Novel Topical Treatment for Postherpetic Neuralgia

描述（由申请人提供）：本项目的目标是开发一种新的局部给药载体来治疗带状疱疹后神经痛（PHN）。PHN被定义为带状疱疹（HZ）皮疹愈合后持续或出现的受影响皮区疼痛。虽然许多PHN病例随着时间的推移而消退，但对许多患者来说，疼痛是慢性的，对生活质量造成破坏性影响。PHN的全身治疗与不良反应相关，这对于老年患者尤其成问题。局部治疗，如辣椒碱乳膏、乙酰水杨酸（阿司匹林）、麻醉剂乳膏和利多卡因贴剂，要么需要每日多次应用，要么由于局部化合物的全身吸收可能增加而限制其使用。 在以前的工作中，生物医学开发公司（BDC）开发了一种新型的聚合物基涂料组合物，可用于多种生物医学应用。该涂层能够持续局部药物递送。该项目的目的是使用这些涂层作为治疗带状疱疹后神经痛相关疼痛的方法。具体目标1：配制用于治疗带状疱疹后神经痛的涂层具体目标2：在与公共卫生相关的人体临床试验中证明涂层的功效：带状疱疹带状疱疹是美国最常见的神经系统疾病之一。虽然还没有系统的尝试来调查带状疱疹后神经痛的患病率，在美国，PHN的发病率估计在50万到100万之间。带状疱疹患者中PHN的发病率在10%到70%之间，并且随着年龄的增长而增加，疼痛的顽固性也可能随着年龄的增长而增加。由于人口老龄化和儿童水痘疫苗接种，预计带状疱疹的发病率以及PHN的发病率在未来几十年将增加。持续的自发性疼痛，特别是PHN的异常性疼痛成分可能会使人衰弱，并可能导致共病，如抑郁症、社交孤立、焦虑和睡眠障碍，以及增加医疗保健利用。

DESCRIPTION (provided by applicant): The goal of this project is to develop a novel topical drug delivery vehicle to treat postherpetic neuralgia [PHN). PHN is defined as pain in the affected dermatome that persists or appears after the rash of herpes zoster (HZ) has healed. Although many cases of PHN resolve over time, for many patients the pain is chronic, causing a devastating impact on quality of life. Systemic treatments for PHN are associated with undesirable adverse effects, which can be particularly problematic for elderly patients. Topical treatments such as capsaicin cream, acetylsalicylic acid (aspirin), anesthetic creams, and lidocaine patches either require multiple daily applications or are limited in their use due to the potential for elevated systemic absorption of the topical compound. In previous work, Biomedical Development Corporation (BDC) has developed a novel polymer-based coating composition that is useful for several biomedical applications. The coating is capable of sustained topical drug delivery. The objective of this project is to use these coatings as a treatment for the pain associated with postherpetic neuralgia. The Specific Aims of the grant are as follows: Specific Aim 1: Formulate Coatings for the Treatment of Postherpetic Neuralgia Specific Aim 2: Demonstrate Efficacy of Coatings in a Human Clinical Trial Relevance to Public Health: Herpes zoster (shingles) is one of the most common neurologic diseases in the U.S. Although there have been no systematic attempts to investigate the prevalence of post herpetic neuralgia, estimates have ranged from 500,000 to 1 million in the U.S. The incidence of PHN among those with herpes zoster ranges from 10 to 70 percent and increases with advancing age and the intractability of the pain may also increase with age. The incidence of herpes zoster, and therefore the incidence of PHN, is predicted to increase in the coming decades because of both the aging population and as a consequence of childhood varicella vaccination. The ongoing spontaneous pain and particularly the allodynic component of PHN can be debilitating and can lead to co-morbid conditions such as depression, social isolation, anxiety and sleep disturbance, as well as increased health care utilization.