Kang Na-Ling, Wu Lu-Ying, Zheng Qi, Yu Xue-Ping, Hu Ai-Rong, Guo Yue, Li Huan, Ye Xiang-Yang, Ruan Qing-Fa, Lu Zhong-Hua, Wu Ling, Jin Wen, Liu Yu-Rui, Pan Chen, Liu Shan-Shan, Zhang Ji-Ming, Jiang Jia-Ji, Zeng Da-Wu
Department of Hepatology, Hepatology Research Institute, The First Affiliated Hospital, Clinical Research Center for Hepatopathy and Intestinal Diseases of Fujian Province, Fujian Medical University, Fuzhou, China.
Department of Hepatology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
Aliment Pharmacol Ther. 2024 Mar;59(5):692-704. doi: 10.1111/apt.17862. Epub 2024 Jan 4.
We aimed to define gender-specific, optimal alanine aminotransferase (ALT) cut-off values for the prediction of significant liver histological changes (SLHC) in Chinese patients with grey zone (GZ) chronic hepatitis B (CHB) and normal ALT.
In a retrospective study, we included 1101 consecutive patients with GZ CHB and normal ALT assigned to training or internal validation cohorts. We included an independent cohort of 842 patients for external validation. We performed receiver operating characteristic (ROC) curve, smoothed curve fitting, and threshold effect analyses to determine optimal ALT cut-off values. Area under the curve (AUC) values were calculated to assess their predictive performance.
A proportion of 79.3% of patients with GZ CHB and normal ALT (≤40 U/L) had SLHC. ROC curve analysis initially identified optimal ALT cut-off values of 29 U/L (male) and 22 U/L (female). After smoothed curve fitting and threshold effect analyses, new optimal cut-off values were 27 U/L for males and 24 U/L for females. AUCs for these values were 0.836 (male) and 0.833 (female) in the internal validation cohort, and 0.849 (male) and 0.844 (female) in the external validation cohort. The accuracy and discriminative ability of the newly defined ALT cut-off values were greater than those of the current recommendations.
This study established novel optimal ALT cut-off values for more precise prediction of SLHC among Chinese patients with GZ CHB and normal ALT levels. This may help identify individuals who will benefit from timely antiviral therapy.
我们旨在确定特定性别的最佳丙氨酸氨基转移酶（ALT）临界值，以预测中国灰色区（GZ）慢性乙型肝炎（CHB）且ALT正常患者的显著肝脏组织学改变（SLHC）。
在一项回顾性研究中，我们纳入了1101例连续的GZ CHB且ALT正常的患者，将其分配至训练或内部验证队列。我们纳入了一个由842例患者组成的独立队列进行外部验证。我们进行了受试者工作特征（ROC）曲线、平滑曲线拟合和阈值效应分析，以确定最佳ALT临界值。计算曲线下面积（AUC）值以评估其预测性能。
79.3%的GZ CHB且ALT正常（≤40 U/L）患者存在SLHC。ROC曲线分析最初确定的最佳ALT临界值为男性29 U/L，女性22 U/L。经过平滑曲线拟合和阈值效应分析后，新的最佳临界值男性为27 U/L，女性为24 U/L。在内部验证队列中，这些值的AUC男性为0.836，女性为0.833；在外部验证队列中，男性为0.849，女性为0.844。新定义的ALT临界值的准确性和判别能力高于当前推荐值。
本研究建立了新的最佳ALT临界值，以更精确地预测中国GZ CHB且ALT水平正常患者的SLHC。这可能有助于识别将从及时抗病毒治疗中获益的个体。
