State Clinical Drug Trial Institution, Beijing You An Hospital, Capital Medical University, Beijing, China.
Interventional Therapy Center for Oncology, Beijing You An Hospital, Capital Medical University, Beijing, China.
J Gastroenterol Hepatol. 2023 Jul;38(7):1018-1027. doi: 10.1111/jgh.16240. Epub 2023 Jun 7.
With the global increase in chronic liver disease and cirrhosis, there is an increasing need to identify non-invasive biomarkers to measure the severity of disease progression while reducing reliance on pathological biopsies. This study aimed to comprehensively evaluate the diagnostic value of PRO-C3 as a biomarker for staging liver fibrosis in patients with viral hepatitis or fatty liver disease.
Articles published until January 6, 2023, were searched in the PubMed, Embase, MEDLINE, Web of Science, and Cochrane Library databases. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to evaluate the quality of the included studies. Pooled sensitivity, specificity, diagnostic odds ratio, and likelihood ratios were integrated using a random-effects model, and a summary receiver operating characteristic curve was constructed. Publication bias was also detected. Subgroup and meta-regression analyses, as well as sensitivity analysis, were also performed.
Fourteen studies with 4315 patients were included. Summary area under the curve of PRO-C3 for the identification of significant fibrosis (≥ F2) and advanced fibrosis (≥ F3) was 0.80 (95% confidence interval: 0.76-0.83). Subgroup and meta-regression analyses suggested that disease type and sample size may be the primary factors of heterogeneity in PRO-C3 diagnosis of ≥ F2, while study design, study sample type, and enzyme-linked immunosorbent assay kit brand may be the primary sources of heterogeneity in PRO-C3 diagnosis of ≥ F3.
PRO-C3 demonstrated clinically meaningful diagnostic accuracy when used alone as a non-invasive biomarker for diagnosing the liver fibrosis stage in individuals with viral hepatitis or fatty liver disease.
随着全球慢性肝病和肝硬化的增加，越来越需要寻找非侵入性生物标志物来衡量疾病进展的严重程度，同时减少对病理活检的依赖。本研究旨在全面评估 PRO-C3 作为一种生物标志物用于诊断病毒性肝炎或脂肪性肝病患者肝纤维化分期的诊断价值。
检索 PubMed、Embase、MEDLINE、Web of Science 和 Cochrane Library 数据库，直到 2023 年 1 月 6 日发表的文章。使用诊断准确性研究的质量评估-2 工具评估纳入研究的质量。使用随机效应模型综合合并敏感性、特异性、诊断比值比和似然比，并构建汇总受试者工作特征曲线。还检测了发表偏倚。进行了亚组和 meta 回归分析以及敏感性分析。
纳入了 14 项研究，共计 4315 名患者。PRO-C3 对显著纤维化（≥F2）和高级纤维化（≥F3）的识别的汇总曲线下面积为 0.80（95%置信区间：0.76-0.83）。亚组和 meta 回归分析表明，疾病类型和样本量可能是 PRO-C3 诊断≥F2 异质性的主要因素，而研究设计、研究样本类型和酶联免疫吸附测定试剂盒品牌可能是 PRO-C3 诊断≥F3 异质性的主要来源。
PRO-C3 作为一种单独的非侵入性生物标志物，用于诊断病毒性肝炎或脂肪性肝病患者的肝纤维化分期，具有临床意义的诊断准确性。
