Intervention Review

Hepatitis B vaccination for patients with chronic renal failure

  1. Robert J Schroth2,
  2. Carol A Hitchon3,
  3. Julia Uhanova4,
  4. Ayman M Noreddin5,
  5. Shayne P Taback6,
  6. Michael Moffatt7,
  7. James M Zacharias1,*

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 19 JUL 2004

Assessed as up-to-date: 23 MAY 2004

DOI: 10.1002/14651858.CD003775.pub2

How to Cite

Schroth RJ, Hitchon CA, Uhanova J, Noreddin AM, Taback SP, Moffatt M, Zacharias JM. Hepatitis B vaccination for patients with chronic renal failure. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD003775. DOI: 10.1002/14651858.CD003775.pub2.

Author Information

  1. 1

    University of Manitoba, Section of Nephrology, Winnipeg, Manitoba, Canada

  2. 2

    University of Manitoba D341-Faculty of Dentistry, Dental Diagnostic & Surgical Sciences, Winnipeg Manitoba, Canada

  3. 3

    University of Manitoba RR149 Rehabilitation Hospital, Internal Medicine, Winnipeg Manitoba, Canada

  4. 4

    University of Manitoba 803B John Buhler Research Centre, Internal Medicine, Winnipeg Manitoba, Manitoba, Canada

  5. 5

    Faculty of Medicine, University of Manitoba, Medical Microbiology, Winnipeg, Manitoba, Canada

  6. 6

    University of Manitoba, Department of Pediatrics and Child Health, Winnipeg, Manitoba, Canada

  7. 7

    Winnipeg Regional Health Authority, Research & Applied Learning, Winnipeg, Manitoba, Canada

*James M Zacharias, Section of Nephrology, University of Manitoba, Ge441B - 820 Sherbrook St, Health Sciences Centre, Winnipeg, Manitoba, R3A 1R9, Canada. jzacharias@hsc.mb.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 JUL 2004

SEARCH

 

Abstract

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

Background

Chronic renal failure patients are at particular risk of hepatitis B virus infection. Early studies have demonstrated that renal failure patients benefit from vaccination; however, not all studies have consistently shown benefit.

Objectives

To determine the beneficial and harmful effects of hepatitis B vaccine and of a reinforced vaccination series in chronic renal failure patients.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Renal Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library (Issue 1, 2002), PubMed/MEDLINE (1966 to July 2003), EMBASE (1985 to November 2003), Current Clinical Practice Guidelines (Canadian Immunization Guide and Vaccine Preventable Diseases Surveillance Manual), and Science Citation Index as well as journals, published abstracts, and reference lists of articles.

Selection criteria

Randomised clinical trials comparing plasma vaccine with placebo, recombinant vaccine with placebo, recombinant vaccine with plasma vaccine, and a reinforced vaccination series (ie, more than three inoculations) with three inoculations of vaccine in chronic renal failure patients.

Data collection and analysis

Primary outcome measures included incidence of patients developing hepatitis B virus antibodies and infections while secondary outcomes included adverse events, liver-related morbidity, and mortality. Random effects models were used and reported relative risks and 95% confidence intervals (RR and 95% CI).

Main results

We included seven randomised clinical trials. None of them had high quality. Plasma vaccine was significantly more effective than placebo in achieving hepatitis B antibodies (RR 23.0, 95% CI 14.39 to 36.76, 3 trials). We found no statistically significant difference between plasma vaccine or placebo regarding hepatitis B virus infections (RR 0.50, 95% CI 0.20 to 1.24). We found no statistically significant differences between recombinant vaccine and plasma vaccine in achieving hepatitis B antibodies (RR 0.65, 95% CI 0.28 to 1.53, 2 trials). Heterogeneity was significant and appeared to be attributable to the dose of vaccine. Two trials examined a reinforced recombinant vaccine strategy, which was not statistically more effective than three inoculations of recombinant vaccine regarding development of hepatitis B antibodies (RR 1.36, 95% CI 0.85 to 2.16).

Authors' conclusions

Plasma derived vaccines are more effective than placebo in achieving hepatitis B antibodies, while no statistically significant difference was found between recombinant and plasma vaccines. No statistically significant difference of effectiveness was observed between a reinforced vaccination series versus routine vaccinations of three inoculations of recombinant vaccine.

