替比夫定阻断孕晚期HBV母婴传播的疗效及安全性Meta分析

A meta-analysis for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus

目的：评价替比夫定阻断HBV母婴传播的效果和安全性。方法检索2010年1月至2012年12月万方数据、中国知网和NCBI数据库，根据纳入标准、排除标准，对入选随机对照试验（RCT）的研究结果，采用RevMan 5.0软件进行分析。结果共检索到符合标准的文献8篇，共518例。替比夫定组治疗后孕妇HBV DNA水平显著下降，差异具有统计学意义（OR =3.95，95%CI：3.61～4.28， P ＜0.00001）。替比夫定组婴儿在出生时HBsAg阳性率和HBV DNA阳性率均显著低于对照组，差异有统计学意义（OR =0.28，95%CI：0.17～0.46，P ＜0.00001；OR =0.22，95%CI：0.12～0.40，P＜0.00001）；随访6个月时婴儿HBsAg阳性率和HBV DNA阳性率均低于对照组，差异具有统计学意义（OR =0.17，95%CI：0.80～0.35，P ＜0.00001；OR =0.12，95%CI：0.05～0.29，P ＜0.001）；替比夫定组和对照组孕妇在服药期间和婴儿的的不良反应发生率无明显差异。结论替比夫定能够安全、有效地阻断母婴传播。

Objective To evaluate the efficacy and safety of telbivudine blocking mother-to-child transmission of hepatitis B virus （HBV） in pregnant patients with chronic hepatitis B. Methods Papers were searched from January 2010 to December 2012 in the database of WANGFANG, CNKI and NCBI according to inclusion criteria and exclusion criteria. The selected randomized controlled trials （RCT） results were analysed by RevMan 5.0 Software. Results The RCTs comprised a total of 518 subjects. Levels of HBV DNA were significantly reducted after treatment in the telbivudine-treated group （OR = 3.959, 95%CI：3.61-4.28, P 〈 0.00001）. Infants born to telbivudine-treated mothers had a significant lower rate of HBsAg positivity and HBV DNA positivity at birth than infants of the control group （OR = 0.28, 95%CI： 0.17-0.46, P 〈 0.00001; OR = 0.22, 95%CI： 0.12-0.40, P 〈 0.00001）. Infants born to telbivudine-treated mothers also had significantly lower rates of mother to child transmitted HBV at 6 months （OR = 0.17, 95% CI： 0.8-0.35, P 〈 0.00001; OR = 0.12, 95%CI： 0.05-0.29, P 〈 0.001）. There was no evidence of telbivudine treatment being associated with more adverse side effects or complications during pregnancy or in the infant. Conclusion Telbivudine could effectively and safely prevent mother-to-child transmission of HBV from mothers with chronic hepatitis B.