Intervention Review

Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers

  1. Chuanfang Lee2,
  2. Yan Gong1,*,
  3. Jesper Brok3,
  4. Elizabeth H Boxall4,
  5. Christian Gluud3

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 19 APR 2006

Assessed as up-to-date: 21 FEB 2006

DOI: 10.1002/14651858.CD004790.pub2


How to Cite

Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD004790. DOI: 10.1002/14651858.CD004790.pub2.

Author Information

  1. 1

    Copenhagen NV, Denmark

  2. 2

    Tri-Service General Hospital, Department of Pharmacy Practice, Taipei, Taiwan

  3. 3

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

  4. 4

    Heartlands Hospital, Public Health Laboratory, Birmingham, UK

*Yan Gong, Bispeberg Bakke 26C, 2.th, Copenhagen NV, 2400, Denmark. gong_yan2002@yahoo.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 APR 2006

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Hepatitis B vaccine and hepatitis B immunoglobulin are considered for newborn infants of HBsAg-positive mothers to prevent hepatitis B infection.

Objectives

To assess the beneficial and harmful effects of hepatitis B vaccines and hepatitis B immunoglobulin in newborn infants of HBsAg-positive mothers.

Search methods

Trials were identified through The Cochrane Neonatal Group Controlled Trials Register, The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, and EMBASE (until February 2004), authors of trials, and pharmaceutical companies.

Selection criteria

Randomised clinical trials comparing: plasma-derived vaccine (PDV) or recombinant vaccine (RV) versus no intervention, placebo, or other active vaccines; hepatitis B immunoglobulin versus no intervention, placebo, or other control immunoglobulin; as well as PDV or RV plus hepatitis B immunoglobulin versus no intervention, placebo, or other control vaccines or immunoglobulin.

Data collection and analysis

Outcomes are assessed at maximal follow-up. The primary outcome measure was hepatitis B occurrence, based on a blood specimen positive for HBsAg, HBeAg, or antibody to hepatitis B core antigen (anti-HBc). Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality of the trial, mother's HBe-Ag status, and time of immunisation after birth.

Main results

We identified 29 randomised clinical trials, five of which were considered high quality. Only three trials reported inclusion of hepatitis B e-antigen negative mothers. Compared with placebo/no intervention, vaccine reduced hepatitis B occurrence (RR 0.28, 95% confidence interval (CI) 0.20 to 0.40, 4 trials). No significant differences of hepatitis B occurrence were found comparing recombinant vaccine (RV) versus plasma-derived vaccine (PDV) (RR 1.00, 95% CI 0.71 to 1.42, 4 trials) and high-dose versus low-dose vaccine (PDV: RR 0.97, 95% CI 0.55 to 1.68, 3 trials; RV: RR 0.78, 95% CI 0.31 to 1.94, 1 trial). Compared with placebo/no intervention, hepatitis B immunoglobulin or the combination of vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (hepatitis B immunoglobulin: RR 0.50, 95% CI 0.41 to 0.60, 1 trial; PDV plus hepatitis B immunoglobulin: RR 0.08, 95% CI 0.03 to 0.17, 3 trials). Compared with vaccine, vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (RR 0.54, 95% CI 0.41 to 0.73, 10 trials). Hepatitis B vaccine and hepatitis B immunoglobulin seem safe, but few trials reported on adverse events.

Authors' conclusions

Vaccine, hepatitis B immunoglobulin, and vaccine plus hepatitis B immunoglobulin prevent hepatitis B occurrence in newborn infants of HBsAg positive mothers.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Hepatitis B vaccine, hepatitis B immunoglobulin, and hepatitis B vaccine plus immunoglobulin prevent perinatal transmission of hepatitis B

Hepatitis B vaccination and hepatitis B immunoglobulin are considered as preventive measures for newborn infants of HBsAg positive mothers. When all the identified trials were combined, hepatitis B vaccine alone, hepatitis B immunoglobulin alone, and hepatitis B vaccine plus hepatitis B immunoglobulin reduced perinatal transmission of hepatitis B compared with placebo or no intervention. Hepatitis B vaccine plus hepatitis B immunoglobulin were superior to hepatitis B vaccination alone. Adverse events were rare and mostly non-serious.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

