Abstract：
Antiviral therapy improves the clinical outcomes of patients with chronic hepatitis B (CHB), including those with cirrhosis. In the present study, we validated the Baveno VII definition of recompensation and explored the criteria for stable improvement of liver function tests in entecavir-treated patients with CHB-related decompensated cirrhosis.
In this multicentre prospective study, patients with decompensated (ascites) CHB-related cirrhosis were enrolled and treated with entecavir for 120 weeks. Patients were followed up for clinical events, viral and biochemical tests, and ultrasonography every 6 months. The recompensation rate per Baveno VII criteria was calculated. Multivariate regression models were used to identify the predictors of recompensation. Finally, the criteria for stable improvement of liver function tests were explored.
Of the 320 recruited patients, 283 completed the 120-week study, with 261/283 (92.2%) achieving HBV DNA levels <20 IU/ml and 171/283 (60.4%) achieving resolution of ascites, encephalopathy, and absence of recurrent variceal bleeding for at least 12 months. We identified model for end-stage liver disease <10 and/or liver function tests within Child-Pugh Class A (albumin >35 g/L, international normalised ratio <1.50 and total bilirubin <34 μmol/L) as the criteria for stable improvement of liver function tests. Accordingly, 56.2% (159/283) of patients fulfilled the Baveno VII definition of recompensation with a stable improvement of liver function tests defined by the current study.
Our study defined the criteria for a stable improvement of liver function tests required by the Baveno VII definition of recompensation in patients with CHB-related decompensated cirrhosis on antiviral therapy. The criteria derived from this multicentre prospective study warrant further validation in patients with cirrhosis of other aetiologies.
Decompensation of cirrhosis marks the point at which the liver is no longer able to function normally (and symptoms become apparent). Recently the idea of recompensation was proposed for individuals who may experience an improvement in liver function if the underlying cause of their liver disease is addressed (e.g. antivirals for viral cirrhosis). Herein, we show that over 50% of patients with hepatitis B-related decompensated cirrhosis treated with antivirals could recompensate and we propose laboratory criteria which could be used to define recompensation.
In this multicentre prospective study, patients with decompensated (ascites) CHB-related cirrhosis were enrolled and treated with entecavir for 120 weeks. Patients were followed up for clinical events, viral and biochemical tests, and ultrasonography every 6 months. The recompensation rate per Baveno VII criteria was calculated. Multivariate regression models were used to identify the predictors of recompensation. Finally, the criteria for stable improvement of liver function tests were explored.
Of the 320 recruited patients, 283 completed the 120-week study, with 261/283 (92.2%) achieving HBV DNA levels <20 IU/ml and 171/283 (60.4%) achieving resolution of ascites, encephalopathy, and absence of recurrent variceal bleeding for at least 12 months. We identified model for end-stage liver disease <10 and/or liver function tests within Child-Pugh Class A (albumin >35 g/L, international normalised ratio <1.50 and total bilirubin <34 μmol/L) as the criteria for stable improvement of liver function tests. Accordingly, 56.2% (159/283) of patients fulfilled the Baveno VII definition of recompensation with a stable improvement of liver function tests defined by the current study.
Our study defined the criteria for a stable improvement of liver function tests required by the Baveno VII definition of recompensation in patients with CHB-related decompensated cirrhosis on antiviral therapy. The criteria derived from this multicentre prospective study warrant further validation in patients with cirrhosis of other aetiologies.
Decompensation of cirrhosis marks the point at which the liver is no longer able to function normally (and symptoms become apparent). Recently the idea of recompensation was proposed for individuals who may experience an improvement in liver function if the underlying cause of their liver disease is addressed (e.g. antivirals for viral cirrhosis). Herein, we show that over 50% of patients with hepatitis B-related decompensated cirrhosis treated with antivirals could recompensate and we propose laboratory criteria which could be used to define recompensation.
摘要：
抗病毒治疗改善慢性乙型肝炎（CHB）患者的临床结局，包括肝硬化患者.在本研究中,我们验证了BavenoVII对再补偿的定义,并探讨了恩替卡韦治疗的CHB相关失代偿期肝硬化患者肝功能检查稳定改善的标准.
在这项多中心前瞻性研究中，失代偿期（腹水）CHB相关性肝硬化患者被纳入并接受恩替卡韦治疗120周。对患者的临床事件进行随访，病毒和生化测试，每6个月做一次超声检查.计算了根据BavenoVII标准的补偿率。多元回归模型用于确定再补偿的预测因子。最后,探讨了肝功能检查稳定改善的标准。
在招募的320名患者中,283完成了为期120周的研究，261/283（92.2％）实现HBVDNA水平<20IU/ml和171/283（60.4％）实现腹水的分辨率，脑病,并且至少12个月内没有复发静脉曲张出血。我们确定了终末期肝病的模型<10和/或Child-PughA级肝功能测试（白蛋白>35g/L，国际标准化比率<1.50和总胆红素<34μmol/L）作为肝功能检查稳定改善的标准。因此，56.2％（159/283）的患者符合BavenoVII的再补偿定义，目前的研究定义的肝功能测试稳定改善。
我们的研究定义了在抗病毒治疗CHB相关的失代偿性肝硬化患者的BavenoVII定义的再补偿所需的肝功能测试的稳定改善标准。这项多中心前瞻性研究得出的标准值得在其他病因肝硬化患者中进一步验证。
肝硬化的失代偿标志着肝脏不再能够正常运作（并且症状变得明显）。最近，如果解决其肝病的根本原因（例如病毒性肝硬化的抗病毒药物），则可能经历肝功能改善的个体提出了再补偿的想法。在这里，我们表明，超过50％的乙型肝炎相关失代偿期肝硬化患者接受抗病毒药物治疗可以进行再补偿，我们提出了可用于定义再补偿的实验室标准。
在这项多中心前瞻性研究中，失代偿期（腹水）CHB相关性肝硬化患者被纳入并接受恩替卡韦治疗120周。对患者的临床事件进行随访，病毒和生化测试，每6个月做一次超声检查.计算了根据BavenoVII标准的补偿率。多元回归模型用于确定再补偿的预测因子。最后,探讨了肝功能检查稳定改善的标准。
在招募的320名患者中,283完成了为期120周的研究，261/283（92.2％）实现HBVDNA水平<20IU/ml和171/283（60.4％）实现腹水的分辨率，脑病,并且至少12个月内没有复发静脉曲张出血。我们确定了终末期肝病的模型<10和/或Child-PughA级肝功能测试（白蛋白>35g/L，国际标准化比率<1.50和总胆红素<34μmol/L）作为肝功能检查稳定改善的标准。因此，56.2％（159/283）的患者符合BavenoVII的再补偿定义，目前的研究定义的肝功能测试稳定改善。
我们的研究定义了在抗病毒治疗CHB相关的失代偿性肝硬化患者的BavenoVII定义的再补偿所需的肝功能测试的稳定改善标准。这项多中心前瞻性研究得出的标准值得在其他病因肝硬化患者中进一步验证。
肝硬化的失代偿标志着肝脏不再能够正常运作（并且症状变得明显）。最近，如果解决其肝病的根本原因（例如病毒性肝硬化的抗病毒药物），则可能经历肝功能改善的个体提出了再补偿的想法。在这里，我们表明，超过50％的乙型肝炎相关失代偿期肝硬化患者接受抗病毒药物治疗可以进行再补偿，我们提出了可用于定义再补偿的实验室标准。
