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

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 慢性疲劳综合征(CFS)是一种以持续至少6个月的慢性疲劳和多个躯体症状为特征的无力状态，包括记忆力丧失、注意力难以集中和头晕。缺乏生物标志物，以及任何可重复性的双盲、安慰剂对照研究未能证明任何治疗反应，使CFS成为一种极难诊断和治疗的疾病。我推测，某些形式的CFS是由于脑血流不足导致慢性疲劳综合征的症状，包括疲劳、头晕和认知障碍。 这种受损的脑血流在脑SPECT扫描上会显示为充盈缺陷。因此，对CFS的适当治疗将包括选择性增加脑血流量的药物。我们建议，增加脑血流量的直接方法是使用西丹尼非(伟哥)，一种5型环鸟苷一磷酸(CGMP)磷酸二酯酶的抑制剂。 因此，我们的目标是检验以下假设：接受西地那非治疗的CFS患者预计会增加脑血流量，改善他们的疲劳和功能状态以及SPECT扫描异常。 这一假设将被研究如下：患者将在一项随机、双盲、安慰剂对照的研究中接受西地那非或安慰剂，为期6周的活性药物。在基线和每个疗程结束后，将监测功能状态、疲劳指数和脑SPECT扫描。

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.