 

Plain language summary

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

Hepatitis B vaccines achieve antibody production in patients with chronic renal failure, but we do not know if the vaccines are protective

Patients with chronic renal failure are at increased risk of hepatitis B virus infections. This review was undertaken to determine the beneficial and harmful effects of vaccination against hepatitis B and of a reinforced recombinant vaccination series. None of the trials had high methodological quality. Plasma vaccine was significantly more effective than placebo in achieving hepatitis B antibodies. Yet no statistically significant difference was found between the use of plasma vaccine or placebo in preventing hepatitis B virus infections. No trials comparing recombinant vaccine with placebo were identified. There was no significant difference between recombinant and plasma vaccines or between a reinforced vaccination series and routine vaccinations of three inoculations using recombinant vaccine regarding achieving hepatitis B antibodies.

 

摘要

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

背景

慢性腎衰竭病人接種B型肝炎疫苗成效之評估

慢性腎衰竭病人有較高度的風險感染到B型肝炎病毒。早期研究已經證明慢性腎衰竭病人接種疫苗會有益處;不過,並非所有的研究都一致性地顯示接種疫苗是有好處的。

目標

評估慢性腎衰竭病人接種B型肝炎疫苗及強化免疫疫苗接種療程(reinforced vaccination series)之利弊

搜尋策略

作者搜尋The Cochrane HepatoBiliary Group Controlled Trials Register,The Cochrane Renal Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library (2002年第一期), PubMed/ MEDLINE (1966到2003年七月), EMBASE (1985到2003年11月), 當今臨床實踐指導準則(加拿大免疫注射指南和疫苗可預防的疾病監視手冊),以及科學引證索引以及雜誌,出版的摘要和文章中的參考文獻。

選擇標準

隨機臨床試驗比較血漿製劑疫苗和安慰劑,合成疫苗與安慰劑,合成疫苗與血漿製劑疫苗,強化免疫疫苗接種療程(大於三次的接種)與三次的疫苗接種在慢性腎衰竭病人的成效。

資料收集與分析

主要結果的評估包括病人產生B型肝炎病毒抗體和感染B型肝炎病毒的比率。次要結果的評估包括不良事件,肝臟相關的罹病率和死亡率。使用隨機效應模型並且報告相對危險性和95%信賴區間(RR and 95% CI).

主要結論

作者選出7個隨機臨床試驗。沒有一個具有高品質。B型肝炎血漿製劑疫苗比安慰劑有顯著地產生B型肝炎抗體(RR 23.0, 95% CI 14.39 to 36.76,3 個試驗)。關於感染到B型肝炎病毒的現象,B型肝炎血漿製劑疫苗比安慰劑產生B型肝炎抗體較顯著(RR 0.50, 95% CI 0.20 to 1.24)。合成疫苗和血漿製劑疫苗產生B型肝炎抗體的比率並沒有顯著差異(RR 0.65, 95% CI 0.28 to 1.53, 2個試驗)。研究之間有顯著的異質性並且看起來與疫苗的劑量有關。有兩個試驗比較使用強化免疫疫苗接種療程的合成疫苗與三次的疫苗接種療程,產生B型肝炎抗體並沒有顯著地有效(RR 1.36, 95% CI 0.85 to 2.16)。

作者結論

B型肝炎血漿製劑疫苗比安慰劑更有效地產生B型肝炎抗體,但是合成疫苗和血漿製劑疫苗比較並沒有顯著差異。強化免疫疫苗接種療程與常規三次合成疫苗接種療程的有效性並沒有統計學上顯著的差異。

翻譯人

本摘要由臺中榮民總醫院王建得翻譯。

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型肝炎疫苗可以使慢性腎衰竭病人產生B型肝炎抗體,但是作者無法得知疫苗是否具保護力。慢性腎衰竭病人有較高的風險感染到B型肝炎病毒。本回顧目的在探討B型肝炎疫苗和強化免疫疫苗接種之有利和有害效應。沒有一個試驗在方法學上具有高品質。B型肝炎血漿製劑疫苗比安慰劑更有效地產生B型肝炎抗體。但是,在預防B型肝炎病毒的感染,B型肝炎血漿製劑疫苗和安慰劑並沒有顯著差異。沒有試驗比較合成疫苗和安慰劑的有效性。合成疫苗與血漿製劑疫苗以及強化免疫疫苗接種療程與常規三次合成疫苗接種療程產生B型肝炎抗體的情形並沒有統計學上顯著的差異。