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Intervention Review

Voriconazole versus amphotericin B in cancer patients with neutropenia

  1. Karsten Juhl Jørgensen*,
  2. Peter C Gøtzsche,
  3. Helle Krogh Johansen

Editorial Group: Cochrane Gynaecological Cancer Group

Published Online: 25 JAN 2006

Assessed as up-to-date: 4 NOV 2007

DOI: 10.1002/14651858.CD004707.pub2


How to Cite

Jørgensen KJ, Gøtzsche PC, Johansen HK. Voriconazole versus amphotericin B in cancer patients with neutropenia. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004707. DOI: 10.1002/14651858.CD004707.pub2.

Author Information

  1. Rigshospitalet, Dept. 3343, The Nordic Cochrane Centre, Copenhagen Ø, Denmark

*Karsten Juhl Jørgensen, The Nordic Cochrane Centre, Rigshospitalet, Dept. 3343, Blegdamsvej 9, Copenhagen Ø, 2100, Denmark. kj@cochrane.dk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 25 JAN 2006

SEARCH

This is not the most recent version of the article. View current version (24 FEB 2014)

 

Abstract

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

Background

Opportunistic fungal infections are a major cause of morbidity and mortality in neutropenic cancer patients and antifungal therapy are used both empirically and therapeutically in these patients.

Objectives

To compare the benefits and harms of voriconazole with those of amphotericin B and fluconazole when used for prevention or treatment of invasive fungal infections in cancer patients with neutropenia.

Search methods

Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, MEDLINE (PubMed), (November 2007). Letters, abstracts and unpublished trials were accepted. Contact to trial authors and industry.

Selection criteria

Randomised clinical trials comparing voriconazole with amphotericin B or fluconazole.

Data collection and analysis

Data on mortality, invasive fungal infection, colonisation, use of additional (escape) antifungal therapy and adverse effects leading to discontinuation of therapy were extracted by two review authors independently.

Main results

Two trials were included. One trial compared voriconazole to liposomal amphotericin B as empirical treatment of fever of unknown origin (suspected fungal infections) in neutropenic cancer patients (849 patients, 58 deaths). The other trial compared voriconazole to amphotericin B deoxycholate in the treatment of confirmed and presumed invasive Aspergillus infections (391 patients, 98 deaths). In the first trial, voriconazole was significantly inferior to liposomal amphotericin B according to the trial authors' prespecified criteria. More patients died in the voriconazole group and a claimed significant reduction in the number of breakthrough fungal infections disappeared when patients arbitrarily excluded from analysis by the trial authors were included. In the second trial, the deoxycholate preparation of amphotericin B was used without any indication of the use of premedication and substitution with electrolytes and salt water to avoid handicapping this drug. This choice of comparator resulted in a marked difference in the duration of treatment on trial drugs (77 days with voriconazole versus 10 days with amphotericin B), and precludes meaningful comparisons of the benefits and harms of the two drugs.

Authors' conclusions

Liposomal amphotericin B is significantly more effective than voriconazole for empirical therapy of neutropenic cancer patients and should be preferred. For treatment of aspergillosis, there are no trials that have compared voriconazole with amphotericin B given under optimal conditions.

 

Plain language summary

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

Prevention and treatment of fungal infections in cancer patients with voriconazole.

Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given to prevent fungal infections in such patients, or when they have an infection. This review found that voriconazole was inferior to liposomal amphotericin B for treatment of suspected fungal infections. We also found that voriconazole has not been compared with amphotericin B given under optimal conditions for the treatment of invasive aspergillosis.

 

摘要

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

背景

Voriconazol與amphotericin B在嗜中性白血球減少的癌症患者使用上的比較

伺機性黴菌感染是造成嗜中性白血球減少的癌症患者發病及死亡的一種主要原因. 在這些病患身上的抗黴菌治療通常是根據經驗療法及治療準則.

目標

比較voriconazol及amphotericine及fluconazole在用來預防或治療嗜中性白血球減少的癌症患者得到侵入性黴菌感染的好處及傷害.

搜尋策略

MEDLINE及the Cochrane Library (2005年五月). 通訊,摘要及尚未發表的試驗均包括在內. 與作者及企業取得聯繫.

選擇標準

比較voriconazole和amphotericin B或fluconazole的隨機化試驗.

資料收集與分析

由兩位作者分別摘錄有關致死率,侵入性黴菌感染,菌落生成情形,使用附加的(例外的)抗黴菌治療及造成治療終止的副作用的資料.

主要結論

澳有兩個試驗被納入. 第一個試驗比較voriconazole及liposomal amphotericine B在嗜中性白血球減少的癌症患者(849個病人,58個死亡)不明熱(疑似黴菌感染)的成效. 另一個試驗則比較voriconazole及amphotericin B deoxycholate治療確診及推測為侵入性Aspergillus感染(391個病人,98個死亡)的結果. 在第一個試驗中,根據作者先前已定義的標準來看, voriconazole明顯地比liposomal amphotericin B效果來的差. 當把原先被作者武斷地排除在分析外的病人重新納入分析後,使用voriconazole的組別中,會有更多的死亡個案,同時,之前看到的突破性的黴菌感染個案有意義地減少的現象則消失了. 在第二個試驗中,在使用deoxycholate amphotericin B之前並沒有先說明如何給予先驅藥物及補充電解質和食鹽水,來避免因該藥物副作用而停止治療. 在這種情況下,因為這兩種試驗藥物能夠使用的治療時間有很大的差別 (voriconazole可以用77天,而amphotericin B只用了10天),以致對這兩種藥物的好處和危害其實無法做有意義地比較.

作者結論

依經驗療法, Liposomal amphotericin B治療嗜中性白血球減少的癌症患者明顯地比voriconazole來的有效,且應該被優先使用. 對於治療aspergillosis,並沒有適當的條件下的試驗可比較voriconazole及amphotericin B的優劣.

翻譯人

本摘要由臺灣大學附設醫院黃婉儀翻譯。

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

總結

用voriconazole作為預防及治療癌症病患身上的黴菌感染 接受化學治療或骨隨移植的癌症病患得到黴菌感染的風險比較高. 這樣的感染可以是致命性的. 因此,這些病患常得使用抗黴菌感染藥物來預防或治療黴菌感染. 這篇回朔分析發現voriconazole在治療這樣的黴菌感染上比liposomal amphotericin B來的差. 我們同時也發現在治療侵入性的aspergillosis上,並沒有足夠的條件來比較voriconazole及amphotericin B.