Ishiba Hiroshi, Fujii Hideki, Kamada Yoshihiro, Sumida Yoshio, Takahashi Hirokazu, Seko Yuya, Toyoda Hidenori, Hayashi Hideki, Yamaguchi Kanji, Iwaki Michihiro, Yoneda Masato, Arai Taeang, Shima Toshihide, Morishita Asahiro, Kawata Kazuhito, Tomita Kengo, Kawanaka Miwa, Yoshida Yuichi, Ikegami Tadashi, Notsumata Kazuo, Oeda Satoshi, Fukushima Hideaki, Miyoshi Eiji, Aishima Shinichi, Itoh Yoshito, Okanoue Takeshi, Nakajima Atsushi
Department of Gastroenterology, Osaka General Hospital of West Japan Railway Company, Abeno, Osaka, Japan.
Department of Hepatology, Osaka Metropolitan University, Osaka, Japan.
Hepatol Commun. 2024 Dec 11;9(1). doi: 10.1097/HC9.0000000000000563. eCollection 2025 Jan 1.
Various noninvasive tests can be used to identify high-risk groups of patients with metabolic dysfunction-associated steatotic liver disease/steatohepatitis (MASLD). In this study, we compared the diagnostic performance of serum type 4 collagen 7S (COL4-7S) and the Enhanced Liver Fibrosis (ELF) score for detecting fibrosis in patients with MASLD.
Among 1368 patients with MASLD who underwent liver biopsy, 794 with values for both serum COL4-7S and the ELF score were enrolled in this multicenter study. The diagnostic performance of COL4-7S and ELF for detecting fibrosis stage ≥2, fibrosis stage ≥3, and at-risk metabolic dysfunction-associated steatohepatitis were evaluated using ROC curve, continuous net reclassification improvement, and integrated discrimination improvement analyses.
Both COL4-7S and ELF scores increased significantly with increasing fibrosis. The AUROC for each outcome was higher for COL4-7S than ELF, but not significantly. The diagnostic performance for detecting fibrosis stage ≥2 was significantly better for COL4-7S than for the ELF score (s net reclassification improvement=16.7%, p=0.018; integrated discrimination improvement=3.9%, p<0.01). In patients without diabetes, the diagnostic performance for each outcome did not differ significantly between COL4-7S and ELF score, but in patients with diabetes, the diagnostic performance for fibrosis stage ≥2 was higher for COL4-7S than for the ELF score (AUROC=0.817 vs. 0.773, p=0.04; s net reclassification improvement=32.7%, p<0.01; integrated discrimination improvement=5.6%, p<0.01).
The diagnostic performance of serum COL4-7S (a single marker) for identifying more advanced disease in patients with MASLD was at least equivalent to that of the ELF score (a combined marker).
多种非侵入性检测方法可用于识别代谢功能障碍相关脂肪性肝病/脂肪性肝炎（MASLD）的高危患者群体。在本研究中，我们比较了血清4型胶原蛋白7S（COL4-7S）和增强肝纤维化（ELF）评分在检测MASLD患者纤维化方面的诊断性能。
在1368例行肝活检的MASLD患者中，794例同时有血清COL4-7S和ELF评分值的患者被纳入这项多中心研究。使用ROC曲线、连续净重新分类改善和综合判别改善分析评估COL4-7S和ELF在检测纤维化分期≥2、纤维化分期≥3以及有风险的代谢功能障碍相关脂肪性肝炎方面的诊断性能。
COL4-7S和ELF评分均随纤维化程度加重而显著升高。COL4-7S对各结局的曲线下面积（AUROC）高于ELF，但差异无统计学意义。COL4-7S检测纤维化分期≥2的诊断性能显著优于ELF评分（净重新分类改善=16.7%，p=0.018；综合判别改善=3.9%，p<0.01）。在无糖尿病患者中，COL4-7S和ELF评分对各结局的诊断性能差异无统计学意义，但在糖尿病患者中，COL4-7S检测纤维化分期≥2的诊断性能高于ELF评分（AUROC=0.817对0.773，p=0.04；净重新分类改善=32.7%，p<0.01；综合判别改善=5.6%，p<0.01）。
血清COL4-7S（单一标志物）在识别MASLD患者更严重疾病方面的诊断性能至少等同于ELF评分（联合标志物）。
