QUANTITATIVE ASSESSMENT OF HEPATIC FUNCTION IN CHRONIC HCV (QLFT)

慢性丙型肝炎肝功能的定量评估 (QLFT)

• 批准号: 7719422
• 负责人: Gregory Thomas Everson
• 金额: $ 0.15万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719422
• 关键词: Alanine Transaminase; Alkaline Phosphatase; Antipyrine; Ascites; Aspartate Transaminase; Bilirubin; Biochemical; Blood; Caffeine; California; Cholates; Chronic; Clinical; Colorado; Computer Retrieval of Information on Scientific Projects Database; Computers; Confidence Intervals; Consent; Data; Data Coordinating Center; Development; Encephalopathies; End Point; Enrollment; Functional disorder; Funding; Galactose; Grant; Hemorrhage; Hepatic; Hepatic Mass; Hepatobiliary; Injury; Institution; Interferons; Lidocaine; Liver; Liver Function Tests; Liver diseases; Mails; Maintenance; Measurement; Measures; Medical; Multivariate Analysis; New England; Outcome; Participant; Patients; Predictive Value; Prevention therapy; Reporting; Research; Research Institute; Research Personnel; Resources; Saliva; Sampling; Scanning; Serum; Source; Spleen; Standards of Weights and Measures; Techniques; Testing; Treatment Protocols; United States National Institutes of Health; Universities; Virginia; cholate; college; liver function; monoethylglycinexylidide; single photon emission computed tomography; stable isotope

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. Long-term use of PEG Interferon (maintenance treatment) may slow the progression of liver disease. Endpoints for effective therapy are prevention of clinical decompensation (ascites, variceal hemorrhage, and encephalopathy) and stabilization of liver function. Conventional liver tests (serum bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) do not quantitate hepatic function but only assess the presence or absence of hepatobiliary injury. We hypothesize that quantitative tests of liver function will be more useful than standard biochemical measurements, and more sensitive than clinical endpoints for evaluating the degree and progression of hepatic dysfunction. Patients enrolled in the HALT C trial at the University of Colorado, Medical College of Virginia, and University of California, Irvine, will be invited to participate. A signed consent, specific for this study, will be required of all participants. Participants will undergo quantitative assessment of hepatic function at baseline, and at 2 and 4 years of the maintenance treatment protocol. Hepatic function will be measured by clearance techniques and quantitative liver-spleen scan. Test compounds used in clearance studies will include: cholate (dual stable isotopes, blood), lidocaine (MEGX, blood), antipyrine (saliva), caffeine (saliva), and galactose (blood). Quantitative radioscintigraphy (SPECT liver-spleen scan) will be used to measure perfused hepatic mass. Test compounds will be administered both orally (2H4-cholate, caffeine, antipyrine) and intravenously (13C-cholate, galactose, lidocaine). Quantitative Liver-Spleen Scan (SPECT) will also be performed. Tapes/computer files from these studies will be electronically transferred or mailed to the analytical computing facility (UCI). Data generated from this trial will be managed and analyzed by New England Research Institute (NERI), a separately funded data coordinating center (DCC). All of the studies done to quantitate hepatic function are continuous variables and will be reported to the Data Coordinating Center using standard report forms. The results of the baseline studies will be characterized by mean, median, distribution, and confidence intervals for each of the measures of hepatic function (caffeine kelim, antipyrine kelim, antipyrine Vd, antipyrine clearance, galactose elimination capacity, MEGX15min, cholate kelim iv, cholate Vd iv, cholate Cliv, cholate Clpo, cholate SF, and perfused hepatic mass). The median value for each test will be used to divide the patient sample into two groups for analysis of the ability of the test to predict clinical progression. The predictive value of the various tests will be compared and interaction between the quantitative tests in predicting outcome will be performed by multivariate analysis of the continuous independent variables (quantitative tests) against the binomial dependent variable (development or absence of clinical decompensation).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 长期使用PEG干扰素（维持治疗）可能会减慢肝病的进展。 有效治疗的终点是预防临床代偿作用（腹水，静脉曲张出血和脑病）和肝功能的稳定。 常规的肝检测（血清胆红素，丙氨酸氨基转移酶，天冬氨酸氨基转移酶，碱性磷酸酶）不要定量肝功能，而只能评估肝胆管损伤的存在或不存在。 我们假设肝功能的定量测试将比标准的生化测量更有用，并且比临床终点更敏感，以评估肝功能障碍的程度和进展。 将邀请参加科罗拉多大学弗吉尼亚大学医学院和加利福尼亚大学欧文分校的Halt C试验的患者参加。 所有参与者都需要对本研究的签署同意。 参与者将在基线以及维护治疗方案的2和4年进行肝功能的定量评估。 肝功能将通过清除技术和定量肝脏扫描来测量。 清除研究中使用的测试化合物将包括：巧克力（双重稳定同位素，血液），利多卡因（MEGX，血液），抗吡啶（唾液），咖啡因（唾液）和半乳糖（血液）。 定量射线镜（Spect Liver-Spleen扫描）将用于测量灌注肝肿块。 测试化合物将同时口服（2H4-甲酸，咖啡因，抗吡啶）和静脉内（13c-循环，半乳糖，利多卡因）。 还将进行定量肝脏扫描（SPECT）。 这些研究中的磁带/计算机文件将通过电子传输或邮寄到分析计算设施（UCI）。 该试验产生的数据将由单独资助的数据协调中心（DCC）的新英格兰研究所（NERI）进行管理和分析。 量化肝功能的所有研究都是连续变量，并将使用标准报告表格报告给数据协调中心。 The results of the baseline studies will be characterized by mean, median, distribution, and confidence intervals for each of the measures of hepatic function (caffeine kelim, antipyrine kelim, antipyrine Vd, antipyrine clearance, galactose elimination capacity, MEGX15min, cholate kelim iv, cholate Vd iv, cholate Cliv, cholate Clpo, cholate SF, and perfused hepatic 大量的）。 每种测试的中位数将用于将患者样本分为两组，以分析测试预测临床进展的能力。 将比较各种测试的预测价值，并通过对连续独立变量（定量测试）对二进制依赖变量（开发或没有临床解说）进行多变量分析来进行定量测试之间的相互作用。