摘要
目的系统评价乙肝免疫球蛋白(HBIG)对乙肝病毒(HBV)母婴垂直传播的阻断效果和安全性。方法计算机检索EMbase(1980～2007.4)、MEDLINE(1996～2007.4)、Cochrane图书馆(2007年第3期)、中国生物医学文献数据库(CBM,1978～2007.4),纳入比较孕期单独使用HBIG与不使用HBIG阻断HBV母婴垂直传播的随机对照试验。由两名评价者独立选择试验、提取资料和进行方法学质量评估。研究数据的统计分析采用Cochrane协作网提供的RevMan4.2.8软件进行。结果最终纳入4个RCT,共359例孕妇。Meta分析结果显示,试验组HBVDNA(+)孕妇所生新生儿血HBVDNA(+)率为8.65%,对照组为35.06%,其差异具有统计学意义[OR0.17,95%CI(0.09,0.31),P<0.00001]。此外,无论是对孕妇还是胎儿都没有报道与HBIG相关的严重不良反应。结论现有研究结果显示,与空白对照比较,HBIG能有效提高乙肝病毒宫内感染的阻断率,并且无明显药物不良反应。由于本系统评价纳入的RCT质量均为C级且患者例数有限,存在选择性偏倚和发表偏倚的高度可能性,我们期待将来高质量的随机双盲对照试验提供高质量的证据。
Objective To assess the effectiveness and safety of hepatitis B immunoglobulin （HBIG） in interrupting the intrauterine transmission of HBV. Methods The Cochrane Library （Issue 3, 2007）, MEDLINE （1996 to April 2007）, CBM （1978 to April 2007）, and EMBASE （1980 to April 2007） were searched. The quality of included studies was evaluated and meta-analysis was performed. Results Four studies involving 359 participants with HBVDNA （＋）were included. All the included studies were judged to be inadequate in regard to the reporting of randomization, concealment of allocation and blinding. Meta-analysis based on the included studies showed that HBIG significantly decreased the intrauterine transmission rate of HBV compared to the control group [OR 0.17, 95%CI （0.09 to 0.31）, P〈0.000 01]. No HBIG-related severe adverse reactions were reported. Conclusions HBIG is effective and safe for the interruption of intrauterine transmission of HBV. However, because of the high risk of selection and detection bias in the included studies, this evidence is not strong enough. Large-scale randomised trials on the use of HIBG for the interruption of intrauterine transmission of HBV are needed
出处
《中国循证医学杂志》
CSCD
2007年第11期782-788,共7页
Chinese Journal of Evidence-based Medicine
关键词
乙肝免疫球蛋白
乙肝病毒
宫内感染
随机对照试验
系统评价
Hepatitis B immunoglobulin
Viral hepatitis B
Intrauterine infection
Randomized controlled trials
Systematic review
