目的 评价妊娠早期给予替比夫定口服对乙型肝炎病毒(HBV)高载量孕妇母婴垂直传播的阻断疗效和安全性.方法 采用随机对照试验设计方案,将80例HBV高载量孕妇随机分为试验组和对照组,每组40例.试验组受试者在孕12周口服替比夫定600 mg,1次/d,服药至产后12周,同时给予复方甘草酸苷保肝治疗;对照组受试者只接受复方甘草酸苷保肝治疗.两组新生儿在出生后均接种乙型肝炎免疫球蛋白200 IU和乙肝疫苗20μg.比较两组孕妇受试者在分娩即刻和分娩后12 w血清HBV DNA水平.评估两组新生儿在出生时和6月龄时血清HBsAg和HBV DNA阳性率,并比较两组新生儿胎龄、身长、头围、体质量和Apgar评分.同时,密切观察两组孕妇在服药期间的不良反应发生情况.结果 分娩即刻和分娩后12 w,试验组受试者血清HBV DNA水平为(3.58±0.56)lg copies/ml和(2.98±0.32)lg copies/ml,显著低于对照组的(7.93±0.47)lg copies/ml和7.46±0.43)lg copies/ml(P<0.01);新生儿出生时,试验组HBsAg和HBV DNA阳性率分别为5.0%和2.5%,显著低于对照组的20.0%和17.5%(P<0.05);两组新生儿出生时胎龄(P=0.64)、身长(P=0.44)、头围(P=0.93)、体质量(P=0.46)、Apgar评分(P=0.45)均无明显差异.结论 乙型肝炎病毒高载量孕妇在孕12周开始应用替比夫定预防性抗病毒治疗可显著降低孕妇血清HBV DNA水平,降低新生儿HBV感染率,且未见孕妇和新生儿有不良反应.%Objective To assess the efficacy and safety of telbivudine in preventing mother-to-infant transmission of hepatitis B virus (HBV) in pregnant women with high HBV DNA load. Methods This study was a randomized controlled trial and eighty pregnant women with high serum load of HBV DNA were randomly divided into the intervention group and the control group,with 40 in each group. Patients in the intervention group received telbivudine 600 mg orally once daily at the 12th week of gestation until 12 weeks after delivery. In the same time,they were also administered with compound glycyrrhizin for liver protection. The patients in the control group only received compound glycyrrhizin. All infants in both groups were vaccinated with hepatitis B immunoglobulin (200 IU) and hepatitis B vaccine (20 μg) immediately after birth. The serum HBV DNA levels in pregnant women in both groups at and 12 weeks after delivery were assayed,and the positive rates of HBsAg and HBV DNA in infants in both groups at birth and 6 months after birth were also determined. In addition,the gestation weeks,length,head circumference,weight,and Apgar scores of all infants were also recorded. Meanwhile, adverse reaction in pregnant women in two groups during the period of taking medicine was observed closely. Results At delivery and 12 weeks after delivery,serum HBV DNA levels were (3.58 ±0.56) lg copies/ml and (2.98±0.32) lg copies/ml in the intervention group,significant lower than those in the control group [(7.93±0.47) lg copies/ml and (7.46 ±0.43) lg copies/ml,respectively,P<0.01];At birth,the positive rates of serum HBsAg and HBV DNA in infants were 5.0% and 2.5% in the intervention group,significant lower than those in the controlgroup [20.0% and 17.5,P <0.05];In addition,no significant differences were found in neonates between the two groups at birth as respect to gestational age (P=0.64),height (P=0.44),head circumference (P=0.93),body weight (P=0.46) and Apgar scores (P=0.45). Conclusion Telbivudine can significantly decrease HBV DNA levels in pregnant women with high HBV DNA load,and reduce the infectious rates of HBV infection for newborns without adverse events.
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