Gai Xiao-Dong, Wu Wei-Feng
The Second Department of Liver Medicine, The Second Affiliated Hospital of Southeast University, Nanjing, Jiangsu 210003, P.R. China.
Exp Ther Med. 2017 Oct;14(4):3908-3914. doi: 10.3892/etm.2017.4963. Epub 2017 Aug 18.
Chronic hepatitis B virus (CHB) infection is a burden on global healthcare and is associated with a higher risk of serious sequelae, including cirrhosis and hepatocellular carcinoma. The clinical application of entecavir as a treatment for CHB has produced positive outcomes, and so is an attractive form of pharmacological therapy. However, little data exists comparing the safety and efficacy of entecavir for the treatment of hepatitis B virus (HBV)-related compensated, and decompensated cirrhosis, respectively. The aim of the present study was to evaluate entecavir therapy as a treatment for patients with HBV-related compensated and decompensated cirrhosis. A retrospective analysis of 46 compensated patients (compensated group) and 51 decompensated cirrhotic patients (decompensated group) treated with entecavir was conducted. Baseline demographics, clinical outcomes, and adverse events during the treatment were compared. Treatment with entecavir for 96 weeks resulted in significant improvements in serum levels of HBV DNA (P=0.002), albumin (P=0.014), cholinesterase (CHE; P=0.001), HBV DNA negativity rate (P=0.004), Child-Turcotte-Pugh score (P=0.030), alanine aminotransferase normalized rate (P=0.039), and the degree of esophageal varices liver stiffness (P=0.002) in the two groups. However, statistical analysis revealed that the improvements were significantly higher in the compensated group compared with the decompensated group (P<0.05). The complement component (C)3 and C4 levels were also significantly increased in the compensated group compared with the decompensated group at weeks 24, 48 and 96 (P<0.05). In addition, the incidences of hepatocellular carcinoma, upper digestive tract hemorrhage and ascites were significantly higher in the decompensated group compared with the compensated group (P<0.05). In conclusion, treatment with 96-week entecavir therapy produced similar clinical outcomes in compensated and decompensated cirrhotic patients via inhibiting HBV-DNA viral load and recovering complement C3 and C4; however, entecavir exerts a better effect on patients with compensated cirrhosis, and so this therapy may improve the prognosis of such patients.
慢性乙型肝炎病毒（CHB）感染是全球医疗保健的一项负担，并且与包括肝硬化和肝细胞癌在内的严重后遗症的较高风险相关。恩替卡韦作为CHB治疗方法的临床应用已产生了积极效果，因此是一种有吸引力的药物治疗形式。然而，关于恩替卡韦分别治疗乙型肝炎病毒（HBV）相关代偿期和失代偿期肝硬化的安全性和疗效比较的数据很少。本研究的目的是评估恩替卡韦治疗HBV相关代偿期和失代偿期肝硬化患者的效果。对46例接受恩替卡韦治疗的代偿期患者（代偿组）和51例失代偿期肝硬化患者（失代偿组）进行了回顾性分析。比较了基线人口统计学数据、临床结局以及治疗期间的不良事件。恩替卡韦治疗96周后，两组患者的血清HBV DNA水平（P = 0.002）、白蛋白（P = 0.014）、胆碱酯酶（CHE；P = 0.001）、HBV DNA阴性率（P = 0.004）、Child-Turcotte-Pugh评分（P = 0.030）、丙氨酸氨基转移酶正常化率（P = 0.039）以及食管静脉曲张肝脏硬度程度（P = 0.002）均有显著改善。然而，统计分析显示，代偿组的改善程度显著高于失代偿组（P < 0.05）。在第24、48和96周时，代偿组的补体成分（C）3和C4水平也显著高于失代偿组（P < 0.05）。此外，失代偿组的肝细胞癌、上消化道出血和腹水的发生率显著高于代偿组（P < 0.05）。总之，96周恩替卡韦治疗通过抑制HBV-DNA病毒载量和恢复补体C3和C4，在代偿期和失代偿期肝硬化患者中产生了相似的临床结局；然而，恩替卡韦对代偿期肝硬化患者的效果更好，因此这种治疗可能会改善此类患者的预后。
