替诺福韦酯联合双重免疫方案阻断HBV携带孕妇母婴病毒传播效果研究

Efficacy of tenofovir disoproxil fumarate and dual immunization regimen in blocking mother-to-child hepatitis B viral transmission in pregnant women with hepatitis B virus carrier

目的观察应用替诺福韦酯联合双重免疫方案处理慢性乙型肝炎病毒(HBV)携带孕妇对母婴病毒传播阻断的效果。方法2016年12月~2019年9月我院收治的HBV携带孕妇120例,采用随机数字表法分为对照组60例和观察组60例。对照组孕妇未进行抗病毒治疗,观察组孕妇在孕26~28个月时开始口服替诺福韦酯,治疗至分娩。所有新生儿出生后立即接种乙肝疫苗和乙型肝炎免疫球蛋白进行双重免疫。采用聚合酶链式反应法检测血清HBV DNA,采用胶体金法检测血清HBsAg和HBeAg。结果在分娩时,观察组血清ALT水平为(23.2±3.6)IU/L,与对照组【(26.9±4.0)IU/L,P>0.05】比,无显著性差异,血清HBV DNA载量为(3.1±0.7)lg copies/mL,显著低于对照组【(5.9±0.8)lg copies/mL,P<0.05】;观察组新生儿Apgar评分为(9.7±0.3)分,与对照组【(9.9±0.5)分,P>0.05】比,无显著性差异,两组新生儿身高、体质量和头围比较,无显著性差异(P>0.05);在分娩时、出生后6个月和12个月,观察组婴儿HBV感染率为1.7%、1.7%和1.7%,与对照组(分别为11.7%、11.7%和13.3%,P>0.05)比,无显著性差异。结论应用替诺福韦酯联合双重免疫方案处理HBV携带孕妇及其新生儿能显著降低孕妇血清HBV载量,可能降低婴儿HBV感染率,值得进一步扩大观察。

Objective The purpose of this study was to observe the efficacy of tenofovir disoproxil fumarate and dual immunization regimen in blocking mother-to-child hepatitis B viral transmission in pregnant women with hepatitis B virus(HBV)carrier.Methods 120 HBV carrying pregnant women were admitted to our hospital between December 2016 and September 2019,and were randomly divided into control and observation group.The pregnant women in the control group didn’t receive any antiviral treatment,while those in the observation group were treated with tenofovir disoproxil fumarate at gestational week 26 to 28 until delivery.The newborns were inoculated with dual immunization regimen,e.g.hepatitis B vaccine and hepatitis B immunoglobulin immediately after birth.Serum HBV DNA loads were detected by PCR,and serum HBsAg and HBeAg were assayed by colloidal gold method.Results At delivery,serum ALT level in the observation women was(23.2±3.6)IU/L,not significantly different compared to[(26.9±4.0)IU/L,P>0.05]in the control,serum HBV DNA loads was(3.1±0.7)lg copies/mL,significantly lower than[(5.9±0.8)lg copies/mL,P<0.05]in the control;the Apgar score in the observation new infants was(9.7±0.3),not significantly different compared to[(9.9±0.5),P>0.05]in the control,and the lengths,body masses and head circumferences in the two group newborns were not significantly different(P>0.05);at delivery,six months and twelve months after delivery,the positive HBV infection in the observation infants were 1.7%,1.7%and 1.7%,not significantly lower than 11.7%,11.7%and 13.3%(P>0.05)in the control.Conclusion The management of pregnant women with HBV carrier with oral tenofovir disoproxil fumarate and double immunization program in time for newborns could significantly reduce serum HBV loads,and therefore might decrease mother to infant HBV transmission,which needs multi-center investigation.