AASLD 2013恩替改善肝功能，肝纤维化乙型肝炎病毒相关肝硬化

StephenW

TITLE: Entecavir Improve Liver Function and Fibrosis in Patients with Hepatitis B Virus-associated Liver Cirrhosis: 2 Years Study.

AUTHORS (FIRST NAME, LAST NAME): Hyeonsu Park1, Oh Sang Kwon1, Jong Joon Lee1, Young Kul Jung1, Duck Joo Choi1, Yun Soo Kim1, Ju Hyun Kim1
Institutional Author(s):
INSTITUTIONS (ALL): 1. Internal Medicine, Gachon University Gil Medical Center, Inchon, Korea, Republic of.
ABSTRACT BODY: Background and aims: Entecavir (ETV) induces biochemical and histologic improvement of the liver in patients with chronic hepatitis B. This study aimed to verify whether ETV improves liver function and fibrosis in patients with hepatitis B virus (HBV)-associated liver cirrhosis (LC) during 2 years treatment.
Methods: A total 145 naïve patients with HBV associated LC was treated by ETV for at least 2 years, between March 2007 and December 2012. All patients had HBV DNA level over than 4 log10 copies/mL and ALT level over than 40 IU/mL, because of regulation of Korea national health insurance. Exclusion criteria were the patients who 1) skipped the ETV more than 3 months and 2) developed hepatocelullar carcinoma within 2 years after ETV treatment. For the evaluation of liver function, laboratory findings, model for end stage liver disease (MELD) score, Child-Pugh (CP) score and class were compared between the baseline and 2 years after ETV treatment. For the evaluation of fibrosis, AST platelet ratio index (APRI) score, FIB-4 index, and fibrosis index (FI) were compared between the baseline and 2 years after ETV treatment.
Results: The final 111 patients were enrolled. The mean age was 53±9 years old and 62.2% of patients was male. The baseline mean AST and ALT were 110±83 IU/L and 110±87 IU/L, respectively. The mean HBV DNA level was 6.8±1.2 log10 copies/mL. At 2 years after ETV treatment, the rate of ALT normalization was 77.8%, HBeAg loss in HBeAg positive-patients (n=58) was 43.1% and the undetectable rate of HBV DNA (by real-time polymerase chain reaction) was 90.1%. The changes of total bilirubin, albumin, platelet count, MELD score, and CP score between the two time points were from 2.1±3.2 to 1.3±1.0 mg/dL (p=0.014), from 3.6±0.6 to 4.1±0.5 g/dL (p<0.001), from 102±44 to 110±48×1000>/mm3 (p=0.013), from 9.2±5.2 to 6.7±5.2 (p<0.001), and from 6.4±1.8 to 5.5±1.0 (p<0.001), respectively. The distribution of CP class at baseline was 66.7% in A, 26.1% in B, and 7.2% in C. The distribution of CP class at 2 year after ETV treatment was 88.3% in A, 10.8% in B, and 0.9% in C. The improvement of CP class between the two time points was significant (p<0.001). The changes of APRI score, FIB-4 index, and FI between the two time points were from 3.2±2.4 to 1.1±0.9 (p<0.001), from 6.8±4.1 to 4.3±3.0 (p<0.001), and from 3.4±0.9 to 2.9±0.9 (p<0.001), respectively.
Conclusions: Entecavir improves not only liver function but also fibrosis in patients with HBV-associated LC for long-term treatment.

StephenW

恩替卡韦（ ETV ）诱导慢性乙型肝炎本研究旨在验证是否ETV改善肝功能和肝纤维化患者与乙肝病毒（HBV）相关肝患者的肝脏生化和组织学的改善治疗2年内肝硬化（ LC ） 。
方法：初治患者与乙肝病毒相关的LC共有145 ETV治疗至少2年， 2007年3月至2012年12月。所有患者的HBV DNA水平超过4 log10拷贝/ mL和ALT水平超过大于40国际单位/毫升，因为韩国国民健康保险的监管。 ETV治疗后2年内开发hepatocelullar癌患者排除标准为1 ）跳过ETV超过3个月和2 ） 。对于肝功能化验结果，终末期肝病模型（MELD）的评价得分进行比较， Child-Pugh分级评分（ CP ）和类之间的基线和2年后， ETV治疗。对于肝纤维化的评价， AST血小板比值指数（ APRI）得分， FIB - 4指数，纤维化指数（FI ）之间进行比较的基线和ETV治疗2年后。
结果：最终的111例患者入选。平均年龄为53± 9岁， 62.2 ％的患者为男性。基线平均AST和ALT分别为110± 83 IU / L和110 ± 87 IU / L ，分别。 HBV DNA水平平均为6.8 ± 1.2 log10拷贝/毫升。 ETV治疗2年后， ALT复常率分别为77.8 ％ ，在HBeAg阳性患者HBeAg转阴组（n = 58 ）为43.1 ％的检测率， HBV DNA （由实时聚合酶链反应）为90.1 ％ 。总胆红素，白蛋白，血小板计数， MELD评分的变化，两个时间点之间的CP得分从2.1 ± 3.2至1.3 ± 1.0毫克/升（ P = 0.014 ） ，从3.6 ± 0.6至4.1 ± 0.5克/升（ P < 0.001 ） ，从102 ±44到110 ±48 ×1000个/ mm3 （ P = 0.013） ，从9.2 ± 5.2至6.7 ±5.2 （ P < 0.001 ），并从6.4± 1.8至5.5 ± 1.0 （ P < 0.001） 。 CP类的分布在基线为66.7 ％ ，在A ， B， 26.1 ％和7.2 ％， C.分配的CP类ETV治疗后2年为88.3 ％，在A ， B中的10.8％ ，及0.9％两个时间点之间的CP类C.改善显着（ P < 0.001 ） 。 FIB - 4指数APRI得分，和FI两个时间点之间的变化是从3.2± 2.4至1.1 ±0.9 （ P < 0.001 ） ，从6.8 ± 4.1至4.3 ± 3.0 （ P < 0.001 ） ，从3.4 ± 0.9至2.9 ± 0.9（ P < 0.001 ） ，分别为。
结论：恩替卡韦不仅改善肝功能，但也纤维化患者长期治疗HBV相关LC 。