高乙型肝炎病毒载量孕妇妊娠中晚期应用替比夫定或富马酸替诺福韦酯抗病毒治疗效果的比较  

Comparison of anti-viral efficacies of telbivudine and tenofovir disoproxil fumarate during the second and third trimester in pregnant women with high viral load of hepatitis B virus

作　　者：江红秀 韩国荣 王根菊 王翠敏 曹敏恺 周冠伦 王晨旭 陈超[1] Jiang Hongxiu;Han Guorong;Wang Genju;Wang Cuimin;Cao Minkai;Zhou Guanlun;Wang Chenxu;Chen Chao(Department of Gynecology and Obstetrics,The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine,Nanjing 210003,China;Department of Obstetrics,The People′s Hospital of Guangxi Zhuang Autonomous Region,Nanning 541100,China;Gynecology and Obstetrics,The Affiliated Wuxi Maternity and Child Health Care Hospital of Nanjing Medicine University,Wuxi City 214002,Jiangsu Province,China;Medical School of Nanjing University,Nanjing 210093,China)

机构地区：[1]南京中医药大学附属南京医院妇产科,210003 [2]广西壮族自治区人民医院产科,南宁541100 [3]南京医科大学附属无锡妇幼保健院妇产科,214002 [4]南京大学医学院,210093

出　　处：《中华传染病杂志》2021年第6期345-350,共6页Chinese Journal of Infectious Diseases

基　　金："十三五"国家重大传染病防治科技专项(2017ZX10201201-002-001、2017ZX10201201-001-002)。

摘　　要：目的分析比较高乙型肝炎病毒(hepatitis B virus,HBV)载量孕妇妊娠中晚期应用替比夫定或富马酸替诺福韦酯(tenofovir disoproxil fumarate,TDF)抗病毒治疗的效果。方法纳入2016年1月1日至2018年12月31日于南京中医药大学附属南京医院产科门诊进行产前检查发现为慢性HBV感染,并在妊娠中晚期进行抗病毒治疗的506例孕妇,回顾性分析其抗病毒治疗效果和母儿安全性。根据服用药物分为TDF组和替比夫定组。比较两组治疗期间的HBV DNA下降程度及转阴率、HBV母婴传播率、肝功能复常率,新生儿出生体质量、出生缺陷,以及早产率等。统计学分析采用χ^(2)检验、独立样本t检验或秩和检验。结果替比夫定组为239例,TDF组为267例,两组孕妇治疗前HBV DNA分别为(7.83±0.75)lg IU/mL和(7.82±0.66)lg IU/mL;分娩前两组的HBV DNA分别为2.91(1.20)lg IU/mL和2.83(1.01)lg IU/mL,两组中慢性乙型肝炎(chronic hepatitis B,CHB)孕妇的丙氨酸转氨酶(alanine aminotransferase,ALT)复常率分别为95.00%(38/40)和98.18%(54/55),差异均无统计学意义(t=0.097,U=1.040,χ^(2)=0.767,均P>0.05)。TDF组和替比夫定组CHB孕妇产后1个月的HBV DNA转阴率分别为85.45%(47/55)和82.50%(33/40),ALT复常率分别为94.55%(52/55)和92.50%(37/40),两组间差异均无统计学意义(χ^(2)=0.152、0.164,P=0.697、0.687)。替比夫定组和TDF组HBV母婴传播率分别为0.43%(1/231)和0(0/262),差异无统计学意义(χ^(2)=1.127,P=0.288)。替比夫定组产后选择继续服药患者中,2例于产后11个月HBV P区rt204位点出现耐药突变,改为TDF治疗;而TDF组未发现病毒反弹和变异。替比夫定组无明显肌酸激酶升高,TDF组无明显钙磷代谢异常。TDF组与替比夫定组之间早产率差异无统计学意义[7.87%(21/267)比4.18%(10/239),χ^(2)=2.970,P=0.085]。TDF组新生儿出生体质量为(3204.72±490.50)g,低于替比夫定组的(3374.31±467.50)g,差异有统计学意义(t=3.780,P<0.01)。治疗过程中无Objective To compare the efficacy and safety of telbivudine(LDT)and tenofovir disoproxil fumarate(TDF)treatment during the second and third trimester in pregnant women with high viral load of hepatitis B virus(HBV).Methods Totally 506 pregnancy women with HBV infection who received antiviral therapy during the second and third trimester of pregnancy in the obstetrical clinic of The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine from January 1,2016 to December 31,2018 were retrospectively enrolled,and the anti-viral efficacy and safety in mothers and neonates were evaluated.Pregnancy women were divided into TDF group and LDT group according the medications.The efficacies including decline and negative rate of HBV DNA,the vertical transmission(VT)rate,the normalization rate of liver function in mothers between the two groups were compared.The safeties including birth weight of neonates,congenital deformities and the rates of preterm between the two groups were also compared.Chi-square test,independent sample t test or rank sum test were used for statistical analysis.Results There were 239 pregnant women in the LDT group and 267 in the TDF group.The maternal HBV DNA levels before treatment in the LDT and TDF groups were(7.83±0.75)lg IU/mL and(7.82±0.66)lg IU/mL,respectively,while the maternal HBV DNA levels prior to delivery were 2.91(1.20)lg IU/mL and 2.83(1.01)lg IU/mL,respectively.The normalization rates of alanine aminotransferase(ALT)of chronic hepatitis B(CHB)pregnant women prior to delivery in TDF group and LDT group were 95.00%(38/40)and 98.18%(54/55),respectively.There were all no significant differences between the two groups(t=0.097,U=1.040 andχ^(2)=0.767,respectively,all P>0.05).For CHB pregnant women,the HBV DNA negative rate at one month postpartum in TDF group was 85.45%(47/55)and that in LDT group was 82.50%(33/40).The normalization rate of ALT in TDF group was 94.55%(52/55),and that in LDT group was 92.50%(37/40).There were no significant differences between the two groups(

关 键 词：肝炎病毒 乙型 妊娠 抗病毒治疗 母婴传播 

分 类 号：R714.251[医药卫生—妇产科学]