INTRAVENOUS ACYCLOVIR TREATMENT FOR POSTHERPETIC NEURALGIA

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。带状疱疹后遗神经痛(PHN)是带状疱疹(带状疱疹)消退后出现的一种疼痛状态。它主要发生在50岁以上的人群中。症状，包括持续的灼热或刺痛和皮肤极度敏感，可能会显著影响他们的生活质量，并导致绝望的感觉。许多治疗方法，包括三环类抗抑郁药、抗惊厥药和阿片类麻醉剂，在老年患者中往往无效或有严重的副作用。此外，这些治疗策略旨在缓解症状，而不是消除疼痛的原因。虽然PHN的发病机制尚不清楚，但有趣的证据表明，水痘带状疱疹病毒在感觉神经节的持续感染可能导致PHN。因此，用抑制病毒复制的抗病毒药物积极治疗PHN，应能有效缓解疼痛，提高生活质量。在这项研究中登记的患者，在满足所有纳入和排除标准后，将进入GCRC 14天，并接受阿昔洛韦静脉输注治疗。在GCRC期间，患者将每天监测治疗的任何不良反应，包括每隔一天测量一次基本代谢指标，并在第9天检测CBC。第1、5、9和13天的血样也将被用来通过聚合酶链式反应来评估血液单个核细胞中是否存在VZV DNA。患者将被要求填写两份问卷，疼痛评估调查和简短的36健康调查，共四次：在研究开始时，静脉注射治疗后立即，口服治疗后立即，以及口服万乃洛韦治疗结束后四周。疼痛评估调查由疼痛数字评分表、患者对变化的总体印象和疼痛描述组成。疼痛将使用数字疼痛评分表进行评估，11分制中0分代表没有疼痛，10分代表经历过的最严重的疼痛。生活质量将使用患者全球变化印象和SF-36健康调查进行评估。整个PAS只需不到15分钟即可完成，SF-36只需不到10分钟即可完成。主要终点是NRSP分数的变化。初步疗效分析将基于治疗第一天至口服万乃洛韦方案完成后四周内NRSP评分的改善或恶化。次要终点是疼痛的改善，通过患者对变化的总体印象量表和SF-36健康调查衡量的生活质量来衡量。改善程度将通过治疗第一天、静脉注射治疗后、口服治疗后和口服万乃洛韦治疗结束后四周的评分差异来衡量。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Postherpetic neuralgia (PHN) is a painful condition that occurs after resolution of herpes zoster rash (shingles). It occurs primarily in people over the age of 50. Symptoms, including persistent burning or lancinating pain and extreme skin sensitivity, may significantly affect their quality of life and lead to feelings of despair. Numerous treatments, including tricyclic antidepressants, anticonvulsants, and opioid narcotics, are often ineffective or have serious adverse side effects in elderly patients. Additionally, these treatment strategies are designed to relieve symptoms, not eliminate the cause of the pain. Although the mechanism of PHN is unknown, intriguing evidence has emerged suggesting that a persistent infection of varicella-zoster virus in sensory ganglia may lead to PHN. Therefore, aggressive treatment of PHN by antiviral drugs that inhibit viral replication should effectively relieve pain and improve quality of life. Patients enrolled in this study, after satisfying all inclusion and exclusion criteria, would be admitted to the GCRC for 14 days and treated with an intravenous infusion of acyclovir. While on the GCRC, patients would be monitored daily for any adverse effects of the treatment, including a basic metabolic panel measured every other day, and a CBC on day 9. Blood drawn on days 1, 5, 9 and 13 would also be used to assess the presence of VZV DNA in blood mononuclear cells using the polymerase chain reaction. Patients would be asked to fill out two questionnaires, the Pain Assessment Survey and the Short Form 36 Health Survey four times: at the beginning of the study, immediately after IV therapy, immediately after oral therapy, and four weeks following the end of treatment with oral valacyclovir. The Pain Assessment Survey consists of the Numeric Rating Scale for Pain, the Patient Global Impression of Change, and the Pain Description. Pain will be assessed using the Numeric Rating Scale for Pain, an 11-point scale with 0 representing no pain and 10 representing the worst pain ever experienced. Quality of life will be assessed using the Patient Global Impression of Change and the SF-36 Health Survey. The entire PAS takes less than 15 minutes to complete, and the SF-36 takes less than 10 minutes to complete. The primary endpoint is the change in NRSP score. The primary efficacy analysis will be based on the improvement or deterioration in the NRSP score between the first day of treatment and four weeks after completion of the oral valacyclovir regimen. The secondary end points are improvement in pain measured by the Patient Global Impression of Change scale and quality of life as measured by the SF-36 Health Survey. Improvement will be measured by the difference in scores on the first day of treatment, after IV therapy, after oral therapy, and four weeks following completion of the oral valacyclovir treatment.