A Controlled Prospective Study of Transfusion-associated Hepatitis

输血相关性肝炎的对照前瞻性研究

• 批准号: 6431805
• 负责人: HARVEY J ALTER
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6431805
• 关键词: alanine transaminase; antiviral antibody; blood donor; blood tests; blood transfusion; clinical research; clinical trials; disease /disorder prevention /control; disease /disorder proneness /risk; epidemiology; heart surgery; hepatitis B antigens; hepatitis B virus group; hepatitis C; hepatitis C virus; hepatitis G virus; human subject; longitudinal human study; mass screening; postoperative complications; questionnaires

This project culminates a series of studies of transfusion-associated hepatitis (TAH) in prospectively followed transfusion recipients undergoing open-heart surgery. The studies have sequentially shown the efficacy of adopting an all volunteer donor system, testing for the hepatitis B surface antigen, utilizing the surrogate assays, alanine aminotransferase (ALT) and anti-hepatitis B core antibody (anti-HBc), and testing for antibodies to the hepatitis C virus (HCV). Overall, the studies have shown a decline in TAH incidence from near 30 percent in the 1960s, 10 to 20 percent in the 1970s, 8 to 12 percent in the early 80s, and 4 to 5 percent in the late 80s. Since 1990, the study has focused on the impact of the introduction of donor screening assays to detect carriers of (HCV). Following first generation anti-HCV testing, introduced in 1990, the rate of TAH fell from 3 to 4 percent to 1.5 percent. Since the introduction of more sensitive second generation assays in 1992, we have followed over 650 recipients and the overall TAH rate has fallen to 0.2 percent while the rate of transfusion associated hepatitis C has fallen to zero. The overall rate reflects only a single mild case whose etiology is undetermined. Hence, in this approximate 30-year span, we have documented the virtual disappearance of TAH.A new prospective study is being initiated that will follow both adult and pediatric patients for a large variety of potential transfusion-transmitted infections. We will continue to look for HBV, HCV, HIV, and HTLV infections to monitor the continued efficacy of existing donor screening measures. However, the main thrust of the study will be to determine the incidence and clinical outcome of infections for which donor screening is not routinely performed. This would include newly proposed hepatitis viruses (TTV and SEN-V), cytomegalovirus (CMV), parvovirus B-19, and the human herpes virus, type 8 (HHV-8). Other infections such as borrelia (lyme disease), babesia (babesiosis), trypanosoma cruzi (Chagas) and HHV-6 may also be monitored. Although, we will continue to measure serologic responses, the study will focus on molecular assays. A primary goal of the study will be to establish a linked donor and recipient repository that can be used to rapidly assess if a newly emergent agent represents a threat to the blood supply. This repository will be linked to the RADAR repository.

该项目最终导致了一系列对前瞻性的输血接受者进行开心手术的研究。这些研究依次表明了采用全志愿供体系统，测试乙型肝炎表面抗原，利用替代测定，丙氨酸氨基转移酶（ALT）和抗肝炎B核B核抗体（抗HBC）以及对抗体抗体的抗肝炎。总体而言，这些研究表明，TAH发病率从1960年代的近30％下降，1970年代的10％至20％，80年代初的8％至12％，在80年代末4％至5％。自1990年以来，该研究一直集中在引入捐赠者筛选测定方面检测（HCV）载体的影响。在1990年推出的第一代抗HCV测试之后，TAH的速度从3％下降到4％至1.5％。自1992年引入更敏感的第二代测定法以来，我们跟踪了650多名接受者，总TAH率下降到0.2％，而与丙型肝炎相关的输血率下降到零。总体速率仅反映了一个轻度病因，该病因不确定。因此，在大约30年的时间里，我们已经记录了TAH的虚拟消失。一项新的前瞻性研究正在启动，该研究将跟随成人和儿科患者，以了解各种潜在的输血传播感染。我们将继续寻找HBV，HCV，HIV和HTLV感染，以监测现有供体筛查措施的持续疗效。但是，该研究的主要目的是确定不常规进行供体筛查的感染的发生率和临床结果。这将包括新提出的肝炎病毒（TTV和SEN-V），巨细胞病毒（CMV），细小病毒B-19和人类疱疹病毒，第8型（HHV-8）。也可以监测其他感染，例如渗透症（莱姆病），巴贝斯（Babesiosis），克鲁氏锥虫（Chagas）和HHV-6。虽然，我们将继续衡量血清学反应，但该研究将集中于分子测定。该研究的主要目标是建立一个链接的捐助者和接受者存储库，该存储库可快速评估新出现的代理是否代表了对血液供应的威胁。该存储库将链接到雷达存储库。