拉米夫定对乙型肝炎病毒母婴传播的影响及安全性

Efficacy and Safety of Lamivudine Treatment on Preventing Hepatitis B Virus Vertical Transmission in Pregnant Women

目的评价妊娠中期应用拉米夫定对HBV传播的影响及安全性,寻求最佳预防宫内传播的方法。方法拉米夫定组57例孕妇于孕20～26周开始服用拉米夫定100 mg/天至分娩后,乙型肝炎免疫球蛋白(HBIG)组66例孕妇于孕28周开始使用HBIG 200 IU行宫内阻断治疗,2组新生儿出生均予主、被动联合免疫,观察新生儿宫内感染发生情况、抗病毒疗效及母婴异常情况,随访到婴儿1岁并分别在0、1、7、12月龄时监测其血清HBV DNA、HBsAg和抗-HBs定量变化。结果拉米夫定组孕妇于分娩前HBV DNA显著下降(t=18.72,P<0.05),转阴率为33.3%,肝功能异常者全部恢复正常。该组57例新生儿随访至1月龄时HBsAg或HBV DNA均阴性,宫内感染率为0,与HBIG组宫内感染率(15.2%)相比,差异有统计学意义(χ2=9.40,P<0.05)。2组婴儿1岁时的血清抗-HBs水平无差异(t=0.71,P>0.05),拉米夫定组HBV慢性感染为0,HBIG组10例宫内感染婴儿均为HBsAg、HbeAg、抗-HBc、HBV DNA阳性,2组孕妇及婴儿均未发现不良反应。结论对于HBV水平较高孕妇,妊娠中期采用拉米夫定降低病毒含量,阻断HBV母婴垂直传播(宫内传播及产时传播)是行之有效的。

Objective To evaluate the efficacy and safety of lamivudine treatment during the second trimester of pregnancy on pre- venting vertical hepatitis B）virus （HBV） transmission in pregnant women, and explore the optimal method for preventing intrauterine HBV infection. Methods Fifty seven pregnant women in lamivadine group were given 100 mg lamivudine daily from week 20 - 26 of gestation till after parturition. Sixty six pregnant women in hepatitis B immunoglobulin（HBIG） group were administrated with 200 IU HBIG from week 28 of gestation. Infants of pregnant women in the two groups were given both active and passive immunization. Intra- uterine HBV infection of infants, the efficacy of antiviral therapy and anomalies of infants and mothers were observed. The infants were followed up for one year and serum HBV DNA levels,hepatitis B surface antigen （HBsAg） and anti -HBs at month 0,1,7,12 were detected. Results Serum HBV DNA levels in pregnant women before delivery in lamivudine group decreased significantly （t = 18.72, P 〈0.05）. The HBV DNA negative rate was 33.3% and the liver function normalization rate was 100%. Serum HBsAg and HBV DNA were both negative in 57 newborns of women in lamivudine group at 1 month old and the HBV intrauterine transmission rate was 0, which was significantly olwer than that in HBIG group （ 15.2% ,x^2 = 9.40 ,P 〈 0.05 ）. The serum levels of anti - HBs of infants at 1 year old in two groups were not significantly different （t =0.71 ,P 〉0.05 ）. The rate of chronic HBV infection of infants in lamivu- dine group was 0 ,while there were 10 cases of HBV intrauterine infection in the HBIG group, with HBsAg, HBeAg, anti -HBc and HBV DNA all positive. No side effects were observed in both pregnant women and infants in 2 groups. Conclusion For pregnant women with high levels of HBV DNA ,lamivudine therapy interdicted from the second transmission （intrauterine transmission and trans- mission during delivery）.