Usefulness of Cytokeratin-18M65 in Diagnosing Non-Alcoholic Steatohepatitis in Japanese Population.
OBJECTIVE
The aim of this study was to evaluate cytokeratin-18M65 (CK-18M65) for distinguishing between simple steatosis (SS) and non-alcoholic steatohepatitis (NASH) against healthy individuals (HIs) in Japanese population.


METHODS
The serum from 24 HIs, 21 patients with SS and 20 patients with NASH were examined. Serum CK-18M65 was measured by enzyme-linked immunosorbent assay.


RESULTS
Aspartate aminotransferase was significantly different between NASH patients and HIs with p < 0.0001 (SS patients and HIs: p < 0.0001), as was alanine aminotransferase between NASH patients and HIs with p < 0.0001 (SS patients and HIs: p < 0.0001). Serum CK-18M65 increased in a stepwise fashion in HIs and also in SS and NASH patients. Multivariate logistic regression analysis revealed that NASH could be diagnosed with the use of CK-18M65 alone (p = 0.0285, OR 1.0038, 95% CI 1.0004-1.0073). At the optimal cut-off level of 548 U/l, CK-18M65 had an AUC value of 0.7369, 60.00% sensitivity and 85.70% specificity. In patients with NASH, no significant difference was observed between low fibrosis (Stage 0-1, 794.30 ± 454.41, n = 10) and high fibrosis (Stage 2-3, 809.70 ± 641.43, n = 10; p = 0.5967) and between slight steatosis (<33%, 512.89 ± 229.65, n = 9) and moderate steatosis (≥33%, 655.13 ± 480.78, n = 32) in patients with non-alcoholic fatty liver disease (NAFLD; p = 0.7647) with the use of CK-18M65.


CONCLUSIONS
Serum CK-18M65 distinguished NASH from SS, but could not assess the severity of steatosis in NAFLD patients or the grade of fibrosis in NASH patients in Japanese population.
Department of Pharmacy, Division of Medical Technology, Shinko Hospital, Kobe, Japan.
Yutaka
Y
Hasegawa
Soo Ryang
SR
Kim
Takashi
T
Hatae
Mitsuhiro
M
Ohta
Aya
A
Fujinami
Kayo
K
Sugimoto
Ke Ih
KI
Kim
Susumu
S
Imoto
Madoka
M
Tohyama
Soo Ki
SK
Kim
Yoshihiro
Y
Ikura
Masatoshi
M
Kudo
D000328:Adult; D000368:Aged; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay; D005234:Fatty Liver / Q000097:blood / Q000175:diagnosis; D005260:Female; D006801:Humans; D053538:Keratin-18 / Q000097:blood*; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000097:blood / Q000175:diagnosis*
D015415:Biomarkers; D053538:Keratin-18