孕晚期使用HBIG阻断HBV宫内感染的系统评价

Systematic Review of the Use of Hepatitis B Immune Globulin in Late Pregnancy for the Prevention of Intrauterine Transmission of HBV

目的:运用循证医学理论和方法,就孕晚期使用乙肝免疫球蛋白(HBIG)阻断乙肝病毒(HBV)宫内感染的阻断效果和安全性进行系统评价。方法:采用Cochrane系统评价的方法,计算机检索PubMed(1980-2012年)、EMBASE(1980-2012年)、Cochrane图书馆(2012年第3期)、中国生物医学文献数据库(CBMdisc,1980-2012年)、中国学术期刊全文数据库(CNKI,1980-2012年)、中文科技期刊全文数据库VIP(1980-2012年),手工检索2002-2012年相关杂志。两个评价员首先独立地阅读文章标题及摘要,如符合纳入标准则阅读全文,并进行数据资料提取及质量评价。不同意见通过讨论解决或由第三方判断。从随机方法、分配隐藏、盲法、有无失访几方面,对纳入研究的方法学质量进行评价,数据采用Rev Man 4.2软件进行统计分析。结果:通过电子检索与手工检索,获得相关文献共18 631篇,经质量评估筛选后,其中5个随机对照试验(包含442例孕妇)符合纳入标准,对其进行了系统评价。经分析,这5个纳入研究仅1个研究提及随机分配方法,余均未介绍具体的随机及分配方法,也未提到分配隐藏。干预措施实施环节和终点指标测量环节均未提及盲法。存在选择性偏倚、实施偏倚和测量性偏倚的高度可能性,故质量等级均为"C"级。Meta分析结果显示,与试验组和对照组宫内感染发生率分别为15.3%、41.2%,RR 0.38,95%CI(0.27,0.54),两组比较差异有统计学意义(P<0.000 01)。经亚组分析和敏感性分析,均提示该Meta分析结果具有较好的稳定性。此外,无论是孕妇还是新生儿,均没有报道与HBIG相关的不良反应。结论:经系统评价,与对照组相比,孕晚期使用HBIG能显著降低新生儿HBV宫内感染发生率,且未见相关不良反应。

Objective： To systematically review the efficacy and safety of hepatitis B immune globulin（HBIG） injected in late pregnancy for preventing intrauterine transmission of hepatitis B virus（HBV）.Method： According to principles of Evidence Based Medicine（EBM）, we searched PubMed（1980-2012）, EMBASE（1980-2012）, Cochrane Library（Issue 3, 2012）, Chinese Biomedical Literature Database （CBMdisc, 1980-2012）, China National Knowledge Infrastructure （CNKI, 1980-2012）, VIP database（1980-2012）, and hand searched several related Chinese journals in the past ten years.Two reviewers independently screened the studies for eligibility, extracted data and evaluated their methodological quality.The titles and abstracts of every record retrieved were firstly scanned to determine which were possibly relevant to our review.Any record that appeared likely to meet the inclusion criteria was obtained in full text.Differences in opinion between reviewers were resolved by discussion or decided by the third party.The methodological quality of the included trials such as randomization, allocation concealment, blind and following-up was assessed.Meta-analysis was performed by using Rev Man 4.2 software.Result： A total of 18 631 studies were identified by both electronic and hand searches.After the process of quality assessment, 5 randomized control trails including 442 patients, which met our inclusion criteria, were included.Only 1 of the five included studies mentioned the randomization procedure, others did not give a clear description of the randomization procedure, and no allocation concealment or blind was used.So we considered each included study was at high risk of different biases and graded as category ＂C＂ .Based on meta-analysis, there was strong evidence that HBIG versus placebo could effectively reduce the rate of intrauterine transmission of HBV （HBIG： 15.3%; Placebo： 41.2%）.The difference between the two groups（HBIG versus placebo） had statistical significance[RR=0.38, 95%CI （0.27, 0.54）, P〈0.000 01].The good stabihty of the results was also verified by both subgroup analyses and sensitivity analyses.In addition, no data regarding severe maternal or infant adverse events associated with HBIG were available.Conclusion： Based on our study, HBIG injected in late pregnancy could significantly reduce the rate of intrauterine transmission of HBV as compared to placebo, and no relative adverse events were reported.