Hair Ethyl Glucuronide as a Long Term Alcohol Biomarker

描述（由申请人提供）：需要一种高灵敏度（> 90%）和特异性（> 90%）的长期生物标志物来检测和监测重度酒精使用者。使用尿葡萄糖醛酸乙酯（EtG）监测受损专业人员短期（3-5天）酒精使用和滥用情况已被证明具有敏感性和特异性（bbb90 %）。最近，有证据表明，头发中的EtG可能能够以接近100%的灵敏度检测出长期酗酒者。以这些结果为背景，本I期研究将从罗杰斯纪念医院（RMH）住院治疗的酒精使用障碍患者的头发中提取EtG。RMH的酒精治疗项目的人口统计数据包括受损的专业人员，超过40%的患者是女性。本I期研究的目的是确定头发中的EtG水平是否可以区分重度酗酒者（n=50）和非饮酒者（n=50），灵敏度和特异性大于90%。使用接受者工作特征（ROC）图的统计程序，我们将在获得的整个毛发EtG值范围内检查整个灵敏度和特异性谱。我们还将通过分析在45天的住院治疗后从酒精患者身上采集的头发样本来研究长期戒酒对他们头发EtG水平的影响。在本研究中，将毛发EtG作为酒精长期滥用标志物的可行性定义为灵敏度和特异性≥90%的测试。如果第一阶段研究的可行性得到确立，第二阶段研究将扩大到包括妇女和怀孕、酗酒和大学酗酒、移植接受者和商业头发EtG测试的开发。酒精滥用是一种对人们的日常生活、身心健康以及国家经济造成巨大影响的疾病。疾病的治疗取决于早期诊断，目前的自我报告方法和现有的酒精诊断测试不能发现大多数酒精滥用情况。与目前使用的酒精生物标志物相比，毛发葡萄糖醛酸乙酯试验可能被证明具有更高的敏感性、特异性和检测慢性酒精滥用的能力，并且是第一个对这种疾病的治疗有真正重大影响的新一代酒精生物标志物。

DESCRIPTION (provided by applicant): There is a need for a highly sensitive (> 90%) and specific (> 90%) long term biomarker to both detect and monitor individuals who are heavy users of alcohol. Monitoring short term (3-5 days) alcohol use and abuse by impaired professionals by using urine ethyl glucuronide (EtG) has been shown to be both sensitive and specific (> 90%). Recently, evidence has emerged that EtG in hair may be able to detect long term abusers of alcohol with a sensitivity approaching 100%. With these results as background, this Phase I study will extract EtG from hair of patients admitted for residential treatment of alcohol use disorders at Rogers Memorial Hospital (RMH). The demographics of RMH's alcohol treatment program include impaired professionals and more than 40% of patients are women. The aim of this Phase I study is to determine whether EtG levels in hair can distinguish between heavy abusers of alcohol (n= 50) and non-drinking (n=50) with a sensitivity and specificity of greater than 90%. Using the statistical procedure of a receiver-operating characteristic (ROC) plot we will examine the whole spectrum of sensitivities and specificities over the entire range of hair EtG values obtained. We will also investigate the effects of long- term abstinence of the alcoholic patients on their hair EtG levels by analyzing hair samples taken from them after 45 days of residential treatment. In this study, feasibility of hair EtG as an alcohol long term abuse marker is defined as a test having a sensitivity and specificity of 90% or greater. If feasibility in this Phase I study is established, a Phase II study will expand to include women and pregnancy, binge and college drinking, transplant recipients and the development of a commercial hair EtG test. Alcohol abuse is an illness that has monumental consequences on people's every day lives, their physical and mental health, and the economies of nations. Treatment of an illness is dependent upon an early diagnosis and the current methods of self-reporting and the diagnostic tests for alcohol that are available do not detect most instances of alcohol abuse. The hair ethyl glucuronide test may prove to have superior sensitivity, specificity and ability to detect chronic alcohol abuse than the alcohol biomarkers currently in use, and be the first of a new generation of alcohol biomarkers that have a really significant impact on the treatment of this disease.