替比夫定阻断乙型肝炎病毒母婴传播效果及安全性的荟萃分析  

Efficacy and safety of telbivudine treatment to block mother-to-child transmission of hepatitis B virus： a metaanalysis

作　　者：徐鹤翔[1] 王莉娟[1] 余亚新 吴亚平[1] 徐云芳[1] 刘兴祥[1] 陈勇[1] 

机构地区：[1]江苏省淮安市第四人民医院肝病研究所,223001

出　　处：《中华肝脏病杂志》2012年第10期755-760,共6页Chinese Journal of Hepatology

基　　金：基金项目：江苏省淮安市科技支撑计划项目（HAS2010033）

摘　　要：目的综合评价妊娠期替比夫定阻断HBV母婴传播的效果和安全性。方法在数据库中系统检索相关文献，按纳入和排除标准从中选择符合条件的8篇文献，提取资料后采用RevMan5．1软件进行荟萃分析。结果共检索到符合标准的文献8篇，共678例。替比夫定组婴儿在出生时HBsAg阳性率和HBVDNA阳性率均明显低于对照组，差异有统计学意义[OR=0．27，95％CI（0．17，0．43），P〈0．00001；OR=0．14，95％CI（0．06，0．32），P〈0．00001]；婴儿随访6个月时HBsAg阳性率和HBVDNA阳性率均低于对照组，差异有统计学意义[OR=0．06，95％CI（0．02，0．22），P〈0．00001；OR=0．05，95％CI（0．01，0．25），P=0．0003]；婴儿随访12个月时HBsAg阳性率和HBVDNA阳性率均低于对照组，差异有统计学意义[OR=0．13，95％CI（0．03，0．56），P=0．007；OR=0．08，95％CI（0．02，0．37），P=0．001]。替比夫定治疗前两组孕妇HBVDNA水平差异无统计学意义[OR=0．12，95％甜（0．00，0．24），P=0．04]，分娩前替比夫定组孕妇HBVDNA水平低于对照组，差异有统计学意义[OR=-3．92，95％CI（-4．90，-2．95），P〈0．00001]；替比夫定组和对照组孕妇在服药期间不良反应发生率和婴儿的的不良反应发生率差异无统计学意义[OR=1．72，95％CI（0．68，4．38），P=0．25；OR=0．69，95％CI（0．04，11．24），P=0．80]。结论高HBV病毒载量的孕妇服用替比夫定抗病毒治疗能够有效阻断母婴传播。Objective To evaluate the efficacy and safety of telbivudine treatment in pregnant patients with chronic hepatitis B to block mother-to-child transmission of hepatitis B virus （HBV）. Methods Medline and the Chinese Biomedical Literature Database were searched for studies of HBV, mother-to-child transmission, and telbivudine. Of the 68 potentially relevant publications, eight randomized controlled trials （RCTs） conformed to the inclusion and exclusion criteria. Following data extraction, a meta-analysis was carried out with RevMan5.1 software. Results Seven of the eight RCTs were in Chinese, and the remaining study was in English but carded out at a Chinese site. The RCTs comprised a total of 678 subjects, including 352 cases and 326 controls. Infants born to telbivudine-treated mothers had a significantly lower rate of HBsAg positivity and HBV DNA positivity at birth than the control group of infants （odds ratio （OR） = 0.27, 95% confidence interval （CI）： 0.17, 0.43, P 〈 0.00001; OR = 0.14, 95% （71： 0.06, 0.32, P 〈 0.00001）. Infants born to telbivudine-treated mothers also had significantly lower rates of mother-to-child transmitted HBV at 6 months （OR = 0.06, 95% （7I： 0.02, 0.22,P 〈 0.00001; OR = 0.05, 95% CI： 0.01, 0.25,P= 0.0003） and 12 months （OR = 0.13, 95% CI： 0.03, 0.56, P = 0.007; OR = 0.08, 95% CI： 0.02, 0.37, P = 0.001） after birth. The pre-telbivudine treatment levels of HBV DNA were not significantly different between pregnant women in the telbivudine-treated group and the control group （OR = 0.12, 95% CI： 0.00, 0.24, P = 0.04）, but the HBV DNA levels were significantly lower in the telbivudine-treated group of pregnant women prior to delivery （OR = -3.92, 95% CI： -4.90, -2.95, P 〈 0.00001）. There was no evidence of telbivudine treatment being associated with more adverse side effects or complications during pregnancy or in the infant （OR = 1.72, 95% CI： 0.68, 4.38,P= 0.25; OR=0.69, 95% CI： 0.04, 11.24, P = 0.80）. Conclusion Telbiv

关 键 词：肝炎病毒 乙型 替比夫定 母婴传播 宫内感染 META分析 

分 类 号：R51[医药卫生—内科学]