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Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

  • Review
  • Intervention

Authors


Abstract

Background

Fever occurring in a neutropenic patient remains a common life-threatening complication of cancer chemotherapy. The common practice is to admit the patient to hospital and treat empirically with intravenous broad-spectrum antibiotics. Oral therapy could be an alternative approach for selected patients.

Objectives

To compare the efficacy of oral antibiotics versus intravenous (IV) antibiotic therapy in febrile neutropenic cancer patients.

Search methods

The Cochrane Central Register of Controlled Trials (CENTRAL), (September 2007) on the Cochrane Library (Issue 2, 2007), MEDLINE (1966 to 2007), EMBASE (1980 to 2007) and LILACS (1982 to 2007). We searched several databases for ongoing trials. We checked the conference proceedings of the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) 1995 to 2007 and all references of included studies and major reviews were scanned.

Selection criteria

RCTs comparing oral antibiotic/s to intravenous antibiotic/s for the treatment of neutropenic cancer patients with fever. The comparison between the two could be started initially (initial oral), or following an initial course of intravenous antibiotic treatment (sequential).

Data collection and analysis

Two reviewer authors independently assessed trial eligibility, methodological quality and extracted data. Data concerning mortality, treatment failures and adverse events were extracted from included studies assuming an "intention-to-treat" basis for the outcome measures whenever possible. Relative risks (RR) with 95% CIs (CI) for dichotomous data were estimated.

Main results

Eighteen trials were included in the analyses. The mortality rate was similar comparing oral to intravenous antibiotic treatment (RR 0.95, 95% CI 0.54 to 1.68, 9 trials, 1392 patients, median mortality 0, range 0 to 8.8%). Treatment failure rates were also similar (RR 0.95, 95% CI 0.85 to 1.07, all trials). No significant heterogeneity was shown for all comparisons but adverse events. This effect was stable in a wide range of patients. Quinolones alone or combined with another antibiotics were used with comparable results. Adverse reactions, mostly gastrointestinal were more common with oral antibiotics.

Authors' conclusions

Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, not having pneumonia, infection of a central line or a severe soft-tissue infection. The wide CI for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

摘要

背景

以口服與靜脈注射劑型的抗生素治療癌症病人的嗜中性白血球低下引起的發燒(Febrile Neutropenia)症狀

嗜中性白血球低下引起的發燒症狀一直是癌症化學治療中,會危及生命的常見併發症,常用的處理方法就是請病人到醫院,並憑經驗地為病人靜脈注射廣效性的抗生素,而口服劑型的抗生素可用在一些特定病人作為替代治療方案。

目標

比較口服及靜脈注射劑型的抗生素治療癌症病人的嗜中性白血球低下引起發燒症狀的療效。

搜尋策略

我們搜尋了Cochrane Central Register of Controlled Trials (CENTRAL), (2007年9月) 位於Cochrane Library (Issue 2, 2007), MEDLINE (1966年到2007 年),EMBASE (1980 年到2007年) 和 LILACS (1982年到2007年)等資料庫。 我們搜尋數份正在持續進行試驗的數據,我們查詢Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC)會議的公報,從1995年到2007年,以及檢索包含試驗的所有參考資料及主要的回顧性文獻。

選擇標準

我們只收納以「口服」比較「靜脈注射」劑型的抗生素治療中性白血球低下引起的發燒症狀之隨機對照試驗。可能先開始使用其中一種劑型(先用口服的),或者於緊接著靜脈注射抗生素治療的療程(按照順序) 。

資料收集與分析

由兩位作者獨立進行評估試驗的合格性及試驗方法的品質,和數據摘錄,對任何可能時間的結果測量,從假設以�意向治療(intentiontotreat)�為標準的已收錄試驗中取得數據,包含死亡率、治療的失敗率和不良反應,預測RR和95%CI等二元化資料(dichotomous data) 。

主要結論

本分析總共收納了18份文獻,比較口服及靜脈注射劑型的抗生素療法的死亡率,結果顯示這2種劑型有類似的死亡率(RR 0.95, 95% CI 0.54 to 1.68,9 項試驗共1,392位病人,中位數的死亡率是0 ,範圍從0 到8.8%);2種劑型也是具有相同的治療失敗率。(RR 0.95, 95% CI 0.54 to 1.68, 9 trials, 1392 patients, median mortality 0, range 0 to 8.8%). 在所有比較性文獻中也顯示:除了不良反應之外,這2種劑型的表現是沒有顯著異質性。對大多數的病人而言,觀察結果是一致的。單一使用Quinolones或併用其它抗生素有可類比的結果。口服抗生素的較多不良反應為腸胃道反應。

作者結論

基於目前的數據,對於嗜中性白血球低下引起發燒的癌症病人(不包括急性白血病患者)而言,當病人具有穩定的心血管功能,及沒有器官衰竭現象,也沒有肺炎、中央靜脈管感染及嚴重的軟組織感染時,口服比起靜脈注射劑型是一個較令人可接受的治療替代方案。廣泛CI的死亡率允許,對預期有低死亡風險的病人使用口服劑型,因此未來的研究應致力於釐清低風險病人的界定範圍。

翻譯人

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

總結

口服劑型的抗生素是一個較令人可接受的替代方案,用來治療低併發症風險的癌症病人出現,嗜中性白血球低下引起的發燒症狀。 嗜中性白血球低下(白血球數目低下)是癌症化療的併發症之一,這會使得病人暴露於有致命風險的感染中,目前臨床對嗜中性白血球低下的發燒病人是住院及以靜脈注射劑型的抗生素作為處置方法。嗜中性白血球低下引起的發燒屬嚴重疾病的範圍,而低風險病人可以不需太被積極治療的。 這份隨機對照試驗的回顧文獻中,顯示對患有實體癌症、慢性白血病或淋巴癌的低風險病人、無關年紀、感染源和嗜中性白血球低下程度,比較口服及靜脈注射劑型的抗生素對死亡和衰竭的比率。

Plain language summary

Oral antibiotics are an acceptable alternative to intravenous antibiotics for treating febrile neutropenia in cancer patients at low risk for complications

Neutropenia (low white blood count) is a complication of cancer chemotherapy exposing patients to life-threatening infections. Current practice for neutropenic patients with fever is hospital admission and treatment with intravenous antibiotics. Febrile neutropenia encompasses a spectrum of disease severity and low risk patients may be treated less aggressively. This review of randomised controlled trials (RCTs) showed comparable death and failure rates for oral and intravenous antibiotics for low risk patients, with solid tumours, chronic leukaemia or lymphoma, independent of age, source of infection and severity of the neutropenia.

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