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: 8173587
• 负责人: THEODORE FRIEDMAN
• 金额: $ 8.36万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8173587
• 关键词: Biological Markers; Brain; Cerebrovascular Circulation; Chronic; Chronic Fatigue Syndrome; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cyclic GMP; Defect; Diagnosis; Disease; Dizziness; Double-Blind Method; Failure; Fatigue; Funding; Grant; Impairment; Institution; Memory Loss; Monitor; Patients; Pharmaceutical Preparations; Placebos; Randomized; Research; Research Personnel; Resources; Scanning; Source; Testing; Therapeutic; United States National Institutes of Health; Viagra; 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. 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. 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 慢性疲劳综合征（CFS）是一种致残性疾病，其特征是持续至少6个月的慢性疲劳和多种躯体症状，包括记忆力丧失、注意力不集中和头晕。缺乏一个生物标志物，以及失败的任何可重复的双盲，安慰剂对照研究，以证明任何治疗反应，使CFS一个非常困难的疾病诊断和treat. I假设，某些形式的CFS是由于脑血流量不足，导致在包括疲劳，头晕和认知障碍的慢性疲劳综合征中看到的神经病学。 这种受损的脑血流量在脑SPECT扫描中可以作为填充缺陷而可见。因此，CFS的适当治疗应包括选择性增加脑血流量的药物。我们建议，一个直接的方法来增加脑血流量将使用sildanifil（伟哥），5型环磷酸鸟苷（cGMP）磷酸二酯酶的抑制剂。 因此，我们的目的是检验以下假设：预计接受西地那非治疗的CFS患者的脑血流量增加，疲劳和功能状态以及SPECT扫描异常得到改善。 该假设将按如下方式进行研究：患者将在一项随机、双盲、安慰剂对照研究中接受西地那非或安慰剂治疗6周活性药物。将在基线和每个治疗期后监测功能状态、疲劳指数和脑SPECT扫描。