Dreytser Ekaterina, Blyuss Oleg, Mudrova Anastasiya, Turankova Taisiia, Gurusamy Kurinchi Selvan, Pavlov Chavdar S
I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Cochrane Database Syst Rev. 2025 Aug 4;8(8):CD014222. doi: 10.1002/14651858.CD014222.
This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the diagnostic accuracy of the aspartate aminotransferase-to-platelet ratio index (APRI) for staging and screening fibrosis in adults with chronic hepatitis C infection when compared with liver biopsy as the reference standard. To achieve this, we will compare at least significant fibrosis (stages F2-F4) to no significant fibrosis (stages F0-F1) as this group of people is prioritised for treatment; at least advanced fibrosis (stages F3-F4) compared to no advanced fibrosis (stages F0-F2) as this group of people is at high risk for developing complications, i.e. hepatocellular carcinoma; cirrhosis (stage F4) compared to no cirrhosis (stages F0-F3) as the duration and effectiveness of treatment in these population groups of people are different. Secondary objectives We also aim to identify the pooled sensitivity and specificity of the most common cut-off values of APRI for the staging of fibrosis in adults with chronic hepatitis C. We plan to investigate heterogeneity for the following covariates if adequate data are available (Investigations of heterogeneity).
a) studies with high methodological quality; b) studies with low or unclear methodological quality Interval of liver biopsy and APRI: a) done in one day; b) more than one day, but less than or equal to three months Mean length of biopsy samples: a) less than 15 mm; b) mean length equal to or more than 15 mm Number of portal tracts in a biopsy sample: a) less than 11; b) number of portal tracts equal to or more than 11.
这是一项Cochrane系统评价（诊断性）的方案。目标如下：确定与肝活检作为参考标准相比，天冬氨酸转氨酶与血小板比值指数（APRI）在慢性丙型肝炎感染成人患者中用于纤维化分期及筛查的诊断准确性。为实现这一目标，我们将比较至少显著纤维化（F2 - F4期）与无显著纤维化（F0 - F1期），因为这组人群是治疗的优先对象；比较至少重度纤维化（F3 - F4期）与无重度纤维化（F0 - F2期），因为这组人群发生并发症（即肝细胞癌）的风险较高；比较肝硬化（F4期）与无肝硬化（F0 - F3期），因为这些人群组的治疗持续时间和效果不同。次要目标我们还旨在确定APRI最常见截断值在慢性丙型肝炎感染成人患者纤维化分期中的合并敏感性和特异性。如果有足够的数据，我们计划调查以下协变量的异质性（异质性调查）。
a）方法学质量高的研究；b）方法学质量低或不明确的研究肝活检与APRI的间隔时间：a）在一天内完成；b）超过一天，但小于或等于三个月活检样本的平均长度：a）小于15毫米；b）平均长度等于或大于15毫米活检样本中的门静脉分支数量：a）小于11个；b）门静脉分支数量等于或大于11个。
