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Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients

  1. Giovanni FM Strippoli1,*,
  2. Elisabeth M Hodson2,
  3. Cheryl A Jones3,
  4. Jonathan C Craig4

Editorial Group: Cochrane Renal Group

Published Online: 17 FEB 2010

Assessed as up-to-date: 9 NOV 2005

DOI: 10.1002/14651858.CD005133.pub2

Database Title

Additional Information

How to Cite

Strippoli GFM, Hodson EM, Jones CA, Craig JC. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005133. DOI: 10.1002/14651858.CD005133.pub2.

Author Information

  1. 1

    c) Diaverum Medical Scientific office, d) Mario Negri Sud Consortium, Italy, a) School of Public Health, University of Sydney, b) Cochrane Renal Group, Westmead, NSW, Australia

  2. 2

    School of Public Health, The University of Sydney, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia

  3. 3

    The University of Sydney, Discipline of Paediatrics and Child Health, Westmead, Sydney, NSW, Australia

  4. 4

    (b) School of Public Health, The University of Sydney, (a) Cochrane Renal Group, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia

*Giovanni FM Strippoli, a) School of Public Health, University of Sydney, b) Cochrane Renal Group, c) Diaverum Medical Scientific office, d) Mario Negri Sud Consortium, Italy, Locked Bag 4001, Westmead, NSW, 2145, Australia. Giovanni.Strippoli@diaverum.com. strippoli@negrisud.it.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 17 FEB 2010

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Abstract

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

Background

Cytomegalovirus (CMV) is a significant cause of morbidity and mortality in solid organ transplant recipients. Pre-emptive treatment with antiviral agents of patients with CMV viraemia has been widely adopted as an alternative to routine prophylaxis to prevent CMV disease.

Objectives

This review was conducted to evaluate the efficacy of pre-emptive treatment in preventing symptomatic CMV disease.

Search methods

The Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library Issue 2, 2005), MEDLINE (1966 to February 2005), EMBASE (1980 to February 2005) and reference lists and conference proceedings were searched.

Selection criteria

We included randomised controlled trials (RCTs) of pre-emptive treatment versus placebo, no treatment or antiviral prophylaxis in solid organ transplant recipients.

Data collection and analysis

Two authors assessed the quality and extracted all data. Analysis was with a random-effects model and results expressed as risk ratio (RR) and 95% confidence intervals (CI).

Main results

Ten eligible trials (476 patients) were identified, six of pre-emptive treatment versus placebo or treatment of CMV when disease occurred (standard care), three of pre-emptive treatment versus antiviral prophylaxis and one of oral versus intravenous pre-emptive treatment. Compared with placebo or standard care, pre-emptive treatment significantly reduced the risk of CMV disease (six trials, 288 patients: RR 0.29, 95% CI 0.11 to 0.80) but not acute rejection (three trials, 185 patient: RR 1.06, 95% CI 0.64 to 1.76) or all-cause mortality (two trials, 176 patients: RR 1.23, 95% CI 0.35 to 4.30). Comparative trials of pre-emptive therapy versus prophylaxis showed no significant difference in the risks of CMV disease, acute rejection or all-cause mortality.

Authors' conclusions

Few RCTs have evaluated the effects of pre-emptive therapy to prevent CMV disease. Pre-emptive therapy is effective compared with placebo or standard care, but additional head-to-head trials are required to determine the relative benefits and harms of pre-emptive therapy and prophylaxis to prevent CMV disease in solid organ transplant recipients.

 

Plain language summary

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

Pre-emptive treatment with antiviral agents reduces the risk of cytomegalovirus disease when compared to placebo or usual care

Cytomegalovirus (CMV) is the most common virus pathogen in solid organ transplant recipients (kidney, heart, liver, lung and pancreas) and is the major cause of morbidity and mortality during the first six months after transplantation. CMV disease is characterised by fever, leucopenia (very low white blood cells) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction. Two main strategies to prevent CMV disease have been adopted: prophylaxis of organ recipients with antiviral agents, or pre-emptive treatment of solid organ recipients, who develop evidence of CMV infection during routine screening. This review looked at the benefits and harms of pre-emptive treatment with antiviral agents in preventing CMV disease in solid organ transplant recipients. Ten trials (476 participants) were identified comparing pre-emptive treatment with placebo or usual care, pre-emptive treatment with antiviral prophylaxis and oral versus intravenous treatment. Compared with placebo or usual care, pre-emptive treatment significantly reduced the risk of CMV disease but not acute rejection or all-cause mortality. Pre-emptive therapy versus prophylaxis and oral versus intravenous pre-emptive treatment showed no significant difference in the risks of CMV disease or all-cause mortality. More trials comparing pre-emptive treatment with antiviral prophylaxis are needed.

