Petersen John R, Stevenson Heather L, Kasturi Krishna S, Naniwadekar Ashutosh, Parkes Julie, Cross Richard, Rosenberg William M, Xiao Shu-Yuan, Snyder Ned
*Department of Pathology, University of Texas Medical Branch, Galveston **Internal Medicine, Division of Gastroenterology, Kelsey-Seybold Clinic, Houston, TX †Hernando Gastroenterology Associates, Brooksville, FL ‡Riverside Health System, 805 Progress Court, Newport News, VA §Public Health and Medical Statistics, University of Southampton, Southampton ∥iQur Limited ¶Division of Medicine, The Institute for Liver and Digestive Health, University College London, London, UK #Department of Pathology, University of Chicago, Chicago, IL.
J Clin Gastroenterol. 2014 Apr;48(4):370-6. doi: 10.1097/MCG.0b013e3182a87e78.
The assessment of liver fibrosis in chronic hepatitis C patients is important for prognosis and making decisions regarding antiviral treatment. Although liver biopsy is considered the reference standard for assessing hepatic fibrosis in patients with chronic hepatitis C, it is invasive and associated with sampling and interobserver variability. Serum fibrosis markers have been utilized as surrogates for a liver biopsy.
We completed a prospective study of 191 patients in which blood draws and liver biopsies were performed on the same visit. Using liver biopsies the sensitivity, specificity, and negative and positive predictive values for both aspartate aminotransferase/platelet ratio index (APRI) and enhanced liver fibrosis (ELF) were determined. The patients were divided into training and validation patient sets to develop and validate a clinically useful algorithm for differentiating mild and significant fibrosis.
The area under the ROC curve for the APRI and ELF tests for the training set was 0.865 and 0.880, respectively. The clinical sensitivity in separating mild (F0-F1) from significant fibrosis (F2-F4) was 80% and 86.0% with a clinical specificity of 86.7% and 77.8%, respectively. For the validation sets the area under the ROC curve for the APRI and ELF tests was, 0.855 and 0.780, respectively. The clinical sensitivity of the APRI and ELF tests in separating mild (F0-F1) from significant (F2-F4) fibrosis for the validation set was 90.0% and 70.0% with a clinical specificity of 73.3% and 86.7%, respectively. There were no differences between the APRI and ELF tests in distinguishing mild from significant fibrosis for either the training or validation sets (P=0.61 and 0.20, respectively). Using APRI as the primary test followed by ELF for patients in the intermediate zone, would have decreased the number of liver biopsies needed by 40% for the validation set. Overall, use of our algorithm would have decreased the number of patients who needed a liver biopsy from 95 to 24-a 74.7% reduction.
This study has shown that the APRI and ELF tests are equally accurate in distinguishing mild from significant liver fibrosis, and combining them into a validated algorithm improves their performance in distinguishing mild from significant fibrosis.
评估慢性丙型肝炎患者的肝纤维化对于判断预后和决定抗病毒治疗方案至关重要。虽然肝活检被认为是评估慢性丙型肝炎患者肝纤维化的参考标准，但它具有侵入性，且存在抽样误差和观察者间差异。血清纤维化标志物已被用作肝活检的替代指标。
我们对191例患者进行了一项前瞻性研究，在同一次就诊时采集血液并进行肝活检。利用肝活检结果确定了天冬氨酸转氨酶/血小板比率指数（APRI）和增强肝纤维化（ELF）的敏感性、特异性以及阴性和阳性预测值。将患者分为训练集和验证集，以开发并验证一种区分轻度和显著纤维化的临床实用算法。
训练集的APRI和ELF检测的ROC曲线下面积分别为0.865和0.880。区分轻度（F0 - F1）与显著纤维化（F2 - F4）的临床敏感性分别为80%和86.0%，临床特异性分别为86.7%和77.8%。对于验证集，APRI和ELF检测的ROC曲线下面积分别为0.855和0.780。验证集的APRI和ELF检测区分轻度（F0 - F1）与显著（F2 - F4）纤维化的临床敏感性分别为90.0%和70.0%，临床特异性分别为73.3%和86.7%。在训练集或验证集中，APRI和ELF检测在区分轻度与显著纤维化方面均无差异（P值分别为0.61和0.20）。对于验证集，以APRI作为主要检测指标，中间区域的患者再进行ELF检测，可使所需肝活检的数量减少40%。总体而言，使用我们的算法可使需要进行肝活检的患者数量从95例减少至24例，减少了74.7%。
本研究表明，APRI和ELF检测在区分轻度与显著肝纤维化方面同样准确，将它们组合成一种经过验证的算法可提高其区分轻度与显著纤维化的性能。
