替比夫定阻断乙肝病毒母婴传播的疗效和安全性研究

 目的 观察HBsAg和HBeAg双阳性孕妇妊娠晚期应用替比夫定阻断乙型肝炎病毒（HBV）母婴传播的疗效和安全性。方法 选择HBsAg和HBeAg双阳性且乙型肝炎病毒 DNA≥1×10⁶拷贝·mL^-1的孕妇80例，分为治疗组和对照组各40例。治疗组自孕28周开始口服替比夫定600 mg，1次·d^-1，至分娩时停药，对照组不服用替比夫定及其他抗病毒药。观察治疗组服药后出现的不良反应，并检测两组孕妇在孕28周、分娩时和产后6个月时血清乙型肝炎病毒 DNA水平；两组孕妇所产婴儿在出生时和1个月时肌注乙肝免疫球蛋白各200 IU，同时在出生时、1个月和6个月时肌注乙肝疫苗各10 μg，检测两组婴儿在出生时、6个月和12个月时血清HBsAg及乙型肝炎病毒 DNA的阳性率。结果 ①孕28周时治疗组与对照组孕妇血清乙型肝炎病毒 DNA水平比较，差异无统计学意义；分娩时治疗组孕妇血清乙型肝炎病毒 DNA（3.48±0.90）×10²拷贝·mL^-1较对照组血清乙型肝炎病毒 DNA（6.96±0.94）×10⁶拷贝·mL^-1明显降低，差异有统计学意义（P＜0.05）；产后6个月治疗组与对照组孕妇血清乙型肝炎病毒 DNA水平比较，差异无统计学意义。②治疗组与对照组孕妇所产婴儿12个月时乙型肝炎病毒母婴传播阻断率分别为97.5％和75％，差异有统计学意义（P＜0.05）。③治疗组服药期间未见明显不良反应；两组婴儿出生时Apgar评分及发育指标差异均无统计学意义。结论 HBsAg和HBeAg双阳性孕妇在妊娠晚期服用替比夫定可有效阻断乙肝病毒母婴传播，安全性好。

Evaluation of the Efficacy and Safety of Telbivudin in Preventing Mother-to-infant HBV Transmission

OBJECTIVE To evaluate the efficacy and safety of telbivudine in preventing mother-to-infant HBV transmission in pregnant women who have positive HBsAg and HBeAg during the third trimester of pregnancy.METHODS A total of 80 pregnant women， who had positive HBsAg and HBeAg with HBV DNA levels of ≥ 1×10⁶ copies·mL^-1 were divided into two groupsthe treatment group and the control group. Each group comprised 40 cases. The subjects in the treatment group received telbivudine 600 mg once daily from the 28th weeks of pregnancy till delivery.The subjects in the control group did not receive telbivudine or other anti-virus drugs.The adverse reactions of the subjects in the treatment group were observed， and the serum HBV DNA levels in the two groups were measured at the 28th weeks of pregnancy，upon delivery and 6 months after delivery， respectively. The infants in the two groups received IM HBIG 200 IU immediately after birth and 1 month after birth. And both of the groups received IM hepatitis B vaccine 10 μg immediately after birth as well as 1 month and 6 months after birth. The serum HBsAg and HBV DNA levels in all infants were measured at birth， 6 months， and 12 months after birth，respectively. RESULTS There was no significant difference in serum HBV DNA levels between the treatment group and the control group at the 28th weeks of pregnancy. The serum HBV DNA level immediately after delivery in the treatment group （3.48±0.90）×10² copies·mL^-1] was significantly decreased compared with the control group （6.96±0.94）×10⁶ copies·mL^-1 ] (P<0.05).There was no significant difference in HBV DNA levels between the treatment group and the control group 6 months after delivery. The rates of mother-to-infant HBV transmission in 12-month-old infants in the treatment group and the control group were 97.5% and 75%， respectively. The difference was statistically significant (P < 0.05). No adverse reaction was found in the treatment group， and abnormal development was not found in the infants of the two groups. CONCLUSION Telbivudine appears to be effective and safe in preventing HBV mother-to-infant transmission and has no influence on infant development.