Design and validation of a histological scoring system for nonalcoholic fatty liver disease

Design and validation of a histological scoring system for nonalcoholic fatty liver disease
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DOI:
10.1002/hep.20701
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发表时间:
2005-06-01
期刊:
影响因子:
13.5
通讯作者:
Sanyal, AJ
Sanyal, AJ
中科院分区:
医学1区
文献类型:
--
作者:
Kleiner, DE;Brunt, EM;Sanyal, AJ

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非酒精性脂肪性肝病(NAFLD)的特征是在没有显著饮酒史或其他已知肝病的情况下发生肝脂肪变性。非酒精性脂肪性肝炎(NASH)是NAFLD的进展形式。NASH临床研究网络的病理学委员会设计并验证了一种组织学特征评分系统,该系统解决了NAFLD病变的全谱,并提出了用于临床试验的NAFLD活动评分(NAS)。评分系统包括14个组织学特征,其中4个进行了半定量评价:脂肪变性(0-3)、小叶炎症(0-2)、肝细胞气球样变(0-2)和纤维化(0-4)。另外9个特征被记录为存在或不存在。收集、编码并分发了一个包含50例病例的匿名研究集(32例来自成人肝病服务,18例来自儿科肝病服务)。对于验证研究,通过使用加权kappa统计评价评分和诊断分类(“NASH”、“临界”或“非NASH”)的一致性。成人病例的评定者间一致性为:纤维化0.84,脂肪变性0.79,损伤0.56,小叶炎症0.45。诊断类别的一致性为0.61。使用多元逻辑回归,成人活检中有五个特征与NASH的诊断独立相关:脂肪变性(P =.009)、肝细胞气球样变(P =.0001)、小叶炎症(P =.0001)、纤维化(P =.0001)和不存在脂肪肉芽肿(P =.001)。拟定的NAS是脂肪变性、小叶炎症和肝细胞气球样变评分的未加权总和。总之,我们为NAFLD和NASH提供了一个强大的评分系统和NAS,具有合理的评分者间重现性,对于患有任何程度NAFLD的成人和儿童的研究都是有用的。NAS>= 5与NASH的诊断相关,并且评分小于3的活检被诊断为“非NASH”。"
Nonalcoholic fatty liver disease (NAFLD) is characterized by hepatic steatosis in the absence of a history of significant alcohol use or other known liver disease. Nonalcoholic steatohepatitis (NASH) is the progressive form of NAFLD. The Pathology Committee of the NASH Clinical Research Network designed and validated a histological feature scoring system that addresses the full spectrum of lesions of NAFLD and proposed a NAFLD activity score (NAS) for use in clinical trials. The scoring system comprised 14 histological features, 4 of which were evaluated semi-quantitatively: steatosis (0-3), lobular inflammation (0-2), hepatocellular ballooning (0-2), and fibrosis (0-4). Another nine features were recorded as present or absent. An anonymized study set of 50 cases (32 from adult hepatology services, 18 from pediatric hepatology services) was assembled, coded, and circulated. For the validation study, agreement on scoring and a diagnostic categorization ("NASH," "borderline," or "not NASH") were evaluated by using weighted kappa statistics. Inter-rater agreement on adult cases was: 0.84 for fibrosis, 0.79 for steatosis, 0.56 for injury, and 0.45 for lobular inflammation. Agreement on diagnostic category was 0.61. Using multiple logistic regression, five features were independently associated with the diagnosis of NASH in adult biopsies: steatosis (P =.009), hepatocellular ballooning (P =.0001), lobular inflammation (P =.0001), fibrosis (P =.0001), and the absence of lipogranulomas (P =.001). The proposed NAS is the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores. In conclusion, we present a strong scoring system and NAS for NAFLD and NASH with reasonable inter-rater reproducibility that should be useful for studies of both adults and children with any degree of NAFLD. NAS of >= 5 correlated with a diagnosis of NASH, and biopsies with scores of less than 3 were diagnosed as "not NASH."