 

摘要

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

背景

預防在有巨大細胞病毒血症之器官移植接受者發生巨大細胞病毒疾病的先行攻擊性療法

巨大細胞病毒 (CMV) 為器官移植接受者的重要罹病及死亡原因。利用抗病毒藥劑治療巨大細胞病毒血症 (CMV viremia) 患者的先行攻擊性療法已被視為預防巨大細胞病毒疾病 (CMV disease) 之常規預防療法的替代方案。

目標

此篇評論性文章之目的在於評估先行攻擊性療法預防症狀性巨大細胞病毒疾病的療效。

搜尋策略

搜尋Cochrane對照試驗登錄資料庫 (CENTRAL，Cochrane資料庫中2005年第2刊) 、MEDLINE (1966年 – 2005年二月) 、EMBASE (1980年 – 2005年二月) 、參考文獻列表、及研討會議程。

選擇標準

本試驗比較先行攻擊性療法與安慰劑、未以治療或以抗病毒藥物預防治療之所有隨機對照臨床試驗 (RCTs) 。

資料收集與分析

由2位作者進行品質與取得資料的評估，利用隨機效應模型進行分析，而以擁有95% 信賴區間 (CI) 的相對風險 (RR) 表示結果。

主要結論

10項合格的臨床試驗 (476位患者) 被確認並納入分析，其中6項臨床試驗為先行攻擊性療法對安慰劑、或當CMV疾病發生時之治療 (為標準治療組); 3項為先行攻擊性療法對抗病毒預防性療法; 1項為口服對靜脈注射先行攻擊性療法。相較於安慰劑或標準治療組，先行攻擊性療法可明顯降低巨大細胞病毒疾病的風險 (6項試驗，288位患者: 相對風險 0.29，95% 信賴區間 0.11 – 0.80) ，但無法減少急性排斥反應 (3項試驗，185位患者: 相對風險 1.06，95% 信賴區間，0.64 – 1.76) 或所有原因死亡 (2項試驗，176位患者: 相對風險1.23，95% 信賴區間 0.35 – 4.30) 。比較性臨床試驗結果試驗顯示在巨大細胞病毒疾病、急性排斥反應或所有原因死亡的風險方面，先行攻擊性療法與預防療法之間並無明顯差異。

作者結論

針對先行攻擊性療法預防巨大細胞病毒疾病進行評估的隨機對照臨床試驗很少。相較於安慰劑或標準治療組，先行攻擊性療法較有效; 但需要更多的直接對比試驗，以決定先行攻擊性療法及預防療法在預防器官移植接受者發生巨大細胞病毒 (CMV) 疾病的利與弊。

翻譯人

本摘要由馬偕醫院郭馨仁翻譯。

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

總結

相較於安慰劑或標準治療組，以抗病毒藥物做先行攻擊性治療，可以減少發生巨大細胞病毒 (CMV) 疾病的危險。巨大細胞病毒 (CMV) 為器官移植接受者 (包括腎、心、肝、肺和胰臟移植) 最重要致病病毒，也是移植後前六個月患者罹病和死亡最主要原因。巨大細胞病毒疾病的臨床表現，包括發燒、白血球減少症 (非常低的血中白血球數目) 和血小板減少症 (非常低的血中白血球數目) ，可伴隨有或沒有特殊器官功能失調。當在常規篩檢發現有巨大細胞病毒感染的證據時，臨床上主要有兩種方式來預防巨大細胞病毒疾病的發生，包括以抗病毒藥物做預防性治療或先行攻擊性治療。此篇文章就是在評估以先行攻擊性療法預防巨大細胞病毒疾病發生的利與弊。共有10個臨床試驗 (476位患者) 被確認並納入分析，比較先行攻擊性療法對安慰劑、或標準治療組以及比較先行攻擊性療法對預防性治療組; 以及口服藥物與靜脈注射藥物治療等差異。結果發現先行攻擊性療法比安慰劑、或標準治療組能有效地減少發生巨大細胞病毒疾病的危險；但卻無法減少發生急性排斥或所有原因死亡的危險。先行攻擊性療法對預防性治療組的比較以及口服藥物與靜脈注射藥物治療的比較，發生巨大細胞病毒疾病的危險或所有原因死亡的危險，各組間都沒有顯著的差異。然而，比較先行攻擊性療法對預防性治療的差異，仍有賴更多研究證實

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