Ogawa Yuji, Tomeno Wataru, Imamura Yasushi, Baba Masaru, Ueno Takato, Kobayashi Takashi, Iwaki Michihiro, Nogami Asako, Kessoku Takaomi, Honda Yasushi, Notsumata Kazuo, Fujikawa Hirotoshi, Kaai Megumi, Imajo Kento, Kawanaka Miwa, Hyogo Hideyuki, Hisatomi Mitsurou, Takeuchi Mamiko, Hakamada Taku, Honda Takashi, Tatsuta Miwa, Morishita Asahiro, Mikami Shigeru, Furuya Ken, Manabe Noriaki, Kamada Tomoari, Kawaguchi Takumi, Yoneda Masato, Saito Satoru, Nakajima Atsushi
Department of Gastroenterology, NHO Yokohama Medical Center, Yokohama, Japan.
Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.
Hepatol Res. 2024 Oct 4. doi: 10.1111/hepr.14117.
The multisociety consensus nomenclature has introduced steatotic liver disease (SLD) with diverse subclassifications, which are metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD), alcohol-associated liver disease (ALD), specific etiology, and cryptogenic. We investigated their prevalence, as per the new definition, in individuals undergoing health check-ups. Additionally, we analyzed the distribution of Fibrosis-4 (FIB-4) index and vibration-controlled transient elastography (VCTE)-derived liver stiffness measurement (LSM) for MASLD.
In this cross-sectional study, 6530 subjects undergoing a health check-up in Japan were included. Conventional B-mode ultrasound was carried out on all 6530 subjects, and those with MASLD underwent VCTE.
The prevalence of SLD was 39.5%, comprising MASLD 28.7%, MetALD 8.6%, ALD 1.2%, specific etiology SLD 0.3%, and cryptogenic SLD 0.7%. Subjects with VCTE-derived LSM ≥8 kPa constituted 2.1% of MASLD. FIB-4 ≥1.3 showed that the sensitivity, specificity, positive predictive value (PPV), and negative predictive value for diagnosing VCTE-derived LSM ≥8 kPa were 60.6%, 77.0%, 5.3%, and 98.9%, respectively. The referral rate to specialists was 23.8% using FIB-4 ≥1.30. "FIB-4 ≥1.3 in subjects <65 years and FIB-4 ≥2.0 in subjects ≥65 years" showed higher PPV (6.7%) and lower referral rate (17.1%) compared with FIB-4 ≥1.3, but the sensitivity (54.5%) did not show adequate diagnostic capability as a noninvasive test for diagnosing VCTE-derived LSM ≥8 kPa.
Acknowledging the selection bias in hepatology centers, we undertook this prospective health check-up study. Although the FIB-4 index proves to be a convenient marker, it might not perform well as a primary screening tool for liver fibrosis in the general population (UMIN Clinical Trials Registry No. UMIN000035188).
多学会共识命名法引入了脂肪性肝病（SLD）及其多种亚分类，即代谢功能障碍相关脂肪性肝病（MASLD）、代谢功能障碍和酒精相关脂肪性肝病（MetALD）、酒精性肝病（ALD）、特定病因及隐源性。我们根据新定义调查了健康体检人群中这些疾病的患病率。此外，我们分析了MASLD患者的纤维化-4（FIB-4）指数分布及基于振动控制瞬时弹性成像（VCTE）的肝脏硬度测量（LSM）情况。
在这项横断面研究中，纳入了6530名在日本接受健康体检的受试者。对所有6530名受试者进行常规B型超声检查，对患有MASLD的受试者进行VCTE检查。
SLD的患病率为39.5%，其中MASLD占28.7%，MetALD占8.6%，ALD占1.2%，特定病因的SLD占0.3%，隐源性SLD占0.7%。VCTE测量的LSM≥8 kPa的MASLD患者占2.1%。FIB-4≥1.3时，诊断VCTE测量的LSM≥8 kPa的敏感性、特异性、阳性预测值（PPV）和阴性预测值分别为60.6%、77.0%、5.3%和98.9%。使用FIB-4≥1.3时，转诊至专科医生的比例为23.8%。与FIB-4≥1.3相比，“年龄<65岁的受试者FIB-4≥1.3，年龄≥65岁的受试者FIB-4≥2.0”显示出更高的PPV（6.7%）和更低的转诊率（17.1%），但其敏感性（54.5%）作为诊断VCTE测量的LSM≥8 kPa的非侵入性检查，诊断能力不足。
考虑到肝病中心存在的选择偏倚，我们开展了这项前瞻性健康体检研究。尽管FIB-4指数是一个方便的指标，但在普通人群中作为肝纤维化的初步筛查工具可能效果不佳（UMIN临床试验注册号：UMIN000035188）。
