三级护理环境中慢性乙型肝炎相关肝纤维化的最佳FIB-4和APRI

StephenW

Identification and external validation of the optimal FIB-4 and APRI thresholds for ruling in chronic hepatitis B related liver fibrosis in tertiary care settings
Kecheng Liu  1 , Mengbin Qin  1 , Kunlin Tao  1 , Zhihai Liang  2 , Fuqing Cai  1 , Liebin Zhao  1 , Peng Peng  1 , Shiquan Liu  1 , Jun Zou  1 , Jiean Huang  1
Affiliations
Affiliations

    1
    Department of Gastroenterology, The Second Affiliated Hospital of Guangxi Medical University, Nanning, China.
    2
    Department of Gastroenterology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.

    PMID: 33146916 DOI: 10.1002/jcla.23640

Abstract

Background: With the initially defined thresholds, the most widely used serum biomarkers for staging liver fibrosis (ie, APRI and FIB-4 scores) proved to be ineffective among patients with chronic hepatitis B virus infection (CHB). Whether optimizing the FIB-4 and APRI thresholds could improve their diagnostic accuracy requires further research.

Methods: Using data of treat-naïve CHB patients from three tertiary hospitals, we explored the optimal FIB-4 and APRI thresholds to rule in liver fibrosis accurately. Subsequently, we validated the applicability of the newly defined thresholds to the CHB patients from another two tertiary hospitals.

Results: The fibrosis stages between discovery cohort (n = 433) and the external validation cohort (n = 568) were statistically different (P < .001). When ruling in significant fibrosis and advanced fibrosis by the newly defined FIB-4 thresholds (2.25 and 3.00, respectively), 24.0% and 14.3% of patients, respectively, could be classified with excellent accuracy (PPVs of 91.3% and 80.6%, respectively; misdiagnosis rates of 6.0% and 5.4%, respectively), supported by the internal and external validation tests. Regrettably, the more accurate and robust thresholds of APRI score for ruling in significant fibrosis and advanced fibrosis could not be found. Besides, the FIB-4 and APRI scores should not be recommended for ruling in cirrhosis because of poor clinical diagnostic performance.

Conclusion: The newly defined FIB-4 thresholds for ruling in significant fibrosis and advanced fibrosis showed superior and reproducible clinical diagnostic accuracy. The well-validated threshold (≥2.25) of FIB-4 score could aid in antiviral treatment decisions for treat-naïve adult CHB patients by accurately ruling in significant fibrosis in tertiary care settings.

Keywords: biomarkers; clinical decision rules; diagnostic errors; hepatitis B; liver cirrhosis.

© 2020 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley Periodicals LLC.

StephenW

三级护理环境中慢性乙型肝炎相关肝纤维化的最佳FIB-4和APRI阈值的确定和外部验证
刘克成1，秦孟斌1，陶昆林1，梁志海2，蔡福清1，赵列斌1，彭鹏1，刘世权1，邹俊1，黄杰安1
隶属关系
隶属关系

    1个
    广西医科大学第二附属医院消化内科，南宁
    2
    广西医科大学附属第一医院消化内科，南宁

    PMID：33146916 DOI：10.1002 / jcla.23640

抽象

背景：使用最初定义的阈值，用于肝纤维化分期的最广泛使用的血清生物标志物（即APRI和FIB-4评分）在慢性乙型肝炎病毒感染（CHB）患者中被证明是无效的。优化FIB-4和APRI阈值是否可以提高其诊断准确性还需要进一步研究。

方法：使用来自三家三级医院的未治疗过的CHB患者的数据，我们探索了最佳FIB-4和APRI阈值，以准确控制肝纤维化。随后，我们验证了新定义的阈值对另外两家三级医院的CHB患者的适用性。

结果：发现队列（n = 433）和外部验证队列（n = 568）之间的纤维化阶段在统计学上不同（P <.001）。当通过新定义的FIB-4阈值（分别为2.25和3.00）对严重纤维化和晚期纤维化进行裁决时，可以将24.0％和14.3％的患者准确分类（PPV分别为91.3％和80.6％） ；误诊率分别为6.0％和5.4％），由内部和外部验证测试支持。遗憾的是，未找到更准确和更可靠的APRI评分阈值来判定严重纤维化和晚期纤维化。此外，由于临床诊断性能差，不建议将FIB-4和APRI评分推荐给肝硬化患者。

结论：新定义的针对严重纤维化和晚期纤维化的裁决的FIB-4阈值显示出优越且可重复的临床诊断准确性。经过验证的FIB-4阈值（≥2.25）可以通过准确判定三级护理环境中的明显纤维化来帮助未接受治疗的成人CHB患者做出抗病毒治疗决策。

关键词：生物标志物；临床决策规则；诊断错误；乙型肝炎；肝硬化。

©2020作者。由Wiley Periodicals LLC发布的《临床实验室分析杂志》。

StephenW

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/jcla.23640