接受抗病毒治疗的代偿性HBV肝硬化患者肝相关事件的预测

StephenW

Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy

    Xiaoning Wu, Jialing Zhou, Yameng Sun, Huiguo Ding, Guofeng Chen, Wen Xie, Hongxin Piao, Xiaoyuan Xu, Wei Jiang, Hui Ma, Anlin Ma, Yongpeng Chen, Mingyi Xu, Jilin Cheng, Youqing Xu, Tongtong Meng, Bingqiong Wang, Shuyan Chen, Yiwen Shi, Yuanyuan Kong, Xiaojuan Ou, Hong You & Jidong Jia

Hepatology International volume 15, pages82–92(2021)Cite this article

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Abstract
Background and aims

Many models have been developed to predict liver-related events (LRE) in chronic hepatitis B, few focused on compensated HBV-induced cirrhosis. We aimed to describe the incidence of LRE and to determine independent risk predictors of LRE in compensated HBV-induced cirrhosis patients receiving antiviral therapy using routinely available parameters.
Methods

Prospective cohorts of treatment-naïve adults with compensated HBV-induced cirrhosis were enrolled. Patients were treated with entecavir (ETV) or ETV + thymosin-alpha1 (Thy-α1) or lamivudine (LAM) + adefovir (ADV). Data were collected at baseline and every 6 months. LRE was defined as development of decompensation, HCC or death.
Results

Totally 937 patients were included, 608 patients treated with ETV, 252 with ETV + Thy-α1, and 77 with LAM + ADV. After a median follow-up of 4.5 years, 88 patients developed LRE including 48 with HCC. The cumulative incidence of LRE at year 1, 3, and 5 was 2.1%, 7.0%, and 12.7%, respectively, and was similar for three treatment groups. All models using variables at month 6 or 12 had better fit than models using baseline values. The best model for prediction of LRE used PLT, GGT, and AFP at month 6 [AUC: 0.762 (0.678–0.814)], for hepatic decompensation—PLT, LSM and GGT at month 12 (AUC: 0.834 (0.675–0.919)), and for HCC—AFP and GGT at month 6 [AUC 0.763 (0.691–0.828)]. All models had negative predictive values of 94.0–98.8%.
Conclusion

Models using on-treatment variables are more accurate than models using baseline variables in predicting LRE in patient with compensated HBV-induced cirrhosis receiving antiviral therapy. ClincialTrials.gov number NCT01943617, NCT01720238, NCT03366571, NCT02849132.

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Abbreviations

ADV:

    Adefovir
ALT:

    Alanine transaminase
ALB:

    Albumin
AFP:

    Alpha-fetoprotein
AST:

    Aspartate aminotransferase
CTP:

    Child-Turcotte-Pugh
Cr:

    Creatine
ETV:

    Entecavir
GGT:

    Gamma-glutamyl transferase
HCC:

    Hepatocellular carcinoma
HE:

    Hepatoencephalopathy
INR:

    International normalized ratio
LAM:

    Lamivudine
LRE:

    Liver-related event
LSM:

    Liver stiffness measurement
MELD:

    Model for end-stage liver disease
PLT:

    Platelet
RCT:

    Randomized controlled trial
Thy-α1:

    Thymosin-alpha1
TB:

    Total bilirubin
VB:

    Variceal bleeding

StephenW

接受抗病毒治疗的代偿性HBV肝硬化患者肝相关事件的预测

    吴小宁，周嘉玲，孙亚萌，丁辉国，陈国峰，谢文，朴红新，徐晓媛，江伟，马辉，马鞍林，陈永鹏，徐明义，程吉林，徐有庆，孟彤彤，王炳琼，陈淑艳，施以文，孔远源，欧小娟，洪有＆贾东东

国际肝病学杂志第15卷，第82–92（2021）页，引用本文

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抽象的
背景和目标

已经开发出许多模型来预测慢性乙型肝炎的肝相关事件（LRE），很少集中于补偿性HBV引起的肝硬化。我们的目的是使用常规可用参数描述接受抗病毒治疗的代偿性HBV诱发的肝硬化患者中LRE的发生率，并确定LRE的独立风险预测因子。
方法

纳入了未接受过治疗的，补偿性HBV引起的肝硬化的成年人的前瞻性队列。患者接受恩替卡韦（ETV）或ETV +胸腺素α1（Thy-α1）或拉米夫定（LAM）+阿德福韦（ADV）治疗。在基线和每6个月收集一次数据。 LRE被定义为代偿失调，肝癌或死亡。
结果

总共包括937例患者，其中608例接受ETV治疗，252例接受ETV +Thy-α1治疗，77例接受LAM + ADV治疗。中位随访4.5年后，有88例患者发生LRE，其中48例患有HCC。 LRE在第1、3和5年的累积发生率分别为2.1％，7.0％和12.7％，并且在三个治疗组中相似。所有使用变量在第6或12个月的模型比使用基线值的模型具有更好的拟合度。预测LRE的最佳模型在第6个月时使用PLT，GGT和AFP [AUC：0.762（0.678–0.814）]，在第12个月时进行肝功能失代偿—PLT，LSM和GGT（AUC：0.834（0.675–0.919）） ，以及HCC-AFP和GGT在第6个月时[AUC 0.763（0.691-0.828）]。所有模型的阴性预测值为94.0–98.8％。
结论

使用治疗变量的模型比使用基线变量的模型更准确地预测接受抗病毒治疗的代偿性HBV肝硬化患者的LRE。 ClincialTrials.gov编号为NCT01943617，NCT01720238，NCT03366571，NCT02849132。

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缩略语

ADV：

    阿德福韦
ALT：

    丙氨酸转氨酶
ALB：

    白蛋白
法新社：

    甲胎蛋白
AST：

    天冬氨酸转氨酶
CTP：

    特尔科特·普格
铬

    肌酸
ETV：

    恩替卡韦
GGT：

    γ-谷氨酰转移酶
肝癌：

    肝细胞癌
他：

    肝性脑病
INR：

    国际标准化比率
我是：

    拉米夫定
LRE：

    肝脏相关事件
LSM：

    肝硬度测量
融合：

    终末期肝病模型
PLT：

    血小板
RCT：

    随机对照试验
Thy-α1：

    胸腺素α1
结核病：

    总胆红素
VB：

    静脉曲张出血