CLINICAL TRIAL: USE OF SILDENAFIL (VIAGRA) TO ALTER FATIGUE

临床试验：使用西地那非（伟哥）缓解疲劳

• 批准号: 8359850
• 负责人: THEODORE FRIEDMAN
• 金额: $ 3.64万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8359850
• 关键词: Biological Markers; Brain; Cerebrovascular Circulation; Chronic; Chronic Fatigue Syndrome; Clinical Trials; Cyclic GMP; Defect; Diagnosis; Disease; Dizziness; Double-Blind Method; Failure; Fatigue; Funding; Grant; Impairment; Memory Loss; Monitor; National Center for Research Resources; Patients; Pharmaceutical Preparations; Placebos; Principal Investigator; Randomized; Research; Research Infrastructure; Resources; Scanning; Source; Testing; Therapeutic; Translational Research; United States National Institutes of Health; Viagra; cost; functional status; indexing; inhibitor/antagonist; phosphoric diester hydrolase; placebo controlled study; response; sildenafil; single photon emission computed tomography; treatment duration

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Chronic Fatigue Syndrome (CFS) is a diabling condition characterized by chronic fatigue of at least 6 months duration an multiple somatic complaints, including memory loss, trouble concentrating and dizziness. The lack of a biological marker as well failure of any reproducible double-blind, placebo-control studies to demonstrate any therapeutic response makes CFS an extremely difficult disease to diagnose and treat. I hypothesize that some forms of CFS are due to inadequate cerebral blood flow resulting in the symptomatology seen in chronic fatigue symdrome including fatigue, dizziness and congitive impairment. This impaired cerebral blood flow would be visible as filling defects on brain SPECT scans. Appropriate treatment for CFS, therefore, would include agents which selectively increase cerebral blood flow. We propose that a directed approach to increase cerebral blood flow would be to use sildanifil (Viagra), an inhibitor of the type 5 cyclic guanosine monophosphate (cGMP) phosphodiesterase. Our objectives, therefore, are to test the following hypothesis: Patients with CFS treated with sildenafil are expected to have increased cerebral blood flow with an improvement of their fatigue and functional status as well as SPECT scan abnormalities. This hypothesis will be studied as follows: Patients will receive either sildenafil or placebo in a randomized, double-blind, placebo-controlled study for 6 weeks of active drug. Functional status, fatigue index, and brain SPECT scans will be monitored at baseline andd after each treatment period.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 慢性疲劳综合征（CFS）是一种脱皮状况，其特征是慢性疲劳至少持续6个月的持续时间多，包括记忆力丧失，注意力集中和头晕。缺乏生物学标志物以及任何可重复的双盲的失败，安慰剂控制研究证明任何治疗反应使CFS成为极为困难的诊断和治疗疾病。我假设某些形式的CF是由于脑血流不足所致，导致慢性疲劳象征中看到的症状，包括疲劳，头晕和联合性损害。 这种受损的脑血流可见，因为脑Spect扫描填充缺陷。因此，对CFS的适当治疗方法将包括有选择地增加脑血流的药物。我们建议一种增加脑血流的定向方法是使用Sildanifil（伟哥），这是5型环状鸟苷单磷酸（CGMP）磷酸二酯酶的抑制剂。 因此，我们的目标是检验以下假设：用西地那非治疗的CF患者有望增加脑血流，并改善其疲劳和功能状态以及SPECT扫描异常。 该假设将如下研究：患者将在随机，双盲，安慰剂对照研究中接受西地那非或安慰剂，进行6周的活性药物。在每个治疗期间，将在基线和基线监测功能状态，疲劳指数和脑SPECT扫描。