富马酸替诺福韦、替比夫定在妊娠晚期阻断乙型肝炎病毒母婴传播的研究  

Feasibility study on the application of tenofovir fumarate and telbivudine in blocking mother-to-child transmission of HBV in late pregnancy

作　　者：冷颖 周红燕 吴灵 李娟 LENG ying;ZHOU hongyan;WU ling;LI juan(Department of Gynecology&Obstetrics,Yichun Maternal&Children's Health Hospital,Jiangxi Yichun 336000,China;Department of Infectious Diseases,Second Affiliated Hospital,Yichun University,Jiangxi Yichun 336000,China)

机构地区：[1]宜春市妇幼保健院妇产科,江西宜春336000 [2]宜春学院第二附属医院感染科,江西宜春336000

出　　处：《中国医院药学杂志》2024年第23期2789-2792,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:探究富马酸替诺福韦、替比夫定在妊娠晚期阻断乙型肝炎病毒(hepatitis B virus,HBV)母婴传播的可行性。方法:选取2017年1月至2022年10月期间于宜春市妇幼保健院就诊的孕晚期HBV感染孕妇204例,根据孕妇的用药情况分为富马酸替诺福韦(tenofovir fumarate,TDF)组和替比夫定(telbivudine,LDT)组。比较两组产妇、新生儿的一般资料、乙肝表面抗原(HBsAg)、乙肝e抗原(HBeAg)、乙肝病毒DNA(HBV-DNA)、谷丙转氨酸(ALT)和不良反应发生情况。结果:LDT组的HBsAg、HBeAg、基线HBV-DNA和产后HBV-DNA均低于TDF组,差异有统计学意义(P<0.05)。两组用药后至分娩时血清HBV DNA水平均显著低于治疗前,其中TDF组[(7.4±1.2)lg copies·mL^(-1)]显著降低至[(3.6±1.1)lg copies·mL^(-1)](P<0.05),LDT组[(7.3±1.1)lg copies·mL^(-1)]显著降低至[(4.1±1.2)lg copies·mL^(-1)](P<0.05),但治疗后两组血清HBV DNA水平比较差异无统计学意义(P>0.05)。治疗前后两组血清ALT水平变化差异无统计学意义,部分产妇停药后血清ALT轻度升高,但均在3个月后恢复正常。两组产妇均未出现因不良反应停药者。TDF组产妇的头痛和消化道症状更显著,恶心呕吐、腹胀、食欲减退、腹泻和胃痛的发生率均高于LDT组,差异有统计学意义(P<0.05)。LDT组的关节痛和乏力症状明显,与TDF组差异具有统计学意义(P<0.05)。其他症状差异无统计学意义(P>0.05)。TDF组和LDF组新生儿窒息、早产、足月低体质量儿、巨大儿、病理性黄疸及肺炎等不良事件发生情况比较,差异无统计学意义(P>0.05)。结论:妊娠晚期应用TDF或LDT对降低新生儿HBV感染率有着重要作用,可为阻断HBV母婴传播的研究提供一定的理论依据。OBJECTIVE To explore the feasibility of using tenofovir fumarate and telbivudine for blocking mother-to-child transmission of hepatitis B virus(HBV)during late pregnancy.METHODS From January 2017 to October 2022,204 pregnant women hospitalized with HBV infection in late pregnancy were selected.They were assigned into two groups of tenofovir fumarate(TDF)and telbivudine(LDT)according to specific medications.General profiles,HBsAg,HBeAg,HBV-DNA,alanine aminotransferase(ALT)and adverse reactions of two groups was compared.RESULTS HBsAg,HBeAg,baseline HBVDNA and postpartum HBV-DNA levels were lower in LDT group than those in TDF group(P<0.05).The serum levels of HBV DNA dropped markedly in both groups as compared with pre-treatment values.In TDF group,HBV DNA dropped from(7.4±1.2)to(3.6±1.1)lg copies·mL^(-1)(P<0.05)versus(7.3±1.1)to(4.1±1.2)lg copies·mL^(-1)in LDT group(P<0.05).No statistically significant inter-group difference existed in serum ALT level before or after treatment.A few parturients experienced a slight elevation of ALT after discontinuing drugs.However,all normalized within 3 months.No maternal discontinuation due to adverse reactions occurred in neither groups.TDF group reported a higher incidence of nausea,vomiting,abdominal distension,loss of appetite,diarrhea and gastric pain as compared with LDT group(P<0.05).Conversely,joint pain and fatigue were more prevalent in LDT group than those in TDF group(P<0.05).And no significant difference existed in other symptoms(P>0.05).Additionally,the incidence of neonatal adverse events,including asphyxia,premature birth,low birth weight,macrosomia,pathological jaundice and pneumonia,showed no significant inter-group differences(P>0.05).CONCLUSION Using TDF or LDT in the third trimester of pregnancy significantly may lower HBV infection rate in neonates,offering theoretical rationales for researches on preventing mother-to-child transmission of HBV.

关 键 词：富马酸替诺福韦 替比夫定 乙型肝炎病毒感染 孕晚期 母婴传播 

分 类 号：R714.1[医药卫生—妇产科学] R969.3[医药卫生—临床医学]