妊娠晚期应用替比夫定阻断乙型肝炎病毒垂直传播的临床观察

Clinical study on telbivudine in preventing mother-to-infant HBV transmission during the late pregnancy

目的观察妊娠晚期应用替比夫定阻断HBV垂直传播的疗效和安全性。方法妊娠晚期慢性乙型肝炎患者50例,其中25例给予口服替比夫定600 mg,1次/d。对照组不给予抗病毒药物。新生儿均予主被动联合免疫,出生后0、6、12个月检测HBsAg、HBV DNA等乙型肝炎标志物,进行Apgar评分和行为神经评分(NABA),观察其生长发育指标。治疗组婴儿进行Gesell新生儿智能发育评估。结果婴儿出生后6个月及12个月时,治疗组血清HBsAg及HBV DNA阳性率均低于对照组(χ2=4.35,P<0.05)。两组新生儿Apgar评分和NABA差异无统计学意义。治疗组新生儿生长发育指标和智能发育商均在正常婴儿范围内。结论替比夫定可以较安全有效地阻断乙型肝炎病毒垂直传播且不影响婴儿发育。

Objective To investigate the efficacy and safety of telbivudine in preventing mother - to - infant HBV transmission in HBV - infected pregnant women during the late pregnancy. Methods 50 pregnant chronic hepatitis B （CHB） patients were enrolled and 25 patients were treated by telbivudine 600mg once daily, 25 patients in the Control group were not given antiviral treatment. All infants received active and passive immu- nization after birth. The serum HBsAg and HBV DNA levels in all infants were measured at 0, 6 and 12 months , respectively. The Apgar score and behavioral neurological assessment （NABA） were measured. Their growth and development were observed. Gesell were measured in the treatment group＇s infants. Results HBsAg-positive rate and HBV DNA positive rate in 6 month old and 12 month old infants of treatment groups were lower than those of control groups （X2 = 4. 35,P 〈 0. 05 ）. There was no significant difference in Apgar score and NABA between the two groups. The growth and intelligence of the treatment groups＇ infants was in the normal range. Conclusion Telbivudine appears to be effective and safe in preventing mother -to -infant HBV transmission and has no influence on infant development.