Novel Topical Treatment for Postherpetic Neuralgia

带状疱疹后神经痛的新型局部治疗

• 批准号: 6991051
• 负责人: Charles J Gauntt
• 金额: $ 19.69万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6991051
• 关键词: analgesia; chemotherapy; chronic pain; clinical research; clinical trials; drug delivery systems; drug design /synthesis /production; drug screening /evaluation; human subject; human therapy evaluation; local anesthetics; patient oriented research; polymers; shingles; slow release drug; topical drug application

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.

描述（由申请人提供）：该项目的目标是开发一种新型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，受影响皮区持续存在或出现的疼痛。尽管许多 PHN 病例会随着时间的推移而缓解，但对于许多患者来说，疼痛是慢性的，对生活质量造成毁灭性影响。 PHN 的全身治疗会产生不良副作用，这对于老年患者来说尤其成问题。辣椒素霜、乙酰水杨酸（阿司匹林）、麻醉霜和利多卡因贴剂等局部治疗药物要么需要每天多次使用，要么由于可能会增加局部化合物的全身吸收而限制其使用。 在之前的工作中，生物医学发展公司 (BDC) 开发了一种新型聚合物基涂层组合物，可用于多种生物医学应用。该涂层能够持续局部给药。该项目的目标是使用这些涂层来治疗与带状疱疹后神经痛相关的疼痛。该拨款的具体目标如下： 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：在人体临床试验中证明涂层的功效 与公共健康的相关性：带状疱疹（带状疱疹）是美国最常见的神经系统疾病之一。尽管尚未系统地尝试调查带状疱疹后神经痛的患病率，但估计范围为500,000 至 美国有 100 万人，带状疱疹患者中 PHN 的发病率为 10% 至 70%，并且随着年龄的增长而增加，并且疼痛的难治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，带状疱疹的发病率以及因此导致的 PHN 发病率预计在未来几十年将增加。持续的自发性疼痛，尤其是 PHN 的异常性疼痛可能会使人衰弱，并可能导致抑郁、社交孤立、焦虑和睡眠障碍等共病，以及医疗保健利用率的增加。