母體有B肝表面抗原陽性的新生兒,關於B肝的防疫

母體有B肝表面抗原陽性的新生兒,應注射B肝疫苗和B肝免疫球蛋白,以避免感染B肝。

目標

評估母體有B肝表面抗原陽性的新生兒,注射B肝疫苗和B肝免疫球蛋白的利弊。

搜尋策略

透過搜尋he Cochrane Neonatal Group Controlled Trials Register,、The Cochrane HepatoBiliary Group Controlled Trials Register、Cochrane Library的The Cochrane Central Register of Controlled Trials in The Cochrane Library、 MEDLINE,和 EMBASE(至2004年2月以前), 聯繫試驗作者和製藥公司

選擇標準

比較血清性疫苗(PDV) 或重組疫苗(RV)與無干預法、安慰劑、其他活性疫苗的隨機臨床試驗;B肝免疫球蛋白對照無干預法、安慰劑、其他控制免疫球蛋白;血清性疫苗或重組疫苗加上B肝免疫球蛋白,對照無干預法、安慰劑、其他控制疫苗或免疫球蛋白。

資料收集與分析

在最長的追蹤時間裏評估結果。初步結果在於評估,根據B肝表面抗原、e抗原呈陽性的血液樣本,或有B肝核心抗原的抗體的血液樣本中,B肝的發生。二分法結果記錄成相對風險度(relative risks RR) 及其95%信賴區間 (CI)。針對試驗的研究方法學品質,母親的e抗原狀態,和出生後的免疫時間,實施亞組分析。

主要結論

我們找到29個隨機臨床試驗,其中包含5個高品質的試驗。只有3個試驗納入(並記載)B肝e抗原陰性的母親。對照安慰劑/無干預法,疫苗降低B肝的發生率(RR 0.28,95%信賴區間(CI) 0.20 – 0.40, 4次試驗)。比較重組疫苗(RV)和血源性疫苗(PDV) (RR 1.00, 95% CI 0.71 – 1.42, 4個試驗),以及高劑量和低劑量疫苗(PDV: RR 0.97, 95% CI 0.55 – 1.68, 3個試驗; RV: RR 0.78, 95% CI 0.31 – 1.94, 1個試驗), B肝發生率並無顯著差異。和安慰劑/無干預法比較, B肝免疫球蛋白或B肝免疫球蛋白加疫苗都降低了B肝發生率 (B肝免疫球蛋白: RR 0.50, 95% CI 0.41 – 0.60, 1 個試驗; PDV加B肝免疫球蛋白: RR 0.08, 95% CI 0.03 – 0.17, 3次試驗)。與疫苗相比,B肝免疫球蛋白加上疫苗降低B肝發生率 (RR 0.54, 95% CI 0.41 – 0.73, 10次試驗)。 B肝疫苗和B肝免疫球蛋白使用似乎安全,但有少數報導不良事件。

作者結論

疫苗、B肝免疫球蛋白、以及B肝免疫球蛋白加上疫苗,都可以避免表面抗原陽性母親的新生兒感染B肝。

翻譯人

本摘要由臺中榮民總醫院黃芳亮翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

B肝疫苗, B肝免疫球蛋白,免疫球蛋白加上B肝疫苗,都可以避免B肝在周產期傳播。 B肝 疫苗和B肝免疫球蛋白被認為是預防表面抗原陽性母親的新生兒感染B肝的措施。 結合所有已確定的試驗之後,與安慰劑或無干預法相比,單獨使用B肝疫苗, 單獨使用B肝免疫球蛋白, B肝疫苗結合B肝 免疫球蛋白一起使用,都可以降低B肝在周產期的傳播。B肝免疫球蛋白加上B肝疫苗比單獨使用B肝疫苗更好。不良事件比較罕見,多數是不嚴重的事件。