INTRAVENOUS ACYCLOVIR TREATMENT FOR POSTHERPETIC NEURALGIA

静脉注射阿昔洛韦治疗带状疱疹后神经痛

• 批准号: 7377812
• 负责人: DIANNA QUAN
• 金额: $ 10.55万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377812
• 关键词: INTRAVENOUS; ACYCLOVIR; TREATMENT; POSTHERPETIC; NEURALGIA

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。带状疱疹后神经痛（PHN）是带状疱疹（带状疱疹）消退后发生的疼痛状况。它主要发生在50岁以上的人身上。症状，包括持续的烧灼或刺痛和极端的皮肤敏感，可能会显着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，在老年患者中通常无效或具有严重的不良副作用。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的机制尚不清楚，但有趣的证据表明，感觉神经节中水痘带状疱疹病毒的持续感染可能导致PHN。因此，通过抑制病毒复制的抗病毒药物积极治疗PHN应有效缓解疼痛并改善生活质量。入选本研究的患者，在满足所有入选和排除标准后，将进入GCRC 14天，并接受静脉输注阿昔洛韦治疗。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小组，以及第9天的CBC。在第1、5、9和13天抽取的血液也将用于使用聚合酶链反应评估血液单核细胞中VZV DNA的存在。患者将被要求填写两份问卷，疼痛评估调查和简明健康调查表36四次：在研究开始时，IV治疗后立即，口服治疗后立即，口服伐昔洛韦治疗结束后四周。疼痛评估调查包括疼痛数字评定量表、患者总体印象变化和疼痛描述。将使用疼痛数字评定量表评估疼痛，该量表为11分量表，0分代表无疼痛，10分代表有史以来最严重的疼痛。将使用患者总体印象变化和SF-36健康调查评估生活质量。整个PAS需要不到15分钟完成，SF-36需要不到10分钟完成。主要终点是NRSP评分的变化。主要疗效分析将基于治疗第一天至口服伐昔洛韦方案完成后四周之间NRSP评分的改善或恶化。次要终点是通过患者总体印象变化量表测量的疼痛改善和通过SF-36健康调查测量的生活质量。改善将通过治疗第一天、IV治疗后、口服治疗后和口服伐昔洛韦治疗完成后四周的评分差异来衡量。