验证新的 2021 EASL 算法对非酒精性脂肪肝疾病晚期肝纤维化的

StephenW

验证新的 2021 EASL 算法对非酒精性脂肪肝疾病晚期肝纤维化的无创诊断

EASL 算法可准确检测 NAFLD 中的晚期纤维化

EASL 国际肝脏大会 2022，伦敦，2022 年 6 月 22 日至 26 日

马克·马斯科里尼

EASL 提出的用于非酒精性脂肪性肝病 (NAFLD) 患者晚期肝纤维化的无创诊断顺序算法在对 1051 名接受肝活检的 NAFLD 患者进行的分析中具有很高的准确性 [1]。仿真表明，该算法可用于初级保健和糖尿病患者。

EASL（欧洲肝脏研究协会）在其 2021 年指南中提出了一种诊断 NAFLD 患者晚期肝纤维化的算法。该算法依次考虑了 FIB4、振动控制瞬态弹性成像 (VCTE) 以及 - 在创新步骤中 - 获得专利的血清测试。

该算法指定 FIB4 低于 1.30 表示晚期纤维化的风险非常低，无需转诊。较高的 FIB4 需要 VCTE 来测量肝脏硬度。 VCTE 低于 8 kPa 表明晚期纤维化的风险非常低，无需进一步测试。 VCTE 高于 8 kPa 表明需要转诊至肝脏专家，以通过专利血清测试（ELF、Fibrotest 或 FibroMeter）确认晚期纤维化。 VCTE 和血清检测结果不一致表明应考虑进行肝活检。

由于 EASL 算法在临床实践中仍未得到验证，法国研究人员对 1051 名活检确诊的 NAFLD 患者进行了此类评估。主要结果是晚期纤维化（F3-F4 NASH CRN）。研究参与者来自昂热、波尔多和格勒诺布尔。每个人都有验血结果计算FIB4、VCTE、FibroMeter、Fibrotest； 396 人有 ELF 结果。

研究组的中位年龄为 58.1 岁，中位体重指数为 31.2 kg/m2（在肥胖范围内），而 59.5% 的参与者是男性，50% 患有糖尿病，40% 患有晚期纤维化。

每个单独测试的测试准确性都证明很高，并且在整个队列和 ELF 子集中相似，此处列出：接受者操作特征曲线下的 FIB4 面积 (AUROC) 0.768、VCTE AUROC 0.855、Fibrotest AUROC 0.770、FibroMeter AUROC 0.837 和 ELF奥罗克 0.869。 FibroMeter 和 ELF 结果与 FIB4 或 Fibrotest 的结果相似且更好。

在整个队列中，FIB4 的敏感性为 81%，研究人员认为这是可以接受的。但 FIB4 的阳性预测值仅达到 58%，这意味着应该对 FIB4 阳性的人进行额外的测试。 VCTE 在该队列中具有 88% 的出色敏感性，这使研究人员能够排除 33% 没有晚期纤维化的人。

VCTE 阳性预测值仅为 62%，但在连续使用 FIB4 和 VCTE 时达到 73%。在 VCTE 中添加专利血清测试后，阳性预测值微升至 77%。不一致的 VCTE 和血清检测结果确定了一个亚组，其阳性预测值非常低，为 35% 至 47%（取决于血清检测）。正如 EASL 算法所规定的，该结果验证了在 VCTE 血清检测结果不一致的人群中使用肝活检。

对于整个队列，FIB4、VCTE 和 FibroMeter 序列的诊断准确性为 81.4%，敏感性为 71.3%，特异性为 88.0%，仅 6.8% 需要活检。对于 FIB4、VCTE 和 Fibrotest 序列，诊断准确率为 82.8%，敏感性为 71.3%，特异性为 90.2%，其中 12.7% 需要活检。结果证明在 ELF 子集中是相似的。例如，对于 FIB4、VCTE 和 ELF 序列，诊断准确率为 87.4%，敏感性为 73.5%，特异性为 94.3%，活检需要为 11.9%。

研究人员得出结论，他们的发现验证了 EASL 的建议，即使用 FIB4、VCTE 和专利血清测试来诊断 NAFLD 患者的晚期肝纤维化。诊断准确性与分析的三种血清测试相似——FibroMeter、Fibrotest 和 ELF。仿真表明，该算法适用于初级保健和糖尿病诊所。

参考
1. Canivet CM、Lannes A、Costentin C 等人验证新的 2021 EASL 算法用于非酒精性脂肪性肝病晚期肝纤维化的无创诊断。 ASL 国际肝脏大会 2022，伦敦，2022 年 6 月 22-26 日。摘要 OS099。

