CAJ | 학술논문

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，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18631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<0.00001)。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。
목적：운용순증의학이론화방법，취잉만기사용을간면역구단백(HBIG)조단을간병독(HBV)궁내감염적조단효과화안전성진행계통평개。방법：채용Cochrane계통평개적방법，계산궤검색PubMed(1980-2012년)、EMBASE(1980-2012년)、Cochrane도서관(2012년제3기)、중국생물의학문헌수거고(CBMdisc，1980-2012년)、중국학술기간전문수거고(CNKI，1980-2012년)、중문과기기간전문수거고VIP(1980-2012년)，수공검색2002-2012년상관잡지。량개평개원수선독입지열독문장표제급，여부합납입표준칙열독전문，병진행수거자료제취급질량평개。불동의견통과토론해결혹유제삼방판단。종수궤방법、분배은장、맹법、유무실방궤방면，대납입연구적방법학질량진행평개，수거채용Rev Man 4.2연건진행통계분석。결과：통과전자검색여수공검색，획득상관문헌공18631편，경질량평고사선후，기중5개수궤대조시험(포함442례잉부)부합납입표준，대기진행료계통평개。경분석，저5개납입연구부1개연구제급수궤분배방법，여균미개소구체적수궤급분배방법，야미제도분배은장。간예조시실시배절화종점지표측량배절균미제급맹법。존재선택성편의、실시편의화측량성편의적고도가능성，고질량등급균위“C”급。Meta분석결과현시，여시험조화대조조궁내감염발생솔분별위15.3%、41.2%，RR 0.38，95%CI (0.27，0.54)，량조비교차이유통계학의의(P<0.00001)。경아조분석화민감성분석，균제시해Meta분석결과구유교호적은정성。차외，무론시잉부환시신생인，균몰유보도여HBIG상관적불량반응。결론：경계통평개，여대조조상비，잉만기사용HBIG능현저강저신생인HBV궁내감염발생솔，차미견상관불량반응。
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 stability 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.