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-interfero...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 was no significant difference in HBsAg conversion rate(1.8%[1/56]i^s.4.1%[3/73],P=0.809)and HBeAg conversion rate(12.5%[7/56]i/s.11.0%[8/73],P=0.787),as well as HBV-DNA,sustained virologic response(93.2%vs.98.5%,P=0.150)between the two groups.Conclusions:Both therapies supported liver function recovery and histology improvement.Combination therapy did not show better anti-viral efficacy in HBsAg or HBeAg seroconversion compared with monotherapy.However,combination therapy played a more positive role in reversing hepatic fibrosis compared with monotherapy.Trial registration:ClinicalTrials.gov:NCT02849132;https://clinicaltrials.gov/ct2/show/NCT02849132.展开更多
目的分析血清丙氨酸氨基转移酶(alanine aminotransferase,ALT)在慢性乙型肝炎中的表达及其对抗病毒疗效的评估作用。方法选取2017年1月至2019年6月东港市中医院收治的80例慢性乙型肝炎患者作为研究对象,根据治疗前基线血清ALT水平分为...目的分析血清丙氨酸氨基转移酶(alanine aminotransferase,ALT)在慢性乙型肝炎中的表达及其对抗病毒疗效的评估作用。方法选取2017年1月至2019年6月东港市中医院收治的80例慢性乙型肝炎患者作为研究对象,根据治疗前基线血清ALT水平分为正常组(n=8)、升高组(n=48)及显著升高组(n=24)。3组均给予恩替卡韦治疗,比较3组治疗前后ALT水平、治疗后应答、乙肝病毒的脱氧核糖核酸(hepatitis B virus DNA,HBV-DNA)lg值下降情况、临床疗效。结果治疗前,3组ALT水平比较差异有统计学意义(P<0.05),显著升高组ALT水平高于升高组和正常组,升高组高于正常组,差异有统计意义(P<0.05);治疗后,3组ALT水平低于治疗前,差异有统计意义(P<0.05),3组间ALT水平比较差异无统计学意义。3组HBV-DNA转阴率、乙型肝炎e抗原(hepatitis B e antigen,HBeAg)转阴率、HBeAg血清转换率、血清ALT复常率比较差异无统计学意义。随访12、24周,显著升高组HBV-DNA下降值高于正常组和升高组,且升高组高于正常组,差异有统计学意义(P<0.05);随访48周,3组HBV-DNA下降值比较差异无统计学意义。3组治疗总有效率比较差异无统计学意义。结论慢性乙型肝炎患者血清ALT水平以高表达为主,且血清ALT水平不影响抗病毒疗效。展开更多
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).
文摘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 was no significant difference in HBsAg conversion rate(1.8%[1/56]i^s.4.1%[3/73],P=0.809)and HBeAg conversion rate(12.5%[7/56]i/s.11.0%[8/73],P=0.787),as well as HBV-DNA,sustained virologic response(93.2%vs.98.5%,P=0.150)between the two groups.Conclusions:Both therapies supported liver function recovery and histology improvement.Combination therapy did not show better anti-viral efficacy in HBsAg or HBeAg seroconversion compared with monotherapy.However,combination therapy played a more positive role in reversing hepatic fibrosis compared with monotherapy.Trial registration:ClinicalTrials.gov:NCT02849132;https://clinicaltrials.gov/ct2/show/NCT02849132.
文摘目的分析血清丙氨酸氨基转移酶(alanine aminotransferase,ALT)在慢性乙型肝炎中的表达及其对抗病毒疗效的评估作用。方法选取2017年1月至2019年6月东港市中医院收治的80例慢性乙型肝炎患者作为研究对象,根据治疗前基线血清ALT水平分为正常组(n=8)、升高组(n=48)及显著升高组(n=24)。3组均给予恩替卡韦治疗,比较3组治疗前后ALT水平、治疗后应答、乙肝病毒的脱氧核糖核酸(hepatitis B virus DNA,HBV-DNA)lg值下降情况、临床疗效。结果治疗前,3组ALT水平比较差异有统计学意义(P<0.05),显著升高组ALT水平高于升高组和正常组,升高组高于正常组,差异有统计意义(P<0.05);治疗后,3组ALT水平低于治疗前,差异有统计意义(P<0.05),3组间ALT水平比较差异无统计学意义。3组HBV-DNA转阴率、乙型肝炎e抗原(hepatitis B e antigen,HBeAg)转阴率、HBeAg血清转换率、血清ALT复常率比较差异无统计学意义。随访12、24周,显著升高组HBV-DNA下降值高于正常组和升高组,且升高组高于正常组,差异有统计学意义(P<0.05);随访48周,3组HBV-DNA下降值比较差异无统计学意义。3组治疗总有效率比较差异无统计学意义。结论慢性乙型肝炎患者血清ALT水平以高表达为主,且血清ALT水平不影响抗病毒疗效。