StephenW

Validation of the new 2021 EASL algorithm for the non-invasive diagnosis of advanced liver fibrosis in non-alcoholic fatty liver disease   

EASL Algorithm Accurate for Advanced Fibrosis in NAFLD

EASL International Liver Congress 2022, London, June 22-26, 2022

Mark Mascolini

An EASL-proposed sequential algorithm for noninvasive diagnosis of advanced liver fibrosis in people with nonalcoholic fatty liver disease (NAFLD) had high accuracy in an analysis of 1051 NAFLD patients with liver biopsy [1]. Simulation indicated that the algorithm can be used in primary care and for people with diabetes.

In its 2021 guidelines EASL (the European Association for the Study of the Liver) proposed an algorithm for diagnosing advanced liver fibrosis in people with NAFLD. The algorithm sequentially considers FIB4, vibration-controlled transient elastography (VCTE), and—in an innovative step—a patented serum test.

The algorithm specifies that FIB4 below 1.30 indicates very low risk of advanced fibrosis and no need for referral. Higher FIB4 calls for VCTE to measure liver stiffness. VCTE below 8 kPa indicates very low risk of advanced fibrosis and no need for further testing. VCTE above 8 kPa indicates a need for referral to a liver specialist to confirm advanced fibrosis with a patented serum test—ELF, Fibrotest, or FibroMeter. Discordant results with VCTE and a serum test indicate liver biopsy should be considered.

Because the EASL algorithm remained unvalidated in clinical practice, French researchers undertook such an evaluation in 1051 patients with biopsy-confirmed NAFLD. The primary outcome was advanced fibrosis (F3-F4 NASH CRN). Study participants came from Angers, Bordeaux, and Grenoble. Everyone had blood test results to calculate FIB4, VCTE, FibroMeter, and Fibrotest; 396 people had ELF results.

Median age of the study group stood at 58.1 and median body mass index at 31.2 kg/m2 (in the obese range), While 59.5% of participants were men, 50% had diabetes, and 40% had advanced fibrosis.

Test accuracy proved high for each individual test and was similar in the entire cohort and the ELF subset, listed here: FIB4 area under the receiver operating characteristic curve (AUROC) 0.768, VCTE AUROC 0.855, Fibrotest AUROC 0.770, FibroMeter AUROC 0.837, and ELF AUROC 0.869. FibroMeter and ELF results were similar and better than results with FIB4 or Fibrotest.

In the entire cohort FIB4 had a sensitivity of 81%, which the researchers called acceptable. But positive predictive value with FIB4 reached only 58%, which means an additional test should be used on people with a positive FIB4. VCTE had an excellent sensitivity of 88% in this cohort, which allowed the researchers to exclude 33% of people without advanced fibrosis.

VCTE positive predictive value stood at a meager 62% but reached 73% with sequential use of FIB4 and VCTE. Positive predictive value inched up to 77% with a patented serum test added to VCTE. Discordant VCTE and serum test results identified a subgroup with a very low positive predictive value of 35% to 47% (depending on the serum test). That result validates use of liver biopsy in people with discordant VCTE-serum test results, as the EASL algorithm stipulates.

For the whole cohort, the sequence FIB4, VCTE, and FibroMeter had a diagnostic accuracy of 81.4%, sensitivity of 71.3%, specificity of 88.0%, and need for biopsy in only 6.8%. For the sequence FIB4, VCTE, and Fibrotest, diagnostic accuracy stood at 82.8%, sensitivity at 71.3%, and specificity at 90.2%, with 12.7% requiring biopsy. Results proved similar in the ELF subset. For example with the sequence FIB4, VCTE, and ELF, diagnostic accuracy was 87.4%, sensitivity 73.5%, specificity 94.3%, and need for biopsy 11.9%.

The researchers concluded that their findings validate EASL advice to use FIB4, VCTE, and a patented serum test to diagnose advanced liver fibrosis in people with NAFLD. Diagnostic accuracy is similar with the three serum tests analyzed—FibroMeter, Fibrotest, and ELF. Simulation showed that this algorithm is appropriate for primary care and for diabetes clinics.

Reference
1. Canivet CM, Lannes A, Costentin C, et al  Validation of the new 2021 EASL algorithm for the non-invasive diagnosis of advanced liver fibrosis in non-alcoholic fatty liver disease. ASL International Liver Congress 2022, London, June 22-26, 2 022. Abstract OS099.