Wu Xi-Xi, Zheng Kenneth I, Boursier Jérôme, Chan Wah-Kheong, Yilmaz Yusuf, Romero-Gómez Manuel, El Kassas Mohamed, Targher Giovanni, Byrne Christopher D, Huang Zhi-Ming, Zheng Ming-Hua
Department of Gastroenterology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
MAFLD Research Center, Department of Hepatology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
EClinicalMedicine. 2021 Oct 1;41:101145. doi: 10.1016/j.eclinm.2021.101145. eCollection 2021 Nov.
There is an unmet need for non-invasive biomarkers for the diagnosis of nonalcoholic steatohepatitis (NASH) in non-specialized settings. We aimed to develop and validate a non-invasive test for diagnosing NASH in individuals with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
We developed a non-invasive test named the that combines serum creatinine and aspartate aminotransferase levels in a derivation cohort of 390 Chinese NAFLD patients admitted to the hepatology center of the First Affiliated Hospital of Wenzhou Medical University (China) between December 2016 and September 2019 and subsequently validated in five external cohorts of different ethnicities of patients with biopsy-confirmed NAFLD (pooled n=1,089).
The performance of the acNASH index for identifying NASH (defined as NAFLD activity score ≥5 with score of ≥1 for each steatosis, lobular inflammation and ballooning) was good in the derivation cohort with an area under receiver operating characteristics (AUROC) of 0·818 (95%CI 0·777-0·860). A cutoff of acNASH index <4·15 gave a sensitivity (Se) of 91%, a specificity (Sp) of 48% and a negative predictive value (NPV) of 83% for ruling-out NASH, conversely, a cutoff of acNASH >7·73 gave a Sp of 91%, Se of 53% and a positive predictive value (PPV) of 85% for ruling-in NASH. In the pooled validation cohort (n=1,089), the diagnostic performance of the index was also good with AUROC=0·805 (95%CI 0·780-0·830), NPV of 93% for ruling-out NASH and PPV of 73% for ruling-in NASH. Subgroup analyses showed similar performance in patients with diabetes or subjects with normal serum transaminase levels.
The acNASH index shows promising utility as a simple non-invasive biomarker for diagnosing NASH among adults with biopsy-proven NAFLD of different ethnicities from different countries.
The National Natural Science Foundation of China (82070588), High Level Creative Talents from Department of Public Health in Zhejiang Province (S2032102600032) and Project of New Century 551 Talent Nurturing in Wenzhou.
在非专科环境中，对于非酒精性脂肪性肝炎（NASH）诊断的非侵入性生物标志物存在未满足的需求。我们旨在开发并验证一种用于诊断经活检证实患有非酒精性脂肪性肝病（NAFLD）个体的NASH的非侵入性检测方法。
我们开发了一种名为acNASH指数的非侵入性检测方法，该方法将血清肌酐和天冬氨酸转氨酶水平相结合，在2016年12月至2019年9月期间入住温州医科大学附属第一医院肝病中心的390例中国NAFLD患者的推导队列中进行研究，并随后在五个不同种族的经活检证实为NAFLD患者的外部队列中（合并n = 1089）进行验证。
在推导队列中，acNASH指数用于识别NASH（定义为NAFLD活动评分≥5，脂肪变性、小叶炎症和气球样变每项评分≥1）的性能良好，受试者工作特征曲线下面积（AUROC）为0·818（95%CI 0·777 - 0·860）。acNASH指数<4·15的截断值用于排除NASH时，敏感性（Se）为91%，特异性（Sp）为48%，阴性预测值（NPV）为83%；相反，acNASH>7·73的截断值用于确诊NASH时，Sp为91%，Se为53%，阳性预测值（PPV）为85%。在合并验证队列（n = 1089）中，该指数的诊断性能也良好，AUROC = 0·805（95%CI 0·780 - 0·830），排除NASH的NPV为93%，确诊NASH的PPV为73%。亚组分析显示在糖尿病患者或血清转氨酶水平正常的受试者中表现相似。
acNASH指数作为一种简单的非侵入性生物标志物，在诊断来自不同国家、不同种族且经活检证实患有NAFLD的成年人的NASH方面显示出有前景的效用。
中国国家自然科学基金（82070588）、浙江省卫生健康委高层次创新人才（S2032102600032）以及温州市新世纪551人才培养工程。
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