FAS（A = 无疼痛， I = 最严重的疼痛）评分系统和视觉模拟测量评分(VAS，0 = 无疼痛，10 =最严重的疼痛)来评估LidoSite系统的有效性。结果显示，LidoSite系统组患者与安慰剂组患者相比，疼痛分值明显较低。LidoSite系统最常见的不良反应是轻微红斑，但大多在24小时内自行消退。
 
LidoSite
Generic Name: Lidocaine HCl and Epinephrine Iontophoretic Patch
Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Localized Pain Treatment

FDA Approves LidoSite
The United States Food and Drug Administration (FDA) has approved LidoSite Topical System.

The LidoSite system has been approved for use on normal intact skin to provide a local analgesia that numbs the skin prior to the administration of superficial dermatological procedures such as venipuncture (drawing blood with a needle from a vein usually in the forearm), intravenous cannulation (administration of fluids and/or medications), and laser ablation (high power laser pulses) of superficial skin lesions. LidoSite is approved for use on patients five-years-of-age and older.

What is LidoSite?
LidoSite uses an active transdermal delivery technology known as iontophoresis, which administers medications through the skin via a mild electric current. The LidoSite system administers lidocaine and epinepherine using a patented electrotransport technology that enables the controlled delivery of medication over a predetermined period of time, from minutes to days. Topical anesthetic creams and patches can take up to an hour to numb the skin, while LidoSite works in 10 minutes. LidoSite has successfully completed clinical trials and has been found to significantly decrease pain from needle injections and similar procedures in both adults and children. Lidosite is intended to also address a strong need in adult applications. Its major impact is expected to be in the pediatric population, where pain associated with needlesticks, blood-draw procedures and immunizations is a major issue for the clinician, child and parent.

Studies Demonstrate LidoSite Safety and Efficacy
More than 1,000 adults and children (ages 5 to 17 years) participated in clinical studies evaluating the safety and efficacy of the LidoSite system in providing topical anesthesia. Two pivotal LidoSite studies compared the system (administering lidocaine 10% and epinephrine 0.1%) with placebo for use prior to needle injections or intravenous (IV) insertions. Additional studies evaluated the efficacy of the system for use prior to the removal of surface skin lesions (via incision or laser treatment). Patients treated with Vyteris' LidoSite system experienced significantly less pain associated with needlestick procedures compared with subjects treated with the placebo system. Consequently, fewer patients in the active group reported experiencing severe pain and most reported feeling little or no pain in contrast to patients in the placebo group. In these studies, the patients were evaluated using established pain assessment tools including the Facial Affective Scale (FAS) (A = no pain, I = maximal pain) or the Visual Analogue Scale (VAS) (0 = no pain, 10 = maximal pain) methods. Evaluations were taken immediately following LidoSite patch removal and at 24 hours for side effects. Pain score evaluations from both scales resulted in statistically significantly less pain for those who used the LidoSite system, as compared to placebo. In these studies, the most common side effect was mild erythema (skin redness), which disappeared for most patients within 24-hours.

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 详细处方信息以本药内容附件PDF文件（201111123374728.pdf）的“原文Priscribing Information”为准
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2011-1-12更新