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替比夫定与拉米夫定及恩替卡韦用于初治失代偿期乙型肝炎病毒相关性肝硬化的治疗比较

Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis.

作者信息

Yue-Meng Wan, Li Yu-Hua, Wu Hua-Mei, Yang Jing, Xu Ying, Yang Li-Hong, Yang Jin-Hui

机构信息

Gastroenterology Department II or Hepatology Center, The Second Affiliated Hospital of Kunming Medical University, Kunming City, Yunnan Province, China.

出版信息

Clin Exp Med. 2017 May;17(2):233-241. doi: 10.1007/s10238-016-0420-7. Epub 2016 Apr 19.

Abstract

The long-term effects of telbivudine (TBV) on decompensated hepatitis B virus (HBV)-related cirrhosis were still not established. This study aimed to investigate the efficacy and safety of TBV in such cohort of patients as compared to lamivudine (LAM) and entecavir (ETV). We retrospectively evaluated 130 treatment-naïve patients with HBV-related decompensated cirrhosis who started treatment with TBV (n = 31), LAM (n = 45) or ETV (n = 54). After 24 months of treatment, cumulative virological response (VR) rates (HBV DNA <500 copies/mL) were 83.7, 65.3 and 89.1 % in TBV, LAM and ETV groups, respectively (p = 0.009). Reduction in HBV DNA levels in TBV was -3.66 ± 0.56, significantly higher than LAM (-3.34 ± 0.59; p < 0.05) and lower than ETV group (-3.98 ± 0.52; p < 0.05). The rates of HBeAg loss or seroconversion and normalization of alanine aminotransferase (ALT) were similar among the groups. Child-Turcotte-Pugh (CTP) score and model for end-stage liver disease score in TBV were significantly improved compared to at baseline without difference among the groups. TBV resulted in similar cumulative rates of survival and incidence of hepatocellular carcinoma (HCC) to LAM and ETV. Frequencies of complications from cirrhosis, including variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis, were comparable among the groups. Four patients (16.7 %) in TBV displayed virological breakthrough, lower than LAM and higher than ETV (p = 0.004). Cox regression analysis showed that baseline HBV DNA (hazard ratio 0.743; 95 % confidence interval 0.582-949, p = 0.017) was an independent predictor for VR at 24 months. Long-term therapy with TBV was effective and safe in HBV-related decompensated cirrhosis.

摘要

替比夫定(TBV)对失代偿期乙型肝炎病毒(HBV)相关肝硬化的长期影响尚未明确。本研究旨在调查与拉米夫定(LAM)和恩替卡韦(ETV)相比,TBV在此类患者队列中的疗效和安全性。我们回顾性评估了130例初治的HBV相关失代偿期肝硬化患者,这些患者开始接受TBV(n = 31)、LAM(n = 45)或ETV(n = 54)治疗。治疗24个月后,TBV、LAM和ETV组的累积病毒学应答(VR)率(HBV DNA <500拷贝/mL)分别为83.7%、65.3%和89.1%(p = 0.009)。TBV组HBV DNA水平的下降为-3.66±0.56,显著高于LAM组(-3.34±0.59;p < 0.05),但低于ETV组(-3.98±0.52;p < 0.05)。各组间HBeAg血清学转换率和丙氨酸氨基转移酶(ALT)复常率相似。与基线相比,TBV组的Child-Turcotte-Pugh(CTP)评分和终末期肝病模型评分显著改善,组间无差异。TBV导致的累积生存率和肝细胞癌(HCC)发生率与LAM和ETV相似。各组间肝硬化并发症的发生率,包括静脉曲张出血、肝性脑病和自发性细菌性腹膜炎,具有可比性。TBV组有4例患者(16.7%)出现病毒学突破,低于LAM组且高于ETV组(p = 0.004)。Cox回归分析显示,基线HBV DNA(风险比0.743;95%置信区间0.582 - 949,p = 0.017)是24个月时VR的独立预测因素。TBV长期治疗对HBV相关失代偿期肝硬化有效且安全。

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