替比夫定阻断乙肝病毒母婴传播的疗效和安全性研究  

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

作　　者：彭保安[1] 赵轶[2] 杨小福[1] 缪敏芳[1] 诸林华[1] 虞和永[2] 

机构地区：[1]浙江大学医学院附属妇产科医院产科 [2]浙江大学医学院附属妇产科医院药剂科

出　　处：《中国药学杂志》2012年第11期855-857,共3页Chinese Pharmaceutical Journal

摘　　要：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10μg,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。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 I〉 1 ×10^6 copies · mL-l were divided into two groups：the 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 p,g 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） ×10^2 copies · mL-1 ] was significantly decreased compared with the control group [ （6. 96±0. 94）×10^06 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

关 键 词：替比夫定 妊娠晚期 乙型肝炎病毒 母婴传播 安全性 

分 类 号：R969.4[医药卫生—药理学]