:目的 观察拉米夫定(lamivudine，LAM)在慢性乙型肝炎感染者妊娠早期应用的安全性，为慢性乙型肝炎生育年龄妇女肝病及HBV母婴阻断治疗方案选择提供一定依据。
:To evaluate the safety of lamivudine (LAM) treatment for chronic hepatitis B in early pregnancy.
:方法 入组92例孕前或孕早期服用LAM妇女，观察所有孕产期及新生儿随访过程中不良事件，了解HBV母婴阻断失败率。
:A total of 92 pregnant women who received LAM treatment either before pregnancy or in early pregnancy were enrolled in this study. All of the pregnant women volunteered to take lamivudine during pregnancy and were not co-infected with hepatitis C virus, human immunodeficiency virus, cytomegalovirus, or other viruses. All infants received passive-active immunoprophylaxis with 200 IU hepatitis B immunoglobulin and three doses of 10 μg hepatitis B vaccines (0-1-6 mo) according to the guidelines for the prevention and treatment of chronic hepatitis B. Adverse events were observed throughout the entire pregnancy and perinatal period, and the effectiveness of lamivudine treatment for blocking mother-to-infant transmission of hepatitis B virus (HBV) was evaluated. All adverse events in mothers and infants during pregnancy and the perinatal period and the HBV mother-to-infant transmission blocking rate were compared with the literature.
:结果 92例孕妇中11例发生流产，3例流产后再次妊娠；已有72例母亲分娩73例新生儿，其中68例婴儿随访时间≥6月龄。孕妇不良事件主要为流产（11.6%），胎膜早破(11.1%)、早产(6.9%)和羊水污染(5.6%)等；出生后新生儿异常2例，1例为头皮血管瘤，另1例为“脑瘫前期”。母亲孕期的不良事件及新生儿出生后先天性异常的发生率均未超过以往文献报道的普通人群和HBV感染人群。HBV母婴阻断失败2例(2.9%)，低于以往文献报道的母婴阻断失败率。
:Among the 92 pregnant women, spontaneous abortions occurred in 11 cases, while 3 mothers had a second pregnancy after the initial abortion; 72 mothers delivered 73 live infants, of whom 68 infants were followed up for no less than 6 mo, and 12 mothers were still pregnant. During pregnancy, the main maternal adverse events were vaginitis (12/72, 16.7%), spontaneous abortion (11/95, 11.6%), and gestational diabetes (6/72, 8.3%); only one case had 1-2 degree elevation of the creatine kinase level (195 U/L). During the perinatal period, the main maternal adverse events were premature rupture of the membranes (8/72, 11.1%), preterm delivery (5/72, 6.9%), and meconium staining of the amniotic fluid (4/72, 5.6%). In addition, 2 infants were found to have congenital abnormalities; 1 had a scalp hemangioma that did not change in size until 7 mo, and the other had early cerebral palsy, but with rehabilitation training, the infant's motor functions became totally normal at 2 years of age. The incidence of adverse events among the mothers or abnormalities in the infants was not higher than that of normal mothers or HBV-infected mothers who did not receive lamivudine treatment. In only 2 cases, mother-to-infant transmission blocking failed; the blocking rate was 97.1% (66/68), which was higher than has been previously reported.
:结论 本研究中需要治疗的慢性乙型肝炎孕妇孕12周及全孕程应用LAM治疗对母亲和胎儿是安全的，并可提高HBV母婴阻断率。但由于样本量偏少，随访时间较短，其临床应用还需进一步观察。
:Lamivudine treatment is safe for chronic HBV-infected pregnant mothers and their fetuses with a gestational age of less than 12 wk or throughout the entire pregnancy.
