Viral Hepatitis Clinical Research Program, The Kirby Institute, The University of New South Wales (UNSW), Sydney, NSW, Australia.
J Hepatol. 2012 Dec;57(6):1349-60. doi: 10.1016/j.jhep.2012.07.007. Epub 2012 Jul 14.
BACKGROUND & AIMS: Case definitions for recent hepatitis C virus (HCV) infection vary considerably between studies. The aim of this systematic review was to characterize case definitions for recent HCV and explore the heterogeneity in studies performed to date.
A systematic literature search of MEDLINE, SCOPUS, and ISI Web of Knowledge was performed covering all studies of recent HCV infection cited between January 2000 and June 2011. The criteria used by each study to define cases of recent HCV infection were extracted, structured, and analyzed.
Overall, 195 articles were included, with 87% (n=169) providing a clear case definition for recent HCV infection. The most frequently used individual criteria for defining a case included HCV antibody seroconversion (77%), alanine aminotransferase (ALT) elevation (68%), and HCV RNA detection (63%). In studies using HCV antibody seroconversion, the window period between the last negative and the first positive antibody test varied widely across studies (4 weeks to 4 years). Considerable diversity was also observed with respect to the ALT threshold used to characterize ALT elevations, ranging from 2 to 20 times the upper limit of normal. HCV antibody seroconversion was used as a single criterion in 41% of the studies, while all other studies used at least two criteria (range: 2-9). Epidemiology/surveillance studies mostly used a more sensitive case definition, whereas treatment studies, natural history studies, and diagnosis studies used more specific case definitions.
Marked heterogeneity in case definitions for recent HCV infection was observed. Although a single case definition for recent HCV is not warranted, a degree of standardization within specific study categories would enable improved cross-study comparison and more uniform evaluation of HCV prevention and management strategies.
近期丙型肝炎病毒（HCV）感染的病例定义在不同的研究中差异很大。本系统综述的目的是描述近期 HCV 的病例定义，并探讨迄今为止进行的研究中的异质性。
对 MEDLINE、SCOPUS 和 ISI Web of Knowledge 进行了系统的文献检索，涵盖了 2000 年 1 月至 2011 年 6 月间引用的所有近期 HCV 感染研究。提取、构建和分析了每项研究用来定义近期 HCV 感染病例的标准。
共纳入 195 篇文章，其中 87%（n=169）对近期 HCV 感染的病例定义明确。最常用于定义病例的单个标准包括 HCV 抗体血清转换（77%）、丙氨酸氨基转移酶（ALT）升高（68%）和 HCV RNA 检测（63%）。在使用 HCV 抗体血清转换的研究中，最后一次阴性和第一次阳性抗体检测之间的窗口期在研究中差异很大（4 周至 4 年）。此外，用于描述 ALT 升高的 ALT 阈值也存在很大差异，范围从正常上限的 2 倍到 20 倍。41%的研究仅使用 HCV 抗体血清转换作为单一标准，而其他所有研究均使用至少两种标准（范围：2-9）。流行病学/监测研究大多使用更敏感的病例定义，而治疗研究、自然史研究和诊断研究则使用更特异的病例定义。
近期 HCV 感染的病例定义存在明显的异质性。虽然不需要单一的近期 HCV 病例定义，但在特定的研究类别中进行一定程度的标准化将能够促进跨研究比较，并更统一地评估 HCV 预防和管理策略。
