乙肝免疫球蛋白宫内注射阻断乙肝母婴传播的系统评价

目的系统评价乙肝免疫球蛋白(hepatitis B immunoglobulin,HBIG)宫内注射阻断乙肝母婴传播的效果。方法计算机检索PubMed、e Cochrane Central Register of Controlled Trials(CENTRAL)、CNKI、VIP、CBM、WanFang Data数据库,查找HBIG宫内注射阻断乙肝母婴传播的随机对照试验(RCT),检索时间均从1992年1月至2012年5月。对符合纳入标准的RCT,由两位评价员按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用STATA软件进行Meta分析。结果纳入42个RCT,共7 212例患者。尽管所有研究均声称随机,但仅3个研究报告了随机方法。仅1个研究提及盲法,2个研究结果资料不完整,13个研究有其他类型的偏倚,均未报道分隐藏和选择性偏倚情况。Meta分析结果显示:新生儿出生时乙肝感染率试验组为8.971%,对照组为25.470%[RR=0.359,95%CI(0.303,0.425)],半年后试验组为5.385%,对照组为13.919%[RR=0.391,95%CI(0.278,0.550)],1年后试验组为5.318%,对照组为12.457%[RR=0.429,95%CI(0.335,0.551)];出生时抗体保护率试验组为61.964%,对照组为14.523%[RR=6.712,95%CI(1.920,23.467)],半年以上保护率试验组为77.754%,对照组为66.311%[RR=1.209,95%CI(0.989,1.478)]。倒漏斗图表明研究存在一定发表偏倚,敏感性分析表明除随访半年后乙肝抗体保护的研究结果较不稳定外,其余研究结果稳定性良好,与原合并效应值一致。结论乙肝携带孕妇宫内注射HBIG可降低新生儿出生、半年和1年时乙肝感染率,提高出生时抗体保护率,但对提高半年以上抗体保护率无效。由于纳入研究方法学质量欠佳,存在偏倚,对上述结论的临床应用应谨慎。

Effect of Hepatitis B Immunoglobulin Intrauterine Injection on Interrupting Hepatitis B Virus Mother-to-Child Transmission:A Systematic Review

Objectives To evaluate the effects of hepatitis B immunoglobulin(HBIG) intrauterine injection before delivery on interrupting mother-to-child transmission of hepatitis B virus(HBV).Methods The randomized controlled trials(RCTs) on HBIG intrauterine injection on interrupting mother-to-child transmission of HBV published between January 1992 and May 2012 were searched in The Cochrane Library,PubMed,CBM,CNKI,VIP,WanFang Data,etc.The studies were screened according to inclusive and exclusive criteria,the data were extracted,the quality was assessed by two reviewers independently,and meta-analysis,publication bias and sensitivity analysis was conducted using Stata software.Results The total 42 studies involving 7 212 infants were included.The randomized methods were asserted in all studies,three of which reported the details of randomization,one study mentioned blinded method,two studies mentioned incomplete outcome data,13 studies had other potential threats to validity,no allocation concealment and selective outcome reporting was mentioned.Results of meta-analysis indicated that the infant HBV infection rates in the HBIG group and the control group were 8.971% and 25.470%(RR=0.359,95%CI 0.303 to 0.425) at birth,5.385% and 13.919%(RR=0.391,95%CI 0.278 to 0.550) after half a year,5.318% and 12.457%(RR=0.429,95%CI 0.335 to 0.551) after one year;the infant anti-HBs rates in the HBIG group and the control group were 61.964% and 14.523%(RR=6.712,95%CI 1.920 to 23.467) at birth,77.754% and 66.311%(RR=1.209,95%CI 0.989 to 1.478) after half a year.Funnel graphs showed that there was publication bias.Sensitivity analysis showed that the results except the infant anti-HBs protection after half-a-year follow-up were stable and consistent with the original results.Conclusion Injection of HBIG during pregnancy for HBV-carrying mothers can effectively reduce the occurrence of HBV whenever at birth,after half a year or after one year,and increase the infant anti-HBs protection rate at birth,but it is ineffective to improve anti-HBV protection rate after half a year.Owing to the low quality of the included studies and existence of biases,this conclusion should be cautiously put into clinical practice.