Hepatitis B vaccination for patients with chronic renal failure
Editorial Group: Cochrane Hepato-Biliary Group
Published Online: 19 JUL 2004
Assessed as up-to-date: 23 MAY 2004
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 19 JUL 2004
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.
To determine the beneficial and harmful effects of hepatitis B vaccine and of a reinforced vaccination series in chronic renal failure patients.
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.
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).
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).
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
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.
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
作者搜尋The Cochrane HepatoBiliary 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。
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).
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)。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。