妊娠期使用富马酸替诺福韦或替比夫定预防乙型肝炎高病毒载量母婴传播的回顾性队列研究

A retrospective cohort study of tenofovir disoproxil fumarate and telbivudine in the prevention of mother-to-child transmission of hepatitis B virus with high viral load

目的比较孕晚期富马酸替诺福韦(tenofovir disoproxil fumarate,TDF)和替比夫定(telbivudine,LDT)阻断HBV母婴传播的有效性和安全性。方法收集2012年1月1日至2020年12月31日于首都医科大学附属北京佑安医院分娩并于孕晚期接受TDF(300 mg/d)或LDT(600 mg/d)治疗的HBV感染产妇1407例。所有婴儿出生后均接受标准的主被动免疫。比较两组患者产后52周婴儿感染的比例、婴儿不良事件的发生率,以及服药期间及产褥期母亲不良事件的发生率。结果最终1385例产妇完成产后8周随访,其中TDF组205例,LDT组1180例。选择服用TDF的产妇,其HBsAg、HBeAg的滴度和血清HBV-DNA载量均明显高于LDT组,差异有统计学意义(P<0.05);在相同的治疗时间下,两组患者的HBV-DNA下降水平差异无统计学意义(P>0.05)。但TDF组婴儿出生时HBsAg阳性率(9.9%比20.8%)低于LDT组(P<0.05)。两组婴儿出生时孕周、剖宫产率、出生体质量、身长和1 min Apgar评分比较,差异无统计学意义(P>0.05)。共1405例婴儿完成了分娩后52周的随访,其中TDF组213例,LDT组1192例。随访至52周,两组婴儿均无HBsAg和HBV-DNA阳性病例(P=1.000)。TDF组患者服药期间比LDT组产妇消化系统症状的发生率更高,但关节痛的发生率更低,均为轻度不良反应。但停药后,TDF组产妇产褥期ALT升高比例明显低于LDT组(6.3%比15.3%,P=0.001);但ALT升高水平无统计学意义(P>0.05)。结论TDF和LDT在降低HBV母婴传播的有效性相当,但TDF的抗病毒效果更好且对肝功能的影响更小,可作为阻断母婴传播的首选药物。

Objective To compare the efficacy and safety of tenofovir disoproxil fumarate(TDF)and telbivudine(LDT)in the prevention of mother-to-child transmission of HBV in the third trimester.Methods From January 1 st,2012 to December 31 st,2020,1407 pregnant women with HBV infection who delivered in Beijing Youan Hospital,Capital Medical University and received TDF(300 mg/d)or LDT(600 mg/d)treatment in the third trimester were enrolled in the study.All infants received standard immunoprophylaxis.The data of mother-to-child transmission of HBV at 52 weeks after birth,adverse events of infants and mothers during administration and postpartum were compared.Results A total of 1385 pregnant women completed 8-week postnatal follow-up,205 cases in TDF group,1180 cases in LDT group.Compared to LDT group,the patients in TDF group had a higher HBsAg,HBeAg titers and HBV-DNA levels(P<0.05).There was no significant difference in treatment time between two groups(P>0.05).After treatment,the patients in TDF group had higher HBV-DNA reduction level than in LDT group but without statistical significance(P>0.05).However,the positive rate of HBsAg(9.9%vs.20.8%)of the infants in TDF group were lower than that in LDT group(P<0.05).There were no significant differences in gestational age,cesarean section rate,birth weight,body length and one minute Apgar score between the two groups(P>0.05).A total of 1405 infants were followed up for 52 weeks after delivery,including 213 infants in TDF group and 1192 infants in LDT group.At 52 weeks after delivery,there were no infants with HBsAg and HBV-DNA positive in the two groups(P=1.000).The patients in TDF group complained more digestive symptoms and less arthralgia than in LDT group(P<0.05),all of them had gradeⅠ-Ⅱadverse events.During puerperium,ALT abnormal rate in TDF group was significantly lower than that in LDT group(6.3%vs.15.3%,P=0.001).However,there was no significant difference in the average ALT level between the two groups(P>0.05).Conclusions TDF and LDT are equally effective in reducing motherto-child transmission of HBV.However,TDF has better antiviral effect and less impact on liver function,so it can be used as the first choice for prevention of mother-to-child transmission.