高病毒载量慢性乙型肝炎孕妇口服核苷(酸)类抗病毒药母婴阻断的有效性和安全性  

Clinical study on the efficacy and safety of oral nucleos(t)ide analogues in HBV mother-to-infant obstruction of pregnant women with high viral load

作　　者：梁蘅恺 韦璐 苏明华[1] 梁焕[1] 胡伯斌 黄建芳 陈艳红 江建宁[1] LIANG Heng-kai;WEI Lu;SU Ming-hua;LIANG Huan;HU Bo-bin;HUANG Jian-fang;CHEN Yan-hong;JIANG Jian-ning(Department of Infectious Diseases,the First Affiliated Hospital of Guangxi Medical University,Key Laboratory of High-Incidence-Tumor Prevention and Treatment,Ministry of Education,Nanning 530021)

机构地区：[1]广西医科大学第一附属医院感染性疾病科,教育部区域性高发肿瘤早期防治研究重点实验室,南宁530021

出　　处：《肝脏》2023年第3期296-298,308,共4页Chinese Hepatology

基　　金：国家自然科学基金(81960115);广西病毒性肝炎防治研究重点实验室开放课题基金(GXCDCKL202001);教育部区域性高发肿瘤早期防治研究重点实验室自主课题(GKE2019-04);广西医科大学青年科学基金(GXMUYSF201910)。

摘　　要：目的观察高病毒载量慢性乙型肝炎孕妇口服核苷(酸)类抗病毒药母婴阻断的效果和安全性。方法从广西医科大学第一附属医院感染性疾病科慢性HBV感染随访队列中,选取HBV DNA≥1×106拷贝/mL的慢性乙型肝炎孕妇411例,根据孕期有无口服抗病毒药分为阻断组256例、对照组155例,所有婴儿出生后均按标准接种乙肝疫苗和乙肝免疫球蛋白。分别比较阻断组服药基线、临产前、产后3个月的HBV DNA、ALT、AST水平,比较阻断组和对照组临产前HBV DNA水平和分娩婴儿7月至1岁龄的HBsAg阳性率。结果阻断组孕妇临产前DNA、ALT、AST水平低于服药基线分别为(3.16±1.05)lg拷贝/mL比(7.09±0.77)lg拷贝/mL、(21.90±12.00)U/L比(66.08±89.35)U/L、(29.16±9.16)U/L比(52.12±54.97)U/L,差异均有统计学意义(t=61.287、7.409、5.764,均P<0.01)。阻断组孕妇临产前HBV DNA和婴儿HBsAg阳性率低于对照组(3.16±1.05)lg拷贝/mL比(6.96±0.78)lg拷贝/mL、0.00%比9.68%,差异均有统计学意义(t=38.860,χ^(2)=25.713,均P<0.01)。阻断组和对照组均无围生期不良事件的报告。产后停服抗病毒药的产妇HBV DNA、ALT、AST水平高于产后继续服抗病毒药者分别为(6.70±1.39)lg拷贝/mL比(2.24±0.54)lg拷贝/mL、(54.19±50.00)U/L比(34.62±20.04)U/L、(42.50±28.04)U/L比(33.40±11.66)U/L,差异均有统计学意义(t=33.787、3.985、3.284,均P<0.01)。结论高病毒载量的慢性乙型肝炎孕妇孕期口服核苷(酸)类抗病毒药联合婴儿接种乙肝疫苗和HBIG的“三重阻断”措施、产后患者继续抗病毒治疗,能成功阻断HBV母婴传播,保障孕期、产后母婴安全。Objective To investigate the effect and safety of nucleos(t)ide analogues(NAs)in hepatitis B virus(HBV)mother-to-infant obstruction of pregnant women with high viral load,and to provide real-world clinical data for interrupting mother-to-child transmission of HBV.Methods A total of 411 pregnant women with HBV DNA≥1×106 copies/mL were retrospectively selected from the follow-up cohort of chronic HBV infection in our hospital,and they were divided into preventing group(256 cases)and control group(155 cases)according to the oral administration of NAs during pregnancy.All infants were vaccinated with hepatitis B vaccine and hepatitis B immunoglobulin as standard after birth.The levels of HBV DNA,alanine aminotransferase(ALT)and aspartate aminotransferase(AST)in the preventing group were compared at baseline.before delivery and 3 months after delivery.The levels of HBV DNA before delivery and hepatitis B surface antigen(HBsAg)positive rate in infants from 7 months to 1 year were compared between 2 groups.Results The levels of DNA,ALT and AST before delivery were lower than baseline in the preventing group[(3.16±1.05)log 10 copies/mL vs.(7.09±0.77)log 10 copies/mL,P<0.01;(21.90±12.00)U/L vs.(66.08±89.35)U/L,P<0.01;(29.16±9.16)U/L vs.(52.12±54.97)U/L,P<0.01].The level of HBV DNA before delivery and the positive rate of HBsAg of infants in the preventing group were lower than those in the control group[(3.16±1.05)log 10 copies/mL vs.(6.96±0.78)log 10 copies/mL,P<0.01;0.00%vs 9.68%,P<0.01].No perinatal adverse events were reported in both groups.The levels of HBV DNA,ALT and AST in parturients who stopped taking NAs after delivery were higher than those who continued taking NAs[(6.70±1.39)log 10 copies/mL vs.(2.24±0.54)log 10 copies/mL,P<0.01;(54.19±50.00)U/L vs.(34.62±20.04)U/L,P<0.01;(42.50±28.04)U/L vs.(33.40±11.66)U/L,P<0.01].Conclusion The combination of oral NAs,hepatitis B vaccination and HBIG during pregnancy for pregnant women with high viral load and continued antiviral treatment for postpartum

关 键 词：慢性乙型肝炎 高病毒载量 母婴阻断 妊娠 核苷(酸)类抗病毒药 

分 类 号：R714.251[医药卫生—妇产科学]