HBsAg阳性孕妇免疫接种阻断HBV宫内感染疗效的Meta分析

Meta-analysis on the effect of antepartum immunoprophylaxis on blocking HBV transmission in uterus for HBsAg positive pregnant women

目的评价HBsAg阳性孕妇产前应用乙肝免疫球蛋白（HBIG）或联用乙肝疫苗阻断胎儿HBV宫内感染的有效性及安全性。方法计算机检索6个数据库,手检9种期刊,并追查参考文献,纳入国内外符合纳入标准的随机对照试验和半随机对照试验,由两名评价员独立筛查文献,评价质量和提取资料。用Revman 4.2.10软件分析数据。采用χ2检验鉴定研究间异质性,使用固定效应或随机效应模型合并结果。结果HBsAg阳性/HBsAg和HBeAg均阳性孕妇孕期应用HBIG总剂量600 IU,胎儿HBV宫内感染率〈空白对照组（RR=0.42,95%CI=0.21-0.83,P=0.01）,新生儿HBV DNA阳性率低于空白对照组（RR=0.30,95%CI=0.10-0.85,P=0.02）,新生儿HBeAg阳性率Anti-HBs阳性率与空白组比较差异无统计学意义;总剂量大于600 IU时,宫内感染率〈空白对照组（RR=0.39,95%CI=0.26-0.58,P〈0.000 01）,新生儿Anti-HBs阳性率与对照组比较差异无统计学意义。HBsAg和HBeAg均阳性孕妇孕期应用HBIG总剂量〉600 IU,胎儿HBV宫内感染率、新生儿HBeAg阳性率、新生儿HBV DNA阳性率、新生儿Anti-HBs阳性率与对照组比较差异均无统计学意义;总剂量600 IU组新生儿HBeAg阳性率和新生儿HBV DNA阳性率与对照组比较差异有统计学意义。结论HBsAg阳性/HBsAg和HBeAg均阳性孕妇孕期应用HBIG可降低胎儿HBV宫内感染率;HBsAg和HBeAg均阳性孕妇孕期应用HBIG阻断宫内感染的疗效尚不清楚。

Objective To evaluate the efficacy and security of using HBIG alone or combined with hepatitis B vaccine to interrupt transmission of HBV in uterus to fetus during antepartum period of pregnant women with HbsAg positive. Methods Six electronic databases and nine kinds of related journals were searched. In addition, the eligible references were searched. Randomized controlled trials or qusi-randomise controlled trials comparing hepatitis B immunoglobulin （HBIG） or HBIG combining with hepatitis B vaccine with no or other intervention in HBsAg positive pregnant women were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Meta-analysis was performed by software Revman 4.2.10. Heterogeneity was examined by Chi square test. Fixed and random effect meta-analysis was used to pool the data. Results It was found by meta-analysis that, compared with no intervention, HBIG（600 IU） for the HBsAg positive/HBsAg and HBeAg double positive pregnant women could decrease the rate of intrauterine infection （RR=0.42, 95%CI=0. 21-0. 83, P=0.01） and the positive rate of HBV DNA of the newborn （RR=0.30, 95%CI=0.10 0.85, P=0.02） significantly, but could not decrease the positive rate of HBeAgand AntiHBs of the newborn significantly. HBIG （〉600 IU） for the HBsAg positive/HBsAg and HBeAg double positive pregnant women could decrease the rate of intrauterine infection （RR=0.39, 95 %CI=0.26-0.58, P〈0.000 01） and could not for the positive rate of Anti-HBs of the newborn significantly. There is no significantly statistical difference in the rate of intrauterine infection and the positive rate of HBeAg and HBV DNA and Anti HBs of the newborn compared with nointervention when HBIG （〉600 IU） for the HBsAg and HBeAg double positive pregnant women; while when the total dose of HBIG is 600 IU, it is reported that the positive rate of HBeAg and HBV DNA of the newborn could be decreased significantly. Conclusion HBIG for the HBsAg positive/HBsAg and HBeAg double positive pregnant women can decrease the rate of intrauterine infection. But the effect of HBIG for HBsAg and HBeAg double positive pregnant women to interrupt intrauterine infection is not clear.