Entecavir add-on Peg-interferon therapy plays a positive role in reversing hepatic fibrosis in treatment-naive chronic hepatitis B patients: a prospective and randomized controlled trial  

作　　者：Jing-Mao Yang Li-Ping Chen Ya-Jie Wang Bei Lyu Hong Zhao Zhi-Yin Shang Jun Li Zhen-Yu Fan Sheng-Di Wu Xiao Ming Xian Li Shao-Ping Huang Ji-Lin Cheng 

机构地区：[1]Department of Gastroenterology and Hepatology,Shanghai Public Health Clinical Center,Fudan University,Shanghai 201500,China [2]Shanghai Medical College of Fudan University,Shanghai 200032,China [3]Department of Gastroenterology and Hepatology,Jinshan Hospital,Fudan University,Shanghai 201500,China [4]Department of Gastroenterology and Hepatology,Zhongshan Hospital,Fudan University,Shanghai 200032,China [5]Department of Gastroenterology and Hepatology,Dongyang People's Hospital,Dongyang,Zhejiang 322100,China.

出　　处：《Chinese Medical Journal》2020年第14期1639-1648,共10页中华医学杂志（英文版）

基　　金：This study was supported by grants from the Major Science and Technology Special Project of China Thirteenth Five-year Plan(No.2013ZX10002004,No.2017ZX10203202-003-007);supported by the Shanghai Science and Technology Development Fund(No.17411969500);the Shanghai Public Health Clinical Center Fund(No.XKJS-2019HBV-06,No.KYGW-2019-32).

摘　　要：Background:The efficacy of entecavir(ETV)add-on peg-interferon therapy compared with ETV monotherapy in treatment-naive hepatitis B virus(HBV)patients remains controversial.We investigated whether adding peg-interferon to ongoing ETV treatment leads to a better curative effect or not.Methods:All patients have been recruited between August 2013 and January 2015 from the Shanghai Public Health Clinical Center and Zhongshan Hospital(China).Eligible HBV patients(n=144)were randomly divided(1:1)to receive either ETV monotherapy(n=70)or peg-interferon add-on therapy from week 26 to 52(«=74).Patients were followed-up for at least 2 years.Indexes including hepatitis B surface antigen(HBsAg)and hepatitis B e antigen(HBeAg)seroconversion rate,sustained virologic response,transient elastography value,and histological scores were evaluated every 3 months until the end of the study.The rate of patients with HBsAg loss was defined as the primary endpoint criteria.Results:At week 26,no patient achieved HBsAg seroconversion in either group.At week 52,one patient in the monotherapy group was HBsAg-negative but there was none in the combination therapy group.The monotherapy group showed significantly better liver function recovery results than the combination therapy group.At week 78,one patient in the combination group had HBsAg seroconverted.At week 104,only three patients in the combination therapy group were HBsAg-negative compared with one patient in monotherapy.The mean alanine aminotransferase and aspartate aminotransferase levels and transient elastography values decreased significantly compared with baseline.Both groups showed a favorable decrease in alpha-fetoprotein(monotherapy:4.5[2.8,7.1]vs.2.2[1.8,3.1]ng/mL,P<0.001;combination therapy:5.7[3.0,18.8]vs.3.2[2.0,4.3]ng/mL,P<0.001)and an improved result of liver biopsy examination scores.The combination group showed a better improvement in histology compared with the monotherapy group(mean transient elastography value 6.6[4.9,9.8]vs.7.8[5.4,11.1]kPa,P=0.028).But there wa

关 键 词：PEG-INTERFERON ENTECAVIR Chronic hepatitis B Curative effect Combination therapy 

分 类 号：R512.62[医药卫生—内科学]